cyrilzakka/clinical-trials huggingface dataset:
Comparison of NN1250 Versus Insulin Glargine in Subjects With Type 2 Diabetes

This trial is conducted in Asia and Japan. The aim of this trial is to compare insulin degludec (NN1250) with insulin glargine both combined with oral antidiabetic drugs (OADs) in subjects with type 2 diabetes never treated with insulin.


Eligibility Criteria:
Inclusion Criteria:

* For Japan only: minimum age is 20 years
* Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
* Current treatment with monotherapy or combination of an insulin secretagouge (sulfonylurea or glinide) and metformin, with or without addition of alfa-glucosidase-inhibitors or a DPP-4 inhibitor with unchanged dosing for at least 3 months prior to visit 1. The dose(s) should as minimum be as stated: -Insulin secretagogue (sulfonylurea or glinide): Minimum half of the daily maximal dose according to local labelling -Metformin: alone or in combination (including fixed combination): Maximum tolerated dose - alfa-glucosidase-inhibitors: Minimum half of the daily maximal dose or maximum tolerated dose -DPP-4 (dipeptyl peptidase 4) inhibitor: According to local labelling
* HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis
* Body Mass Index (BMI) no higher than 35.0 kg/m\^2

Exclusion Criteria:

* Use within the last 3 months prior to Visit 1 of: TZDs (thiazolidinediones), exenatide or liraglutide
* Cardiovascular disease, within the last 6 months prior to visit 1, defined as: stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
* Uncontrolled treated/untreated severe hypertension (systolic blood pressure at least 180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure at least 100 mmHg)
* Pregnancy, breast-feeding, or the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements (for Thailand: adequate contraceptive measures are: diaphragm, condom (by the partner), intrauterine device in place for last three months before trial starts, sponge, cap with spermicide, contraceptive patch, approved hormonal implant (i.e. Norplant), oral contraceptives taken without difficulty for the last three months before trial starts, post menopausal state or sterilisation.)
* Cancer and medical history of cancer (except basal cell skin cancer or squamous cell skin cancer)
Investigating Near-Threshold Perception During Anesthetic Sedation

The researchers expect to gain a deeper understanding of mental function during different levels of anesthesia, and to evaluate if the use of ultrasonic brain stimulation accelerates return to consciousness.

Propofol is FDA approved for use in patients undergoing an anesthetic for medical treatment but is not approved for use in healthy volunteers.

The stimulus set will include real and scrambled images, where the scrambled images will be created by phase-shuffling a randomly chosen real image from each category to preserve category specific low-level image features. Because scrambled images do not include an object stimulus, the images are used as "catch trials" to determine the subjects' baseline tendency to give positive responses to a question about the subjects' recognition experience. Each object category will include four unique real images and one scrambled image. Each image will be repeated 10 times (i.e., trials) for each 16-min session. The pre-stimulus interval will vary randomly from trial to trial between 4 and 8 seconds to prevent stimulus timing predictability. The stimuli will be presented in a randomized order to prevent category predictability.

Eligibility Criteria:
Inclusion Criteria:

* Healthy study subjects with American Society of Anesthesiologists (ASA)-1 status.
* Right-handed
* Body mass index (BMI) less than 30.
* All subjects will be English speakers.

Exclusion Criteria:

* Medical contraindication to magnetic resonance imaging (MRI) scanning; are unable to undergo MRI scanning because of possible pregnancy or currently breastfeeding, BMI\>30, metallic substances in the body, claustrophobia, anxiety, or cardiopulmonary disease; or have an intracranial structural abnormality on T1-weighted MRI scans.
* History of allergy to propofol, eggs or egg products, soybean or soybean products, neurological, cardiovascular, or pulmonary illness; significant head injury with loss of consciousness; learning disability or other developmental disorder; sleep apnea or any severe snoring history; gastroesophageal reflux disease (GERD) or heartburn; pancreatitis or a history of pancreatitis, or sensory/motor loss sufficient to interfere with performance of the study.
* Tattoos in the head or neck region will be excluded from study; other tattoos are subject to determination by investigators based on their assessment regarding participant safety. To eliminate aspiration risk subjects will also be excluded if they have had recent food or liquid intake (within 8 hours).
* History of drug use, have a positive drug screen, are unwilling to abstain from alcohol for 24 hours prior to dosing, or have a current history of nicotine use.
* Pregnancy
Circulating microRNAs as Biomarkers of Sepsis

MicroRNA has been demonstrated to play a crucial role in regulating cell processes. Recently, microRNA was identified to exist in human serum or plasma, and it might be related to certain diseases. Several microRNAs are involved in sepsis, such as miR-146, miR-155, and so on. But whether serum miR-146 is present in serum of septic patients remains unknown. The present study was designed to identify the existence of specific microRNAs, which might be new markers for sepsis and its prognosis.


Eligibility Criteria:
Inclusion Criteria:

* patients who develop sepsis and undergo abdominal surgery
* patients who develop SIRS after cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

* patients with a primary diagnosis of acute pancreatitis
* patients with cirrhosis or renal dysfunction
* patients with dyscrasia
* patients with autoimmunity diseases
* patients with severe cardiac and pulmonary diseases
* patients with hematological diseases
* patients who had organ dysfunction after cardiac surgery with cardiopulmonary bypass
Inflammation in Children With Attention-Deficit/Hyperactivity Disorder

The aim of this study is to investigate the inflammatory response in children with this disorder.

Attention deficit-hyperactivity disorder (ADHD) is a prevalent childhood neuropsychiatric disorder, characterized by age-inappropriate and impairing levels of inattention, hyperactivity and impulsiveness. Approximately 5-10% of school-age children are affected by ADHD, and in many cases, symptoms persist into adolescence and adulthood.

Cytokines are key mediators of immune function and can be either pro-inflammatory or anti-inflammatory. Recently few studies have suggested involvement of cytokine pathways in subjects with ADHD.

Polymorphism of IL-1 receptors antagonists' alleles have been suggested in families and subjects suffering from ADHD. Moreover, a new variant of inflammatory bowel disease, another immunological based disease, was recently suggested in children with ADHD and other developmental disorders. There are no other published reports on cytokine production in children who suffer from ADHD.

Eligibility Criteria:
Inclusion Criteria:

1. A defined condition of ADHD according to TOVA test (TOVA score \> (-1.8), Connor's questionnaire (Connor's score \> 15 points) and Achenbach's questionnaire;
2. A consent form signed by parents or legal guardianships;

Exclusion Criteria:

1. A history of any other neurological or major psychiatric disorder or other significant medical problems;
2. No current medications;
Alfuzosin Versus Placebo in Acute Urinary Retention

The primary objective of the study is to investigate if 14 days of treatment with Alfuzosin compared to placebo, will increase the number of patients with satisfying spontaneous voiding after acute urinary retention treated with Clean Self-Catheterization.

Furthermore is investigated the safety of the medical treatment and self-catheterization.


Eligibility Criteria:
Inclusion Criteria:

* Men with acute urinary retention and catheterized
* Benign hypertrophia of prostate
* Patient is diagnosed in Emergency room or at a acute hospitalization

Exclusion Criteria:

* Known prostate cancer
* Prior urinary retention within 30 days
* Urinary retention occurring in relation to surgery
* Blood in urine
* Difficult or impossible catheterization
* Fever \> 38 degree Celsius
* Decreased kidney function
* Permanent catheter \> 14 days
* Treatment with alfa 1 blocker within 30 days
* Meeting contraindications to treatment with Alfuzosin
* Treatment with other drugs for urinary problems

The above information is not intended to contain all considerations relevant to a patients potential participation in a clinical trial.
Women With Polycystic Ovary Syndrome Have Increased Plasma Chitotriosidase Activity

In the present study, serum chitotriosidase activity and its relationship with insulin resistance were determined in patients with Polycystic Ovary Syndrome (PCOS).

ChT activity is increased in patients with PCOS in concordance with insulin resistance. These findings may reflect the pronounced risk for metabolic syndrome and atherosclerotic diseases in this particular patient group.

Eligibility Criteria:
Inclusion Criteria:

* Absence of significant abnormalities on physical examination except hirsutism
* no lipid lowering, hypoglycemic, antihypertensive or hormone replacement therapy
* normal thyroid function and prolactin level
* absence of history or evidence of metabolic, cardiovascular, respiratory or hepatic disease

Exclusion Criteria:

* Pregnant
* ovarian tumors
* congenital adrenal hyperplasia or BMI greater than 30 kg/m2
Transobturator Urethral Sling Placement With an Autologous Rectus Facia

The investigators aimed to evaluate outcomes of transobturator urethral sling placement using autologous rectus fascia for female stress urinary incontinence at perioperatively and at 2-year follow-up.

Stress urinary incontinence (SUI) is very common condition in middle-aged women, and can affect quality of life. Some clinical trials reported that the lifetime risk of a woman undergoing surgery for SUI is increase in up to 15%. The midurethral synthetic sling is the most common surgery performed for female SUI. This procedure has high efficacy and low perioperative morbidity.

Although many clinical trials have demonstrated that synthetic mid-urethral slings are safe, effective and recommended by several guidelines (e.g. Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction/American Urogynecologic Society and American Urologic Association), the safety and efficacy of surgery for SUI using mesh devices has been questioned by a community of patients and clinicians. After Food and Drug Administration notification on mesh use in pelvic surgery, many patients and providers begin to search of different surgery without synthetic mesh alternatives in SUI. Recently, female patients in England formed the campaign group "Sling the Mesh" to protest the synthetic mesh.

Several options such as the autologous pubovaginal sling, biologic grafts, or urethral bulking agent injection have some problems related to morbidity or efficacy. The autologous pubovaginal urethral sling is associated with a higher risk of postoperative voiding dysfunction.

The investigators aimed to demonstrate the feasibility of an autologous transobturator urethral sling to avoid the related problems of synthetic mesh placement and the increased rate of voiding dysfunction with pubovaginal sling placement.

Eligibility Criteria:
Inclusion Criteria:

* female patients that underwent mid-urethral sling placement

Exclusion Criteria:

* active urinary infection
* neurologic disorders
* malignancies
* history of radiotherapy
DESTINY Breast Respond HER2-low Europe

Trastuzumab deruxtecan (T-DXd) as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2-low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy.

This non-interventional study will investigate the effectiveness withT-DXd, the demographic and clinical characteristics of the patients, treatment patterns, tolerability, management of adverse drug reactions (ADRs), and patient experience of T-DXd in patients with HER2-low unresectable and/or metastatic breast cancer. Patients will be treated according to the proposed indication statement in the Summary of Product Characteristics (SmPC). No drug product will be administered as part of this study.

Data on conventional chemotherapy (i.e., including but not limited to capecitabine, eribulin, gemcitabine, paclitaxel and nab-paclitaxel) will also be collected in a disease registry part of the study.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient (age ≥ 18 years) with histological or cytological confirmed diagnosis of unresectable and/or mBC
* Documented HER2-low status (IHC1+, IHC2+/ISH-)
* Patients who have received prior chemotherapy in the metastatic setting or patients who have developed disease recurrence during or within 6 months of completing adjuvant chemotherapy
* Decision to newly initiate therapy of T-DXd or conventional chemotherapy according to the physicians choice per SmPC
* Written and signed Informed Consent to participate in the study

Exclusion Criteria:

* Pregnancy or breastfeeding
* Patients who at time of data collection for this study are participating in or have participated in an interventional study that remains blinded.

No specific exclusion criteria are defined, as patients will be treated according to the proposed indication statements in the SmPC.
An Innovative Disease-net Management Model for Non-communicable Diseases (SIDERA^B)

The SIDERA\^B telerehabilitation system is enabled by a multi-domain, multi-device platform providing at home multi-component rehabilitation, targeting cardiovascular (Chronic Heart Failure, CHF), pulmonary (Chronic Obstructive Pulmonary Disease, COPD) and neurodegenerative (Parkinson Disease, PD) chronic diseases. The rehabilitation program embeds engagement activities for patient and caregiver, to empower appropriation of the SIDERA\^B care routines and fuel their well-being resources.

The multidisciplinary layering of SIDERA\^B is reflected in the validation protocol including a) clinical and well-being evaluation through a cross-over study confronting usual care with the SIDERA\^B activities; b) technological evaluation: Health Technology Assessment for organizational, legal and equity impacts; c) economic evaluation: process mapping and budget impact analysis to define a sustainable reimbursement process for the innovative telerehabilitation pathway.


Eligibility Criteria:
Inclusion criteria:

1. agreement to participate, with the signature of the informed consent form.
2. availability of a caregiver/study partner, who agrees to support the participant through the SIDERA\^B program.
3. living in one's own home.
4. clinical diagnosis of Chronic Heart Failure (CHF) and

   1. functional New York Heart Association (NYHA) class II and III with an Ejection Fraction (EF) ≤ 40%
   2. etiology of CHF primitive or post-ischemic.
5. clinical diagnosis of Chronic Obstructive Pulmonary Disease (COPD) and

   1. COPD diagnosis according to the American Thoracic Society (ATS) and the European Respiratory Society (ERS) criteria with FEV1/FVC ratio \<70%
   2. presence of airway limitation according to ATS/ERS and GOLD criteria.
6. clinical diagnosis of Parkinson Disease (PD) and

   1. PD diagnosis according to the MDS criteria (Postuma et al., 2015)
   2. staging between 1.5 and 3 on the Hoehn \& Yahr scale (Goetz et al., 2004)
7. age between 18 and 85 years.

Exclusion Criteria:

1. presence of comorbidities that may prevent you from undertaking a secure home program or determining clinical instability (i.e. severe orthopedic or severe cognitive deficits).
2. presence of risk conditions for safety under strain in patients with CHF (i.e. severe symptomatic aortic stenosis, evidence of ischemia due to minimal/low-intensity efforts).
3. COPD patients who do not need rehabilitation treatment (GOLD 1 / A class) or with severe COPD (GOLD 4 / D class)
4. COPD patients with overlap with other respiratory diseases or not in treatment or in the absence of good ventilatory compensation in the last 6 months
5. COPD with global respiratory failure with PaCO2\> 55 mmHg
6. PD patients with other neurological pathologies or with severe psychiatric complications
7. pathological score to a screening test for cognitive impairment (Montreal Cognitive Assessment test - MoCA test \<17.54; Conti et al., 2015).
Assessment of Two Methods for Progesterone Dosage During IVF

Nowadays, 1/7 couple consult because of infertility and some of them will need in vitro fertilization +/- intracytoplasmic sperm injection (IVF+/- ICSI). The IVF process includes a 14 days stimulation with FSH +/- LH in an agonist or antagonist protocol. The monitoring consists of regular ultrasound scan and blood sample. During the stimulation protocol many test have been proposed to predict the success of IVF. However, progesterone dosage on triggering day seems to be the only relevant exam. Indeed, when the progesterone blood concentration is low, the pregnancy rate is decreased. The only way to obtain progesterone concentration is a blood sample. The IVF journey is known to be stressful with many injections. Therefore, the salivary dosage appear to be more patient friendly. This kind of dosage has already been studied yet never use in routine because of a lack of repeatability. The laboratory of Lyon has developed a new technique to overcome this issue by using a liquid chromatography-mass spectrometry.

The aim of this work is as a first step to assess the repeatability, reliability and precision of salivary dosage on triggering day for IVF patient compared to blood concentration of progesterone.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients between 18 and under 43 years old
* in the course of IVF more or less ICSI of the PMA service of the HFME with transfer of fresh embryo
* Signature of an express consent
* Understanding the French language, both oral and written.
* Affiliated to a social security scheme

Exclusion Criteria:

* Persons deprived of their liberty by a judicial or administrative decision
* Persons subject to psychiatric care
* Persons admitted to a health or social establishment for purposes other than research
* Participants in another study that could impact the results of the present study, in particular those related to the level of progesterone.
* Adults subject to a legal protection measure (guardianship, curatorship)
Feasibility of mindBEAGLE in Disorders of Consciousness or Locked-In Syndrome

The primary aims of this study are:

1. To determine the feasibility of deploying mindBEAGLE, a portable, bedside EEG-based system, in the Intensive Care Unit in patients with disorders of consciousness (DOC) or locked-in syndrome (LIS);
2. To determine if mindBEAGLE neurophysiologic markers of cognitive function correlate with bedside behavioral assessments of consciousness;
3. To determine if mindBEAGLE neurophysiologic markers of cognitive function correlate with functional MRI (fMRI) and electroencephalography (EEG) biomarkers of consciousness;
4. To determine if mindBEAGLE can serve as an assistive communication device for people with LIS.

1. To determine the feasibility of deploying mindBEAGLE, a portable, bedside EEG-based system, in the Neurosciences Intensive Care Unit in patients with DOC or LIS;
2. To determine if mindBEAGLE neurophysiologic markers of cognitive function correlate with bedside behavioral assessments of consciousness;
3. To determine if mindBEAGLE can serve as an assistive communication device for people with LIS.

Eligibility Criteria:
Inclusion Criteria:

* Age\>18
* Diagnosis of coma
* Vegetative state
* Minimally conscious state
* Confusional state
* Locked-in state

Exclusion Criteria:

• History of developmental, neurologic, or major psychiatric disorder resulting in functional disability
Comparison of PENG Block and Fascia Iliaca Compartment Block in the Postoperative Pain Control of Hip Capsular Fracture

A prospective cohort study comparing PENG block versus iliac fascia block with the aim of evaluating its effectiveness in the peri-surgical analgesia of intracapsular femoral fracture.

Hip fractures are a very common clinical situation in elderly patients and are associated with significant morbidity and mortality. In addition, they have a great social and economic impact that in most cases requires definitive surgical treatment.

Although it is a very common procedure, in proximal femur surgery there is great variability with respect to anesthetic procedures and their subsequent management. Subarachnoid anesthesia is the most commonly used for this type of surgery. During the last few years, different locoregional techniques have been described with the aim of improving perioperative analgesia in these patients. Some examples are the iliac fascia block, the 3-in-1 block or the femoral nerve block, which allow a lower consumption of opioids and reduce some adverse effects such as postoperative delirium.

The PENG (Pericapsular Nerve Group) block is a block recently described for pain management in proximal femoral surgery. It is a pure sensory block that was initially described as an analgesic technique for the treatment of acute pain after femoral fracture but has expanded its uses. Its target corresponds precisely to the described innervation of the anterior femoral capsule.

Regarding the other locoregional techniques mentioned above, these consist of non-selective blocks of the femoral, lateral femoral cutaneous and obturator nerves. Therefore, although the iliac fascia block is accepted for analgesic control of hip fracture, the PENG block is likely to be more effective because of its high selectivity.

For this reason, the investigators have decided to conduct a prospective cohort study comparing PENG block versus iliac fascia block with the aim of evaluating its effectiveness in the peri-surgical analgesia of intracapsular femoral fracture.

Eligibility Criteria:
Inclusion Criteria:

* Patients with subcapital, basicervical or transcervical femoral fracture in whom definitive surgical treatment is decided.
* Patients who are candidates for nerve block plus intradural anesthesia.
* Patients who agree to participate in the study

Exclusion Criteria:

* Patients with dementia or cognitive impairment (EVN not evaluable)
* Polytraumatized patient
* Patient's refusal to participate in the study
* Patient's refusal to undergo intradural anesthesia or the blockade
* Patient with sensory or motor deficits prior to surgery.
* Patient with anticoagulation or antiplatelet therapy at the time of surgery.
* Hemodynamically unstable patient or patient who becomes unstable during surgery.
* Patient allergic to the local anesthetic.
* Patient with chronic pain in treatment
* Patient with capital femur fracture