cyrilzakka/clinical-trials huggingface dataset:
Therapeutic Drug Monitoring-baSed adalimuMab De-escalatiOn in nOn-infecTious cHronic Uveitis

Uveitis and its complications are thought to account for 10 to 15% of preventable blindness in Western countries. The diagnosis of chronic non-infectious uveitis (CNUI) can be made after exclusion of pseudo uveitis or infectious uveitis, in the case of any persistent uveitis or uveitis with frequent relapses occurring less than 3 months after cessation of treatment. Adalimumab (ADA), an anti-TNFα monoclonal antibody, has marketing authorization and is widely used in the treatment of UCNI as a relay to corticosteroids. The use of ADA has been optimized, in particular through Therapeutic Drug Monitoring (TDM), based on the determination of serum ADA levels and anti-ADA antibodies. Recently, an article showed that a strategy of spacing ADA administrations in RA patients with concentrations \>8 μg/mL was not inferior to standard.

There is currently no formal recommendation for spacing ADA administration in patients with chronic noninfectious uveitis, but promising data from a recent retrospective study conducted by the Croix-Rousse team, led to the proposal of a decision support algorithm. Following the example of what has been shown in rheumatoid arthritis, the investigators propose to compare a strategy of spacing ADA administrations in patients with a satisfactory clinical response associated with high serum ADA concentrations.

Eligibility Criteria:
Inclusion Criteria:

* Informed and having signed the study consent form
* Age ≥ 18 years
* NICU according to the Standardization of Uveitis Nomenclature (SUN) criteria
* Complete ophthalmological response for ≥ 48 weeks (96 weeks for uveitis related to Behçet's disease), all treatments combined
* On ADA 40mg / 14 days for ≥ 24 weeks (i.e. achievement of the steady state for ADA concentrations)
* Not having received systemic corticosteroid therapy for ≥ 12 weeks

Exclusion Criteria:

* Inability or refusal to understand and/or sign the informed consent form to participate in the study.
* Inability and/or refusal to carry out the follow-up examinations required for the study.
* Modification of any background immunomodulatory treatment (e.g. methotrexate, hydroxychloroquine, mycophenolate, etc.) associated with ADA, during the 12 weeks prior to inclusion.
* Uveitis suspected or proven to be of infectious origin
* Planned surgery (or other foreseeable medical event) requiring discontinuation of ADA for the duration of the study.
Efficacy and Safety of the Switch From Sirolimus to Everolimus in Stable Maintenance Renal Transplant Patients Receiving a Calcineurin Inhibitor Free Regimen

The purpose of this study is to assess if a combination of everolimus, steroids, and mycophenolate mofetil is associated with a better renal function than sirolimus.


Eligibility Criteria:
Inclusion Criteria:

* First or second renal transplantation (1 to 10 years post-transplant)
* Treatment with sirolimus + mycophenolate mofetil + steroids + ACE inhibitor or angiotensin II receptor antagonist + statin

Exclusion Criteria

* Treatment with a CNI or azathioprine
* Vascular rejection or biopsy-proven acute rejection within 3 months prior to screening
* Severe dyslipidemia Other protocol-defined inclusion / exclusion criteria may apply
Intervention to Support Participation in Regular Exercise in the Elderly (INSPIRE)

The investigators will conduct a 1-year prospective and randomized study to evaluate the initial efficacy of positive affect vs. an educational control to motivate physical activity in older adults with high burdens of chronic disease.

Older adults with multiple chronic diseases are at high risk for both disability and adverse clinical events, outcomes that can be improved with physical activity, but there have been no trials to establish physical activity recommendations or clinical guidelines for this vulnerable population. A recent randomized controlled trial conducted by Dr. Peterson established the efficacy of inducing positive affect-a feeling of happiness and well-being-in motivating physical activity in older adults with cardiovascular disease. This new randomized controlled trial will pilot test the a new PAIRE (Positive Affect Induction for Regular Exercise) intervention that is specific to older adults with multiple high-risk chronic illnesses versus an educational control group. This work is innovative because it will translate the benefits of a proven intervention focused on positive affect to increase physical activity in older adults with multiple high-risk chronic illnesses, one that is tailored to the clinical and psychosocial challenges of this particularly vulnerable population. This work is significant because an effective intervention promoting physical activity will improve outcomes for older adults with multiple high-risk chronic diseases, and currently one does not exist.

Eligibility Criteria:
Inclusion Criteria:

* Charlson Index greater or equal to 3

Exclusion Criteria:

1. Cognitive impairment
2. Inability to walk
3. \< 12 month anticipated survival
4. enrollment in other behavioral programs
5. lack of medical approval to participate
6. substance/alcohol dependence or participation in a substance abuse treatment program within 12 months
7. major psychiatric illness.
Stimulating Catheter With or Without Ultrasound Guidance

To study whether the combination of ultrasound guidance and stimulating catheter could reduce the time for needle and catheter insertion compared with using stimulating catheter alone. Secondary outcomes: analgesic effects after the surgery.


Eligibility Criteria:
Inclusion Criteria:

* Elective primary total knee replacement surgery under neuraxial anesthesia ASA\<=4
* Able to give informed consent
* Able to cooperate with sensory and motor testing of lower limb function

Exclusion Criteria:

* coagulopathy
* Allergy to local anaesthetic or postanalgesic rescue regimen
* Signs, symptoms or laboratory evidence of local infection or systemic sepsis
* No pre-existing neurological deficit (sensory or motor) affecting lower limb
* Patients with lower limb amputations
Demonstrate the Safety and Preformance of the SRS Device for the Treatment of Pelvic Organ Prolapse

A prospective, single arm, pre-market, multi-center clinical study to evaluate the safety and performance of the SRS (Lyra Medical) vaginal mesh in POP patients


Eligibility Criteria:
Inclusion Criteria:

1. Patient has signed the informed consent form and is willing to participate in the clinical study and data collection.
2. Patient age is between 18 and 75 years old
3. POP-Q: Aa and/or Ba is at least -1

Exclusion Criteria:

1. Patient is pregnant or breastfeeding
2. Patient suffering from active infection (on antibiotic therapy)
3. Patient planning vaginal delivery
4. Patient had Previous vaginal mesh surgery
5. Patient is in high risk for surgery (evidence of clinically significant cardiovascular, renal, hepatic or respiratory diseases).
6. Any condition that in the judgment of the investigators would interfere with the subject's ability to provide informed consent, comply with study instructions, place the subject at increased risk, or which might confound interpretation of study results.
7. Malignancy .
8. Known hypersensitivity to PEEK and polypropylene materials.
9. Participation in another investigational trial that has not completed the primary endpoint or interferes with study participation.
10. Tendency for hyper-scaring reaction
11. Diagnosed with mental or emotional disturbance.
Objective Evaluation of Ocular Surface Lubricants in Two Environments

This study will evaluate ocular surface lubricants in subjects with dry eye syndrome.

This study will objectively evaluate ocular surface lubricants in subjects with dry eye syndrome. Lubricants contain compounds that are purported to improve dry eye symptoms, although objective data is not available. The investigators seek to objectively evaluate the effectiveness of two lubricants and compare the results to a saline eye drop (control).

The investigators will assess the lipid layer before and after the administration of three products in the same eye of 25 dry eye subjects using the ellipsometry, imaging in a "normal" environment. Subsequently the investigators will change the environment to one that causes the subjects' ocular surface to experience "evaporative stress" (warmer, less humid and greater air flow) and perform the before and after drop administration measurements with the same three products in the same eye as the first environment.

Eligibility Criteria:
Inclusion Criteria:

* Age 30-75 years
* Good general health
* Willing to spend time for the study; approximately one hour for a screening visit and 90 minutes for each of the measurement visits
* Currently using an OTC artificial tear for ocular comfort, at least occasionally.
* At least one positive dry eye symptom.

Exclusion Criteria:

* Current eye disease, infection or inflammation that requires the use of any prescription ocular medication.
* Recent past eye surgery.
* Female subjects may not be pregnant or lactating.
* Infectious diseases
The Metabolic Effect of Walnuts in Healthy Subjects

The objectives of the proposed study are to assess whether the metabolic effects of walnut consumption depends on which food components the walnuts substitute (i.e. carbohydrates; saturated fatty acids) and whether it is important to consume walnuts as snacks or with meals.

The objectives of the proposed study are to assess whether the metabolic effects of walnut consumption depends on which food components the walnuts substitute (i.e. carbohydrates; saturated fatty acids) and whether it is important to consume walnuts as snacks or with meals.

The metabolic effects of walnut consumption may not only relate to the ingested walnuts but also to what is not eaten when walnuts are consumed. We want to evaluate whether the metabolic changes are more pronounced if study participants are instructed to reduce carbohydrates or saturated fatty acids to remain on an isocaloric diet. In a third group we will test what food is omitted if no specific instructions are given. Furthermore half of the subjects in each group will be instructed to eat walnuts with meals and half as snacks.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal healthy women and healthy men
* Age \>50 yrs
* Written informed consent prior to study participation

Exclusion Criteria:

* Known allergy to nuts
* Evidence of alcohol (women \>70g/week, men \>140g/week), tabacco or drug abuse
* Obesity ≥35 kg/m2
* Diabetes mellitus
* Hypertension \>140/90 mmHg or history of hypertension
* LDL-cholesterol \>190 mg/dl, Triglycerides \> 350 mg/dl
* History of atherosclerotic disease
* Liver disease of any etiology
* Kidney disease of any etiology (GFR \< 60 ml/min/1.73)
* Uncontrolled thyroid disease or other endocrine diseases
* Acute or chronic inflammatory diseases
* Active malignancy
* Current or previous (within 3 months) treatment with antidiabetic drugs, hypolipidemic drugs, antihypertensive drugs, anti-inflammatory drugs, vitamin E, hormonal replacement therapy
* major surgical intervention within 3 months (or planned)
The Combination of Aripiprazole and Antidepressants in Psychotic Major Depression

The purpose of the study is to assess the safety and effectiveness of the combination of aripiprazole (Abilify) and selective serotonin reuptake inhibitors (SSRIs) in subjects with psychotic major depression.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women aged 18-80 years, inclusive.
2. Drug-free outpatients or inpatients meeting DSM-IV criteria for major depression with psychotic features.
3. Inpatients who undergo a 5-7 day washout period of their medication while concurrently beginning one of the approved SSRI's and abilify.
4. HAM-D-24 score \> 16.

Exclusion Criteria:

1. Pregnant women and women of child bearing potential not using a medically accepted means of contraception (oral contraceptives are allowed).
2. Women who are breast-feeding.
3. Patients meeting DSM-IV criteria for major depression without psychotic features, or psychosis without major depression at the screen visit.
4. Patients with serious suicidal risk.
5. Patients with a history of seizure disorder; unstable physical disorders (cardiovascular, hepatic, renal, respiratory, endocrine, neurologic, or hematologic); or any physical disorder judged to significantly affect central nervous system function.
6. Patients meeting criteria for the following DSM-IV diagnoses: organic mental disorders; substance use disorders, including alcohol, active within the last 6 months; bipolar disorder; schizoaffective disorder; or antisocial personality disorder.
7. Patients who are currently taking an antidepressant, antipsychotic, or mood stabilizing drug and who are responding to one or all of these medications. If patients are not responding to these medications, they may go through a washout period of at least one week under the supervision of a study doctor before entering into this study.
8. Patients who are not able to read and understand the consent form, or who are not capable of understanding or giving informed consent to the procedures of the study
Transcranial Direct Current Stimulation (tDCS) for the Treatment of Tinnitus

The purpose of this study is to determine if repeated sessions of transcranial direct current stimulation (tDCS) are effective for treating chronic subjective tinnitus. Previous studies have reported brief improvements in tinnitus after safe and noninvasive stimulation of the auditory cortex or limbic system. The investigators hypothesize that a greater improvement in tinnitus will be achieved following repeated sessions of tDCS that target both auditory and limbic systems.

Subjective tinnitus is a distressing condition characterized by the sensation of sound or noise in the absence of internal or external stimuli. Research indicates that tinnitus may develop due to maladaptive plastic changes in the auditory cortex and limbic system. These changes can be targeted using safe and noninvasive brain stimulation techniques like transcranial direct current stimulation (tDCS). TDCS alters the excitability of the cortex using a weak direct current and may lead to long-term plastic changes, making it a potential therapeutic tool for the treatment of tinnitus.

Transient improvements in tinnitus have been reported after inhibitory stimulation of the auditory cortex and after excitatory stimulation of the prefrontal cortex, however the effects of a combined stimulation paradigm remain unknown. The investigators hypothesize that a cumulative effect will be observed following repeated sessions of tDCS by modulating both the excitability of the auditory cortex and prefrontal cortex.

Eligibility Criteria:
Inclusion Criteria:

* Age of at least 18 years
* Chronic tinnitus for at least 1 year
* Diagnosis of chronic subjective non-pulsatile tinnitus
* Age-adjusted normal (sensorineural) hearing
* Score of 25 or above on the Mini-mental state examination (MMSE)
* Must comply with use of contraceptives during interventions

Exclusion Criteria:

* Objective tinnitus
* Concurrent treatment for tinnitus
* Prior exposure to transcranial direct current stimulation (tDCS)
* Electronic implants or metallic objects in body, including cardiac pacemakers, cochlear implants, implanted medical pump, metal plate in skull, metal implant in the skull or eyes (other than dental appliances or fillings)
* Skin conditions where electrodes will be applied
* Major neurological co-morbidities
* History of epilepsy and/or seizures
* Pregnancy and/or lactation
Chewing Gum and Gastric Emptying of Water

The aims of this prospective cross over study was to compare the gastric emptying of 250 ml water in fasting volunteers, in two situations : without chewing gum or while chewing gum during 45 min


Eligibility Criteria:
Inclusion Criteria:

* ASA 1 or 2 volunteers

Exclusion Criteria:

* digestive diseases, gastroparesis
* Smokers
* Pregnancy
* Diabetes Mellitus
* Medication affecting gastric motility
* Previous gastrointestinal surgery
A Study Investigating the Renal Tolerability, Efficacy, and Safety of a CNI-free Versus a Standard Regimen in de Novo Heart Transplant (HTx) Recipients

This study will assess whether a calcineurin inhibitor (CNI)-free regimen with everolimus and mycophenolic acid is associated with a better renal outcome as compared to the standard regimen containing cyclosporine A (which belongs to the class of CNIs) and everolimus; while both treatments are expected to be comparable with respect to efficacy.

This study will assess whether a calcineurin inhibitor (CNI)-free regimen with everolimus and mycophenolic acid is associated with a better renal outcome as compared to the standard regimen containing cyclosporine A (which belongs to the class of CNIs) and everolimus; while both treatments are expected to be comparable with respect to efficacy.

Eligibility Criteria:
Inclusion criteria:

* Heart transplantation, 3 months prior to enrollment
* Patients have to receive an immunosuppressive regimen with Sandimmun® Optoral, Certican® and corticosteroids
* Sufficient graft function
* Sufficient renal function
* Females capable of becoming pregnant must have a negative serum pregnancy test within 7 days prior to or at baseline, and are required to practice an approved method of birth control for the duration of the study and for a period of 6 weeks following discontinuation of study medication, even where there has been a history of infertility

Exclusion criteria:

* Multi-organ recipients, re-transplantation, or previous transplant with any other organ.
* Patients who are recipients of A-B-O incompatible transplants
* Cold ischemia time \>6 hours
* Historical or current peak PRA of \> 25% at time of transplantation
* Already existing antibodies against the HLA-type of the receiving transplant Other protocol-defined inclusion/exclusion criteria may apply
eMBC for Perinatal Depression and Anxiety

Depression and anxiety that occur around the time of pregnancy can adversely impact a person's health and well-being, and their child's health and development. Fewer than 20% of affected people are adequately treated, often because of under-use of medications. Measurement based care (MBC) is a model of care where psychiatric symptoms are routinely tracked and reviewed together by a patient and their doctor to better manage symptoms. It has not been systematically evaluated for perinatal depression and anxiety. The overall objective of this study is to test the feasibility of MBC in this population to inform a future large randomized controlled trial for definitive evaluation. In order to avoid known barriers to MBC, electronic MBC (eMBC) will be used. With eMBC, patients can enter their symptoms into their electronic medical records before their appointment so that they can be evaluated by their doctor during the appointment. In this pilot study, the feasibility of recruitment for a future efficacy trial, including feasibility of recruitment, and retention, acceptability and adherence to a trial protocol will be evaluated.

A parallel group randomized controlled trial (RCT) will be conducted. Eligible and consenting patients with depression and/or anxiety will be randomized in a 1:1 ratio to either the eMBC condition or a control condition. The study will be stratified by diagnosis (major depressive disorder vs generalized anxiety disorder).

80 patient participants will be recruited from the Reproductive Life Stages (RLS) Program at Women's College Hospital. The active treatment phase of the study is 12 weeks.

Outcomes will be measured online and by phone at 4-, 8-, and 12- weeks post-randomization. Following the completion of the study, some participants will be asked to participate in follow-up interviews. RLS psychiatrists whose patients participated in the study will participate in a focus group.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18
2. Currently pregnant or mother\* of a live infant 0-12 months of age and living at the same residence

   \*Through natural birth, adoption, surrogacy, including cis women, non-binary and transgender people in all their diversity
3. EPDS \>12 at enrollment

Exclusion Criteria:

1. Active suicidal ideation, substance abuse or dependence
2. Current or past mania or psychosis or current major depressive episode with psychosis

4. Incapable of consenting to participation 5. Unable to read or unable to speak English
"COVID-19 and Diabetes Outcomes"

COVID-19 (Coronavirus Disease-2019) is a life-threatening infectious disease caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that appeared in December 2019 in the Wuhan district. COVID-19 has since affected more than 150 countries across the world and especially France. The first epidemiological data, mostly from Chinese studies, indicate that diabetes is one of the most common comorbidities, with high blood pressure, in patients with COVID-19. Moreover, the presence of diabetes at admission would be a risk factor for both ICU hospitalization and death.

Nevertheless, specific data on people with diabetes and COVID-19 are fragmentary, justifying the achievement of a dedicated prospective observational study.

The French nationwide CORONADO study aims to specifically describe the phenotypic characteristics of patients with diabetes admitted to hospital with COVID-19 infection. Particular attention will be devoted to glycemic control at admission (i.e. the level of HbA1c), the diabetic complications, as well as anti-diabetic and antihypertensive therapies.

This study will provide answers to caregivers and patients with diabetes regarding the risk factors related to diabetes for COVID-19 prognosis. This pilot study will be used for the development of new studies and for the establishment of recommendations for the cost of care in patients with diabetes and COVID-19.


Eligibility Criteria:
Inclusion criteria

* Patients admitted in a hospital center since 10th march 2020
* Patients with COVID19 with biological proof (specific PCR) or with clinical and radiological diagnosis.
* Patient with diabetes known before the admission
* New onset diabetes discovered at admission (HbA1c value strictly greater than 6.5%)

exclusion criteria

* subjects opposed to the use of their data
* minors, adults under guardianship, protected persons
* subject having already been included in the CORONADO study (subject readmitted after discharge following the initial stay). Only the data of the first stay will be maintained.