cyrilzakka/clinical-trials huggingface dataset:
Mineralocorticoid Receptor, NMDA Receptor and Cognitive Function in Depression

The steroid hormone cortisol is released in response to stress and acts in the central nervous system upon glucocorticoid (GR) and mineralocorticoid receptors (MR). GR are widely distributed across the brain while MR are predominantly expressed in the hippocampus and prefrontal cortex - two brain areas closely related to memory and executive function. Stimulation of MR leads to an increase of glutamate that act on glutamatergic NMDA receptors in the hippocampus and prefrontal cortex. In previous studies, the investigators have shown that fludrocortisone, a mineralocorticoid receptor (MR) agonist, improves memory and executive function in depressed patients and healthy controls. However, depressed patients not only exhibit cognitive deficits in traditional neuropsychological domains such as memory or executive function. In addition, there are depression-specific alterations such as cognitive bias and deficits in social cognition, two clinically highly relevant areas. Therefore, the specific aims of this renewal proposal are two-fold:

* To examine whether beneficial effects of fludrocortisone in depressed patients can be extended to depression-specific cognitive bias and to social cognition
* To determine whether beneficial effects of fludrocortisone depend on NMDA-receptor function and whether these beneficial effects can be enhanced by NMDA receptor stimulation.

The investigators hypothesize that fludrocortisone will improve cognitive bias and social cognition in depressed patients and that its beneficial effects depend on the NMDA receptor. Therefore, the investigators further hypothesize that the effects of fludrocortisone can be enhanced by co-administration of the partial NMDA receptor agonist D-cycloserine.

The study not only advances current knowledge by further examining the mechanism of action by which MR stimulation exerts beneficial effects on cognition but extends these effects to depression-specific cognitive bias and alterations in social cognition. Furthermore, a potential interaction between MR and NMDA receptors is highly clinically relevant given the promising results with NMDA receptor antagonists in the treatment of major depression.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years
* Depressed male and female patients according to DSM-V \& minimum of 17-items Hamilton Depression Score of 18
* healthy controls
* informed consent signed

Exclusion Criteria:

* Current use of antidepressants, antipsychotics, or mood stabilizer
* Relevant medical or neurological disorders
* Pregnancy or unsure contraception
* Relevant psychiatric comorbidity (bipolar or psychotic disorders)
* Active alcohol or other substance abuse/dependance
Post-traumatic Stress Disorder Treatment Using Transcranial Direct Current Stimulation (tDCS) Enhancement of Trauma-focused Therapy : a Two-arm Randomized Controlled Multicentric Study.

Post-Traumatic Stress Disorder (PTSD) is an anxiety disorder that can develop after exposure to a terrifying event or ordeal in which there was the potential for or actual occurrence of grave physical harm. Traumatic events that may trigger PTSD include violent personal assaults, natural or human-caused disasters, accidents, and military combat. People with PTSD have persistent frightening thoughts and memories of their ordeal, may experience sleep problems, feel detached or numb, or be easily startled. Its lifetime prevalence is quite high, with 7-8% in various studies and 4% in french studies.

The current PTSD treatment usually involves antidepressants as serotonin-specific reuptake inhibitors (SSRIs) and Cognitive Behavioral Therapies, such as exposure therapy to trauma-linked elements (memories, feelings and thoughts) so the fear associated to the traumatic event can decrease. But the therapeutic response stays partial, even combining these treatments.

To improve the PTSD treatment efficiency, innovative approaches are being explored like new drugs or cerebral stimulation. This project aims to assess the efficacy of a less known but promising therapeutic strategy for PTSD : the use of transcranial Direct-Current Stimulation (tDCS) to enhance the trauma-focused therapy results.


Eligibility Criteria:
Inclusion Criteria:

* Having a chronic PTSD (for more than 3 months and less than 10 years) without modification of SSRI long-term treatment for more than 4 weeks
* Between 18 and 65 years-old
* Effective contraception for women, or inability of procreate because of medical or surgical reasons
* Able to give his written informed consent
* Affiliation to a social security system
* Not participating to another study with psychoactive substance

Exclusion Criteria:

* Partially-sighted or partially deaf person requiring equipment
* Person with brain injury or neurological disease (epileptic, tumoral, vascular, degenerative), diagnoses in personal history or recognized as hereditary
* Addiction to psychoactive substance for the last 6 months
* Any treatment which could interact with tDCS effects on cortical reactivity (citalopram, amphetamine, L-dopa, sulpiride, pergolide, lorazepam, rivastigmine, dextromethorphan or other N-methyl-D-aspartate (NMDA) receptor antagonists, d-cycloserine, carbamazepine, flunarizine, calcium channel blockers)
* Pregnancy and lactation
* Any intracephalic metallic material
* Person who can't conform to tests instructions
* Person suffering from bipolar disorder, chronic or acute delusional disorder
* Any circumstances making the person unable to understand the trial features, purposes or consequences
A Study to Assess the Effectiveness and Safety of Mayzent in Chinese Patients With Relapsing Forms of Multiple Sclerosis

This was a multicenter, non-interventional, retrospective study aiming to evaluate the real-world effectiveness and safety of siponimod treatment in Chinese patients with relapsing forms of multiple sclerosis (RMS). The data were collected retrospectively through medical records review and abstraction conducted at a single time point per patient by the investigator's site staff or a designate (at the discretion of the site, if allowed by local regulations). There was no prospective patient follow-up for this study. Obtaining informed consent was based on local regulations. Where permissible, waivers could be applied to the Institutional Review Board (IRB) or Independent Ethics Committee (IEC) as appropriate, based on the retrospective collection of non-personally identifiable data, if acceptable per local regulations.

The target patient population included adult patients diagnosed with RMS (including clinically isolated syndrome (CIS), relapsing-remitting multiple sclerosis (RRMS), or active secondary progressive multiple sclerosis (SPMS)), and who received at least 3-months of treatment with siponimod after the index date. The index date is the date of siponimod initiation, defined as the date of first prescription record of siponimod in the patient's medical records with RMS diagnosis. Effectiveness data (i.e., clinical relapses, magnetic resonance imaging (MRI) activity) were collected from the index date, through the end of the observation period. The observation period was from the index date to the date of initiation of medical records abstraction at site, or patient withdrawal of consent, loss of follow-up, or death, whichever occurred first. Among patients who permanently discontinued siponimod during the observation period, safety data were collected up to 30 days after the last dose of siponimod.


Eligibility Criteria:
Inclusion criteria:

* Written informed consent if requested by local regulation.
* Patients had a diagnosis of RMS (including CIS, RRMS, or active SPMS).
* Chinese patients were 18 years or older at the index date.
* Patients had a minimum 3-month persistence on siponimod after the index date.
* Patients had at least one documented clinical visit in the observation period after the initiation of siponimod treatment.

Exclusion criteria:

• Patients previously treated with siponimod (including participation in clinical trials) before the index date.
Real World Evidence of the Effectiveness of Paritaprevir/Ritonavir, Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C

This study seeks to provide evidence of the effectiveness and obtain patient reported outcomes (PRO) and work productivity data of the interferon-free regimen of paritaprevir (PTV)/ritonavir (r) + ombitasvir (OBV), +/- dasabuvir (DSV), +/- ribavirin (RBV) in chronic hepatitis C virus infected patients.


Eligibility Criteria:
Inclusion Criteria:

* Treatment-naïve or -experienced adult male or female patients with confirmed CHC, genotype 1 or 4, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± RBV according to standard of care and in line with the current local label.
* If RBV is co-administered with the ABBVIE REGIMEN, it has been prescribed in line with the current local label (with special attention to contraception requirements and contraindication during pregnancy).
* Patients must voluntarily sign and date a patient authorization to use and/or disclose his/her anonymized health data prior to inclusion into the study.
* Patient must not be participating or intending to participate in a concurrent interventional therapeutic trial

Exclusion Criteria:

-None
Shockwave™ Vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes

The investigators hypothesize that Shockwave with DCB is non-inferior to surgical endarterectomy for common femoral artery (CFA) stenosis with regard to primary efficacy and safety endpoints. The study will challenge the current guideline that recommends common femoral endarterectomy (CFE) as the primary treatment for symptomatic CFA stenosis.

This is a pilot, prospective, randomized clinical trial. This trial compares patients with severe symptomatic moderate to severe calcified CFA stenosis undergoing traditional gold standard CFA endarterectomy to innovative technique of endovascular treatment using Shockwave™ Intra vascular Lithotripsy (IVL) using M5+ balloon with Drug coated balloon to achieve removal and debulking of plaque and achieve luminal gain. Patients who meet inclusion criteria will be informed and consented by a clinical coordinator if they wish to participate in the trial. If participants are candidates for surgery, they will then be randomized into one of two cohorts, receiving either Shockwave™ IVL + DCB (drug-coated balloon) procedure or a standard surgical endarterectomy. The study compares the 1-year efficacy and 6-month safety outcomes post-procedure for patients with severe, symptomatic CFA stenosis receiving Shockwave™ IVL with DCB versus surgical endarterectomy.

Eligibility Criteria:
Inclusion Criteria:

A patient will be eligible for inclusion in this study if he or she meets all of the following criteria (confirmed by core lab):

1. CFA atherosclerotic stenosis 60-100%
2. Moderate to severe calcification reported on imaging
3. Lifestyle-limiting intermittent claudication (IC) or chronic limb-threatening ischemia (CLTI) as described by Rutherford chronic limb ischemia (CLI) category 2-5
4. Failing conservative therapy
5. Operative candidate for CFE prior to enrollment
6. ≥18 years of age

Exclusion Criteria:

A patient will be ineligible for inclusion in this study if he or she meets any of the following criteria:

1. History of CFE or bypass in affected limb
2. Thrombosis of affected CFA
3. Aneurysm in the common femoral artery of target limb
4. Known target lesion restenosis (re-narrowing of the artery to ≥50% following the alleviation of a previous narrowing within 3 months)
5. Any preceding percutaneous cardiovascular intervention within 2 weeks
6. Inability to tolerate DAPT
7. Known coagulopathy or bleeding diathesis, thrombocytopenia with platelet count \<100,000/µL
8. Uncontrolled diabetes (HbA1c ≥10.0%)
9. Non-ambulatory
10. Extensive tissue loss requiring amputation or salvageable only with complex foot reconstruction or non-traditional transmetatarsal amputations
11. MI within 6 weeks (defined as presumed ischemic symptoms (chest pain, ST-segment deviation and troponin higher than 2 times the upper limit of normal))
12. Stroke within 3 months (defined as sudden transient or irreversible focal neurological deficit resulting from a cerebrovascular cause)
13. Pregnant
Obstetric Antiphospholipid Antibody Syndrome : Contribution of the Evaluation of ADAMTS13 Made at the Diagnosis of Pregnancy on Evaluation the Risk of Pre-eclampsia

Study based on data concerning the first pregnancy treated and followed up after the diagnosis of oAPS in the NOH-APS cohort, according to clinical results already published; and on a thematic library collected and preserved at the time of the positive pregnancy test.

ADAMTS 13 will be explored in the available samples defined above: ADAMTS13 antigen (presence of the molecule), ADAMTS13 activity (VWF proteolysis activity of the molecule), global autoantibodies against ADAMTS13 (plasma antibodies recognizing solid phase insolubilized ADAMTS13), these 3 parameters for the description of ADAMTS13 being measured using commercially available diagnostic kits, ELISA type, Technozyme® range, Technoclone, Vienna, Austria.

The clinical endpoint evaluated will be the occurrence (yes/no) of preeclampsia, which is assessed globally, all subtypes combined. Then evaluated according to subtype: late preeclampsia from 34 weeks, early preeclampsia before 34 weeks, eclampsia (convulsions), HELLP syndrome, preeclampsia associated with the birth of a small-for-gestational-age child (defined at percentile 10 of the tables adjusted for gestational age and sex; severe: defined at percentile 3), preeclampsia associated with a retro-placental hematoma, ...


Eligibility Criteria:
Inclusion Criteria:

* Presence of frozen plasma samples from the positive pregnancy test blood sample.
* Adult patients, included in the NOH-APS cohort, who have successfully initiated a new pregnancy after diagnosis of oAPS.

Exclusion Criteria:

* Absence of frozen plasma sample from the blood sample from the positive pregnancy test.
* Patient who objected to the use of their data.
Bortezomib Plus CHOP Every 2 Weeks for Advanced Stage DLBCL

Diffuse large B-cell lymphoma is a most prevalent non-Hodgkin's lymphoma. Recently the clinical results have been improved with new drugs and new modalities such as cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) every 2 weeks. Bortezomib is well known to be effective for multiple myeloma and has been being tried for other malignancies including lymphoma. The investigators will incorporate Bortezomib to CHOP every 2 weeks to further improve the clinical efficacy in diffuse large B-cell lymphoma.

Intended number of patients: 63 patients in total

* Phase I: 9 patients for 3 levels
* Phase II: 50 patients plus 3 patient from Phase I at MTD level
* Plus 4 patients: considering 5% follow-up loss rate

Study design and methodology:

For phase I, 9 patients; 3 levels of bortezomib (1.0, 1.3 and 1.6 mg/m2), 3 patients at each dose level.

If escalation of bortezomib beyond 1.0 mg/m2 is not possible, the trial will be stopped.

For phase II, 53 patients (3 from phase I at MTD level); Reject when complete response rate equal or less than 12/19 or 37/53 by Simon two-stage optimal phase II design.

Treatments:

* Bortezomib:

For phase I, 3 dose levels (1.0, 1.3 or 1.6 mg/m2), days 1 and 4, every 2 weeks.

For phase II, suggested dose of Bortezomib through phase I, days 1 and 4, every 2 weeks.

* CHOP2: cyclophosphamide 750mg/ m2 day 1, vincristine 1.4 mg/ m2 (max. 2 mg) day 1, doxorubicin 50 mg/ m2 day 1, prednisolone 100 mg days 1-5, every 2 weeks.
* G-CSF: Lenograstim 5 microgram/kg subcutaneously days 4-13 every 2 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed DLBCL
* Age 70 years or less
* Previously untreated
* Performance status: ECOG 0-2
* Advanced stage: stage III, IV, or non-contiguous stage II
* Measurable disease: 1 cm or more by spiral CT
* Normal liver function

Exclusion Criteria:

* Platelet count less than 75,000/microL within 14 days before enrollment.
* Absolute neutrophil count of less than 1,500/microlL within 14 days before enrollment.
* Cr more than 2.0 mg/dL and/or calculated or measured creatinine clearance less than 50 mL/min within 14 days before enrollment.
* Peripheral neuropathy of Grade 2 or worse within 14 days before enrollment.
* Hypersensitivity to bortezomib, boron or mannitol.
* Female subject is pregnant or breast-feeding.
* Other investigational drugs with 14 days before enrollment
* Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
* Uncontrolled or severe cardiovascular disease, including MI within 6 months of enrolment, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis
Dynamics of Drug Resistance-associated Mutations in HIV-1 DNA Reverse Transcriptase Clearance During Effective Antiretroviral Therapy

In view of the prolongation of patients living with HIV's life expectancy, the question of optimization of ART, which is still a life-long treatment, becomes central. While most patients achieve virological success, their treatments often need to be optimized in order to limit adverse events, drugs interactions and to improve adherence. The switch to dual regimen strategies represent one of the approaches for treatment optimization.

Circulating HIV-1 resistant variants can be archived in viral reservoirs, where they can persist for an unknown duration and reemerge in case of therapeutic selective pressure.

There is a need to assess the dynamic of archived Drug resistance associated mutations (DRAMs) clearance in cell-associated HIV DNA after a long period of virological control, in the perspective of ARVs recycling.

The investigators postulate that it could be interesting in the future to recycle ARV drugs (that where classified as "resistant" in the past) in subsequent regimen. The question is particularly important for 3TC/FTC for subsequent new regimen and for the use of dual regimen (disappearance of M184V).

Thus, the investigators propose a retrospective, longitudinal analysis on blood-cell-associated HIV-1 DNA samples in order to investigate by Sanger and Ultra Deep Sequencing the dynamics of decay and persistence of DNA HIV-1 variants harboring key drug resistance-associated mutations to NRTIs, in particular M184V, in patients with sustained virological control for at least 5 years under effective ART.


Eligibility Criteria:
Inclusion Criteria:

* HIV-1 infected
* Age ≥ 18 years
* Genotypic resistance test performed at time of failure and harboring at least M184V
* Fully suppressed HIV viral load for at least 5 or 10 years.
* Triple therapy or 2 drug regimen during the entire follow-up
* Availability of at least 1 stored whole blood sample /year

Exclusion Criteria:

* No genotypic resistance test available at time of failure.
Intraarticular Leukocyte-rich and Leukocyte-poor PRP for Osteoarthritis of the Knee

To compare the efficacy of intraarticular knee injection between leukocyte-rich and leukocyte-poor platelet-rich plasma in knee osteoarthritis treatment

Participants were randomized into 3 groups (leukocyte-rich platelet-rich plasma (LR-PRP), leukocyte-poor platelet-rich plasma (LP-PRP), and Corticosteroid (CS)). The primary outcome of this study is The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and was measured pre-treatment and post-treatment at follow-up at 1, 3, and 6 months

Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 50 years old, Plain radiographs knee AP shows Kellgren-Lawrence classification 1-4, Refuse the use of NSAIDs for 2 weeks.

Exclusion Criteria:

* 1) Previous intra-articular injection therapy in the past 6 months; 2) Previously treated with intra-knee PRP injection; 3) History of knee arthritis from other causes such as rheumatoid arthritis, pseudogout or infectious joints 4) History of blood disorder including anemia and thrombocytopenia (Hb \< 12 g/dl, plt \< 150,000/ml ) 5) History of surgery on the aforementioned knee 6) Obvious knee deformity (valgus \> 15, varus \> 20, flexion ROM \< 90 , extension lag \> 20) 7) Pregnancy and lactation
Effects of Vaporized Marijuana on Neuropathic Pain

This study theorized that a low dose of vaporized cannabis could alleviate nerve injury pain.

We conducted a double-blind, placebo-controlled, crossover study evaluating the analgesic efficacy of vaporized cannabis in subjects, the majority of whom were experiencing neuropathic pain despite traditional treatment. Thirty-nine patients with central and peripheral neuropathic pain underwent a standardized procedure for inhaling medium-dose (3.53%), low-dose (1.29%), or placebo cannabis with the primary outcome being visual analog scale pain intensity. Psychoactive side effects and neuropsychological performance were also evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18 and less than 70
* Visual Analogue Scale (VAS pain intensity) greater than 3/10
* A negative urine drug screening test, i.e., no evidence of IV drug abuse
* Neuropathic pain due to reflex sympathetic dystrophy, peripheral neuropathy, post-herpetic neuralgia, post-stroke pain, multiple sclerosis or spinal cord injury

Exclusion Criteria:

* Presence of another painful condition of greater severity than the neuropathic pain condition which is being studied.
* Subjects with moderate-severe major depression, bipolar/mania, bipolar II/hypomania and schizophrenia or schizoaffective disorder.
* Unstable Type 1 or 2 diabetes defined as blood glucose more than 156 mg/dl
* History of traumatic brain injury
* Uncontrolled medical condition, including coronary artery disease, hypertension, cerebrovascular disease, asthma, tuberculosis (TB), chronic obstructive pulmonary disease (COPD), opportunistic infection, malignancy requiring active treatment, active substance abuse (alcohol or injection drugs).
* Current use of marijuana (e.g., within 30 days of randomization)
* Pregnancy as ascertained by a self-report and a mandatory commercial pregnancy test.
TOlerance MOlecular and Genome-wide Studies With Renal Allograft Recipient Material

TOMOGRAM is a European multicentric, prospective, experimental, controlled study that aims to increase our understanding of the causative mechanisms of operational tolerance in kidney transplantation through the achievement of several multimodal whole-genomic analysis in human biological samples.


Eligibility Criteria:
Inclusion Criteria:

* recipient of an allogenic renal allograft,
* have experienced (whatever ongoing or not) at least a whole year with blood creatinine \<1.7 mg/dL and proteinuria \</=1g/day or /g creatinine despite the COMPLETE discontinuation of immunosuppressive drugs,
* alternatively, have experienced (whatever ongoing or not) at least a whole year with stable blood creatinine (max 20% variation) and proteinuria above these criteria despite the COMPLETE discontinuation of immunosuppressive drugs

Exclusion Criteria:

* Past medical history of allogeneic bone-marrow transplantation / combined organ transplantation