cyrilzakka/clinical-trials huggingface dataset:
Teaching Inhaler Use With the INCA Device in a Community Pharmacy Setting

The purpose of this trial is to discover whether providing feedback to patients from a device that records when and how well a patient uses a Seretide Diskus inhaler will lead to:

* Improved compliance with prescribed inhaler use
* Improved technique of inhaler use
* A reduction in respiratory health related outcomes caused by poor inhaler compliance and usage.
* An improvement in patient quality of life scores


Eligibility Criteria:
Inclusion Criteria:

* Must be 18 years old or above
* Capable of understanding and willing to provide voluntary informed consent before any protocol specific procedures are performed
* Capable of understanding and complying with the requirements of the protocol, and demonstrating a willingness to attend for all required visits.
* Able and willing to take inhaled medication.
* Have a valid prescription for use of a Seretide diskus inhaler or already using a Seretide diskus inhaler.
* Have a history of regular attendance in the pharmacy in which they are recruited which will be demonstrated by the subject having collected three prescriptions for any medication in that pharmacy in the six months preceeding their recruitment to the study.

Exclusion Criteria:

* Patient expressly reports that their physician has indicated that they will not be continuing to receive Seretide over the next 6 months
Automated Chest Compression in Cardiac Arrest

To evaluate the effect of use of automated chest compression device on blood pressure in patients presenting with cardiac arrest. Higher systolic, diastolic and mean blood pressures are expected.

The protocol compares arterial pressures produced by an automated self-adjusting load-distributing band device (AutoPulse™ 100, Zoll®) with those of manual cardiopulmonary resuscitation in refractory out-of-hospital cardiac arrest. Each patient will receive first manual compressions and then automated resuscitation.

Patients presenting with cardiac arrest are treated following standard advanced life support guidelines. They are intubated and ventilated, received epinephrine and defibrillation if appropriate. Manuel chest compressions are continued. An arterial catheter is placed to monitor hemodynamics continuously as we usually do in this case. Patients are included at this stage. Three blood pressure values (every 1 minutes) are recorded. Then, the automated band device is started up without any pause, following our procedure for refractory cardiac arrest. Three blood pressure values are recorded again, during automated cardiopulmonary resuscitation.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Refractory cardiac arrest

Exclusion Criteria:

* Defective invasive arterial blood pressure monitoring
Comparison of Desloratadine Associated With Prednisolone Oral Solution Versus Dexchlorpheniramine Associated With Betamethasone for Cutaneous Rash Treatment

The purpose of this study is to evaluate the non-inferiority clinical efficacy of two different drug associations in the treatment of acute cutaneous rash in children between 2 and 12 years old.

* double-blind, non-inferiority, prospective, parallel group trial.
* Experiment duration: 05 days.
* 03 visits (day 0, 48 hours and day 5).
* Efficacy will be evaluated for acute cutaneous rash based on symptoms score
* Adverse events evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Consent of the patient or legal guardian;
* Clinical diagnosis of acute cutaneous rash defined by the presence of erythematous papules on healthy skin, different sizes, itchy and fleeting
* Children aged between 2 and 11 years and 11 months (up to 30 kg);

Exclusion Criteria:

* Participation in clinical trial in 30 days prior to study entry;
* Patients with history of hypersensitivity to desloratadine or prednisolone or with corticosteroids use contraindications ;
* Patients with any clinically significant disease other than cutaneous rash including hematopoietic, cardiovascular, renal, neurological, psychiatric or autoimmune disorders;
* Patients on treatment with monoamine oxidase inhibitors (MAOIs);
* Patients diagnosed with other dermatoses
Drug Reactions Sampling (COLLECTIONTOXIDERMIES)

Intro: Dermatology department of Henri Mondor Hospital (Creteil, France), is a reference center for toxic bullous diseases and severe cutaneous drug reactions (Stevens-Johnson syndrome (SJS), Lyell syndrome (toxic epidermal necrolysis (TEN)), generalized bullous fixed drug reactions, AGEP, DRESS, drug induced immunoglobulin A (IgA) bullous dermatosis, and erythema multiforme). In order to conduct clinical and biological research studies in drug reactions, it is necessary for the investigator's department to implement a collection of clinical data and biological samples.

Hypothesis/Objective: To collect clinical data and cutaneous and biological samples for immunological, biological and genetic studies to improve knowledge about pathophysiology of drug reactions.

Method: The following samples will be performed in addition to the routine practice samples: one skin punch biopsy (6mm); 43 mL of blood; blister fluid aspiration; oral and nose mucous membrane and skin eSWABs, stool samples.

These samples will be stored in a dedicated biological sampling department ("Platform of biological resources").

Conclusion: The implementation of this collection should allow us to conduct pathophysiological studies about drug reactions.


Eligibility Criteria:
Inclusion Criteria:

* Patient ≥ 18 y-old
* Severe cutaneous drug reaction (AGEP, DRESS, SJS/TEN, generalized bullous fixed drug eruption), drug-induced IgA bullous dermatosis, maculopapular exanthema, erythema multiforme
* Signed consent
* Social security affiliation

Exclusion Criteria:

* Patients law protection
Study Evaluating the Feasibility of an Adapted Physical Activity Program During the Hospitalization Phase in Cancer Patients Undergoing Treatment

This is a non-randomized, non-controlled feasibility study which will take place at the Besançon University Hospital in the conventional hospitalization department.

It will be carried out with patients hospitalized in the conventional hospitalization department of the medical oncology department of Besançon University Hospital.

At entry, after presenting the study and obtaining non-opposition from patients, an initial assessment will be carried out before the APA program. This assessment will include an evaluation of physical parameters (measurements of body composition, functional capacities, autonomy in activities of daily living and muscular strength), as well as an evaluation of quality of life relating to health and motivation to practice physical activity.

At the end of the initial assessment, an APA program supervised (individually and in a room) by an APA teacher will be offered to patients. The sessions will be offered daily to patients (maximum 5 times/week). They will last on average 20 minutes each depending on the fatigue, pain and fitness of the patients. The objectives pursued are mainly an improvement in functional independence and mobility.


Eligibility Criteria:
Inclusion Criteria:

* Man or woman aged 18 and over (no age limit)
* Patient followed for cancer,
* Patients with no medical contraindication to adapted physical activity (certificate)
* Patient with a performance index status less than 4
* Patient hospitalized in the conventional medical oncology hospitalization department of Besançon University Hospital.
* Patient not opposed to participating in the study
* Patient affiliated to a French social security scheme or beneficiary of such a scheme.
* For women: menopausal for at least 24 months, surgically sterilized, or, for women of childbearing age, use an effective method of contraception (oral contraceptives, contraceptive injections, intrauterine devices, double-barrier method, patches contraceptives)
* Length of hospitalization estimated at at least 7 days (main objective) and with the patient's objective of returning home or to SSR in the long term

Exclusion Criteria:

* Patient with an absolute medical contraindication to adapted physical activity
* Patient with inability to understand instructions and complete questionnaires.
* Patient with a performance index status of 4
* Patient with legal incapacity or limited legal capacity
* Patient unlikely to cooperate in the study and/or low cooperation anticipated by the investigator
* Patient without health insurance
* Pregnant woman
* Patient being in the exclusion period of another study or provided for by the "national volunteer file".
Determine if Apparent Diffusion Coefficient (ADC) Values Can Differentiate Tumors From Normal Tissue

The purpose of this study is to determine normal measurements (ADC values) from the head and neck of healthy volunteers using 3T MRI.

The purpose of this study is to determine normal measurements (ADC values) from the head and necks of healthy subjects using 3T MRI.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects 18 years of age or older.

Exclusion Criteria:

* Under 18 years of age
* Women of child bearing potential
* Pregnant or lactating women
* All potential volunteers will be pre-screened by MRI personnel to determine if there is any medical reason that you should not be included in this study.
Longitudinal Acute Air Pollution Systemic Effects

Air pollution continues to be a key global issue with many governments focusing great attention on air quality legislation because of its harmful environmental and health impacts. Whilst there is much that remains unknown about the mechanisms underlying the negative health effects of air pollution, it is generally acknowledged that air pollution exposure leads to an increase in cardiovascular, cerebrovascular and respiratory mortality and morbidity. The current study will investigate systemic effects during a 72 hour period after a controlled diesel exhaust exposure.

Exposure to air pollution (both indoor and outdoor sources) contributes to the premature deaths of 7 million people each year, primarily linked to cardiovascular and respiratory conditions. Within the complex mixture which air pollution comprises, combustion derived particulate matter (PM) has been suggested as one of the most harmful components to the cardiopulmonary system. In urban areas PM derived from combustion originates largely from diesel vehicles.

Numerous experimental chamber studies have demonstrated respiratory as well as cardiovascular dysfunctions after the inhalation of diesel exhaust. Many of these dysfunctions are driven by inflammation and oxidative stress. There is much less knowledge concerning the systemic effects of diesel exhaust exposure, and especially over longer time courses than 24 hours.

The investigators aim to investigate the time course of systemic effects (such as markers of inflammation, cardiovascular dysfunction, and oxidative stress) in blood and urine samples taken after a diesel exhaust exposure. The effects of exercise or rest in an experimental chamber exposure will also be investigated.

Eligibility Criteria:
Inclusion Criteria:

* Normal clinical examination
* Normal EKG
* Normal routine blood tests
* Normal lung function
* Normal skinprick test

Exclusion Criteria:

* Cardiovascular disease
* Diabetes Mellitus
* Asthma and/or allergy
* Smoking
The Effect of Virtual Reality and Music Recital on Anxiety and Agitation in Patients Undergoing Spinal Anaesthesia

This study will be carried out in patients undergoing spinal anaesthesia. The effects of virtual reality and music playback on anxiety and agitation in patients will be evaluated.

Virtual reality is a computer technology in which a virtual environment is simulated in three dimensions. This technology isolates the individual from real life by zooming the lenses to the patient's eyes through a headset known as virtual reality glasses. Recently, with technological developments, virtual reality applications have started to take place among nursing practices as non-pharmacological approaches that support pharmacological methods in clinical settings. Various studies have revealed that virtual reality as a distraction method plays an important role in alleviating anxiety and agitation experienced by patients.

Music application is an easy-to-apply and non-invasive non-pharmacological method. Music recitals give a feeling of relaxation by increasing the release of endorphin hormone in individuals and play an important role as a psychosocial intervention. Such activities reduce symptoms of anxiety and depression, improve quality of life and have positive effects on physical symptoms and general well-being. In addition, the effects of music on respiratory rate, blood pressure and heart rate are also observed.

This study aims to evaluate the effects of virtual reality technology and music playback on anxiety, agitation and physiological parameters in patients undergoing spinal anaesthesia and to make important contributions to the literature in this context.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older,
* Clear consciousness, able to communicate,
* No hearing-speech problems,
* Who volunteered to participate in the study,
* Patients who would undergo Urology, General Surgery, Orthopedics, Cardiovascular Surgery, Neurosurgery by spinal anaesthesia were included in the study.

Exclusion Criteria:

* Patients without spinal anaesthesia,
* Patients who participated in the study but voluntarily withdrew at any stage of the study or patients who had to withdraw involuntarily during the operation were not included in the study.
Efficacy and Safety Evaluation of Fecal Microbiota Transplantation in Irritable Bowel Syndrome

Participants will be given FMT through oral capsules or nasojejunal tube once a month. After three-time treatment, participants were followed up for three months. Participants complete specific scales to assess improvement in symptoms, emotion and quality of life. Besides, they report adverse effects and collect fecal samples at each visit.

This prospective, single-arm interventional study aims to evaluate efficacy and safety of fecal microbiota transplantation in refractory IBS patients. Patients meeting the inclusion and exclusion criteria will provide written informed consent and receive FMT from healthy donors for three times. The administration methods include taking oral capsule or delivering microbiota suspension into the duodenum via nasojejunal tube. The patients receive treatment once a month and will be followed up for 3 months. Improvement in IBS symptoms, emotion and quality of life were assessed through IBS symptom severity scale (IBS-SSS), Gastrointestinal symptom rating scale (GSRS), IBS-Global Assessment of Improvement (IBS-GAI), Self-rating Anxiety Scale (SAS), Self-rating Depression Scale (SDS) and IBS-Quality of Life (IBS-QoL) respectively. Patients were asked to complete these scales and collect fecal samples at baseline, post-FMT and at 1, 2, 3 and 4 months after FMT. Primary endpoints were improvement in IBS-SSS score and global symptoms after three-time FMT. Secondary endpoints include Change in GSRS score, improvement in emotion and quality of life at post-FMT, 1 and 6 months, as well as change in fecal microbiota composition.

Eligibility Criteria:
Inclusion Criteria:

* Patients who fulfilled the Rome IV criteria for the diagnosis of IBS, aged 18-70 years;
* Patients who have experienced failure of at least 3 conventional therapies for IBS;
* Absence of red flags such as weight loss, hematochezia;

Exclusion Criteria:

* Pregnant, planning pregnancy or lactating;
* Psychiatric disorder or unable to cooperate with treatment and follow-up visit;
* Immunodeficiency or treatment with immune-modulating medication;
* Use of probiotics within the previous 3 months or treatment with antibiotics within 1 month prior to study entry;
* Having undergone any abdominal surgery, with the exception of appendectomy, cholecystectomy, caesarean section and hysterectomy;
* Presence of uncontrolled diabetes, hypertension, thyroid disease or other systemic disease;
* Presence of severe diseases related to heart, brain, kidney and lung or concomitant malignancies;
Pentafecta Outcomes After Robot-assisted Laparoscopic Radical Prostatectomy

Robot-assisted laparoscopic radical prostatectomy (RALRP) is a surgical technique for the treatment of prostate cancer. The aim of this study was to report our initial experience with RALRP, by applying the concept of pentafecta. Pentafecta consists of the five main outcomes in the postoperative period of RALRP: erectile dysfunction, urinary incontinence, postoperative complications, surgical margins and biochemical failure.

This study will describe a initial experience in RALRP in Brazilian University Hospital. The follow-up of patients was performed as an examination at the medical consultation every three months. Complications were categorized according to the Clavien classification system. Biochemical failure was established by PSA level. Continence was defined as patients who remain dry and who do not require any kind of protection in their everyday activities. Sexual potency was defined as the ability to get and keep an erection for long enough to have satisfying sexual relations with or without the use of type-5 phosphodiesterase inhibitors (PDE-5) and a Sexual Health Inventory for Men (SHIM) score greater or equal to 21. Positive surgical margin is defined as the presence of neoplastic glands in direct contact with the ink on the surface of the piece, with no interposed connective tissue.

Eligibility Criteria:
Inclusion Criteria:

• patients diagnosed with localized Prostate Adenocarcinoma submitted to surgical treatment with Robot-assisted laparoscopic radical prostatectomy

Exclusion Criteria:

* patients undergoing other treatments for adenocarcinoma of the prostate
* conversion to open prostatectomy
* loss of follow-up
Pharmacokinetic Profiles Of Amoxicillin 2000 mg And Clavulanate 125 mg In Adolescent Patients

Clinical research study to test amoxicillin and clavulanate tablet formulation for use in Acute Bacterial Sinusitis (ABS) in adolescent patients weighing at least 40 kilogram (kg) and no more than 16 years old. ABS is an acute bacterial infection of the sinus. The purpose of this study is to find out how children tolerate Augmentin XR and what happens to Augmentin XR in the body after it has been swallowed by children.


Eligibility Criteria:
Inclusion criteria:

* Patient weighs at least 40 kg.
* Younger than 16 years old (no older than their 16th birthday).
* Suspected acute bacterial sinusitis.
* Able to swallow amoxicillin/clavulanate tablets.

Exclusion criteria:

* Personal or family history of adverse reactions or hypersensitivity or allergy to any penicillin or cephalosporin antibiotics.
* History of reaction to multiple allergens (if considered clinically relevant by the principal investigator).
* Patient is participating in another clinical trial or has received or anticipates receiving an investigational drug, vaccine, or medical device prior to the first dose of study medication or during the conduct of the study.
* History or presence of gastrointestinal, hepatic or renal disease or other conditions known to or that may interfere with the absorption, distribution, metabolism or excretion of study medication.
* Treatment with probenecid or allopurinol within 7 days of study entry.
* Female patients with a positive urine hCG (human chorionic gonadotropin) test at screening, or who are lactating (breast feeding) or are unwilling to be abstinent until completion of the follow-up visit.
* History of diarrhea due to Clostridium difficile following treatment with antibiotics.
* History of hypersensitivity or allergy to heparin or related preparations (if the clinical research unit uses heparin to maintain intravenous cannula patency).
* Patient is diagnosed with mononucleosis.
* Estimated Glomerular Filtration Rate (GFR) \<40 ml/min.
An Evaluation of the Team Birth Project

The purpose of this study is to evaluate the feasibility of a pilot project to improve communication and teamwork and to increase vaginal delivery rates at hospital in the United States


Eligibility Criteria:
Clinician Participant Inclusion Criteria:

* All clinicians who have practice privileges at a study site

Clinician Participant Exclusion Criteria:

* None

Implementation Team Participant Inclusion Criteria:

* Champions, super-users and others who have been involved in the implementation of "Team Birth Project" at a study site

Implementation Team Participant Exclusion Criteria:

* None

Patient Participant Inclusion Criteria:

* 18 years or older
* Live birth. Includes: spontaneous or induction of labor; Vaginally, with an instruments (forceps / vacuum), or unscheduled cesarean delivery
* Patient at a study site piloting "Team Birth Project"

Patient Participant Exclusion Criteria:

* Under 18 years old
* Scheduled cesarean delivery
* Experienced intrapartum, stillbirth, or neonatal death
Study of Nutrition Regimens in Treating Patients With Cancer of the Upper Aerodigestive Tract

RATIONALE: It is not yet known which regimen of enteral nutrition is more effective in preventing infections in patients undergoing surgery for cancer of the upper aerodigestive tract.

PURPOSE: This randomized phase III trial is comparing three nutrition regimens in treating patients with cancer of the upper aerodigestive tract.

OBJECTIVES:

Primary

* Determine the efficacy of immunonutrition (IMPACT®) in patients with de novo cancer of the upper aerodigestive tract.

Secondary

* Determine the best time to initiate treatment.
* Compare the intermediate duration of treatment.
* Compare nutritional parameters.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 3 treatment arms.

* Arm I: Patients receive standard oral or enteral nutrition (IMPACT® placebo) over 7 days prior to surgery and over 7 days after surgery.
* Arm II: Patients receive oral or enteral neoadjuvant IMPACT® nutrition over 7 days prior to surgery and enteral adjuvant standard nutrition (IMPACT® placebo) over 7 days after surgery.
* Arm III: Patients receive oral or enteral IMPACT® nutrition over 7 days prior to surgery and enteral adjuvant IMPACT® nutrition over 7 days after surgery.

After completion of study therapy, patients are followed at 30 days after surgery and then at 2 and 3 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of de novo cancer of the upper aerodigestive tract, including the following:

  * Oral cavity
  * Larynx
  * Oropharynx
  * Hypopharynx
* Planned surgical excision of tumors with opening of the mucous membranes, with or without immediate reconstruction by myocutaneous pedicle flap or free-bone graft
* Planned adjuvant enteral nutritional regimen lasting at least 7 days post-operatively

PATIENT CHARACTERISTICS:

* ANC \> 1.8 x 10\^9/L
* Hemoglobin \> 9 g/dL
* Transaminases ≤ 3 times upper limit of normal (ULN)
* Bilirubin ≤ 3 times ULN
* Creatinine 70-250 μmol/L
* Urea ≤ 1.5 times ULN
* Glucose \< 1.5 g/L
* Sodium \< 145 mmol/L
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No psychological, social, geographical, or familial reasons prohibiting follow-up
* No insulin-dependent diabetes
* No severe psychiatric illness

PRIOR CONCURRENT THERAPY:

* No head and neck surgery for cancer within the past year
* No prior oral components of immunonutrition
* No prior neoadjuvant chemotherapy
* No prior radiotherapy to head and neck