cyrilzakka/clinical-trials huggingface dataset:
Anti-IL5 and Other Biotherapies in Cystic Fibrosis

Our project is to describe retrospectively and prospectively CF patients treated with biotherapy in French CF centers.

Main objective: To describe the clinical and paraclinical course of CF patients before and after treatment with anti-IL5 and other biotherapies since 2019.

Secondary objective: To describe adverse events potentially related to the biotherapies.

•Background: ABPA and asthma associated with cystic fibrosis impact the CF course with a more rapid decline in lung function.

Corticosteroid therapy can be harmful and must be avoid in CF to prevent diabetes, osteoporomalacia or mycobacterium infections.

Monoclonal antibodies have the marketing authorization for severe uncontrolled asthma and, up to now, some CF patients with ABPA or severe asthma and high plasma IgE levels benefit from omalizumab.

Anti-Il5 agents are available since February 2019 and have demonstrated their efficacy in severe and hypereosinophilic asthma control (plasma eos.\>300mmol/L).

Some patients with CF who have severe asthma or ABPA are still poorly controlled despite Omalizumab with other treatments (steroids and/or azoles). Some of them have persistent hypereosinophilia suggesting a possibility to treat with antiIL5 antibodies.

About 5% of patients have biotherapy treatment criteria, some have already received it, others are elective to such treatment and will receive in the future.

Methods:

Our project is to describe retrospectively and prospectively the clinical history of CF patients eligible for biotherapy in French CF centers.

Main objective: To describe the clinical and paraclinical course of CF patients before and after treatment with anti-IL5 and other biotherapies since 2019.

Secondary objective: To describe any adverse events potentially related to the biotherapies.

Eligibility Criteria:
Inclusion criteria:

* Cystic fibrosis (2 known variants)
* Age ≥ 6 years
* Plasma hypereosinophilia ≥ 300/µl
* Uncontrolled ABPA or uncontrolled asthma, or failure of other biotherapy (intolerance, ineffectiveness)

Exclusion criteria

- Refusal to participate in this research
Happy Smooth Study

The purpose of this study is to evaluate the stool composition and GI tolerance of an experimental formula with a new fat blend plus L. reuteri vs control formula.

Double-blind, randomized, controlled clinical trial. The purpose of this study is to evaluate the stool composition and GI tolerance of 140 healthy, term infants fed with an infant formula with a new fat blend plus L. reuteri vs a standard infant formula. All enrolled infants will participate in the trial for approximately 71 days.

Eligibility Criteria:
Inclusion Criteria:

* Written Informed Consent
* Infants whose parents/LAR have reached the legal age of majority in the Philippines
* Infants whose parent(s)/LAR are willing and able to comply with scheduled visits, and the requirements of the study protocol
* Infants whose parent(s)/LAR are able to be contacted directly by telephone throughout the study
* Healthy term, singleton infant at birth
* Between 21 to 28 days post-natal age at enrollment visit
* Weight-for-age ≥ 5th and ≤ 95th percentile according to World Health Organization growth tables/charts
* Infants of parent(s)/LAR who have previously made the decision to formula feed their infant at the time of enrollment

Exclusion Criteria:

* Infants with conditions requiring infant feedings other than those specified in the protocol
* Infants receiving complementary foods or liquids
* Infants who have a medical condition or history that could increase the risk associated with study participation or interfere with the interpretation of study results
* Infants who are presently receiving or have received medications that could interfere with the interpretation of the study results
Impact of Different Modes of Ventilation With Laryngeal Mask Airway on Pediatric Cataract Surgery

This study will be conducted to evaluate effects of different modes of ventilation on pediatric cataract surgery aiming to a peri-operative stable anesthesia, better surgical satisfaction and post operative recovery. It is hypothesized that controlled ventilation without muscle relaxation will be advantageous to other modes in providing adequate surgical satisfaction with considerable depth of anesthesia and better recovery profile.

Anesthetic management in pediatric cataract surgery constitutes a special challenge. Any eye movements can lead to an unsatisfactory surgical field and increase the risk of ophthalmological complications. Achieving adequate ventilation of children is considered another challenge due to huge variability in size and lung maturity. Spontaneous breathing is a popular mode of ventilation with several beneficial effects. Controlled ventilation without muscle relaxation using laryngeal mask airway is attractive option because the side effects of muscle relaxants are avoided. Therefore, this study will be conducted to evaluate effects of different modes of ventilation on pediatric cataract surgery aiming to a peri-operative stable anesthesia, better surgical satisfaction and post-operative recovery. This prospective, randomized, comparative clinical study will include 150 children who will be scheduled for elective cataract surgery under general anesthesia in Mansoura ophthalmology center over one year. Informed written consent will be obtained from parents of all subjects in the study after ensuring confidentiality.The study protocol will be explained to parents of all patients in the study who will be kept fasting prior to surgery. Patients will be randomly assigned to three equal groups according to computer-generated table of random numbers using the permuted block randomization method. In the first group, spontaneous ventilation will be maintained with pressure support; while in the two other groups, mechanical ventilation will be applied with pressure controlled modes. The collected data will be coded, processed, and analyzed using SPSS program. All data will be considered statistically significant if P value is ≤ 0.05.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiology (ASA) I and II patients.
* Scheduled for elective cataract surgery.

Exclusion Criteria:

* Parental refusal of consent.
* Contraindication to use of supraglottic airway device as gastroesophageal reflux and oropharyngeal pathology.
* Hyperactive airway disease or respiratory diseases.
* Children with developmental delays, mental or neurological disorders.
* Bleeding or coagulation diathesis.
* History of known sensitivity to the used anesthetics.
* Previous surgery in the same eye.
HIV Acquisition and Life Course of Born-abroad Men Who Have Sex With Men Living in Ile-de-France: the GANYMEDE Study

In France, men who have sex with men (MSM) born abroad are the most affected population by HIV, in terms of HIV incidence and prevalence of undiagnosed infections. Close to 50% of born-abroad HIV-infected MSM are living in the region of Ile-de-France, which is the metropolitan area of Paris. Recent European data, not including France, suggest that born-abroad MSM have the highest rate of post-migration HIV acquisition. Many vulnerability factors could explain le burden of HIV in this group of the population.

A better understanding of vulnerability factors related to post-migration HIV acquisition should allow to improve HIV prevention and screening strategies among born-abroad MSM living in France. This, in turn, should reduce the burden of HIV in this population in France.

A better understanding of vulnerability factors related to post-migration HIV acquisition should allow to improve HIV prevention and screening strategies among born-abroad MSM living in France. This, in turn, should reduce the burden of HIV in this population in France.

Multicenter, cross-sectional, two-year study in the region Ile-de-France. The study is based on the self-completion of a questionnaire, built after an exploratory qualitative study.

Constitution of a representative sample of born-abroad HIV-infected MSM from patients followed up for HIV in Paris area. Questionnaires will collect data needed to estimate the post-migration HIV acquisition rates, and will explore contextual and individual factors leading to high exposure to HIV.

The participants will complete a questionnaire translated into 5 languages (English, Spanish, Portuguese, Arabic, and Russian) in order to allow almost all of the participants to answer the survey themselves, without assistance. In order to not exclude those who cannot read, or those who do not master any of the 6 languages offered, the questionnaire may be administered with the assistance of a member of the research team of the associated center, including through a telephone interpretation service. A brief eCRF will collect clinical and biological data, and historical viral sequences in associated virology departments, when available.

Eligibility Criteria:
Inclusion Criteria:

* Cis-gender men who report having sex with men;
* Over 18 years of age;
* Type 1 HIV infected;
* Born in a country other than France and arrived in France at the age of 15 at the earliest;
* Followed in Ile-de-France for their HIV infection and having consulted at least once in the participating center during the last 12 months;
* Non-opposition to the collection of their health data, after being well informed of the study and the patient rights in accordance with RGPD and LIL (French regulation)

Exclusion Criteria:

* Somatic or psychiatric pathology making it impossible to participate in an investigation;
* Communication disorder making it impossible to read (or oral responses in the event of assisted questionnaire completion).
Bridging Study of L059 (Levetiracetam) in Patients With Epilepsy by Double Blind Method

Double-blind, randomized, placebo-controlled, multi center trial to evaluate the efficacy and safety of levetiracetam as adjunctive treatment in adult Japanese epileptic subjects with partial onset seizures.


Eligibility Criteria:
Inclusion Criteria:

* simple and/or complex partial seizures with or without secondary generalization, and first partial seizure \>= 2 years before selection visit;
* seizures classifiable according to the ILAE classification;
* minimum of 12 partial seizures per 12 weeks with a minimum of two partial seizures per 4 weeks from the selection visit to the end of the baseline period ;
* exposed to two or more standard AEDs;
* taking up to three of the standard AEDs, at the initiation of the trial.

Exclusion Criteria:

* medication influencing the CNS, except for medication taken for antiepileptic treatment;
* partial seizures uncountable due to clustering, including status epileptics, during the 3 months prior to the selection visit;
* history of cerebrovascular disease including transient ischemic attack (TIA) and progressive cerebral disorder or progressive neurological disorder;
* presence or history of any clinically significant allergic condition and complication or history of significant alcohol abuse or drug abuse in the past.
Short Arc Multifidus Study

Patients will be performing Logan short arc banding protocols to see the effect on multifidus size

The subjects will initially be scanned by diagnostic ultrasound by to assess the cross sectional area of their lumbar multifidi. Then they will perform 3 sets of 30 second periods of Logan Short Arc Banding on the ATM machine twice a week for 4 weeks and then they will be scanned again using diagnostic ultrasound to assess the effects of the rehabilitation exercise.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female ages 18-54

Exclusion Criteria:

* Asymptomatic of: Low Back Pain, previous spinal injury, surgery or other condition affecting the spine, local infection, injury or malignancy; pregnancy or any condition affecting muscle reaction time.
Monitoring Blood Flow and Breathing Using a New Device (RFII) Compared to the Gold Standard Device in Post Operative Cardiac Patients

The purpose of this study will be to compare standard of care invasive methods to an FDA approved non-invasive device and a novel wireless non-invasive device, both manufactured by Non-Invasive Medical Technologies Inc., with the goal of correlating the data generated by the novel device to the measurements taken by the standard of care invasive monitors.


Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Weight - 36-136 Kilograms
* Height - 1.52 meters - 1.92 meters (5'- 6'4")
* Scheduled for open heart surgery during the study period

Exclusion Criteria:

* ECG lead adhesive allergy or sensitivity
* Pregnant Patients
* Prisoners
* Cognitively impaired
* Patients requiring mechanical cardiac support, or requirement for hemodialysis
* Patients not requiring pulmonary artery catheters for medical management.
* Patients with significant valvular disease will be enrolled if there is no significant post-repair valvular dysfunction as determined by intraoperative transesophageal echocardiography
Safety, Pharmacokinetics (PK) and Tolerability Study of a Novel Drug for Treatment of Bacterial Infections

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetic profile of an antibacterial compound for treatment of hospital acquired Gram negative infection.

Single-center, randomized, placebo-controlled, double-blind study to determine the safety, tolerability and pharmacokinetic profile of compound in single and multiple doses in young healthy males.

Eligibility Criteria:
Inclusion Criteria:

* Young healthy males, 18-45 years (inclusive) of age
* Healthy as judged by a responsible physician with no clinically significant abnormality
* Surgically sterile OR agrees to abstain from sexual intercourse with a female partner OR agrees to use a condom and spermicide during sexual intercourse with a female partner who uses another form of contraception
* Body weight above 50 kg (Body Mass Index between 19 and 30 kg/m2)
* Non-smokers
* Willing and able to comply with study instructions and commit to all follow-up visits
* Ability to understand, agree to and sign the study Informed Consent Form (ICF)

Exclusion Criteria:

* History of serious adverse reactions or hypersensitivity to any drug; or who have a known allergy to any of the test product(s) or any components in the test product(s); or history of hypersensitivity or allergic reactions to any of the study preparations as described in the Investigator's Brochure
* Any clinically significant central nervous system, cardiac, pulmonary, metabolic, renal, hepatic or gastrointestinal conditions
* Abnormal physical findings of clinical significance at the screening examination or baseline
* History of orthostatic hypotension
* Clinically significant abnormal laboratory values
* Presence or history of allergies requiring acute or chronic treatment
* 12 lead ECG abnormalities
* Major surgical interventions within 6 months of the study
* Has a positive pre-study Hepatitis B surface antigen; positive hepatitis C (HCV) antibody or detectable HCV ribonucleic acid (RNA); or positive HIV antibody result
* Use of prescription or non-prescription drugs
* Has a history of regular alcohol consumption
* Loss of 500 mL blood or more during the 3 month period before the study
* People that follow vegetarian or vegan diet
* Symptoms of a significant somatic or mental illness in the four week period preceding drug administration
* History of drug abuse or dependence within 12 months of the study
* The subject has a positive pre-study alcohol or urine drug screen
* Concurrent participation in another drug or device research study or within 60 days of post participation in another drug or device study
* Considered by the Investigator to be unsuitable candidate for this study
Optetrak Posterior Stabilized Versus Optetrak Hi-Flex

The purpose of this study is to evaluate the differences in clinical outcomes between the Optetrak® Posterior Stabilized ("Optetrak® PS", Exactech, Gainesville, FL) and the Optetrak® Hi-Flex™ ("Optetrak® HF", Exactech, Gainesville, FL) knee designs.

The purpose of this study is to evaluate the differences in clinical outcomes between the Optetrak® Posterior Stabilized ("Optetrak® PS", Exactech, Gainesville, FL) and the Optetrak® Hi-Flex™ ("Optetrak® HF", Exactech, Gainesville, FL) knee designs. The null hypothesis is that there is no difference in postoperative knee flexion between the Optetrak® PS and Optetrak® HF groups.

Eligibility Criteria:
Inclusion Criteria:

1. Patient is indicated for total knee replacement with a posterior stabilized device.
2. Patient is between the ages of 50 and 80 years old
3. Patient has a Body Mass Index (BMI) \< 35.0 using the following method (or comparable method)

   • BMI = Weight (lbs.) ÷ Height (in.)2 x 703
4. Patient is skeletally mature.
5. Patient is willing to participate by complying with pre and postoperative visit requirements, over at least a 1-year period, including completion of studyrequired questionnaires.
6. Patient is willing and able to review and sign a study Informed Consent.

Exclusion Criteria:

1. Patient has a Body Mass Index (BMI) \> 35.0 using the following method (or comparable method)

   • BMI = Weight (lbs.) ÷ Height (in.)2 x 703
2. Patient is skeletally mature
3. Patient is willing to participate by complying with pre and postoperative visit requirements, over at least a 1-year period, including completion of study required questionnaires.
4. Patient is willing and able to review and sign a study Informed Consent.
Pharmacokinetic Study on the Addition of Aprepitant to Cisplatin - Etoposide Treatment in Lung Cancer Patients

The purpose of this study is to determine whether aprepitant can be used in the Cisplatin - Etoposide chemotherapeutic regimen.

Aprepitant acts initially as a moderate inhibitor of CYP3A4 followed by a short period of CYP3A4 induction. Etoposide is a substrate of CYP3A4 and may therefore be suvject to a drug interaction with aprepitant.

CE can be classified as a highly emetogenic chemotherapeutic regimen and the use of aprepitant may therefore be considered when no clinically relevant drug interaction with etoposide can be determined.

Eligibility Criteria:
Inclusion Criteria:

* between 18 and 75 years of age
* able and willing to sign informed consent form
* indication for treatment with CE regimen
* subject is expected to receive at least 2 cycles of CE regimen
* able to swallow capsules

Exclusion Criteria:

* history of sensitivity/idiosyncrasy to aprepitant or excipients
* condition that might interfere with drug absorption, distribution metabolism or excretion.
* history or current abuse of drugs, alcohol or solvents
* inability to understand the nature and extent of the trial and procedures
* participation in a drug trial within 30 days prior to the first dose
* febrile illness within 3 days before the first dose
* concomitant use of agents that are known to interfere with aprepitant pharmacokinetics
* abnormal liver or renal function
Nutritional Intervention With the Dietary Supplement, Immunocal® in MCI Patients: Promotion of Brain Health

Alzheimer disease (AD) is a dementing illness characterized by progressive neuronal degeneration, gliosis, and the accumulation of intracellular inclusions and extracellular deposits of amyloid in discrete regions of the basal forebrain, hippocampus, and the association cortices. Mild cognitive impairment (MCI) refers to individuals with cognitive impairment (often memory loss) that fails to meet clinical criteria for AD or another dementing illness.


Eligibility Criteria:
This study is recruiting Mild Cognitive Impaired (MCI) patients from the Memory Clinic of the Jewish General Hospital only.

Inclusion Criteria:

Subjects meeting diagnostic criteria for MCI:

* Age 55-85
* Male or female
* Non-smoker

To ensure that the subject can physically fit in the scanner:

1. body weight ≤ 120 kg and
2. with a linear dimension max 55cm (shoulders or belly) Expected to remain in the greater Montreal area for the duration of study.

Exclusion Criteria:

* Presence of an active, systemic illness (e.g., cancer, rheumatoid arthritis, etc.) or other chronic neurological (e.g. Parkinson's disease, multiple sclerosis) or psychiatric (e.g. major depression, schizophrenia) disease.
* Subjects taking other experimental medications or psychotropic agents.
* Subjects with MRI contraindications such as pacemaker, aneurysm clips, artificial heart valves, metal fragments, foreign objects or claustrophobia.
* Ambulatory subjects: As wheelchair-bound subjects present additional difficulties for transportation and MRI scanning.

Musculoskeletal abnormalities that preclude the ability of the subject to lie on his/her back for 1hr during MRI scanning.

* Subjects who have a protein restricted diet as per their medical history.
* Pregnancy
* Subjects using N-acetylcysteine, α-lipoic acid supplements, other whey protein supplements or Vitamin C, within 2 months of enrolment and during the entire 6 months study period.
* Allergies to milk proteins/ Milk protein intolerance
Biennial CEM in Women with a Personal History of Breast Cancer

This is a prospective clinical trial that will examine if biennial contrast-enhanced mammography added to annual 3D mammography (tomosynthesis) substantially improves breast cancer detection with minimal increase in false-positives, in women with a personal history of breast cancer.

The investigators seek to determine if improved breast cancer detection is maintained with biennial contrast-enhanced mammography (CEM) added to annual digital breast tomosynthesis (DBT) with overall fewer false positives than from annual DBT plus CEM. The investigators will offer biennial CEM exams for eligible patients. Enrolled participants will have a baseline CEM exam with their routine DBT exam, and then have another CEM exam 24 months after their baseline CEM exam and then again at 48 months. Participants will continue to have their annual DBT exams during this time as a part of their usual care. Two radiologists (one primary) will evaluate each pair of examinations by sequentially interpreting each of DBT and CEM in opposing order (primary reader DBT then CEM and secondary reader CEM then DBT), initially blinded to the other modality. We expect that with biennial screening, at least a similar number of cancers will be detected with CEM (and possibly more that were occult on the DBT-only screen 12 months prior), with a similar incremental false-positive rate and at least similar (if not improved) overall positive predictive value (PPV1).

Eligibility Criteria:
Inclusion Criteria:

* Asymptomatic women, ages 30-79, with a personal history of breast cancer who are at least one year out from any breast cancer surgery and/or treatment and are scheduled to have a routine annual mammogram with tomosynthesis (DBT).

Exclusion Criteria:

* Women with a history of prior moderate or severe iodinated contrast reaction \[only those with a prior mild reaction that can be managed by pre-medication AND with and a strong desire to participate will be allowed to participate. However, among these women with a mild sensitivity, if they are allergic to Benadryl (one of the premedications), they will be excluded\].
* Women with implant(s) in the breasts to be screened (as this creates artifacts and diagnostic performance of imaging in women with implants likely does not generalize to those without implants, and the sample size with implants would be too small to infer conclusions.
* Women who have had bilateral mastectomy
* Women with a history of kidney failure or estimated glomerular filtration rate (eGFR) \< 45 mL/min
* Pregnancy or lactation
* Women actively being treated for cancer of any type with chemotherapy
* Having only one kidney
* Women with stage 4 metastasis to visceral areas or brain
* Women who have a screening breast MRI exam within 24 months prior to the current round of CEM.
* Women who had a CEM exam within the prior 23 months