cyrilzakka/clinical-trials huggingface dataset:
Visual Outcomes of Tecnis Symfony Opti-Blue EDOF Intraocular Lens (IOL)

Tecnis Symfony Optiblue EDOF IOL is the latest version of Tecnis Symfony IOL with a violet light filter (VLF), which blocks short-wavelength light and improves the quality of vision while minimizing visual disturbances. The present study aims to assess the visual outcomes at distance, intermediate, and near following cataract surgery and implantation of Tecnis Symfony Optiblue IOL in patients with retinal comorbidities.

Extended depth of focus (EDOF) IOLs, on the other hand, are based on the principle of creating a single-elongated focal point to enhance the depth of focus (DOF) and eliminate the overlapping of near and far images caused by traditional multifocal IOLs, thus generating a lower incidence of halos and glare. The Tecnis Symfony (Johnson \& Johnson Vision) EDOF IOL incorporates a diffractive echelette design to increase the range of vision. The achromatic technology corrects chromatic aberration and increases retinal image contrast.

The latest version of the Tecnis Symfony lens (DXR00V/ZXR00V) has the OptiBlue violet light filter (VLF), which blocks short-wavelength light. Violet light filtration reduces light scatter, improving contrast and reducing nighttime visual disturbances such as halo, glare, and starbursts. As such, the present study aims to assess the visual outcomes at distance, intermediate and near following implantation of violet light filtering Tecnis Symfony Optiblue EDOF IOLs in patients with retinal comorbidities undergoing cataract surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with retinal comorbidities, with visual acuity potential of 20/30 or better, who wish to undergo bilateral cataract surgery and are willing to provide written informed consent and adhere to study requirements.

Exclusion Criteria:

* Corneal dystrophies
* Central corneal scarring
* Keratoconus
* Proliferative diabetic retinopathy
* Exudative macular degeneration
* Zonular weakness
* Pseudoexfoliation
* Fovea-involving atrophy
* Severe dry eye
* Amblyopia
* Pupil abnormalities
* Need for an IOL outside the range of +5.0 D to +34.0 D or cylinder power over 3.75 D
* Patients who have undergone prior cataract surgery and IOL implantation in either eye; had prior corneal refractive or corneal transplantation surgery; diabetics post-vitrectomy; or who have a history of macula-off retinal detachment will also be excluded.
Randomized, Multicenter, Double-blind, Vancomycin-controlled Study to Evaluate the Efficacy of Ethanol Lock Solution for the Curative Treatment of Implantable Venous Access Port Infection Due to Coagulase-negative Staphylococci

Implantable venous access port infections are mainly due to coagulase negative staphylococci and may be managed by antibiotic lock therapy with retention of the port. Most of the time a vancomycin lock is used. Experimental data show that vancomycin may be poorly effective in eradicating the staphylococcal biofilm in the port. Another disadvantage of Vancomycin-containing lock solution is the occurrence of resistant organisms and the risk of catheter occlusion. Ethanol-containing lock solution is highly effective in vitro and does not expose to the risk of emergence resistance.

Type of study: multi-center, randomized, double-blind, parallel-group, controlled clinical trial.

Number of centers: 9 French centers in Auvergne and Rhône-Alpes regions

Medical product Ethanol 40% + Enoxaparine 400UI/ml Versus Vancomycin 5 mg/ml + Héparine 2500UI/ml

Patients

Patients eligible for inclusion will be randomized to one of the two groups:

* Experimental group: 90 patients will receive 10 injections of ethanol lock solution in implantable venous access port during the first 10 days of the study.
* Control group: 90 patients will receive 10 injections of vancomycin lock solution in implantable venous access port during the first 10 days of the study.
* For each group, in case of bacteraemia, the lock therapy is associated with a systemic antibiotic therapy using another venous line and optimized by a specialist in infectious diseases.

Study Performance

Patients will be assessed at baseline D0, 3 days (D3), 10 days (D10), 14 weeks (W14) after D0 as follows:

Visit 1 (D0 - baseline):

* Signature of an informed consent form.
* Demographic and clinical characteristics (sex, age, disease associated with implantable venous access port, implantable venous access port infection data, bacteraemia data)

Days 1 to 10

* Injection of ethanol or vancomycin lock solution in implantable venous access port
* Ethanolemia 30 minutes after injection, on first day
* Side effects evaluation

Visit 2 (D3) and Visit 3 (D10)

* Side effects evaluation
* Blood culture
* Bacteraemia data (antibiotic therapy modification)

Phone contact each week from week 2 to week 13

End Visit (W14)

* Side effects evaluation
* Blood culture
* Bacteraemia data (antibiotic therapy modification)

Eligibility Criteria:
Inclusion Criteria:

* Man or woman from 18 years old
* With probable or definite implantable venous access port infection
* With or without bacteraemia
* Infection due to coagulase-negative staphylococci (except for lugdunensis Staphylococci)
* Blood culture results available within 48 hours before inclusion
* With health insurance

Exclusion Criteria:

* Pregnant or breastfeeding woman
* Allergy to ethanol
* Patient with prosthetic cardiac valve
* Necessity of venous access port withdrawal
* Prior infection on the same venous access port
* Patients under supervision or (legal) guardianship
Low Dose Atazanavir/r Versus Standard Dose Atazanavir/r (LASA)

This study will compare the efficacy and safety of ATV/r at either 200/100 mg or 300/100mg given daily in Thai patients in combination with 2NRTIs.

To demonstrate non-inferiority of treatment with atazanavir/ritonavir (ATV/r) 200/100 mg once daily (OD) compared to the control group (ATV/r 300/100 mg OD) in regards to the proportion of virologic responders (plasma HIV RNA \< 200 copies/mL) at 48 weeks in ARV-experienced HIV-1 infected subjects.

Eligibility Criteria:
Inclusion Criteria:

1. HIV infected adults aged more than or equal to 18 years
2. Received ritonavir boosted PI-based HAART for \>3 months prior screening visit
3. History of HIV RNA \< 50 copies/ml within 12 months prior to screening visit
4. HIV-RNA \< 50 copies/ml at screening visit
5. Signed written informed consent

Exclusion Criteria:

1. Active AIDS-defining disease or active opportunistic infection
2. History of virological failure (plasma HIV-RNA ≥1,000 copies/ml) while using any ritonavir boosted PI-based HAART
3. Pregnancy or lactation at screening visit
4. Relevant history or current conditions or illnesses that might interfere with drug absorption, distribution, metabolism or excretion e.g. chronic diarrhea, malabsorption
5. Use of concomitant medication that may interfere with the pharmacokinetics of the study drugs e.g. rifampicin, proton pump inhibitor
6. History of sensitivity/idiosyncrasy to the drug or chemically related compounds which may be employed in the study
7. ALT ≥200 IU/L at screening visit
8. Creatinine clearance \< 60 c.c. per min by Cockroft-Gault formula at screening visit
Comparing Radiological Tubal Blockage Versus Laparoscopic Salpingectomy in Infertile Women With Hydrosalpinx During in Vitro Fertilization Treatment

Hydrosalpinx (HX) has a detrimental effect on the rates of implantation, pregnancy, live delivery, and early pregnancy loss during in vitro fertilization (IVF). The effectiveness of radiological tubal blockage has not been compared with the standard treatment of laparoscopic salpingectomy in randomized trials. The investigators aim in this randomized trial to compare the live birth rate of radiological tubal blockage versus laparoscopic salpingectomy in infertility women with HX prior to frozen-thawed embryo transfer (FET). Eligible women will be recruited and randomized into one of the following two groups: (1) the radiological tubal blockage group and (2) the laparoscopic salpingectomy group. The primary outcome is the live birth rate.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 20-43 years at the time of IVF/ICSI treatment
* Unilateral or bilateral HX visible on pelvic ultrasound or hysterosalpingogram
* At least one frozen embryo or blastocyst available for transfer

Exclusion Criteria:

* A history of pelvic inflammatory disease within 6 months
* HX that were already blocked proximally on hysterosalpingogram
* Frozen pelvis from previous laparoscopy
* Women with fibroids interfering with radiological tubal blockage
* Undergoing preimplantation genetic testing
A Study to Assess How Well Certolizumab Pegol Works in Patients With Moderate to Severe Plaque Psoriasis as Part of Routine Clinical Practice

The purpose of the study is to assess the effectiveness of certolizumab pegol in patients with moderate to severe plaque psoriasis as part of routine clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* The patient is ≥18 years of age at observational point 1
* The patient must have a clinical diagnosis of moderate to severe Plaque psoriasis according to the diagnostic criteria used by the physician in routine clinical practice
* The patient has an available PASI assessment prior to the first certolizumab pegol dose according to the standard of care
* The patient must be newly prescribed with certolizumab pegol
* If a patient is participating in an ongoing investigational study, then he/she will not be able to take part in this study

Exclusion Criteria:

Not applicable
Antidepressant Plus Asenapine Versus Antidepressant Plus Placebo for Depression

This is a 6-week comparison of asenapine versus placebo as an add-on to ongoing antidepressant treatment in patients with major depression who have not had a complete therapeutic response to treatment with the antidepressant alone.

The investigators hypothesize that added asenapine will produce greater reductions in depression than will added placebo.

The investigators will undertake a 6-week, double-blind, randomized, parallel-group, placebo-controlled trial of adjunctive asenapine in 130 patients with MDD without psychosis who have had an incomplete therapeutic response to treatment with an antidepressant medication alone.

Eligibility Criteria:
Inclusion Criteria:

-130 male or female patients, 18-65 years of age, with:

1. DSM-IV diagnosis of MDD without psychosis (single episode or recurrent) confirmed by the Mini-International Neuro-psychiatric Interview (MINI)
2. MADRS total score \> 20, and item 1 (Apparent Sadness) score \> 2 at enrollment and randomization
3. Inadequate therapeutic response during their current depressive episode; an inadequate therapeutic response will be defined as continued depressive psychopathology (see criterion 2) following \> six weeks of therapy at adequate doses (according to the US label) of any non-tricyclic, non-MAOI antidepressant medication

Exclusion Criteria:

1. Additional DSM-IV Axis I diagnoses other than Generalized Anxiety Disorder, Panic Disorder with or without Agoraphobia, or Social Phobia within 6 months prior to enrollment
2. DSM-IV Axis II diagnoses that significantly impact the current psychiatric status
3. Current MDD episode lasting \> 12 months
4. Electroconvulsive therapy within the preceding 6 months
5. Substance or alcohol dependence, as defined by DSM-IV criteria, within 6 months prior to enrollment
6. Unstable medical illness, epilepsy, traumatic brain injury, Parkinson disease, or dementia (MMSE \<24)
7. Risk of suicide as defined by MADRS item 10 score \> 4
8. Prior failure to respond to asenapine
9. Pregnancy or failure to use an acceptable form of birth control. Pregnancy as determined by serum pregnancy test at baseline
10. Hepatic impairment and history of low WBC, by medical history and interview.
Reduction of Oxalate and Inflammation by Hemodiafiltration vs. Hemodialysis

The health care burden of CKD is substantial and growing with 10-15% of the population affected in both developed and developing countries. It is well established that CKD is associated with systemic inflammation, which promotes cardiovascular disease and body wasting. However, causal therapies to treat systemic inflammation, and treat its adverse consequences remain sparse. As kidney function declines in all forms of CKD, oxalate levels increase in the plasma, leading to increased systemic exposure to oxalate and consequent tissue injury. Work from the investigators has shown that elevated plasma oxalate levels activate the NLRP3 inflammasome which in turn leads to the processing and release of cytokines. The investigators seek to test the hypothesis that oxalate contributes to the systemic inflammation observed in patients with end-stage renal disease (ESRD). The investigators plan to define the association between plasma oxalate levels and signs of systemic inflammation in patients on hemodialysis. In a second step the investigators will examine whether hemodiafiltration lowers plasma oxalate more efficiently than hemodialysis and reduces signs of systemic inflammation. Confirmation of the hypothesis may lead to the identification of oxalate as a novel therapeutic target for interventional trials aimed at reducing plasma oxalate in patients with ESRD.

The positive interaction between diffusive and convective flux has suggested that hemodiafiltration (HDF) has a higher oxalate extraction rate as compared with hemodialysis (HD). However, it has not been evaluated whether HDF can lower predialysis oxalate levels below the level of supersaturation. By using an intra-individual approach with the inclusion/exclusion criteria listed for the study, we plan to determine plasma oxalate and cytokine levels in 20 patients (10 on regular duration HD, 10 patients on extended duration HD) before dialysis. Subsequently, patients will be switched to HDF and plasma oxalate concentration and cytokines will be analyzed again two weeks following HDF treatment. Plasma oxalate (Pox) will be measured at beginning of treatment, mid, end and 2 hrs post treatment (to determine rebound) in order to provide oxalate kinetics on HD/HDF treatment. Cytokines will only be measured pre HD/HDF treatment to assess steady state inflammation.

Eligibility Criteria:
Inclusion Criteria:

* Blood Flow ≥ 250 ml/min
* Dialysate Flow ≥ 500 ml/min
* Urinary Excretion \< 400 ml/24h
* Duration of Dialysis ≥ 4h
* On HDF/HD treatment for ≥ 4 weeks
* Extended HDF/HD for ≥ 4 weeks

Exclusion Criteria:

* Recirculation (online measurement) \> 15%
* Single needle dialysis or single lumen catheter
* Substitution volume of \< 20l on HDF
Contribution of a Prone Team in Intensive Care During the Covid-19 Epidemic

SARS-CoV-2 induced by COVID 19, involved the hospitalization of 101,932 patients in France, including 4,007 in intensive care (source: Santé Publique France). Alsace was one of the most affected regions on the metropolitan territory with a large number of patients hospitalized at the University Hospital of Strasbourg.

In view of the seriousness of the epidemic and the rapid arrival of new patients requiring mechanical ventilation, 3 new intensive care units have been created on the NHC site alone, making it possible to accommodate a maximum of 111 patients (compared to 52 during normal periods).


Eligibility Criteria:
Criteria for inclusion :

* Major patient (≥18 years old)
* Patient hospitalized in intensive care at the NHC, diagnosed COVID + and requiring a VD session of which at least one is performed by the dedicated team.
* patient who has not expressed, after information, his or her opposition to the re-use of his or her data for the purposes of this research

Exclusion criteria :

* Subject who expressed opposition to participating in the study
* Subject under guardianship, curatorship or safeguarding of justice
Study Evaluating Subcutaneous MOA-728 for the Treatment of Opioid-Induced Constipation (OIC) in Subjects With Chronic Non-Malignant Pain

The primary purpose of the protocol is to evaluate the safety, efficacy, and tolerability of subcutaneous MOA-728 versus placebo in subjects with chronic non-malignant pain who have Opioid-Induced Constipation (OIC).


Eligibility Criteria:
Inclusion Criteria:

* Adult outpatients with opioid-induced constipation and chronic non-malignant pain.
* Taking oral, transdermal, intravenous, or subcutaneous opioids.
* Willingness to discontinue all pre-study laxative therapy and use only study permitted rescue laxatives.

Exclusion Criteria

* History of chronic constipation before the initiation of opioid therapy.
* Other GI disorders known to affect bowel transit.
* Women who are pregnant, breast-feeding, or plan to become pregnant.
duoABLE for People With Stroke and Their Caregivers

The goal of this intervention study is to test whether a behavioral program that involves people with stroke and their caregivers is acceptable, safe, and can promote physically active lifestyles using enjoyable activities. Participant duos (person with stroke and their caregiver) will be asked to complete assessments at 2 timepoints, wear an activity tracker, participate in 12 sessions with an occupational therapist, and complete an interview.


Eligibility Criteria:
Inclusion Criteria (Stroke Participants):

* Stroke diagnosed more than 6 months ago
* Are 18 years of age or older
* Report ≥6 hours of sedentary behavior on a typical day OR report engagement in ≤90 minutes of moderate-to-vigorous physical activity in the past week
* Reside in a community-based setting
* Are mobile within their home, with or without an assistive device and without physical assistance
* Are able to identify an eligible caregiver who will engage in assessments and intervention.

Inclusion Criteria (Caregiver Participants):

* Are 18 years of age or older
* Report ≥6 hours of sedentary behavior on a typical day OR report engagement in ≤90 minutes of moderate-to-vigorous physical activity in the past week
* Reside in a community-based setting
* Are mobile within their home, with or without an assistive device and without physical assistance

Exclusion Criteria (Stroke Participants):

* Severe aphasia
* Are currently receiving chemotherapy or radiation treatments for cancer
* Have a medical diagnosis of neurodegenerative disorder (i.e., dementia, Parkinson's disease, multiple sclerosis, amyotrophic lateral sclerosis, glioblastoma)
* Received inpatient treatment for substance use disorder or psychiatric condition within the past 12 months
* Have a history of skin sensitivity related to adhesives
* Are pregnant or expecting to become pregnant in the next 2 months
* Reside in an institutional setting
* Are currently incarcerated

Exclusion Criteria (Caregiver Participants):

* Have a history of skin sensitivity related to adhesives
* Are currently receiving chemotherapy or radiation treatments for cancer
* Have a medical diagnosis of neurodegenerative disorder (i.e., dementia, Parkinson's disease, multiple sclerosis, amyotrophic lateral sclerosis, glioblastoma)
* Received inpatient treatment for substance use disorder or psychiatric condition within the past 12 months
* Are pregnant or expecting to become pregnant in the next 2 months
* Reside in an institutional setting
* Are currently incarcerated
TMC435-TiDP16-C119 - A Study Comparing 2 New Capsule Formulations of TMC435 to an Established Capsule Formulation and Evaluating the Respective Blood Levels of TMC435 Following Single Dose Administration

The purpose of this study is to compare in healthy volunteers levels of TMC435 in the blood circulation after intake of 2 new capsule formulations with the level of TMC435 in the blood circulation after intake of the capsule formulation used in the Phase IIb studies.

This is a randomized (study drug assigned by chance), open-label (all people involved know the treatment), single dose, crossover (volunteers will receive different treatments sequentially during the trial) study in healthy volunteers. The trial will evaluate the levels of TMC435 in the blood circulation after a single dose of 150 mg TMC435 administered as 3 different capsule formulations following breakfast. There will be a 7-day washout period between treatments and a 4-5 week follow-up at the end. Each volunteer will receive all three treatments. The main focus of the trial is the pharmacokinetic characteristics (how drugs are absorbed in the body, how they are distributed within the body and how they are removed from the body over time) of the different formulations. This evaluation requires multiple blood samples from Day 1 through 72 hours after dosing. Safety assessments (lab work, blood pressure, pulse and electrocardiogram) will follow a different schedule and are measured on Day -1 (day prior to taking first dose of drug), Day 1 (without lab work) and Day 4 of each treatment period, and 1 and 4-5 weeks after the last treatment. Each volunteer will receive 3 treatments, 7 days apart from each other. Each treatment consists of one single oral dose of 150 mg TMC435.

Eligibility Criteria:
Inclusion Criteria:

* Non-smoker for at least 3 months
* Body Mass Index of 18.0 to 30.0 kg/m2
* Healthy based on a medical evaluation including medical history, physical examination, blood tests and electrocardiogram

Exclusion Criteria:

* Infection with Hepatitis A, B or C virus
* Infection with the human immunodeficiency virus (HIV)
* History of, or any current medical condition which could impact the safety of the participant in the study
Locally Administered Clodronate in the Prevention of Aseptic Implant Loosening

Periprosthetic bone-loss after total hip arthroplasty (THA), detected as an early migration of the prosthesis, may predict later loosening. The investigators hypothesized that by reducing bone resorption after THA with bisphosphonates, it might be possible to achieve better early fixation of the implant.

Nineteen patients suffering arthrosis were recruited to a prospective, double-blinded, randomized, placebo-controlled clinical pilot trial. Patients were operated with an uncemented Bimetric stem with tantalum markers, the acetabular cup and liner were chosen by the surgeon. The femoral proximal intramedullary canal was rinsed with 1mM (millimole) clodronate, that was done by adding the clodronate to the 1000 ml 0.9% NaCl (sodium chloride) in nine patients and rinsing solution was the pure 0.9% NaCl for 10 patients. These rinsing packages were labeled only with the code from the pharmacy of the hospital. These patients were followed for two years using radiostereometric analysis (RSA), dual energy x-ray absorptiometry (DXA) and the Harris hip score (HHS).

The purpose of the investigator's study was to examine whether the local intraoperative administration of clodronate could reduce periprosthetic bone loss and further stem migration after primary THA.


Eligibility Criteria:
Inclusion Criteria:

* hip arthrosis and
* a primary THA was planned

Exclusion Criteria:

* renal insufficiency
* hypercalcemia
* malignant tumors
* contemporaneously treatment with another bisphosphonate or aminoglycoside
Transcutaneous Auricular Vagus Nerve Stimulation Treatment on Functional Dyspepsia

Objective: To observe the effect of the treatment of transcutaneous auricular vagus nerve stimulation (taVNS) for the functional dyspepsia (FD).

Methods: We accrued 94 patients at Beijing TongRen Hospital. All treatments were self-administered by the patients at home after training at the hospital. Patients completed questionnaires at baseline and after 4 weeks, 8 weeks, 12 weeks. The FD Symptoms Index, Functional Dyspepsia Quality of Life Scale (FDDQL), Hamilton Anxiety Scale (HAMA), Hamilton Depression Scale (HAMD), and Self-Depression Rating Scale (SDS) were performed to evaluate the therapeutic effects.

A difference of P \< 0.05 was considered statistically significant.


Eligibility Criteria:
Inclusion Criteria:

* 1. Age \>=18 and Age \<=65. 2. Clinical diagnosis of functional dyspepsia.

Exclusion Criteria:

* 1. History of depression, tumors, thyroid disease, diabetes, cardiac diseases. 2. History of gastrointestinal surgery. 3. Pregnant or lactating women.