cyrilzakka/clinical-trials huggingface dataset:
Validation of Questionnaire and Assessment of Patient Satisfaction for Budesonide/Formoterol Fix Combination Dry Powder Inhalers (DPI) in Chronic Obstructive Pulmonary Disease (COPD)

The aim of this study is to describe patient preferences on budesonide/formoterol fix dose combination for the treatment of their COPD, and to find those factors more strongly associated to a better attitude to medication.

Validation of questionnaire and assessment of patient satisfaction for budesonide/formoterol fix combination DPI in COPD

Eligibility Criteria:
Inclusion Criteria:

* Provision of subject informed consent and to be an outpatient
* Clinical diagnosis of COPD according to ICD-10 classification, females and males, aged ≥ 40 years
* To be prescribed a fixed dose combination of inhaled budesonide/formoterol fix combination at least 3 months before the study start

Exclusion Criteria:

* Pregnancy for women
* Use of inhaled medication via a metered dose inhaler (pMDI)
* Currently participating in randomized clinical trials and being included in this study once
Cytotoxicity of Yellow Fever Specific CD8 T Cells Following YF-17D Vaccination

Investigating cytotoxicity of yellow fever specific CD8 T cells following YF-17D vaccination and the following licensing of these epitope-specific CD8 T cells

CD: cluster of differentiation YF: yellow fever

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 to 60 years
* Informed consent given

Exclusion Criteria:

* Fever (orally \>37,5 C) on day of vaccination
* Immunosuppressants
* Pregnant or breast feeding
* Severe immunodeficiency
* Known thymus dysfunction
* Allergy against egg
* Known haemophilia
* Previous severe reaction to vaccine
* Not willing to use anticonceptives 4 weeks after vaccination
Prevalence and Impact of Fatigue in Myasthenic Patients Followed At Clermont-Ferrand University Hospital - "My" Asthenia

After identifying myasthenic patients meeting the inclusion criteria, telephone contact with patients to suggest that they participate in the study by responding to various questionnaires composed of validated scales used in current practice (MG-ADL, MG-QoL-15, MFIS, FSS, PASS, HADS, Godin-Leisure Exercise Time) which will be completed either digitally (REDCap link) or by paper form if necessary. Consultation of patients' medical records to collect information relating to factors associated with fatigue or intrinsic illness (demographic data, comorbidities, progression of the illness, treatments, etc.).

As part of their usual care, myasthenia patients answer questionnaires according to the following procedure :

1. Mailing of questionnaires to all eligible patients before their consultation The questionnaires are composed of scales validated and used in current practice (MG-ADL, MG-QoL-15, MFIS, FSS, PASS, HADS, Godin-Leisure Exercise Time).
2. Collection of questionnaires When patients come for consultation, the completed questionnaires are collected by the medical team.
3. Collection of questionnaires The responses to the questionnaires and the scores and results obtained from these questionnaires are integrated into the patients' medical records.

As part of our study and in parallel with the patient's clinical follow-up, data relating to factors associated with fatigue or intrinsic illness (demographic data, comorbidities, progression of the disease, treatments, etc.) as well as responses to questionnaires will be collected.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients who consulted the neurology department of the Clermont-Ferrand University Hospital between 01/01/2022 and 12/31/2024 in the context of their myasthenia and identified by the BAMARA and PMSI databases of the Clermont-Ferrand University Hospital
* Diagnosis of autoimmune myasthenia gravis based on biological and/or electromyographic criteria
* MGFA class from I to IV

Exclusion Criteria:

* Patients under guardianship or curatorship
* Non-French speaking patients
* Patients refusing to participate in the study
Study to Assess Adverse Events and Compare How Crushed, Ground, and Intact Oral Tablets Venetoclax Moves Through the Body of Healthy Female Adult Volunteers

The objective of this study is to assess the oral bioavailability of crushed and ground venetoclax commercial tablets relative to the intact venetoclax commercial tablets under fed condition in healthy female participants.


Eligibility Criteria:
Inclusion Criteria:

* Must either be: postmenopausal, permanently surgically sterile, or perimenopausal or premenopausal and practicing a method of birth control until at least 1 month after the last dose of study drug.
* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG).

Exclusion Criteria:

* Significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, cardiovascular, pulmonary or hepatic disease within the past 6 months that in the opinion of the investigator would adversely affect her participating in this study.
* History of any clinically significant sensitivity or allergy to any medication or food.
* History of or active medical condition(s) or surgical procedure(s) that might affect gastrointestinal motility, pH, or absorption.
Morphine Titration by Patient Self-controlled by a Mechanical Device Versus Administration by the Nurse for Patients With Severe Acute Pain in the Emergency Department

Intense acute pain is a common reason for Emergency admittance and its management is one of the major public health goals.

In the recommendations formalized experts, it is recommended to use a protocol titration with morphine bolus of 2 mg (for patients less than 60 kg) or 3 mg (for patients over 60 kg) repeated every 5 minutes with a target of the Visual Analog Scale less than or equal to 30.

Despite these specific recommendations and a broad awareness of the teams, management of pain remains to be improved, the major difficulty of morphine titration at the emergency department being the availability of paramedical personnel to perform revaluations and reinjection. Thus, effective analgesia would be obtained in 50% of cases to 30 minutes.

The investigators want to study the self-controlled morphine titration by the patient by a mechanical device for single use (efficacy/safety).


Eligibility Criteria:
Inclusion Criteria:

* Admission to an emergency department
* Acute pain (Visual Analog Scale \> 60)
* Able to assess pain using the numerical scale
* Prescription of morphine titration

Exclusion Criteria:

* Physical or mental disorders limiting the understanding and / or use of a PCA
* History of allergy to morphine / hypersensitivity to any component
* Long-term treatment morphine
* Opioid therapy administered prior to inclusion
* Analgesic treatment level 2 (codeine, tramadol, nefopam ...) administered prior to inclusion or planned
* History of Substance Abuse
* Severe respiratory insufficiency
* Severe hepatic impairment
* Head trauma
* Intracranial hypertension
* Uncontrolled epilepsy
* Pregnant or lactating
* Patient jailed
* Incapacitated adult under guardianship
* Incapable of giving informed consent
Tilt and Tumble vs Divide and Conquer - a Unique Comparison of the Two Cataract Surgery Methods

The purpose of this study is to compare two different methods used during cataract surgery to remove the lens in the eye.

After being informed about the study and potential risks, all participants who have signed the written informed consent will be randomized to undergo cataract surgery with either the method called "Divide and Conquer" or "Tilt and Tumble". Pre- per- and postoperative measurements from the surgery will be filed and compared later on by the investigator.

Eligibility Criteria:
Inclusion Criteria:

* Cataract

Exclusion Criteria:

* Dementia
* Very narrow anterior chamber
* Born after 1965
Interventions for Postoperative Delirium: Biomarker-3

The IPOD-B3 study aims to characterize the relationship between premorbid brain activity and postoperative delirium in patients undergoing major surgery. This is a expansion of the NeuroVISION Bolt-On study, NCT01980511.


Eligibility Criteria:
Inclusion Criteria:

* Cohort 1: Age ≥65 years
* Cohort 2: Age ≥60 years
* Anticipated length of hospital stay of at least 2 days after surgery that occurs under general or neuraxial anesthesia
* Written Informed Consent for potential participation prior to surgery

Exclusion Criteria:

* Contraindication to EEG
* Unable or unwilling to attend the follow-up appointments
* Documented history of dementia
* Deemed incapable of providing consent by surgical team
* Residing in a nursing home
* Undergoing intracranial surgery
* Unable to complete neurocognitive testing due to language, vision or hearing impairment
* Unable to communicate with the research staff due to language barriers
* For optional MRI portion of the study: Contraindication to MRI (e.g., implanted devices not safe for MRI studies, claustrophobia, unable to lie flat or still)
Walnut Consumption, Endothelial Function, and Biomarkers

This study will examine whether a twelve-week intervention with one ounce (28 g) per day of walnuts improves endothelial function measured non-invasively using finger probe (EndoPat-2000) in people with coronary heart disease or type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Age 30+ years
* Prevalent coronary artery disease
* Prevalent type 2 diabetes

Exclusion Criteria:

* Current eating disorder
* Pregnant or lactating women
* Allergy to walnuts or other nuts
* Inability to provide informed consent or blood samples
* History or prevalent diagnosis of cancer, asthma, kidney insufficiency, stroke, seizures, allergic disorders, or congestive heart failure
* Diagnosis of coronary heart disease or diabetes \< 1 year prior to enrollment
* Intention to move out of greater Boston area within one year
* Current use of walnuts for more than 2 ounces per day
* Bleeding disorder
* Treatment with blood thinning drugs (i.e. warfarin, clopidogrel)
* Major surgical operation 3 months before or after screening
* Organ transplantation
* Current participation in another trial or plan to do so during the study
* Use of vasodilators such as nitroglycerin
* Inability to give informed consent
* Inability to travel to the study center at Brigham and Women's Hospital
Descemet Endothelial Thickness Comparison Trial I

Descemet Endothelial Thickness Comparison Trial (DETECT) I is a multi-center, outcome assessor-masked, placebo-controlled clinical trial randomizing 160 patients in a 2x2 factorial design. The purpose of this study is to determine differences in visual outcomes between two types of corneal transplant surgeries, ultrathin Descemet stripping automated endothelial keratoplasty (UT-DSAEK) and Descemet membrane endothelial keratoplasty (DMEK), and to determine the effect of rho-kinase inhibitors on endothelial cell loss.


Eligibility Criteria:
Inclusion Criteria:

* Dysfunctional endothelium from Fuchs Endothelial Corneal Dystrophy (FECD) with guttata extending beyond 4.5 mm of the central cornea or severe edema without visualization of guttata
* Dysfunctional endothelium from Pseudophakic Corneal Edema (PCE) or Iridocorneal Endothelial Syndrome (ICE) or other primary endothelial dysfunction such as Posterior Polymorphous Corneal Dystrophy (PPMD)
* Dysfunctional endothelium from prior graft failure after PKP or EK
* Controlled uveitis (defined as quiet for \> 3 months off of topical steroids with or without systemic immunosuppression) or no uveitis
* Controlled glaucoma with topical medications and/or prior trabeculectomy or tube shunt without ongoing hypotony (IOP \< 5 mmHg) or no glaucoma
* Good candidate for corneal transplantation for either DMEK or UT-DSAEK
* Willingness to participate
* Age greater than 18 years

Exclusion Criteria:

* Aphakia, or anterior chamber IOL or scleral fixated IOL in study eye prior to or anticipated during EK
* Pre-operative central sub-epithelial or stromal scarring that the investigator believes is visually significant and could impact post-operative stromal clarity assessment
* Peripheral anterior synechiae (iris to angle) in the angle greater than a total of three clock hours
* Visually significant optic nerve (ok to have small visual field defects) or macular severe pathology
* Pregnancy
Effect of Acute Psychological Stress on Glucose Concentrations in Patients With Type 2 Diabetes

The study is designed to evaluate the effects of acute psychological stress on blood glucose levels. We will study one group of patients in the fasting state on a control day and a stress test day, another group will undergo the same protocol in the postprandial state.

Patients with type 2 diabetes often complain about changing blood glucose levels in times of emotional or mental stress, most subject's self-reporting higher blood glucose measurements in stressful conditions. To daily distress in diabetes additional emotional or mental stress can add a further momentum to destabilize glucose levels due to the adrenocortical response with enhancing insulin resistance and decreasing the endogenous insulin secretion. Another physiological link between stress and diabetes might be a higher sensitivity of the hypothalamo-pituitary-adrenal axis, leading to antagonizing effects on insulin actions. A study in type 2 diabetes demonstrated that stressors can destabilize blood glucose levels. Stress levels in diabetes have been shown to have a relationship to diabetic complications. Previous studies of psychological stress in type 1 diabetes have shown no effect of elevated catecholamine levels after short-lived psychological stimuli on glucose levels, but a significantly delayed decrease of glucose concentrations after an acute psychological stress in the postprandial state in association with elevated cortisol levels, showing no change of glucose concentration in the fasting state. This was in contrast to previous data in healthy subjects, showing that low glucose levels before a psychological stress prevented the stress-induced activation of the hypothalamus pituitary adrenal axis, but postprandial higher blood glucose levels induced a large cortisol response. These findings of a different cortisol responses in the fasting or fed status in healthy or absolute insulin deficient subjects could also be relevant for glucose metabolism in subjects with type 2 diabetes.

The effect of an acute psychological stress on glucose concentration may critically depend on whether stress is applied in the fasting or fed state. A different metabolic response to stress depending on food intake could explain different findings in other clinical trials and contribute to understanding glucose responses to stress. The aim of our study was thus to test whether the effect of acute psychological stress on glucose concentrations is different in the fasting compared to the fed state in type 2 diabetes.

Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes
* oral antidiabetic treatment and/or long acting insulin overnight

Exclusion Criteria:

* full insulin regimen
* pregnancy or breast-feeding
* instable coronary heart disease
* poor visibility
* proliferative diabetic retinopathy
* uncontrolled arterial hypertension
Plantar Pressures After Pressure Release of the Flexor Digitorum Brevis Muscle Versus a Non-emission Laser.

In this study we will test the effects of pressure release on the Flexor digitorum brevis muscle on the plantar pressures variables using a pressure platform.


Eligibility Criteria:
Inclusion criteria:

* Participants who came to the clinic presenting with pain in both heels and who were diagnosed with active or latent myofascial trigger point in bilateral flexor digitorum brevis muscles.
* Myofascila trigger points of flexor digitorum brevis were the only ones diagnosed in the foot.
* All participants with normal body mass, without obesity.

Exclusion criteria:

* Diagnosis of lower limb injury, such as plantar fasciitis, tendinopathy, bursitis, ligamentous injuries.
* History of previous lower limb surgery.
* Participants will not be subjected to ankle stretching or any other treatment.
* Diabetes due to possible elevation of plantar pressure.
* Toe deformities such as hammertoes and hallux valgus due to possible alteration of plantar pressure.
Kineret in the Treatment of Rheumatoid Arthritis

Objective of the study is to gain knowledge about the administration of Kineret in patients with rheumatoid arthritis in the daily routine treatment and not in controlled trials. In the current survey, the investigation of the response rate of Kineret regarding the date of onset of action, the efficacy, as well as the tolerability and safety are of particular interest.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent by the patient
* Rheumatoid arthritis
* Previous methotrexate therapy with inadequate response

Exclusion Criteria:

* Pregnancy
Dermatological Evaluation of Topic Compatibility-Dermacyd Delicata Pocket BR

The purpose of this study is to demonstrate the absence of irritation potential (primary dermal irritability and cumulated dermal irritability) and allergy (sensibilization) of the product Dermacyd Pocket BR.


Eligibility Criteria:
Inclusion Criteria:

* Phototype Skin I,II, III e IV
* Integral skin test in the region

Exclusion Criteria:

* Lactation or gestation
* Use of Antiinflammatory and/or immunosuppression drugs
* Personnel history of atopy
* History of sensitivity or irritation for topic products
* Active cutaneous disease
* Use of new drugs or cosmetics during the study

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Preoperative Physical Activity Improvement With the Use of Activity Trackers Before Radical Cystectomy (PreAct)

A bicentric, open-label randomised controlled trial (RCT) is planned to investigate whether the use of fitness wristbands in a defined preoperative period prior to radical cystectomy leads to a preoperative increase in participants' physical activity (number of steps per day) up to the day of radical cystectomy.

The goal of the PreAct study is to test whether the use of fitness wristbands in a defined preoperative period prior to radical cystectomy with a daily activity goal and feedback on the achievement of this goal improves the participants' physical activity up to the day of radical cystectomy.

In addition to the fitness tracker, we provide each patient with a smartphone. For each fitness tracker a separate account in a fitness application is set up for (e.g. name: tracker1.0 with the corresponding e-mail address and password). Neither the patients in the Daily activity Goal and Feedback arm nor the No Daily Activity Goal or Feedback arm receive the access data to the accounts. However, the patients in the intervention group receive the access PIN for the smartphone. On this smartphone a messaging service and the fitness application are installed. The patient thus receives, for example the wristband tracker1.0, which is registered with the corresponding access data in the fitness application of the smartphone given to them. For the entire preoperative period, the Bluetooth function on the smartphone must always stay activated so that the fitness application and the fitness tracker are continuously connected to each other. A detailed description of the timing and implementation of the intervention are described in "Study design" and "Arm and Interventions".

Eligibility Criteria:
Inclusion Criteria:

* Planned radical cystectomy with bilateral pelvic lymphadenectomy and one of the different forms of urinary diversion (continent vs. incontinent; orthotopic vs. heterotopic) in patients with bladder cancer
* Participants age ≥ 18 years and capacity to consent
* Mobile participant who is not dependent on a walking aid
* The participant declares his or her consent to participate in this study by signing and dating the informed consent form prior to the surgical procedure

Exclusion Criteria:

* Karnofsky performance status scale ≤ 70% (with 70%: Care for self. Unable to carry on normal activity or to do active work (Ambulatory and capable of all selfcare but unable to carry out any work activities). ) (Range: 0 - 100 percent with 0 percent "participant´s death" and 100 percent "no disabilities"
* ASA Physical Status Classification: ASA \> 3 (3: A patient with severe systemic disease)
* ASA 1, 2, 3 if acute or chronic diseases of the musculoskeletal system or the central nervous system are involved that result in a symptomatic restriction of motor and / or, in the last case, neurological function (healing ruptures and fractures, Parkinson's disease, multiple sclerosis, etc.)
* Emergency intervention
General Anesthesia With or Without Local Ear Block in Middle Ear Surgeries

Background: Proper selection of anesthetic technique is important in middle ear microsurgery. Controlled hypotension in ear surgery decreases blood loss with improved quality of the surgical field, however, it is associated with resistance to vasodilators and delayed recovery from anesthesia. The use of local anesthetic technique alone in middle ear surgery decreases bleeding and reduces postoperative pain, however, pain on injection, noise, and head-neck position had been reported with the increased risk of patient injuries.

This study aimed to compare the effects of local ear block combined with general anesthesia versus general anesthesia alone, regarding intraoperative hemodynamics, anesthetic consumption, recovery characteristics, postoperative pain, adverse effects and postoperative complications.

Eighty adult patients undergoing middle ear surgery (tympanoplasty with or without mastoidectomy) were enrolled in the study. Patients were randomized into two equal groups (40 patients each). A standardized general anesthetic technique was used in both groups. Group I, received general anesthesia combined with ear block using 10 ml of 0.25% bupivacaine and (Group II), received general anesthesia alone combined with ear block using 10 ml saline. Propofol 2-3 mg /Kg was administered to induce anesthesia, which was maintained using isoflurane. Hemodynamic variables, surgical conditions including the quality of the operative field, intraoperative fentanyl, vasodilators (propranolol and nitroglycerine), isoflurane consumption, recovery time, postoperative pain, total analgesics consumption and postoperative complications were recorded

Eligibility Criteria:
Inclusion Criteria:

* ASA I or II status,
* scheduled for tympanoplasty with or without mastoidectomy

Exclusion Criteria:

* patient refusal,
* known allergy to local anesthetics
* cardiovascular diseases (myocardial infarction, hypertension and valvular heart diseases) --- cerebrovascular diseases (including transient ischemic attacks), renal, hepatic insufficiency or coagulation abnormality.