cyrilzakka/clinical-trials huggingface dataset:
Is Short Antibiotherapy Duration After Drainage Suitable for Patients Admitted in Intensive Care Medicine With a Severe Acute Cholangitis?

Acute cholangitis (AC) occurs when biliary stenosis, due to various benign causes (often gallstones) or the presence of a tumour, leads to cholestasis and biliary infection. AC is a life-threatening infection if not diagnosed and treated in time, its mortality ranges from 1.4% to 5.2%. AC can be classified into different stages of severity depending on organ failure. A severity classification has been proposed by the Asian recommendations of Tokyo 2013: Grade I (Benin), Grade II (Moderate) and Grade III (Severe).

AC treatment includes endoscopic or percutaneous bile drainage in combination with systemic antibiotic treatment. It is currently recommended that patients with severe CA (Grade III) have biliary drainage within 24 hours, although it has not been shown to improve their survival. The emergence of antibiotic-resistant germs, which is a public health issue, calls for reasonable and considered use of antibiotics. Reducing the duration of antibiotic therapy is a fundamental measure of antimicrobial management and antibiotics sparing. 7 to 10 days of antibiotic treatment is common in the treatment of CA. A 14-day treatment is recommended in case of associated bacteremia. A recent study of 263 patients showed that reducing the duration of antibiotic therapy to less than 7 days in patients with CA associated with bacteremia with effective drainage does not increase the risk of recurrence or mortality at 30 days. However, this study was monocentric retrospective and compared groups that were unbalanced in terms of CA severity. The optimal duration of antibiotic therapy in the treatment of CA in critically ill patients hospitalized in intensive care remains poorly known.

The main purpose of this study is to compare short antibiotic therapy with long antibiotic therapy in terms of mortality in patients with AC admitted in intensive care unit (ICU).

Using electronic patient data monitoring systems, the investigators reviewed all patients with a diagnosis of AC admitted to digestive liver disease unity or ICUs at the Nantes University Hospital, Rennes University Hospital from January 1, 2006, to december 31, 2018. For enrolled patients, general clinical characteristics were collected. Patients were categorized into two groups according to antibiotics duration, and the differences of these characteristics between two groups were evaluated.

Eligibility Criteria:
Inclusion Criteria:

Adult patients (age \>18 years) with acute cholangitis Admitted in Intensive care units With a successful biliary drainage And treated with antibiotics

Exclusion Criteria:

patients under 18 years unable to receive a drainage or inefficient drainage Patients with a decision to limit care at the admission pregnancy
Comparison of McCoy Laryngoscope and C-MAC D-blade Video Laryngoscope in Obese Patients

Obesity is associated with difficult intubation rate of 30%, and this study was performed to compare the use of McCoy laryngoscope and C-MAC D-blade video laryngoscope for intubation in obese patients. A total 104 patients with body mass index (BMI) ≥ 35kg/m² scheduled for general anesthesia were randomly assigned to be intubated with McCoy laryngoscope or C-MAC D-blade video laryngoscope. The primary outcome was intubation time, and secondary outcomes were mask ventilation scale, intubation difficulty scale (IDS), percentage of glottis opening (POGO) score, and hemodynamic variables including mean arterial pressure, heart rate and saturation.


Eligibility Criteria:
Inclusion Criteria:

* American society of anesthesiologists physical status of I-II patients with BMI ≥ 35 kg/m² scheduled for general anesthesia

Exclusion Criteria:

* patients with tracheal diseases, sore throat, neck pain and loose tooth.
Promoting HPV Vaccine Through Twitter

This study assessed the feasibility of implementing a one-month Twitter campaign to promote knowledge about the human papillomavirus (HPV) vaccine among low-income women living in public housing.

Investigators recruited a convenience sample (n=35) of women ages 18-26 years who resided in public housing in Massachusetts. Investigators assessed the feasibility and acceptability of the campaign. Online assessed changes in HPV knowledge, attitudes, and vaccine intentions before and after the campaign.

Eligibility Criteria:
Inclusion Criteria:

English-speaking women Age18-26 years Residents of public housing in two Massachusetts cities
he Effect of Care and the Use of Virtual Reality Glasses on Pain and Comfort

The research will be conducted to determine the effect of comfort theory-based care and virtual reality glasses on pain and comfort levels in women who have given birth to primiparous babies. The hypotheses of the study are:

H0: Comfort theory-based care and the use of virtual reality glasses have no effect on pain and comfort in the postpartum period.

H1-1: Comfort theory-based care has an effect on pain level in the postpartum period.

H1-2: Comfort theory-based care has an effect on comfort in the postpartum period.

H2-1: The use of virtual reality glasses in the postpartum period has an effect on the level of pain.

H2-2: The use of virtual reality glasses in the postpartum period has an effect on comfort.

Although pregnancy and birth are normal processes, the type of birth affects the comfort level, quality of life, and pain in the natal and postnatal period. In our country, as in many other countries, cesarean delivery rates are quite high.Pain in cesarean births is more severe and lasts longer than in vaginal birth. Along with many methods to reduce pain, the effectiveness of virtual reality applications is also emphasized theoretically or conceptually.In the planned randomized controlled study, the pain level and comfort of individuals will be measured by applying virtual reality glasses to one of the experimental groups and giving Kolcaba's Comfort Theory-based care to the other. Personal Information Form, Postpartum Comfort Scale, Visual Analogue Scale (VAS) and Virtual Reality Glasses Form will be used as measurement tools.This study aims to reduce the pain of the mother in the short term and enable the mother to participate in self-care and baby care in a shorter period of time, and in the long term to minimize maternal and newborn deaths and eliminate deaths under the age of 5.Increasing maternal comfort during the postpartum period is expected to have a direct impact on maintaining maternal health and indirectly on baby care.

Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in research
* Having given birth with epidural anesthesia
* Being between the ages of 18-35
* Having given birth within 37-41 weeks of pregnancy
* Having a primiparous cesarean birth

Exclusion Criteria:

* Having a normal birth
* Having given birth with general anesthesia
* Having a disability that limits vision, hearing or communication
* Having a systemic disease, hypertension, preeclampsia or uterine atony and risk of bleeding
Modified Transplantation Regimen and AGVHD Prophylaxis for Severe Aplastic Anemia in the Setting of Allogeneic Hematopoietic Stem Cell Transplantation

We retrospectively evaluted the safety and efficacy of the modified transplantation conditioning and aGVHD prophylaxis in severe aplastic anemia in two clinical center.

Aplastic anemia (AA) is a group of myelo-hemopoietic failure syndromes caused by a variety of etiologies. If not intervened, the average expected survival time is less than half a year.Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is one of the possible cures for this disease. The success rate of treatment for this disease can be further improved under the previous regimen system. The survival rate reported in the literature is 60%-90%. From Jun. 2020 to Jun 2023, 52 patients in two transplantation center received this modified transplantation system, we designed this clinical trial to retrospectively evaluted the safety and efficacy of the modified transplantation conditioning and aGVHD prophylaxis in severe aplastic anemia in these two clinical center.

Eligibility Criteria:
Inclusion Criteria:1.Patients who were diagnosed with severe aplastic anemia by NCCN guidelines, and has received HSCT with this transplantation preconditioning and aGVHD prophylaxis regimen; 2.Age 3-65 years old; 3.Weight 10Kg-100Kg; 4.Eastern Cooperative Oncology Group (ECOG) score ≤3; 5.No major organ injury (ECG ejection fraction \>45%; bilirubin \< 2 times the upper limit of normal value; AST and ALT \< 3 times the upper limit of normal value; serum creatinine \< 2 times the upper limit of normal value); 6.No severe infection; 7.Subjects voluntarily participated in this clinical trial and signed the informed consent.

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Exclusion Criteria:1.patients with other hematologic diseases who are not eligible for transplantation or who do not wish to receive transplantation; 2.patients with an expected survival of less than 1 month; 3.patients with previous autologous or allogeneic hematopoietic stem cell transplantation; 4.pregnant patients; 5.patients with severe mental or neurological disorders that would affect the ability to provide informed consent and/or to report or observe adverse events; 6.other conditions that the investigator determines to be inappropriate for enrollment.

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Effect of Storage Condition on CD47 Expression Level in Platelet Concentrate

Effect of storage condition on CD47 expression level in platelet concentrate

CD47 is a cell surface glycoprotein expressed on all cell types .It is an attractive target for therapy because it is involved in regulation of cell survival and cell death by acting as a ligand for signal-regulatory protein alpha expressed on macrophages

Eligibility Criteria:
Inclusion Criteria:

* donors met AABB criteria

Exclusion Criteria:

* donors not met AABB criteria
Efficacy of Myo-inositol in Preventing Gestational Diabetes in High-risk Pregnant Women

The aim of this study is to evaluate the efficacy of myo-inositol in preventing gestational diabetes in high risk pregnant women.


Eligibility Criteria:
Inclusion Criteria:

60 women in their first trimester of pregnancy affected by one or more of the following risk factors:

* Glycemia levels \> 92 mg/dl
* BMI \> 30
* At least a parent or a brother (or sister)affected by diabetes
* Pre-existing pregnancy with gestational diabetes

Exclusion Criteria:

* Pregnant women affected by pregestational diabetes
* Twin pregnancy
* Patients affected by pre-existing diseases in pregnancy (diabetes excluded)
* Patients affected by chronic disorders
Sexual Dysfunction and the Quality of Sexual Life in Patients With Colorectal Cancer and Their Partners.

In this project the main focus is on assessing sexual functioning and the quality of sexual life after the treatment of colorectal cancer in patients and their partners.

Patients and their partners complete questionnaires concerning sexual functioning, quality of life, body image, fatigue, anxiety, depressive symptoms, personality factors, and demographic factors. Questionnaires are completed before surgical treatment, 6 weeks, 3 months, 6 months, and 12 months after diagnosis.

The results of this prospective study will give insight in 1) the incidence of sexual problems and the extent patients with colorectal cancer and their partners are bothered by these problems across time, 2) the effect of different treatment modalities on sexual functioning, 3) the relation between sexual problems and quality of life, 4) the determinants of sexual problems and the quality of sexual life adopting the biopsychosocial approach of patients with colorectal cancer who have been treated with surgery, radiation and/or chemotherapy, and more specifically to the role of personality and patient factors and sexual functioning/the quality of sexual life.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are diagnosed with colorectal cancer in one of the participating centra, and their partners are asked to participate in this study prior to treatment.
* Patients have to be between 18 and 75 years old.

Exclusion Criteria:

* Disease recurrence at baseline or metastases.
* Poor expression of the Dutch language.
* Dementia.
* History of psychiatric illness.
Pertussis Vaccination in Pregnant Women

Brief Summary: The study compares four models of pertussis vaccination dispensation to pregnant women on the vaccine coverage obtained. In addition, the cost of the different models of vaccination will be evaluated.

This is a quasi-experimental study with a non-equivalent control group in pregnant women, taking place in 4 regions of Québec (Montréal, Montérégie, Capitale-Nationale, Mauricie). Four models of vaccine dispensation will be evaluated: one university hospital around gestational diabetes screening, local health and social services centres (CSLC) and a high volume clinic. 250 participants will be recruited in each of the four types of centres.

In addition, the study will also evaluate the costs incurred by all those involved in the pertussis vaccination program for pregnant women as well as the cost per woman vaccinated.

Health Professionals:

15 to 20 health professionals involved in providing immunization services to pregnant women: obsterician-gynaecologists, family doctors and nurses in participating clinics will be interviewed to evaluate their knowledge, attitudes and professional practises regarding pertussis vaccination during pregnancy.

Evaluating the Cost:

A detailed costing approach (micro-costing) will be used. Time and movement will be studied by direct observation using a grid on an electronic file in each of the 5 environments studied in order to identify the services and activities carried out as well as to determine the resources involved in the implementation of these services and activities. Three typical vaccination days will be chosen to make these observations, in each of the four study environments.

The main activities observed will be related to preparations for vaccination up to the vaccination itself (informed consent, injection, etc.), the capture of vaccination data the management of vaccines and equipment, clinical manifestations, etc. If necessary, the people observed can be interviewed directly to better understand the activities or services provided. Otherwise, some questions may be included in the interviews described above.

The major cost categories that will be evaluated for each of the delivery modalities are human resources and supplies. The cost components listed are: nursing time (immunization / training), coordination time, support staff time, office supplies, vaccine storage equipment, vaccine transportation equipment, vaccine transportation, health and safety equipment, emergency, single-use vaccination equipment and others.

With regard to the costs borne by women, the main categories of variables evaluated will be: the time spent making appointments and attending vaccination appointments, working time lost, if any, transportation, childcare and other expenses

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women at least 18 years old who speak English or French
* Signed Informed Consent

Exclusion Criteria:

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Evaluation of Reliability of CarieScan PRO Compared With Digital Radiograph and ICDAS-II in Detection of Carious Lesions

The aim of this study is to evaluate the Clinical performance of alternating current impedance spectroscopy (CarieScan PRO) in comparison with digital radiograph and ICDAS-II in detection of occlusal carious lesions.

The visual examination is routinely used for detecting caries in dental clinics and was also used in recent studies comparing the efficacy of various visual aids. It has the benefit that it is quick and easy to perform, does not need expensive equipment, and can be completed without unnecessary radiation or fluorescence (Ismail, et al., 2007). In the current study, ICDAS-II was set as "gold standard" due to validated relationship between its codes and the histological depth of a carious lesion as in many other studies. In addition, several studies have shown good reproducibility and accuracy of ICDAS-II for caries detection in permanent teeth especially caries lesions in the outer half of the enamel (Gugnani, et al., 2010). Bitewing radiographs are used to determine the depth of caries involvement. Most often, bitewing examination is affiliated with the diagnosis of interproximal caries. It is strongly recommended that these radiographs be used in the diagnosis of occlusal caries into dentin (Pitts NB et al., 1991).

Eligibility Criteria:
Inclusion Criteria of teeth:

* Posterior teeth with dark shadow on occlusal surface.
* Vital upper or lower posterior teeth with no signs of irreversible pulpitis.
* Intact contact with opposing teeth.
* Teeth with no previous restorations in other surfaces.

Exclusion criteria of the teeth:

* Periapical pathology or signs of pulpal pathology.
* Tooth hypersensitivity.
* Possible prosthodontic restoration of teeth.
* Heavy occlusion and occlusal contacts or history of bruxism.
* Severe periodontal affection.
A Clinical Trial of Vorinostat (MK0683, SAHA) in Combination With FDA Approved Cancer Drugs in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)(0683-056)

This Phase III clinical trial which incorporates an initial Phase II component will determine the survival of advanced Non-small cell lung cancer patients when treated with MK0683 and paclitaxel plus carboplatin


Eligibility Criteria:
Inclusion Criteria:

* Males and females at least 18 years of age who have confirmed diagnosis of Non-small Cell Lung Cancer
* Patients with no systemic prior systemic treatment for lung cancer except patients at least 12 months from prior adjuvant therapy
* Adequate bone marrow,kidney and liver function
* Must be recovered and at least 4 weeks from major surgery or radiation
* ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1
* Men and women must agree to use birth control during the study
* Women able to have children must have a negative pregnancy test 14 days before study enrollment

Exclusion Criteria:

* Patients with prior treatment with other investigational agents less than 4 weeks before study enrollment
* Pregnant or nursing female patients
* Patients who are HIV positive
* Patients who have Hepatitis A, B, or C
* Patients unable to take study medication by mouth
* Patients with untreated brain cancer
* Patient eligible for treatment with bevacizumab and for whom bevacizumab is available
iOCT for Patients With Diabetic Macular Edema

Patients will be examined before and after surgery with a stand-alone OCT and intraoperative microscope integrated OCT

48 patients with and 48 patients without diabetic macular edema will be recruited for the study. Macular thickness measured with a stand-alone OCT and an intraoperative OCT will be assessed before and after phakoemulsification with intraocular lens Implantation.

Eligibility Criteria:
Inclusion Criteria:

* Cataract with the indication for surgery (visual symptoms) for both groups (study and control group)
* Diabetic macula edema - for the study group
* Age 21 and older
* written informed consent prior to surgery

Exclusion Criteria:

* Any relevant corneal disease
* In case of pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)
RATE Registry - Registry of Atrial Tachyarrhythmia/Atrial Fibrillation (AT/AF) Episodes in the Cardiac Rhythm Management (CRM) Device Population

The purpose of this registry is to produce a prospective, outcome-oriented registry to document the prevalence of AT/AF in the CRM population by using the Advanced AT/AF Diagnostics in select SJM devices.


Eligibility Criteria:
Inclusion Criteria:

* Patient is implanted with a CRM device
* Patient has no documented history of AF (3 months prior to enrollment)
* Patient is \>18 years of age
* Patient has life expectancy of \>24 months
The Role of Myocardial Fibrosis in Patients With Aortic Stenosis

Aortic stenosis is the most common adult valvular heart disease in the western world. Heart failure and sudden cardiac death are complications associated with aortic stenosis. In symptomatic individuals, valve replacement is often the only effective treatment. However, there are no good markers to identify patients who may benefit from early surgery before symptoms developed. The purpose of the study is to test the hypothesis that the presence heart muscle scarring on the cardiac magnetic resonance imaging may predict a worse outcome in patients with aortic stenosis, and thus may be helpful in identifying patients for early valve replacement.

Congestive heart failure and sudden cardiac death are associated complications of aortic stenosis. Currently, the indications for valvular replacement are based on the valvular severity evaluated by echocardiography and the presence of symptoms. There is some evidence to suggest the presence of myocardial fibrosis is associated with a poor outcome in patients with aortic stenosis. The aim of this prospective study is to investigate the prognostic implications of myocardial fibrosis in patients with aortic stenosis. The presence of myocardial fibrosis will be identified by delayed enhancement with the cardiac magnetic resonance imaging at 3T. We will also be evaluating the application of T1 mapping techniques to detect diffuse myocardial fibrosis.

Eligibility Criteria:
Inclusion Criteria:

* Patients with aortic stenosis
* Willing to undergo all investigations

Exclusion Criteria:

* Coexisting mitral valvular heart disease and aortic regurgitation (more than moderate severity)
* Active medical conditions: ongoing heart failure, infection
* Significant comorbidities: advanced malignancy with limited life expectancy
* Unable to give informed consent
* Contraindication for cardiac magnetic resonance imaging: impaired renal function, pacemaker, claustrophobia
Patients With Behavioural Symptoms and Hospitalized in Cognitive and Behavioural Units

Cognitive and behavioral units (CBUs) have been created between 2008 and 2012 French National Alzheimer plan for the management of behavior problems of patients suffering from Alzheimer's disease or other related disorders and necessitating hospitalisation. This Alzheimer plan is promoting the evaluation of these units through the observation of the behavioral and psychological symptoms of dementia (BPSD) evolution. As these units are new, it appears important to assess their long-term impact on patients care.

EXPECTED RESULTS The present study should allow to better understand the long-term impact of CBU on care of patients with Alzheimer disease and BPSD. Moreover, it should allow to identify patients improved by CBU.

Eligibility Criteria:
Inclusion Criteria:

* patient hospitalized on CBUs
* patient with the diagnostic criteria for disease related to dementia stage with a Clinical Demential Rating ≥ 1
* patient with a caregiver who is fairly frequent contact with the patient in order to observe the appearance of behavior changes

Exclusion Criteria:

* Patient living alone at home
* Patient with risk of death within one year