cyrilzakka/clinical-trials huggingface dataset:
A Study of the Safety and Efficacy of Tobramycin for Inhalation in Young Children With Cystic Fibrosis

This study's primary goals are to test the safety and effectiveness of Tobramycin for Inhalation (TOBIr) in cystic fibrosis (CF) patients who are between 6 months and 6 years of age. This drug is an antibiotic that is inhaled into the lungs by the patient. It has already been studied and approved by the FDA for treatment of CF patients 6 years and older. Lung fluid will be examined for bacteria before and after the 28-day treatment. The amount of bacteria before and after treatment will be compared. This will indicate whether the antibiotic was effective in killing bacteria in the lungs. Once treatment begins, patients will be monitored every 2 weeks throughout the study (5 exams in 56 days). Half of the patients will receive TOBIr, half will receive a placebo (a substance that looks like TOBIr but contains no medication).


Eligibility Criteria:
Inclusion Criteria:

* Age at least 6 months and less than 6 years
* Diagnosis of cystic fibrosis with 2 clinical features consistent with CF and confirmed by either sweat chloride \>= 60 mEq/L (by quantitative pilocarpine iontophoresis) or by genotype with 2 identifiable mutations consistent with CF.
* One throat or sputum microbiology culture positive for Pseudomonas aeruginosa (Pa) within 2 weeks to 12 months prior to screening.
* Informed consent by parent or legal guardian.

Exclusion Criteria:

* History of adverse reaction to anesthesia or sedation.
* History of aminoglycoside hypersensitivity.
* History of unresolved anemia (hematocrit \< 30%) or thrombocytopenia (platelet count \< 100,000/mm3).
* History of hemoptysis with 30 days prior to screening.
* History of abnormal renal function (serum creatinine \> 1.5 times the upper limit of normal for age).
* History of clinically documented chronic hearing loss.
* Administration of any investigational drug within 30 days prior to screening.
Pharmacokinetics of Meropenem During High-dose CRRT

Assessment of meropenem plasma concentration in critically ill patients who require CRRT (continuous renal replacement therapy). A standard dose of meropenem is administered, i.e. 1 gram every 8 hours.

This is a prospective observational study performed on critically ill patients. Inclusion criteria are a severe infection on admission requiring the use of meropenem and CRRT.

Both medical and surgical patients will be included. Any type of infections can be included (pulmonary, abdominal, urinary tract, etc.) Antibiotics regimen includes one-hour infusion of meropenem (1.0 gram) intravenously every 8 hours.

Blood samples (2 mL) will be collected at the 15, 30, 45, 60, 75, 90, 120, 180, 240, and 480 minutes after each dose of meropenem for 3 consecutive days. The standard arterial canula will be used to obtain samples.

30 minutes after each sample collection, blood will be centrifuged for 10 minutes at 3,000 rpms. Subsequently, supernatant will be collected and frozen.

Serum meropenem concentration will be measured by high-performance liquid chromatography.

Each patient's hemodynamic parameters will be recorded with the use of transpulmonary thermodilution technique (PICCO). Other therapies, i.e. ventilatory support, sedation, an antifungal agent will be given as required.

Eligibility Criteria:
Inclusion Criteria:

* Patients who require ICU treatment due to severe infection
* age 18-80 years
* an eligible consent obtained from the patient or his/her attendant

Exclusion Criteria:

* allergy to meropenem
* lack of consent to participate in the study
* age of patients below 18 or above 80 years
Safety and Efficacy of Neuromultivit in Treatment of Vertebrogenic Radiculopathy

The purpose of the study is to assess the efficacy and safety of Neuromultivit (solution for injections) in treatment of vertebrogenic radiculopathy L5, S1 in comparison with standard therapy. The patients are randomised into two groups: standard therapy group and standard therapy plus Neuromultivit group.

Group 1 (50 patients) receive Neuromultivit (2 ml per day, i.m.) for 7 days, then -Neuromultivit (2 ml per day, i.m.) every other day for 10 days and standard therapy for 20 days.

Group 2 (50 patients) receive only standard therapy for 20 days.

Standard therapy involves:

* Voltaren (100 mg prolonged-released film-coated tablets once daily) for 20 days
* Sirdalud (2 mg tablets three times a day) for 20 days

Eligibility Criteria:
Inclusion Criteria:

* diagnosed vertebrogenic radiculopathy L5, S1
* radicular pain syndrome
* changes in the low back CT and MRI scans
* minimum 40 mm intensity of spontaneous back pain, rated on the VA scale
* 1 month exacerbation phase; nonuse of any B-group vitamins before the trial
* negative urine pregnancy test; Patient Informed Consent

Exclusion Criteria:

* tumors, inflammatory infections, any neurological diseases, imitating the symptoms of radiculopathy
* concomitant life-threatening medical conditions
* simultaneous administration of acetylsalicylic acid, levodopa, prednisolone; any psychiatric diseases
* epilepsy, alcohol and drug addiction
* pregnancy and breast-feeding
* any condition preventing CT and MRI tests, including obesity and special devices
* participation in any other clinical study 1 month before enrollment.
A Trial to Learn if a COVID-19 Therapeutic is Safe and Well Tolerated, and How it Works in the Body of Healthy Adult Participants

The primary objective of the study is to evaluate the safety and tolerability of REGN14284 in healthy participants, as measured by all treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (SAEs).

The secondary objectives of the study are:

* To assess the concentration-time profile of REGN14284 in serum
* To assess the immunogenicity of REGN14284


Eligibility Criteria:
Key Inclusion Criteria:

1. Has SARS-CoV-2-negative test result from a sample collected ≤72 hours prior to randomization as described in the protocol.
2. Has received complete primary series of standard-of-care COVID-19 vaccination per local guidance, completed at least 2 weeks prior to screening
3. Has a body mass index (BMI) between 18 and 31 kg/m2 (inclusive) at the screening visit
4. Is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, laboratory safety testing and ECGs performed at screening and/or prior to administration of study drug

Key Exclusion Criteria:

1. History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, infectious, autoimmune, oncologic, psychiatric or neurological disease, as assessed by the investigator as described in the protocol
2. Presents any concern to the investigator that might confound the results of the study or poses an additional risk to the participant by their participation in the study
3. Was hospitalized (ie, \>24 hours) for any reason within 30 days of the screening visit
4. Has a history of alcohol or drug abuse as determined by the investigator
5. Has a history of significant multiple and/or severe allergies, or has had an anaphylactic reaction to drugs or food as described in the protocol
6. Use of any medications or nutritional supplements within approximately 5 half-lives or 2 weeks, whichever is longer, prior to first administration of the study drug through the end of the study, except for the permitted medications listed as described in the protocol
7. Participated in any clinical research study evaluating another investigational drug including biologics or specific immunotherapy, within at least 5 half-lives or 90 days (whichever is longer) of an investigational biologic drug, or at least 4 weeks for small molecules or other investigational drugs, prior to the screening visit

NOTE: Other protocol defined inclusion / exclusion criteria apply
Prosthesis Guided Speech Rehabilitation of T1/T2 Cancers of the Tongue

This study will fill a scientific gap in the current knowledge providing data for evaluation of the palatal augmentation prosthesis (PAP) as a therapeutic modality in a robust scientific randomized prospective clinical trial.

Positive outcomes from this study have the potential to dramatically alter the most common issues of oral cancer therapy, namely speech and swallowing functions. Patients will have been diagnosed with a cancer lesion on their tongue requiring surgery and removal of part of the tongue. Smaller cancers of the tongue are sized as T1 or T2. For patients with smaller lesions, a PAP, which can aid in speaking and swallowing is not routinely provided with the device.

This study will randomize patients into two arms; one for oral cancer patients that receive a small device, similar to a denture, called a PAP. The other arm will be patients who are a control and who will not receive a PAP.

The PAP requires patients to have a dental mold created. A dentist customizes the PAP to fit their mouth.

The study will investigate whether the PAP improves speech following tongue cancer as measured by three different scales. Both groups will see a speech language therapist to have their speech evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a new diagnosis of a T1/T2 tongue cancer

Exclusion Criteria:

* Patients with recurrent disease
* Patients with a history of prior head and neck radiation therapy
* Patients who lack adequate maxillary dentition to support a palatal augmentation prosthesis
Study of Satisfaction of Patients and Care Providers for an Alternate Follow-up With In-hospital Consults and Tele-consult for Patients With Cystic Fibrosis

The pandemic forced us to develop home follow-up for patients with chronical diseases . In the same time, the new era of treatment for cystic fibrosis considerably improves the health of patients with this pathology.

This study aims to assess the satisfaction of patients and care providers for an alternated follow-up between tele-consults and in-hospital consults during one year for patients with cystic fibrosis treated by Kaftrio® since at least one year and stable.


Eligibility Criteria:
Inclusion Criteria:

* patients with cystic fibrosis
* Patients treated with Kaftrio® since one year
* autonomous patients
* patients without cognitive disorders
* Patients voluntary for this follow up
* patients with two tele-communication tools
* patients with FEV1\>50%
* patients with less of 2 antibiotics cure per year

Exclusion Criteria:

* all transplanted patients
* Pregnant patients
* Particular follow up needed in-hospital consult
* Persons deprived of their liberty by a judicial or administrative decision
* Persons subject to psychiatric care
* Persons admitted to a health or social establishment for purposes other than research
* Persons not affiliated to a social security scheme or beneficiaries of a similar scheme
Assessing SleeP IN Infants With Atopic Dermatitis by Longitudinal Evaluation

The SPINDLE study will examine sleep in infants with atopic dermatitis by serial assessment over the first year of life, in comparison to infants without atopic dermatitis. Sleep will be assessed using electroencephalography, actigraphy, and sleep questionnaires.

Infants will be recruited at 6 to 8 months and followed up until 18 months of age. Sleep electroencephalography will be performed at 6 to 8 months. Sleep actigraphy will be performed at 6 to 8 months and 12 months. Infant sleep questionnaires will be completed on a monthly basis, and parental sleep questionnaires will be completed at 6 to 8 months, 9 to 10 months, and 12 months. A neurodevelopmental assessment will be performed at 18 months.

Eligibility Criteria:
Inclusion Criteria:

- Moderate to severe atopic dermatitis

Exclusion Criteria:

* Premature birth (under 37 weeks gestation)
* Severe medical condition (such as epidermolysis bullosa or ichthyosis) at time of enrolment that would complicate assessment for AD or preclude the use of investigational tools, or other major health problems (especially genetic or metabolic) that would have implications for neurodevelopment
* Any medical condition requiring the using of sedating medications (eg antihistamines)
Near INfrared Spectroscopy in Aortic valvE ReplacemenT

Transcatheter aortic valve implantation (TAVI) is an alternative for patients, that are considered to be too sick for conventional aortic valve replacement. There is no conclusive opinion about the best anesthesiologic management of these patients. Sedation and general anaesthesia are both adequate and the current literature shows no benefit towards one of these methods.

This study wants to investigate the influence of these two anesthesiologic managements on the cerebral oxygen saturation during the "rapid pacing"-period during valvuloplasty. The patients are randomised allocated to one of these two anaesthesiological managements. The investigators use the Near-Infrared Spectroscopy (NIRS) to measure the cerebral oxygen saturation. Parallel there will be a measurement of cerebral biomarkers to monitor cerebral hypoxia.


Eligibility Criteria:
Inclusion Criteria:

* informed consent
* transcatheter aortic valve implantation

Exclusion Criteria:

* denial by patient
* denial by screening anaesthesist
* active neurodegenerative disease
The Effect of Using Smart Phone Application for Enhancing Adherence to Home Exercise

Background: Knee osteoarthritis (OA) is a serious condition and requires good adherence to interventions such as exercises to achieve optimal management. The use of smart phone technologies could be such a strategy to enhance adherence to the home exercise program (HEP) thus improve pain, physical function and lower limb strength. The study aimed to examine the effect of using an innovative smart phone app on enhancing the adherence to home exercise programs among female older adults with knee OA in Saudi Arabia and the effectiveness of this HEP which delivered through an app, on pain and physical function. Methodology: 40 females aged 50 years or older with knee OA (20 per study arm) recruited to a randomized control trial that uses a parallel study design. All participants assessed and received an education and a set of a home exercise program for knee OA, Participants randomized into the App arm (experimental group) received their HEP in the smart phone application. Participants randomized to the other arm (control group) received HEP in a paper hand-out. After enrolment, the study outcomes were assessed at week three and week six. The primary outcomes were self-reported adherence, ANPRS, and Ar-WOMAC.


Eligibility Criteria:
Inclusion Criteria:

* Female older adults aged 50 and above.
* Diagnosed with unilateral or bilateral chronic knee OA (diagnosed ≥ six months).
* Mild to moderate pain intensity (score ≤ 7 on the Arabic Numeric Pain Rating Scale).
* Ambulate independently.
* Literate, familiar to use smart mobile phone or tablet.
* No previous exercising within the last six months.

Exclusion Criteria:

* Comorbidities that affect their health and wellness (neurological conditions, unstable cardiopulmonary conditions, mental disorders with score \< 24 on Mini-Mental State Examination)
* Waiting for surgical intervention.
* Recent trauma (fall/ accident).
Evaluation of the Rate of Consultations in Gynecological Emergencies Under "Non-urgent" Management

The difference between the demand and the current medical supply poses a real public health problem in terms of the organization of health care systems.

For several years in France, there has been an increase in the number of consultations in emergency services, particularly gynaecological ones. The two causes put forward are a change in user behavior with an increase in requests for rapid but "non-urgent" care and the inadequacy of the supply of care in the private sector.

Few studies have been carried out concerning gynaecological emergencies, unlike general emergencies.

The aim of this study is to measure the frequency of consultations in gynaecological emergencies for non-emergency reasons.

The interest of this study is therefore mainly on the optimization of the care system with the emphasis on the city-hospital network in the management of these patients.


Eligibility Criteria:
Inclusion Criteria:

* Patient whose age is ≥ 18 years
* Patient not pregnant or pregnant \< 14 SA
* Patient admitted for gynecological emergency care at Paris Saint-Joseph Hospital between 01/02/2021 and 30/04/2021
* French-speaking patient

Exclusion Criteria:

* Patient under guardianship or curatorship
* Patient deprived of liberty
* Patient under court protection
* Patient objecting to the use of her data for this research
Incidence and Characteristics of Postoperative Cognitive Dysfunction in Elderly Quebec Francophone Patients

The purpose of this study is to determine what percentage of patients have cognitive problems (for example, memory or concentration difficulties) after surgery and anesthesia, what the characteristics of these problems are, and whether they persist over time. In particular, the investigators want to study this in the French-speaking Quebec population with cognitive evaluation tools adapted for this population.

Multiple experimental and observational studies have established that a non-negligible percentage of individuals undergoing surgery and anesthesia will experience a postoperative decline in mental abilities. These cognitive changes can range from postoperative delirium to more subtle and longer lasting (weeks to months) impairments; these latter changes are often referred to in the literature as postoperative cognitive dysfunction (POCD). While the precise causes of POCD remain nebulous, a clear epidemiological risk factor is advanced age - a demographic group that accounts for an increasing percentage of elective surgeries in North America. Several RCTs have attempted to link specific aspects of anesthesia, such as depth of anesthesia, regional vs general anesthesia, hemodynamic parameters, specific anesthetic agents, etc., to the risk of developing POCD in both the elderly and general populations. Results have often been conflicting and, based on current evidence, it is difficult to identify any specific anesthetic strategy that clearly reduces the risk of POCD. The present study aims to establish the incidence and neuropsychological characteristics of POCD in the investigator's local patient population as well as to establish the feasibility of pre- and postoperative cognitive testing with assessment tools adapted to and validated for Quebec francophones in order to lay the groundwork for future studies by the research group of interventions targeting specific anesthetic techniques and monitoring modalities.

Eligibility Criteria:
Inclusion Criteria:

* 70 years of age or older
* Undergoing elective abdominal, gynecological, or urological surgery requiring post-operative hospitalization and with an expected anesthesia time of 60 minutes or more
* Seen in pre-operative clinic of Maisonneuve-Rosemont hospital

Exclusion Criteria:

* Known dementia or other cognitive impairment
* Psychiatric disease
* Significant hearing or vision impairment
* Inability to communicate in French
* Allergy or other contraindication to medications in standardized anesthesia protocol
Assessment of Two New Electronic Cigarettes in Cigarette Smokers

The purpose of this study is to determine differences in nicotine delivery, user behavior, subjective effects, and physiological effects, when cigarette smokers use an two new electronic cigarette devices (JUUL and IQOS) relative to their using their own brand of cigarettes.


Eligibility Criteria:
Inclusion Criteria--participants must be:

* healthy (determined by self-report)
* between the ages of 18-55
* willing to provide informed consent
* able to attend the lab and abstain from tobacco/nicotine as required and must agree to use designated products according to study protocol
* cigarette smokers

Exclusion Criteria:

* Women if they are breast-feeding or test positive for pregnancy (by urinalysis) at screening.
* Individuals who weigh less than 110 pounds

Some study details about the eligibility criteria are purposely omitted at this time to preserve scientific integrity. Full details will be posted at the conclusion of the study.
Heartfulness Meditation and Corporate Burnout

The purpose of this study is to evaluate the effect of a 4-week heart-based meditation practice wellness workshop on burnout and emotional wellness in corporate employees. Corporate employees can be defined as individuals who work in large institutions with greater than 300 employees.

The specific aim of this study is to assess changes in scores measuring symptoms of emotional exhaustion, depersonalization, and personal accomplishment using the Maslach Burnout Index. We hypothesize that the meditation wellness practice will be associated with reduction in burnout for those who take part in the meditation program in comparison to the participants who did not meditate and participate in the wellness program.


Eligibility Criteria:
Inclusion Criteria:

* Adults above 18 years of age willing to participate in the study.

Exclusion Criteria:

* Individuals less than 18 years of age, active suicidal ideation, current or past diagnoses of serious psychotic disorders- schizophrenia, personality disorders and post-traumatic stress disorder.
Can Austrian Lung Specialists' Assessments of Lung Cancer Screening be Influenced by a Fact Box?"

Lung cancer is the most frequently dianosed cancer worldwide. To date, no screening method has been able to establish itself as routinely recommended by the guidelines. In this prospective study with 1:1 randomized questioning using an Internet tool, physicians will be asked in 2 phases (before and after intervention with a fact box) about their assessment of the benefits and risks of lung cancer screening by thoracic computed tomography and about a potential intention to change referral behavior. Randomly assigned, half of the participants will receive the same information in addition to the fact box graphically presented as a Cates plot.

The topic of lung cancer screening is highly topical and relevant in that this cancer is the most frequently diagnosed worldwide and has the highest mortality among malignancies. To date, no screening method has been able to establish itself as routinely recommended by the guidelines. In the recently published Dutch-Belgian NELSON study on low dose thoracic CT as a screening method in high-risk patients (smokers and ex-smokers), an - albeit small - reduction in mortality was shown in the screening group vs. the control group).

A prerequisite for a detailed information of the patient about the implementation as well as the advantages and disadvantages of screening is that the physician has risk competence and knows and is able to interpret the screening data. The use of a fact box can be used to improve knowledge of statistical data.

In this prospective study with 1:1 randomized questioning using an Internet tool, physicians will be asked in 2 phases (before and after intervention with a fact box) about their assessment of the benefits and risks of lung cancer screening by thoracic computed tomography and about a potential intention to change referral behavior. Randomly assigned, half of the participants will receive the same information in addition to the fact box graphically presented as a Cates plot.

Eligibility Criteria:
Inclusion Criteria:

* Members of the Austrian Society of Pneumology (ÖGP) with a completed pulmonary subject and members of the Austrian Radiological Society (ÖRG), Society for Medical Radiology and Nuclear Medicine with a completed subject.

Exclusion Criteria:

* Non members of the Austrian Society of Pneumology (ÖGP)