cyrilzakka/clinical-trials huggingface dataset:
Parnaparin vs Aspirin in the Treatment of Retinal Vein Occlusion

Retinal vein occlusion (RVO) is the second commonest retinal disease after diabetic retinopathy, and is a common cause of unilateral visual loss. There are two aims in the management of RVO: the identification of modifiable risk factors and their medical management and the recognition and management of sight-threatening complications. The management of the disease includes laser therapy and the control of systemic associated diseases. Many other treatments have been proposed but there is no evidence on their efficacy in modulating the outcome of branch or central RVO. There are currently no adequate clinical trials that have evaluated the efficacy and safety of antithrombotic agents in this setting. Antiplatelet agents are frequently used in clinical practice. Anticoagulant drugs, either heparins or coumarins, are also used in this setting as they represent the first line therapy for the treatment of venous thromboembolism. Aim of this randomized controlled study is to to compare the efficacy and safety of aspirin and of a low molecular weight heparin, parnaparin, in the treatment of RVO. Study treatment is administered for 3 months. Primary end-point of the study is the incidence of functional worsening of the eye with RVO at 6 months. Secondary efficacy outcomes are the following: proportion of cases requiring laser treatment because of the extension of the ischemic lesion and/or the presence of neovascularisation and/or macular oedema, incidence of recurrent RVO objectively documented by fluorescein angiography. Safety outcomes are defined by the incidence of major and minor bleeding events.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 85 years
* A body weight of greater than 50 Kg
* A requirement that no more than 15 days had passed between symptomatic presentation, confirmation of RVO and entry into the study.

Exclusion Criteria:

* Modification of the optic media transparency that could compromise the evaluation of fluorescein angiography, such as cataract or corneal degeneration
* History of major ocular surgery (with the exclusion of cataract extraction)
* Previous RVO
* Other ocular conditions that, in the opinion of the investigator, could have affected macular edema or altered visual acuity during the course of the study - Contraindications to the study drugs (e.g. major bleeding or neurosurgical procedures in the previous 3 months, serum creatinine levels of greater than 2.0 mg/dL, severe liver insufficiency, platelet count \< 100,000 mm3, known active peptic gastric ulcer)
* Active malignancy
* Pregnancy
* Inability to attend for follow up or anticipated non-compliance
* Ongoing treatment with aspirin or anticoagulant drugs at the time of RVO diagnosis
Glycemic Response in Adults with Diabetes

This will be a randomized crossover design with oral nutrition supplement interventions.

This will be a randomized crossover design with two oral nutrition supplement interventions. The subjects will be randomized to one of two interventions on two separate study days, one week apart.

Eligibility Criteria:
Inclusion Criteria:

* Age 20-75 years
* Type 2 diabetes controlled with diet or diet and metformin (Glucophage)
* Hemoglobin A1C less than 9.0%
* Fasting blood glucose less than 180 mg/dl
* Hematocrit levels within normal limits
* Having obtained his/her informed consent

Exclusion Criteria:

* Abnormal thyroid function
* Creatinine \>2.0 mg/dl
* Potassium \<3.5 mEq/l
* Gastrointestinal disease: ulcer, gastritis, diarrhea, gastroparesis, vomiting
* Currently unstable diabetes or under treatment for cancer, heart disease, renal disease
* Patients with anemia
* Current insulin therapy or insulin therapy within the past month
* Patient who are pregnant
* Allergies to milk, soy or any component of the test product
* Patient who in the investigators assessment cannot be expected to comply with treatment
* Patients with anemia
* Currently participating in another clinical trial
Effects of Erector Spinae Plane Block and Intrathecal Morphine Administration on Intraoperative Sevoflurane Consumption

In our study, the investigators aimed to compare the intraoperative sevoflurane consumption and postoperative analgesic needs of patients who underwent lumbar disc herniation surgery and received either ESP block or ITM in the preoperative period with a control group.

The amount of volatile anesthetic agents used for anesthesia maintenance can be significantly reduced with potent and long-acting analgesic interventions administered during the preoperative period. Such interventions enable the maintenance of anesthesia with more optimal levels of agents during surgery, providing significant advantages in terms of both patient safety and cost.

Studies have recommended multimodal analgesia approaches involving the Erector Spinae Plane (ESP) block and intrathecal morphine (ITM) injection for various surgical procedures. These two methods, through different mechanisms of action, not only reduce intraoperative anesthetic agent consumption but also play a critical role in postoperative pain management. Although studies have investigated the effects of ESP block and ITM injection on intraoperative volatile anesthetic consumption, there is limited research directly comparing their impacts on volatile anesthetic consumption and postoperative analgesic requirements.

In our study, we aimed to compare the intraoperative sevoflurane consumption and postoperative analgesic needs of patients who underwent lumbar disc herniation surgery and received either ESP block or ITM in the preoperative period with a control group.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged over 18 years
* Patients receiving general anesthesia
* Patients with an ASA score of I-II
* Patients undergoing elective surgery for single-level lumbar disc herniation
* Patients who provided informed consent after being informed

Exclusion Criteria:

Patients who did not provide informed consent after being informed

* Patients over 65 years of age
* Patients with an ASA score of III or higher
* Patients with recurrent lumbar disc herniation (LDH)
* Patients undergoing surgery for multi-level LDH
* Patients with a body mass index (BMI) of 30 or higher
* Patients with allergies to morphine or bupivacaine
* Patients with major cardiac, respiratory, hepatic, renal, neurological, or psychiatric diseases
* Patients with a history of alcohol or substance abuse
* Patients with a local infection at the injection site
* Patients with bleeding diathesis
* Patients with a history of anticoagulant medication use
* Patients with contraindications to spinal or regional anesthesia
MLD10 for the Treatment of Hypomagnesemic Patients With Type 2 Diabetes Mellitus

To determine the effect of MLD10 (magnesium L-lactate dihydrate extended-release caplets) 10 mEq BID on serum magnesium in Type 2 diabetic patients with hypomagnesemia.


Eligibility Criteria:
Inclusion Criteria:

* Females and males with Type 2 diabetes mellitus
* Body Mass Index between 18 to 40 kg/m2, inclusive, at Screening
* Hypomagnesemia defined as serum magnesium ≤ 1.5 mg/dL at Screening
* Females must be non-pregnant, non-lactating, and have a negative serum pregnancy test before enrollment.

Exclusion Criteria:

* History of clinically significant GI, renal, hepatic, neurologic, hematologic, endocrine other than Type 2 diabetes mellitus, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease.
AVocAdo Extract to Improve gLycemia in Individuals With Obesity (AVAIL)

This two-arm, double blind, randomized clinical trial will compare the effect of an avocado extract, compared to placebo, on cardiometabolic outcomes in adults with obesity.

Sixty eligible participants will be stratified by sex and randomly assigned to placebo or avocado extract supplementation group for 12 weeks. Metabolic testing will be performed at baseline, and at the end of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Men and women 25 - 65 years old
* Waist circumference (\>94cm in men and \>80cm in women)
* BMI 30 - 40 kg/m2
* Willingness to provide written informed consent and willingness to participate and comply with the study

Exclusion Criteria:

* Women planning pregnancy during the course of the study or 3 months after completion of the study, or who are lactating
* Individuals diagnosed with type 1 or type 2 diabetes mellitus, liver or kidney diseases, neoplastic disease in the previous 3 years, chronic gastrointestinal disorders (including inflammatory bowel disease and celiac), cardiovascular event in the previous 6 months, or any other condition deemed unstable
* Biochemical abnormalities or evidence at screening of disease including elevated liver enzymes ALT and/or AST \>3 times normal range limit
* Not weight-stable (\< 5 % fluctuation in their body weight for past 6-months at study entry).
* Current or recent (within 12 months) treatment with medication used to lower blood glucose or antidiabetic medications (metformin, sulfonylureas, glucagon-like peptide-1 (GLP-1) analogues \[i.e. exenatide\], thiazolidinediones or DPP-IV inhibitors \[i.e. 'gliptins'\]), medications affecting weight, appetite or gut motility (i.e. domperidone, cisapride, orlistat, phentermine, topiramate). Participants who are taking stable doses (i.e. \> 12 months) of androgenic medications (i.e. testosterone), thyroxine, corticosteroids, anti-depressants (selective serotonin reuptake inhibitors), anti-hypertensives (ace-inhibitors, calcium channel blockers, beta-blockers, diuretics) and lipid lowering medications (statins, fibrates) will not be excluded.
* Participants who have had bariatric surgery
* Participants with conditions that may interfere with the ability to understand the requirements of the study.
A Study to Evaluate the Risk of Developing a Heart Condition Called Valvular Regurgitation in Patients With Acromegaly Treated With Either Lanreotide or Octreotide

The aim of the study is to compare the risk of acromegaly patients developing valvular regurgitation when receiving lanreotide or octreotide


Eligibility Criteria:
Inclusion Criteria:

* Patient has a diagnosis of Acromegaly
* Patient is being treated with lanreotide or octreotide in any dose form at the selection visit or is a de novo patient who is due to commence treatment within 2 weeks of baseline
* Patient started treatment with either lanreotide or octreotide when both products were available on the market in their country
* Patient must not change treatment form lanreotide to octreotide or vice versa for the duration of the study

Exclusion Criteria:

* Patients with known significant valve abnormalities prior to treatment with either lanreotide or octreotide
* Patients who have received treatment with a somatostatin analogue other than lanreotide or octreotide for more than 3 months
* Patients who have received treatment with a GH antagonist for more than 3 months
* Patients who have had heart valve replacement therapy
Evaluation of Efficacy of Full-mouth Disinfection in Generalized Aggressive Periodontitis Patients

The purpose of this study is to determine whether full-mouth disinfection is effective in the initial periodontal treatment of generalized aggressive periodontitis on clinical parameters, gingival crevicular fluid interleukin-1β (IL-1β) and interleukin-17 (IL-17) and periodontal pathogen levels compared with conventional initial periodontal treatment and full-mouth initial periodontal treatment.

The investigators' hypothesis is to test whether full-mouth disinfection in the initial periodontal treatment of generalized aggressive periodontitis enhance the clinical, biochemical and microbiological parameters in comparison to conventional initial periodontal treatment and full-mouth initial periodontal treatment.

The present study aimed to compare the efficacy of conventional initial periodontal treatment (C-IPT), full-mouth disinfection IPT (FMD-IPT) and full-mouth IPT (FM-IPT) and the levels of gingival crevicular fluid interleukin-1β (IL-1β) and interleukin-17 (IL-17), Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Fusobacterium nucleatum, Prevotella intermedia, Parvimonas micra and Campylobacter rectus in patients with generalized aggressive periodontitis (GAgP) over 6-months period. Forty-two GAgP patients were randomly assigned into 3 groups. IPT was performed in a quadrant-wise manner at 1-week intervals in C-IPT, in 2 sessions within 24 hours in FM-IPT, and in 2 sessions with application of chlorhexidine to the intra-oral niches within 24 hours in FMD-IPT. FMD-IPT group also used daily 0,2% chlorhexidine for 3 weeks. At baseline, 3 and 6 months clinical parameters consisting of plaque index, gingival index, probing depth, bleeding on probing and clinical attachment level were recorded, gingival crevicular fluid and microbiological samples were collected. Gingival crevicular fluid levels of IL-1β and IL-17 were analyzed using ELISA. The quantitative real-time polymerase chain reaction method was used for the quantitative detection of periodontal pathogens.

Eligibility Criteria:
Inclusion Criteria:

* No systemic diseases that could influence the outcome of the therapy
* No smoking
* No medications affecting periodontal tissues
* No pregnancy or lactation
* Presence of at least 15 teeth

Exclusion Criteria:

* Received antibiotic treatment in the previous 3 months
* Smokers
* Pregnancy and lactation
* Received periodontal treatment in the previous 6 months
* Presence of less than 15 teeth
* Presence of systemic diseases
Isokinetic Strength Training in Hemiparetic Patient With Knee Extension Thrust

The purpose of this study is to assess the impact of an isokinetic strength training of knee flexor and extensor muscles on walking performance in hemiparetic patients with knee extension thrust.

The study will be interventional single case experimental design (SCED) with multiple baseline design. SCED are experimental designs aiming at testing the effect of an intervention using a small number of patients using repeated measurements, sequential and randomized introduction of an intervention and method-specific data analysis, including visual analysis and specific statistics.

During baseline, patients will have a rehabilitation program in day hospital (4 days per week) with physiotherapy and physical activity and if necessary occupational and speech therapy. Isokinetic strength training will be added to this conventionnal rehabilitation program and will begin after 3, 4 or 5 weeks of baseline according to randomization

12 patients will be included in this study (6 patients in subacute stage and 6 in chronic stage ).

Eligibility Criteria:
Inclusion Criteria:

* Hemiparetic patient (hemorragic or ischemic stroke)
* Subacute stage (\< 6 Months) ou chronic stage of stroke (\> 6 months) (6 patients in each group)
* Age between 18 and 75 years
* Able to walk 10 meters independently without any assistive devices
* Knee extension thrust during stance phase of gait cycle (rapid posterior movement of the knee toward extension)
* Scheduled rehabilitation program with isokinetic strength training
* affiliation to a social security
* Patients who received and signed informed consent

Exclusion Criteria:

* Major comprehension deficit that not allow to give informed consent and participate to isokinetic strength training (assessed with comprehension subscore of Langague screening Test)
* non stable (unstable cardiovascular condition)
* musculoskeletal disorders with knee pain that not allowed isokinetic strength training
* Botulinum toxin injection less than 3 months or repeated injection in lower limb,
* Proprioception trouble assessed with proprioception section of the Fugl-Meyer Assessment \[FMA-P\] 0/2
* spasticity of triceps surae ≥2 (Modified Ashworth scale)
* ankle dorsiflexion angle less than 90°
* pregnant women or breastfeeding
* persons with safety measure
Feasibility Study of Mixed Reality Exergame on Performance and Cortical Outcomes

The executive dysfunctions are a problem in individuals with MCI which predict conversion to dementia and is positively related to physical activity level. Previous studies found that exercise can prevent executive and physical dysfunctions for people with MCI. However, the motivation is a critical factor in supporting a sustainable exercise. Exergame is combination of exercise and video game. Enjoyment during playing an exergame can support the exercise motivation. Therefore, we will explore the feasibility of using MR exergame in people with MCI.


Eligibility Criteria:
Inclusion Criteria

* Healthy group: 1) MoCA score \> 24; 2) Independent walking without using gait aids; 3) No diagnosis of the dementia by clinician.
* MCI group: 1) MoCA score between 16 to 24; 2) Independent walking without using gait aids.

Exclusion Criteria:

* Uncontrolled high blood pressure (more than 140/90 mmHg)
* Hemodialysis
* Have clinical diagnosis of the disease or symptoms that could influence the performance assessments such as arthritis or severe hand pain which reports by participants and the testing by physiotherapist before testing.
* History of neurological disorder, such as stroke or other neurodegenerative disorder
* Taking medicine which affected to functional movement.
* Unable to follow study protocol.
* Uncorrected visual or hearing impairment.
* Positive screening for contraindication of TMS which will be confirmed by TMS screening questionnaire such as uncontrolled seizures.
Deciphering a Specific Signature of the Immunosenescence Induced in COVID-19+ Patients Versus Rheumatoid Arthritis Patients

Immune aging or immunosenescence is characterized by a loss of T cell clonal diversity and a contraction of naïve T cells with proliferative capacity associated with the functional impairment of many others immune cells as well as a chronic low degree of inflammation. A restrictive T cell repertoire is likely more prone to antigen-mediated exhaustion observed during chronic viral infections. Notably, lymphopenia is the most consistent laboratory abnormality in COVID-19 infected patients and both lung-resident and circulating T cells potently up-regulate markers of T cell exhaustion. It is not clear today if the association of COVID-19 disease severity with age is mainly related with the immunosenescence of infected patients. Interestingly, T cell exhaustion and premature immunosenescence have also been observed in chronic inflammatory diseases such as rheumatoid arthritis (RA). To better understand the immunological mechanisms involved in SARS-Cov-2 pathophysiology, the investigators propose to compare the immunosenescence patterns observed during RA, aging and SARS-Cov-2 infected patients in order to design improved therapeutic interventions.


Eligibility Criteria:
Inclusion Criteria for Active RA Patients:

* Patients with rheumatoid arthritis (RA) meeting the 2010 ACR/EULAR diagnostic criteria
* Patients in inflammatory flare of RA (DAS28 \> 3.2)
* Patients who have been off biological disease-modifying antirheumatic drugs (bDMARDs) or targeted synthetic antirheumatic drugs (tsDMARDs) for RA for at least 2 weeks (except for rituximab, where a delay of at least 12 months is required)
* Conventional synthetic DMARDs (Methotrexate, Hydroxychloroquine, Leflunomide, Sulfasalazine) are allowed
* Beneficiary of a social security system
* Informed consent

Inclusion Criteria for Healthy Controls:

* Absence of chronic diseases and current infection
* Beneficiary of a social security system
* Informed consent

Inclusion Criteria for COVID-19+ Patients:

* Patients with ongoing SARS-Cov-2 infection (PCR+)
* Patients hospitalized at D7-D14 of symptoms onset
* Patients with two or more SARS-Cov-2 symptoms (including fever, cough, dyspnea, sore throat, chest pain, anosmia, diarrhea)
* Membership in or beneficiary of a social security scheme
* Collection of free and informed consent

Exclusion Criteria for All Groups:

* Subjects under 18 years of age
* HIV positive patients
* Diabetic patients
* Morbidly obese patients (BMI \> 40kg/m2)
* Use of senolytic drugs in the week prior to inclusion (azithromycin, metformin, cyclosporine, JAK inhibitors)
* Use of steroids in doses greater than 10 mg/day in the week prior to inclusion
* Subjects unable to give consent
* Pregnant, breastfeeding, or non-menopausal women not taking effective contraception
* Vulnerable subjects protected by law
* Subjects under guardianship or curatorship
Non-invasive vs Invasive Cardiac Output Monitoring During Cesarean Section

This study aims to evaluate the consistency of hemodynamic monitoring between NICAP and NICCO technologies (T20A; Chongqing, China) and the traditional pulse wave analysis method (EV1000; USA).

The uterine placenta lacks autonomous regulatory ability, thus making maternal cardiac output (CO) the primary source of blood supply. Therefore, monitoring hemodynamics, including maternal CO, is of significant importance and provides guidance for anesthesia decisions such as fluid management and the administration of vasopressors during cesarean section. This study aims to evaluate the consistency of hemodynamic monitoring between NICAP and NICCO technologies (T20A; Chongqing, China) and the traditional pulse wave analysis method (EV1000; USA).

Eligibility Criteria:
Inclusion Criteria:

* 18-45 years
* Primipara or multipara
* Singleton pregnancy ≥37 weeks
* American Society of Anesthesiologists physical status classification I to II
* Scheduled for cesarean section under spinal anesthesia

Exclusion Criteria:

* Body height \< 150 cm
* Body weight \> 100 kg or body mass index (BMI) ≥ 40 kg/m2
* Eclampsia or chronic hypertension or baseline blood pressure ≥140 mmHg
* Hemoglobin \< 7g/dl
* Fetal distress, or known fetal developmental anomaly