cyrilzakka/clinical-trials huggingface dataset:
The ANCA Vasculitis Questionnaire (AAV-PRO©)

The aim of this project is to develop a disease specific patient reported outcome measure (PROM) for patients with AAV (the AAV-PRO). Investigators are developing and validating a questionnaire to assess quality of life in patients with ANCA-associated vasculitis (AAV). Patients with AAV have inflammation in the small blood vessels leading to involvement of a range of organs and can suffer from ongoing disease activity or treatment side effects. Quality of life can be measured by patient reported outcome measures (PROMs).

Patients with ANCA-associated vasculitis have inflammation in the small vessels that impact a range of organs and Investigators understand that patients may suffer ongoing disease activity, as well as side effects from the treatments. Assessing patients quality of life can be an important tool for conducting clinical trials for new treatments and medications.

Quality of life can be measured by questionnaires called "patient reported outcome measures" (PROM). What is a patient-reported outcome? Patient-reported outcomes, or PROs, are patients' feedback on what they are feeling or what they are able to do as participants are dealing with a chronic disease . Patient-reported outcomes are important because they provide doctors and researchers information about patients' quality of life. Questionnaires can be designed to measure specific PROs that are of specific importance to a disease and can provide much needed information on evaluating the effectiveness of health care. The aim of this survey is to develop a disease specific patient reported outcome measure, or PROM, for patients with AAV.

A small group of Investigators and Patient-Partners developed this survey for people with ANCA-associated vasculitis (the AAV-PRO). Investigators will invite patients with AAV to complete the questionnaire they have designed, called the AAV-PRO. By analysing how people fill in the questionnaire, Investigators will be able to find out how well the questions work, and whether they need to ask all of them.

Eligibility Criteria:
Inclusion Criteria:

* Registered in the Vasculitis Patient-Powered Research Network (V-PPRN)
* Patients greater than 18 years of age
* Diagnosis of ANCA-associated vasculitis including: Eosinophilic Granulomatosis with Polyangiitis (also called Churg-Strauss Syndrome), Granulomatosis with Polyangiitis (also called Wegener's granulomatosis or GPA), Microscopic Polyangiitis (MPA)
The Effect of Avocado Consumption on Vascular Health

The study will investigate the effect of avocado consumption on markers of vascular health. Sixty participants will be enrolled in the 6-week study. A randomized parallel design will be utilized. Participants will either receive a typical American diet, or a modified typical American diet in which avocado is substituted for foods that contain moderate and high amounts of saturated fat, to allow the isoenergetic inclusion of avocado.


Eligibility Criteria:
Inclusion Criteria:

* BMI between 25 and 42 kg/m2
* Age 28 to 70 years during the intervention
* Fasting glucose ≤ 126 mg/dl
* Blood pressure ≤ 160/100 mm Hg

Exclusion Criteria:

* Presence of kidney disease, liver disease, gout, certain cancers, thyroid disease, gastrointestinal, other metabolic diseases, or malabsorption syndromes
* Women who have given birth during the previous 12 months
* Pregnant women or women who plan to become pregnant or become pregnant during the study
* Lactating women
* Type 2 diabetes requiring the use of oral antidiabetic agents or insulin
* History of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets)
* Volunteers who routinely participate in "heavy" exercise or volunteers who initiate an exercise program during the study.
* Volunteers who have lost 10% of body weight within the last 12 months
* Use of prescription or over-the-counter antiobesity medications or supplements (e.g., phenylpropanalamine, ephedrine, caffeine, during and for at least 6 months prior to the start of the study) or history of a surgical intervention for obesity
* Active cardiovascular disease (such as heart attack or procedure within the past three months or participation in a cardiac rehabilitation program within last three months, stroke or history/treatment for transient ischemic attacks in the past three months, or documented history of pulmonary embolus in past six months)
* Smokers or other tobacco users (during the 6 months prior to the start of the study)
* Unable or unwilling to give informed consent or communicate with study staff
* Self-report of alcohol or substance abuse within the past twelve months and/or current acute treatment or rehabilitation program for these problems (Long-term participation in Alcoholics Anonymous is not an exclusion.)
* Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol.
Local Collagen-Gentamicin and Extra Fixation of the Sternum for Prevention of Sternal Wound Infection in Cardiac Surgery

The aim of the present study is to evaluate a new technique for prevention of sternal wound infection consisting of local application of collagen-gentamicin in addition to routine i.v. antibiotic prophylaxis.

The technique has been evaluated in a previous randomised study. The aim of the present study is to evaluate the technique after it has been introduced in clinical practise to monitor the bacterial antibiotic susceptibility and to verify that the suggested reduction in sternal wound infection still exits.

A new technique for prevention of sternal wound infections after cardiac surgery is studied. Local application directly in the surgical wound of aminoglycoside antibiotics (gentamicin) bound to collagen reduced the incidence of wound infection with more than 50 % in a previous prospective randomised trial.

As the technique has been introduced in clinical practise two questions need to be monitored:

* Are there signs of change in the bacteria that cause the wound infections with a shift over time towards more gentamicin resistant agents?
* Is the effect of the prophylaxis still comparable to that which was seen in the previous study?

Furthermore, results from the previous study indicated that the effect of the local antibiotic was better when combined with an extra rigid sternal wound infection, defined as at least one extra steel wire for sternal fixation.

The study is conducted at those two Swedish cardiothoracic surgery centers where it was first studied. There are thus two objectives of the study: first to analyze the microbiologic findings of the sternal wound infections that occur, and secondly to monitor the incidence of sternal wound infection (especially deep infections) when the local collagen-gentamicin prophylaxis is used in daily routine in combination with a specific surgical technique for optimization of the strength of sternal fixation.

Eligibility Criteria:
Inclusion Criteria:

* All consecutive cardiac surgery patients operated via median sternotomy

Exclusion Criteria:

* Existing inclusion of the patient in another study of treatment aimed at reducing postoperative SWI.
* Known allergy or other contraindication to gentamicin or bovine collagen.
* Pregnancy or breast feeding
* Treatment with aminoglycosides during the last week
Protective Effect of Phenytoin on Glaucoma

since glaucoma is considered an optic neuropathy, new treatments for glaucoma are being continuously investigated, including neuroprotection.

Previous studies implied that phenytoin, a potent anti-convulsive drug, has a neuroprotective role, and Na+ channels blockage was suggested as a possible mechanism.

This study predicts that glaucoma patients taking Phenytoin will have a less advanced glaucoma as compared to patients not taking the drug. Glaucoma severity will be determined by visual acuity, visual fields, optic disc cupping and nerve fiber layer thickness

The study will examine adult patients who suffer from glaucoma and epileptic disorders on the same time. the study group will include glaucoma patients, being treated with oral Phenytoin for their epileptic disorder. The study group will be compared to 2 control groups:

* Glaucoma patients with epileptic disorder,receiving different medication than Phenytoin
* Glaucoma patients with no epileptic disorder.

  4 parameters will be evaluated for all groups:
  1. Best corrected visual acuity
  2. Optic disc cupping
  3. visual fields and general perimetric indices
  4. peripapillary retinal nerve fiber layer.

Every participant in the study,after giving his informed consent, will be evaluated by a senior ophthalmologist in a single office appointment. The appointment will include a visual acuity, complete ophthalmic examination,Humphrey perimetric visual field testing and peripapillary RNFL thickness measurement by OCT.

no drug or other treatment will be given to the participants

after data collection, average +/-Standard deviation for the 4 parameters will be compared between the 3 groups. Student T-test and one- way ANOVA will be used for statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of glaucoma
* chronic treatment with phenytoin for any indication

Exclusion Criteria:

* pregnancy
* visual acuity less then 6/60
High-flow Nasal Cannula Oxygen Versus Conventional Oxygen Therapy After Pulmonary Lobectomy

The primary objective of this study is to evaluate the effect of early application of nasal high flow oxygen therapy after pulmonary lobectomy on the incidence of postoperative hypoxemia

High-flow nasal cannula oxygen (HFNCO) treatment has been showed to have several clinical advantages compared with conventional oxygen therapy. Currently, no reports have described the effects of HFNCO in postoperative patients after thoracic surgery. The primary objective of this study is to determine the incidence of postoperative hypoxemia (defined as a PaO2/FiO2 ratio \<300) in patients with lung cancer after pulmonary lobectomy.

In the postoperative period after extubation, patients will be randomly assigned to either:

1. standard oxygen therapy group (control group) or
2. HFNCO group (study group).

In the control group, patients will receive oxygen treatment by means of a conventional face mask, with a level of fraction of inspired oxygen (FiO2) set to maintain peripheral oxygen saturation (SpO2) = 92% - 98%. Patients in the study group will be given HFNCO treatment with a gas flow level = 50 L/min and a FiO2 set to maintain peripheral oxygen saturation (SpO2) = 92% - 98%. After 48 hours from study entry, all patients will be evaluated for possible interruption of oxygen treatment on the basis of their clinical conditions.

Eligibility Criteria:
Inclusion Criteria:

* planned pulmonary lobectomy for lung cancer

Exclusion Criteria:

* age \<18 years
* patient refusal
* body mass index ≥35 kg/m2
* sleep apnea syndrome
* tracheostomy
* home oxygen therapy
* pregnancy
Clinical Observation of Technologic Application of No-touch Fluid-air Exchange in Surgery of Idiopathic Macula Hole

The purpose of this study is to observe the technologic application of no-touch fluid-air exchange in Surgery of Idiopathic Macula Hole.


Eligibility Criteria:
Inclusion Criteria:

* All patients were diagnosed as having an idiopathic macular hole(IMH) by Optical Coherence Tomography(OCT).

Exclusion Criteria:

* Myopia of \>6 diopters
* Ocular trauma and other systematic or ocular issues associated with IMHs，such as the other macula disease, for example the degeneration of macula.
Efficacy and Safety of Faropenem in Bangladeshi Adult Patients with Community-Acquired Bacterial Pneumonia (CABP)

The goal of this clinical trial is to evaluate the efficacy and safety of faropenem in comparison to co-amoxiclav and clarithromycin in Bangladeshi adults diagnosed with community-acquired bacterial pneumonia (CABP). Eligible participants will be randomly assigned to one of two treatment arms. The first arm will receive faropenem at a dosage of 200 mg administered three times daily for a duration of seven days. The second arm will receive co-amoxiclav 625 mg, also three times daily, along with clarithromycin 500 mg, administered twice daily for seven days. All participants included in the study will undergo follow-up assessments over a period of four weeks. This research aims to provide valuable insights regarding the potential role of faropenem, thereby enhancing clinical outcomes and informing antibiotic stewardship in a region significantly burdened by CABP and characterized by limited treatment alternatives.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients aged between 18 to 65 years.
* Have an acute illness (less than or equal to 7 days duration) with any of the following signs and symptoms consistent with a lower respiratory tract infection (new or worsening):

  1. Fever (body temperature \> 38.0 °C (100.4 °F) measured orally)
  2. Shortness of breath
  3. New onset or increased cough with or without sputum production.
  4. Chest pain.
* Have radiographically documented bacterial pneumonia:

  1. Infiltrates in a unilateral, lobar distribution
  2. Diffuse opacities or white condensed area
  3. The alveoli fill with white inflammatory fluid

Exclusion Criteria:

* Patients with severe pneumonia (Clinical \& Radiological Assessment)
* Patients with suspicion of viral pneumonia (bilateral, patchy opacities, etc., in chest radiography.)
* Patients with suspicion of nosocomial pneumonia, aspiration pneumonia, etc.
* History of hypersensitivity, known or suspected contraindications, or intolerance to any of the study drugs.
* Intake of an antibiotic within the last 48 hours before study admission.
* History of hospitalization within the last 28 days.
* Patients in pregnancy and lactational state.
* Patients with Renal impairment (screening eGFR \< 30mL/min).
* Significant hepatic impairment (Alanine aminotransferase \> three times the upper limit of normal).
* Serious diseases that affect the immune system, such as Acquired Immunodeficiency Syndrome (AIDS), cancer, etc.
* Patients who are taking steroid medications, at least 20 mg daily dose of prednisolone (or equivalent doses of other glucocorticoids).
* Patients who are accepting chemotherapy or anti-cancer therapy or plan to receive such treatment during the trial or six months prior to enrollment.
* Had epilepsy, stroke, or other central nervous system disorders or uncontrolled psychiatric history.
Abdominal Plain X-ray in the Emergency Departement

There are only few recognized indications for the realization of plain abdominal X-rays in the emergency departement.

The objective of this study is to explore the reasons for abdominal plain X-rays prescription in the Emergency departments (EDs) of two hospitals.

All abdominal plain x-rays prescription will be reviewed in order to identify reasons for prescribing this exam. The indications will be compared to international guidelines in order to identify whether abdominal plain x-rays are overprescribed. Reasons for overprescription will be identify by chart review.

Eligibility Criteria:
Inclusion Criteria:

* \>= 16 years
* prescription of an abdominal plain x-ray during their stay in the ED

Exclusion Criteria:

* \< 16 y
* no abdominal plain x-ray prescribed
Prevalence, Associated Factors Points and Implementation of Care Procedures of Chronic Obstructive Pulmonary Disease Exacerbation in Healthcare Institution

Chronic Obstructive Pulmonary Disease (COPD) is a public health problem responsible for high mortality rate and significant costs for society. The disease evolution is punctuated by exacerbations worsening the health state of patients.

Many guidelines of care procedures have been written but many disparities persist in medical practices.

This pilot prospective observational study is an overview of current local practices in the university health center of Grenoble Alpes and it is the first step towards developing a regional observatory in order to standardize and improve patient cares. The primary outcome is to compare the international guidelines to the local practices regarding the prescription of key treatments of exacerbation, especially antibiotics.


Eligibility Criteria:
Inclusion Criteria:

* Patient older than 18 years (included)
* Known or suspected Chronic Obstructive Pulmonary Disease
* Admitted for COPD exacerbation in emergency department or pneumology department or intensive care unit of university health center of Grenoble Alpes during the period of data collection.

Exclusion Criteria:

* opposition to participate at the study
* Patients under the law
Internet-administered Interpersonal Psychotherapy for Depressive Symptoms

The aim of the study is to test the efficacy of a treatment for depression based on interpersonal psychotherapy (IPT). The treatment will be accessed via an internet platform built for this study. A therapist will provide support weekly, as well as on-demand when needed. The treatment lasts for 10 weeks.


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of Major depressive disorder (as indicated by the MINI 7.0 Neuropsychiatric interview) and/or depressive symptoms equal to or more severe than mild depression on the MADRS-S (equal to or above 13 points) and/or BDI (equal to or above 14 points).
* Age of at least 18 years old.
* Adequate ability to speak, write, and read Swedish.
* Internet access for the duration of the study.

Exclusion Criteria:

* Ongoing substance abuse.
* Suicidal plans.
* A diagnosed personality syndrome (as diagnosed before the study by a licensed psychiatric healthcare professional).
* Other ongoing psychological treatment.
* Other severe psychiatric comorbidity that requires specialized care (e.g. anorexia nervosa, psychosis).
* Recent changes in psychotropic medication or planned changes during the initial treatment period.
Evening Primrose Oil to Misoprostol During Induction of Second-trimester Missed Miscarriage

Termination of pregnancy is an important subject that has complex and emotional controversies. The most common time of termination of pregnancy is the mid-trimester which has two-thirds of all serious abortion-related complications. There are many indications for mid trimester termination of pregnancy such as missed abortion, serious fetal abnormalities and lastly some women do not wish to continue a pregnancy and will often request termination of pregnancy


Eligibility Criteria:
Inclusion Criteria:

* Nullipara or previous vaginal delivery only
* Bishop score was ≤ 5
* Women who will accept to participate in the study

Exclusion Criteria:

* Multiple gestations
* Rupture of fetal membranes
* Previous cesarean sections
* Women with heavy bleeding
* Evidence of low implanted placenta by US
* Evidence of intra-uterine infection (either clinical or laboratory)
Feeding and Swallowing Problems in Infants With Laryngomalacia

Observational cross-sectional study Infants with laryngomalacia Feeding and swallowing assessment

Identification of swallowing and feeding disorders in infants with laryngomalacia.

Identify if there is relation between severity of laryngomalacia and feeding and swallowing disorder.

Eligibility Criteria:
Inclusion criteria:

* Infants up to 2 years old diagnosed with laryngomalacia.
* Full term infants.

Exclusion criteria:

* Infants with other possible causes of dysphagia e.g., craniofacial anomalies, BDMH and neurological affection secondary to birth trauma, hypoxic ischemic encephalopathy and other brain insults.
* Infants who were lethargic and/or medically unstable and were generally unable to participate to protocol of assessment.
* Premature infants.
Heart & Diabetes - Feasibility Study

The main purpose of this study is to validate an intensive protocol of insulin infusion and subsequent subcutaneous insulin administration with the support of continuous glucose monitoring, in addition to reference finger-stick values.

Heart failure is a common disease (prevalence worldwide: 22 million; incidence worldwide: 2 million; prevalence in Italy: 750.000; incidence in Italy: 170.000), affecting 1-2% of overall population and accounting for a significant proportion of healthcare costs. Recurrent hospital admissions represent the majority of the disease-related cost. About 15-25% of patients with HF are diabetics: the presence of diabetes significantly worsens prognosis in patients with heart failure and increases the risk of death by 30% compared to subject without diabetes.

The intensive control of glycemia during acute heart failure is an objective of primary importance, which can be obtained only with a proper strategy of patient management and with a considerable organizational effort. In a shared protocol aimed at a tight control of glycemia, the use of Continuous Glucose Monitoring (CGM) is expected to allow an easier management of the patient and a more accurate implementation of the protocol.

The main purpose of this study is to validate an intensive protocol of insulin infusion and subsequent subcutaneous insulin administration with the support of continuous glucose monitoring, in addition to reference finger-stick values.

Eligibility Criteria:
Inclusion Criteria (all of the following inclusion criteria must be met for the patient to be enrolled in the study):

* acute heart failure, defined according to current ESC Guidelines
* HbA1c \> 7.5% at admission in Cardiology Unit
* glycemia \> 180 mg/dL at admission in Cardiology Unit
* the patients signed the Informed Consent

Exclusion Criteria (if any of the following criteria are met, patients cannot be enrolled in the study):

* heart failure in acute infarction or cardiogenic shock
* creatinemia \> 3.5 mg/dL at admission or in hemodialytic therapy
* cirrhosis
* acute infective pathology
* cardiac revascularization during the hospitalization or in the preceding 3 months
* life expectance \< 12 months
* age \< 18 years
* pregnant women
* informed consent not signed
* subject included in other protocols