cyrilzakka/clinical-trials huggingface dataset:
Changes in Arterial Stiffness and Endothelial Glycocalyx in Patients With Poorly Controlled Diabetes Mellitus Type 1 or Type 2 After Optimization of Antidiabetic Medication.

Arterial stiffness is associated with increased risk for cardiovascular disease. Moreover, the integrity of endothelial glycocalyx plays a vital role in vascular permeability, inflammation and elasticity. The purpose of this study is to investigate changes in arterial stiffness and endothelial glycocalyx thickness in patients with poorly controlled diabetes mellitus type 1 or type 2 after glycemic control by optimal medication.

The investigators will study two groups matched for age and sex: 30 patients with uncontrolled type 1 diabetes and 30 patients with uncontrolled type 2 diabetes. Individuals should not be treated with statins, beta-blockers, ACE inhibitors, sartans, hormonal preparations, drugs that interfere with the function of platelets and hemostasis. Furthermore, they should not have heart failure, nephropathy and retinopathy. 10 people will remain uncontrolled after the expiration of 3 months after the modification of antidiabetic medication used as a control group .

At 0, 3, 6 and 12 months the investigators will measure:

1. Carotid-femoral pulse wave velocity (PWV, m/sec) and augmentation index (AI%) by the method of arteriography (Arteriograph, TensioMed) and Complior (SP ALAM).
2. Perfused boundary region (PBR, micrometers) of the sublingual arterial microvessels (ranged from 5-25 micrometers) using Sideview Darkfield imaging (Microscan, Glycocheck). Increased PBR is considered an accurate non invasive index of reduced endothelial glucocalyx thickness.
3. Flow mediated dilatation (FMD) of the brachial artery.
4. Determination of following parameters in blood: glucose, insulin, free fatty acids, triglycerides, glycerol, C-reactive protein (CRP), transforming growth factor-b (TGF-b), Lipoprotein-Associated Phospholipase A2 (LP-LPA2), tumor necrosis factor-a (TNF-a), IL6 and IL10 (interleukins), propeptide of type I procollagen (PIP), propeptide of procollagen type III (PIIINP), matrix metallopeptidases 9 and 2 (MMP), macrophage-colony stimulating factor (MCSF), growth differentiation factor-15 (GDF-15), N-terminal pro b-type natriuretic peptide (NT-proBNP) and galectin-3.

Eligibility Criteria:
Inclusion Criteria:

* Patients with uncontrolled diabetes mellitus

Exclusion Criteria:

* valvular heart disease
* congestive heart failure
* peripheral vascular disease
* liver or kidney failure
* history of alcohol or drug abuse
* treatment with statins, beta- blockers, ACE inhibitors or sartans
Efficacy of Dehydrated Cell and Protein Concentrate Versus Corticosteroid

To compare the efficacy of Ascent injection versus corticosteroid injection in treating knee osteoarthritis.

To compare the functional outcomes in patients undergoing treatment of knee osteoarthritis using cortisone steroid injections (CSI) or a dehydrated cell and protein concentrate (dCPC) product, Ascent

Eligibility Criteria:
Inclusion Criteria:

* Age greater than 20 years but less than 75 years old
* Both male and female (non-pregnant)
* Valid knee radiograph within 3 months of beginning treatment;
* Diagnosis of OA of the knee
* OA pain in the knee despite conservative measures
* Average daily VAS \>= 3
* Off any NSAIDs for 1 week prior to injection, may then continue for no more than 5 consecutive days after injection
* Kellgren-Lawrence system of Grade II, III, or IV

Exclusion Criteria:

* Kellgren-Lawrence Grade I
* Tense effusion of the knee
* Significant valgus/varus deformities
* Viscosupplementation within 6 months
* Surgery in the knee within the past 6 months Systemic or intraarticular injection of costicosteroids in any joint within 3 months before screening
* Chronic opioid usage
* History of Leukemia or Lymphoma
* History of any autoimmune disorders and disease
* Immunosuppressive medications
* Active, suspected, or prior infection to the joint
* Vulnerable populations (pregnant women and breast-feeding women, cognitively impaired, prisoners, etc...)
* NSAIDs used within 1 week of the procedure
* History of bleeding disorders or inflammatory joint disease
* Patients who plan on becoming pregnant during study period
Multi-Centre, Prospective, Non-Interventional Study to Intensively Monitor the Safety of Sintilimab in Clinical Practice Among Chinese Patients

In recent years, immunotherapy has become one of the important treatments for malignant tumors. Among them, PD-1 inhibitors have been widely used in clinical practice, and have shown a significant survival benefits in many patients. However, the incidence of immune-related adverse reactions (irAEs) of PD-1 inhibitors is relatively high, and severe cases can even threaten patients's life. At present, irAEs have become a bottleneck and it is urgent to establish a prevention strategy for the prediction of irAEs. In this study, the investigators intends to use Sintilimab as the research drug. A prospective cohort study was carried out. Part of the sample which was used as a training set would be detected for producing a time-series multi-dimensional data such as differential genes, metabolites and immune factors. Then gene expression programming (GEP) was used to explore the irAEs recognition model. Then, based on this recognition model, internal verification ( part of samples from the center 1 ) and external verification ( part of samples from the center 2 and center 3 samples) are carried out to accurately predict the high-risk population of irAEs and realize the early-stage warning of Sintilimab induced- irAEs.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 and ≤75 years old;
2. Subjects with histologically or cytologically confirmed are prepared to receive Sintilimab treatment;
3. Life expectancy of at least 6 months;
4. Eastern Cooperative Oncology Group (ECOG) PS status≤ 2 or Karnofsky (KPS) ≥ 60;
5. No prior immune checkpoint inhibitor treatment
6. Signed written informed consent before any study-related procedure;
7. Adequate hematopoietic function as defined by an absolute neutrophil count ≥1.5×109 /L, platelet count≥80×109 /L, hemoglobin≥90 g/L
8. Adequate hepatic function, defined as a total bilirubin level≤1.5 ×upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤2.5 × ULN in subjects without liver metastases, AST and ALT levels ≤5 × ULN in subjects with documented liver metastases;
9. Adequate renal function, defined as serum creatinine (Cr)≤1.5×ULN or calculated creatinine clearance≥60ml/min (Cockcroft-Gault formula);
10. Serum albumin ≥28g/L;
11. Thyroid-stimulating hormone (TSH)≤1×ULN (if abnormal,subject with the normal levels of FT3 and FT4 can be enrolled).

Exclusion Criteria:

1. Has active autoimmune disease;
2. Severe heart, lung, brain, kidney, gastrointestinal or systemic diseases;
3. has interstitial lung disease;
4. Simultaneous use of drugs that can affect the results of this study;
5. Treatment may interfere with the results of the study
6. Allergy or intolerance to the study drug
7. subject with unconsciousness and psychiatric disorder
8. Pregnant and lactating women
9. Subject with poison and alcohol abuse
Control of Metabolic and Cardiovascular Risk in Patients With Schizophrenia and Overweight

To analyse the progress of modifiable metabolic risk factors (Blood pressure, cigarette smoking, waist perimeter, BMI, glycemia and lipidic profile) in schizophrenic patients with overweight for 12 months.

To analyse the perceived health status and the level of functioning and disability of patients with schizophrenia and overweight and their progress at 3, 6 and 12 months.

To assess the progress of the symptoms of the disease at 6 and 12 months.

Consecutive patient sampling. Any investigational site four consecutive patients with diagnosis of Schizophrenia (DSM-IV TR) and Overweight (BMI more or equal to 25 Kg/m2)

Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosis of schizophrenia, schizophreniform or schizoaffective disorder (DSM-IV TR)
* Patients with BMI (body mass index) more or equal to 25 Kg/m2
* Patients or their legal representative have provided written informed consent

Exclusion Criteria:

* Patients are unable to complete or to understand health questionnaires in Spanish language
* Patients are currently enrolled on clinical trials or other investigational studies
Electronic-health Application To Measure Outcomes REmotely Clinical Trial

This is a phase II feasibility, safety, tolerability and preliminary efficacy study of an e-Health application versus in-person nutritional counseling to maintain or increase weight in patients with neurodegenerative diseases including amyotrophic lateral sclerosis (ALS), Parkinson's Disease (PD) and Huntington's disease (HD). Primary Objectives include the feasibility, safety, tolerability and efficacy of an e-Health application to maintain or increase body weight compared to in-person nutritional counseling. Secondary Objectives are to measure the number of calories required to maintain or increase body weight in neurodegenerative diseases at all stages of the disease. Tertiary Objectives are to test the effects of an e-Health application compared to in-person nutritional counseling on disease progression using the ALSFRS-R, UHDRS or UDysRS, on survival, and on quality of life using the PROMIS SF v1.1 scale.

This is a single center, randomized, open-label, placebo controlled, parallel group study. The study treatment period is approximately 6 months and observation period is approximately 7 months. There are three parallel treatment groups: in-person nutritional counseling, nutritional counseling using an e-Health App, and standard care. Subjects will be randomly assigned in a 1:1:1 ratio using a computer-generated randomization scheme. Subjects in the two intervention arms will be given caloric recommendations designed to cause weight stability or modest weight gain, depending on their current BMI and weight loss history. All participants in the intervention arms will receive counseling either in-person or remotely through the App by registered dietitians (RD) working in the Bionutrition department of the Clinical Research Center at MGH. At MGH, approximately 150 ALS subjects (50 per treatment group) will be enrolled. Approximately 75-150 PD and HD subjects will enroll.

Eligibility Criteria:
Inclusion Criteria:

1. Adults with neurodegenerative diseases such as ALS, PD or HD with or without a history of unintentional weight loss.
2. Male or female subjects aged 18 years or older.
3. Participants must be capable of providing informed consent and complying with trial procedures.
4. Participants must have an MGH swallowing screening tool score\>5 at the time of the screening visit
5. Participants or a designated caregiver must be able to obtain home weights and communicate to their RD

Exclusion Criteria:

1. Clinical evidence of unstable medical or psychiatric illness, in the investigator's judgment, which would prevent the participant from completing their assessments.
2. BMI \> 35 combined with a history of cardiovascular disease; or a history of diabetes regardless of BMI.
Impact of Oxidized Silver Wound Dressings on Wound Bacteria

Chronic non-healing wounds considerably impact quality of life in affected patients and are a substantial burden on the Canadian health care system. Microbes colonizing a chronic wound play an important role in impeding effective healing. Chronic wounds are colonized by polymicrobial communities and no single organism can be seen as causal. Only a small fraction of wound bacteria are cultured by diagnostic tests and studies have shown little agreement between culture and molecular based approaches, therefore an effective diagnostic for wound microbes is required. It is know that the composition of the microbial community associated with a wound changes as it heals although the causal relationship is somewhat unclear. Although not very effective in treating chronic non-healing wounds, antibiotics are often administered, contributing to concerns of antibiotic resistance. The wound dressings produced by Exciton Technologies Inc. (ETI) effectively aid in the healing process in chronic wounds through unknown mechanisms. ETI's wound dressings contain a combination of silver salts with three different valence, +1, +2 and +3 that have antimicrobial activity and are effective in reducing biofilm formation in vitro. However, it is not known how these silver salts impact microbial ecology of the wound and the role this plays in wound healing. The objectives of this research are to develop a new diagnostic tool based on molecular characterization of wound sites so as to predict how to best treat wounds and to identify new microbes to be targeted by ETI's technology. This project will utilize molecular microbial ecology for the assessment and evaluation of topical silver interventions, gaining insight into the management of chronic infection. Substantiating the microbiota-modifying effectiveness of silver wound dressings towards increasing clinician and patient understanding to improving clinical outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. Signed or verbal informed consent
2. \>17 yrs and \<70 yrs of age
3. have a chronic wound (defined as \>6 weeks, non-healing), with or without clinical signs of infection.
4. requires visitation or admittance to the clinic and subsequent visits for dressing changes

Exclusion Criteria:

1. Systemic antibiotics within the last 2 weeks.
2. known skin sensitivity to any of the dressing components
3. Poor prognosis and who are unlikely to survive the trial period.
4. Participating in another concurrent trial.
5. Exhibiting any other medical condition, which, according to the investigator, justifies the subject's exclusion from the trial.
Efficacy and Safety Assessment of T4030 Eye Drops Versus Ganfort® UD in Ocular Hypertensive or Glaucomatous Patients.

To demonstrate the non-inferiority of T4030 unpreserved eye drops compared to Ganfort® UD in terms of efficacy.

Efficacy Parameters IOP assessment in each eye

Eligibility Criteria:
Inclusion Criteria:

* Informed consent signed and dated\*
* Patient aged ≥18 years old
* Both eyes with a central corneal thickness assessment ≥500 µm and ≤600 μm a
* Both eyes with diagnosed ocular hypertension or open angle glaucoma

Exclusion Criteria:

* History of narrow angle and/or angle closure glaucoma
* Advanced stage of glaucoma
A Human Experimental Model for Neuropathic Pain Using Combined Application of Capsaicin and Local Anesthetics

Main of the present study was to develop a model of concomitant C-fibre block and sensitization eliciting spontaneous pain as well applying topical capsaicin and local anesthetics (LA) to examine the sensory alterations after combined C-fiber block and sensitization in both different application orders (sensitization of blocked C-fibers and block of sensitized C-fibers), compared to each of both mechanisms alone. Thereby, we expect stronger sensory changes during the combined substance application than during the monoapplication. We expect also contralateral sensory alterations mirroring the changes on the intervention site after the combined capsaicin and LA application, being stronger than after sensitization alone absent after C-fiber block alone.


Eligibility Criteria:
Inclusion Criteria:

* healthy subject, older than 18 years, provided written informed consent

Exclusion Criteria:

* insufficient comprehension of the German language, history of severe internal, neurological or dermatological diseases, substance abuse, manifest psychiatric diseases, chronic and acute pain, any medication intake (except contraceptives in females) regularly or on demand during the last 14 days before study inclusion and during the study period, hypersensitivity to lidocaine or other amide-type anesthetics, hereditary or acquired methemoglobinemia, pregnancy, nursing, abnormal sensory profile in the quantitative sensory testing (QST) with side-to-side differences beyond the normal range at baseline and participation in clinical trials during the last month.
Essure Permanent Birth Control, Effectiveness and Safety: A French Survey

Since 2002, in CHU Amiens, Essure implants started to be used for women in need of voluntary sterilization in accordance with French national recommendations. Recently patient committees emerged to alert health agency and governments about various symptoms possibly link to the Essure implants. New studies have been launched in order to determinate if Essure implants were involved with the symptoms described. According to the scientific literature no solid link between Essure and the symptomatology was highlighted. French National College of Gynecologists and Obstetricians send a letter of information for patient and gynecologists. French National agency of medicament suspended Essure authorization in august 2017 for 3 months. Bayer industry decided to withdraw from the market the Essure implants in autumn 2017. Currently Essure procedures have been stopped to be used in CHU Amiens since august 2017. But, in CHU Amiens, health institutions still have to manage patients with Essure implants and potential adverse effects.

The purpose of this study is to determine if the patients treated between 2002 and 2017 with Essure implant present complications, had a proper follow up after the Essure implantation, and that the Essure implantation respected the medical guidelines in order to offer the best medical care with these new informations.

Medical data from patients who received Essure procedure will be collected with medical file and a survey about adverse effects will be submitted to patients by phone if they agree to take part of the study after loyal information.


Eligibility Criteria:
Inclusion Criteria:

* women more than 18 years old
* patients who benefit of Essure permanent birth control in CHU Amiens between 2002 and 2017
* signed informed consent form

Exclusion Criteria:

* women Under 18 years old
* refusal to participate
* patient Under administrative supervision
CogT pSOPT Intervention Study

(JUSTIFICATION: This is the R33 stage of an NIH funded R21/R33 study. R21 stage (IRB-61727) was focused on intervention development; R33 stage will focus on pilot testing the effect of the intervention. The R21 phase was not considered a NIH defined clinical trial; R33 will be considered a NIH defined clinical trial)

The purpose is to develop and test the effect of a "personalized" computer-based cognitive training program. The personalized program tailors the difficulty of the training tasks using a participant's biofeedback (i.e., heart rate) and cognitive performance. Such a personalization will ensure that the participant can perform at his/her ideal training capacity. Participants will be randomized into one of 2 groups and each group will play a different version of computerized training game and have ECG collected to allow subject blinding.


Eligibility Criteria:
Inclusion Criteria:

1. criteria related to defining "mild cognitive impairment": a. Presence of memory complaint; b. Rey Auditory Verbal Learning Test delayed recall (for memory) \< 59% of age-adjusted norm; c. Montreal Cognitive Assessment (for global cognition) ranged 18 and 27; d. Functional Assessment Questionnaire (for activities of daily living) \< 20.
2. intact score for San Diego Brief Assessment of Capacity to Consent (UBACC).
3. if a participant is on AD medication (i.e., memantine, cholinesterase inhibitors, amyloid antibodies), antidepressants, anxiolytics, or vascular risk or diseases related medications (e.g., beta-blocker), the dose should be stable for 3 months prior to recruitment.
4. age 60+,
5. read and understand English
6. adequate visual and hearing acuity for testing by self-report,
7. community-dwelling (including independent living).

Exclusion Criteria:

1. current enrollment in another cognitive improvement study;
2. uncontrollable major depression;
3. major cerebrovascular and cardiovascular diseases (e.g., congestive heart failure, pacemaker, prior myocardial infarction);
4. having an active legal guardian (indicating impaired capacity for decision making);
5. currently pregnant
6. 3T MRI contraindication
7. Neurological conditions: Neurodegenerative disease diagnosis such as Parkinson's, Alzheimers, dementia, multiple sclerosis. Of note, other neurological conditions/injury such as stroke, seizures, traumatic brain injury, will be evaluated for inclusion/exclusion on a case-by-case basis based on event recency, severity, and recovery.
Effects of Pilates Exercises Applied With Face-to-Face and Telerehabilitation on Menstrual Pain

Pain is one of the most common symptoms of menstrual syndrome that significantly affects quality of life. The aim of our study is to compare the effect of Pilates on menstrual pain and the effectiveness of the applications within themselves.

20 women experiencing severe pain during menstruation were randomized into two groups. The same exercise program is applied to 10 participants face-to-face, and to 10 participants via telerehabilitation. Exercises are applied for 6 weeks, 2 days a week. Visual Analog Scale (VAS) is used for pain assessment, SF-36 Short Form is used to assess quality of life, and Menstrual Attitude Scale is used to assess symptoms in the premenstrual/menstrual period. Evaluations are performed twice in total, before and after treatment. Statistical analysis will be performed with SPSS 24.0 program. If the data is parametric, paired sample t-test will be used for within-group evaluation; independent sample t-test will be used for between-group evaluation. If the data is non-parametric, Wilson test will be used for within-group evaluation and Mann Whitney U test will be used for between-group evaluation.

Eligibility Criteria:
Inclusion Criteria:

* People between the ages of 18-30 who have a continuing menstrual cycle.
* Women with menstrual pain VAS\>5.
* People with regular menstrual cycles.

Exclusion Criteria:

* Being in menopause.
* Using birth control pills.
* Taking hormone therapy.
* Having exercise intolerance.