cyrilzakka/clinical-trials huggingface dataset:
Determining of Normal Values and Conformity Assessment of the Dosage of a Plasmatic Marker of the Cellular Captation of Glucose: the IRAP Protein

The purpose of this study is on one hand to verify the measurement conformity of the IRAP dosage and on the other hand to obtain normal values of the blood IRAP concentration on healthy volunteers.

This study consists of two visits, from two to five days apart.

The first visit :

* Healthy volunteers will be on an empty stomach.
* they will have a clinical examination, blood tests and blood samples will be taken to constitute a blood collection. the IRAP concentration will be measured with those samples.

The second visit : This visit will take place in an interval from 2 to 5 days after the first visit.

* Subjects will be on an empty stomach
* An oral glucose tolerance test (OGTT) of 3 hours will be performed. Blood samples will be taken three time 15 minutes apart at Baseline (before taking the glucose). And then after the glucose intake, blood sample will be taken every 15 minutes to measure insulinemia, blood glucose, and IRAP concentration.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index between 19 and 25 Kg/m²
* No intercurrent disease during the last week
* No chronic infectious disease
* No smoker, no alcoholic

Exclusion Criteria:

* history of : thyroid disease, liver or renal disease, endocrine and metabolic disease, cardiovascular disease, lung disease, gastroenterological disorders, psychiatric disease, Epilepsy
* Consumption of narcotic drug
* Blood donation dating less than 2 months
* Pregnancy or breast-feeding, or intent to become pregnant during the study period
* legal exclusion criteria
Non-randomized, Open-labeled, Interventional, Single Group, Proof of Concept Study With Multi-modality Approach in Cases of Brain Death Due to Traumatic Brain Injury Having Diffuse Axonal Injury

This is the proof of concept study with multi-modality approach (using intra-thecal bioactive peptides, stem cells, laser and transcranial IV laser and Median Nerve stimulation as adjuvants) in cases of brain death due to traumatic brain injury having diffuse axonal injury to document possibility of reversal of brain death (BD).


Eligibility Criteria:
Inclusion Criteria:

* Individuals declared Brain dead from a traumatic brain injury having diffuse axonal injury on MRI
* Not willing for organ donation
* Written informed consent from the legally acceptable representative of the patient

Exclusion Criteria:

* Metallic clips/ metal implants or intracranial implants in the brain.
* Pregnancy
Dissemination of the Donor Application: Utilizing Social Media to Identify Potential Live Organ Donors

This study utilizes a web-based application to help patients on the organ transplant waitlist communicate patient's need for a living donor via social media and provide interested potential donors the opportunity to engage with the evaluation process.

Barriers to identifying a live donor include lack of education and hesitance to initiate a conversation about live donation. For these reasons, many transplant candidates are hesitant to discuss candidate's illness and are therefore reluctant to pursue live donor transplantation. The investigators hypothesize that utilization of social media to spread awareness about candidate's illness and candidate's need for a live donor will enable many transplant candidates to successfully identify live donors. In this study, participants will use a novel web-based application, called the "Donor App", to create and share candidate's story via Facebook and other social networks to assist in the search for a live donor.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* On the kidney-only or liver-only transplant waiting list at a collaborating center

Exclusion Criteria:

* Younger than 18 years of age
* Not on the kidney or liver transplant waiting list
* On multiple organ transplant waiting lists
Bladder Displacement During Abdominal and Pelvic Floor Exercises

This study evaluates the bladder base displacements during abdominal and pelvic floor exercises in postpartum women comparing to nulliparous women

Postpartum women are at increased risk of suffering pelvic floor dysfunctions. However, only a few researches are focused on the exercises physiological effect at the postpartum recovery period.

A prospective observational study was designed to evaluate the protective or the prolapsed effect of abdominal and pelvic floor exercises in postpartum women.

Two groups were established: Group A was composed of primiparous women during postpartum period and group B of nulliparous women. Both groups practiced the same set of 6 abdominal and perineum exercises. The bladder descent was registered by ultrasonography, and the correct execution was controlled in both groups by superficial pelvic floor and abdominal electromyography.

A Graphical User Interface on MATLAB software has been developed for aiding in offline measurement process.

Eligibility Criteria:
Inclusion Criteria:

* women at postpartum period (more than 6 and less than 12 weeks after vaginal birth)
* willingness to participate in the study
* ability to contract Pelvic Floor Muscles correctly
* written consent to participate.

Exclusion Criteria:

* pregnancy
* caesarean birth
* pelvic Floor disorders
* neurological diseases
Cervical Transforaminal Injection of Steroids Guided by Ultrasound

Cervical transforaminal epidural steroid injections (TFESI) are indicated in cervical radicular pain resistant to conservation therapy, by which steroids can be delivered into anterior epidural space surrounding target spinal nerve roots to help alleviate pain in the upper limb or neck. Cervical TFESI is traditionally commended to perform with guidance of fluoroscopy or CT. As fluoroscopy can not monitor the injection route whether it pass vessel or not, many serious neurological complications caused by inadvertent intra-arterial injection have been reported2. Here, the investigators will introduce a novel cervical TFESI guided by ultrasound, which incidence of inadvertent vessel injury or injection might be lower than those guided by fluoroscopy.


Eligibility Criteria:
Inclusion Criteria:

* evidence of a cervical radiculopathy involving 1 spinal nerve of at least 1 month's duration refractory to medical treatment
* symptoms of cervical pain radiating to the upper limb
* and signs of altered sensations, ab- normal reflexes, or motor weakness caused by degenerative spondylosis and/or disk herniation as documented at CT or MR imaging and a current mean pain VAS score of six.

Exclusion criteria:

* evidence of vertebral fracture, tumor, or infection of the cervical spine
* treatment with cervical corticosteroid injections within the past 3 months
* coagulopathy
* allergy to iodinated contrast media.
Validation of Sleepware G3 Autoscoring Algorithm

The objective of this study is to validate the ability of the Sleepware G3 polysomnography software platform to correctly identify and score sleep related events.


Eligibility Criteria:
Inclusion Criteria:

* AASM Compliant PSG studies

Exclusion Criteria:

* NA
A Study of the Safety, Tolerability, and Efficacy of Epacadostat Administered in Combination With Nivolumab in Select Advanced Cancers (ECHO-204)

This is a Phase 1/2, open label study. Phase 1 consists of 2 parts. Part 1 is a dose-escalation assessment of the safety and tolerability of epacadostat administered with nivolumab in subjects with select advanced solid tumors and lymphomas. Part 2 will evaluate the safety and tolerability of epacadostat in combination with nivolumab and chemotherapy in subjects with squamous cell carcinoma of head and neck (SCCHN) and non-small cell lung cancer (NSCLC).

Phase 2 will include expansion cohorts in 7 tumor types, including melanoma, NSCLC, SCCHN, colorectal cancer, ovarian cancer, glioblastoma and diffuse large B-cell lymphoma (DLBCL).


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects, age 18 years or older
* Subjects with histologically or cytologically confirmed NSCLC, MEL (including I/O relapsed MEL or I/O refractory MEL), CRC, SCCHN, ovarian cancer, recurrent B cell NHL or HL, or glioblastoma
* Presence of measurable disease by RECIST v1.1 for solid tumors or Cheson criteria for B cell NHL (including DLBCL) or HL. For subjects with glioblastoma, presence of measurable disease is not required.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
* Fresh baseline tumor biopsies (defined as a biopsy specimen taken since completion of the most recent prior chemotherapy regimen) are required for all cohorts except glioblastoma

Exclusion Criteria:

* Laboratory and medical history parameters not within Protocol-defined range
* Currently pregnant or breastfeeding
* Subjects who have received prior immune checkpoint inhibitors or an IDO inhibitor (except select Phase 2 cohorts evaluating I/O relapsed or I/O refractory MEL). Subjects who have received experimental vaccines or other immune therapies should be discussed with the medical monitor to confirm eligibility
* Untreated central nervous system (CNS) metastases or CNS metastases that have progressed
* Subjects with any active or inactive autoimmune process
* Evidence of interstitial lung disease or active, noninfectious pneumonitis
* Subjects with any active or inactive autoimmune process
* Ocular MEL
Hysteroscopic Metroplasty in Unexplained Infertile Women With Dysmorphic Uterus

The correlation between dysmorphic uterus and infertility still remains enigmatic. We aim to evaluate the reproductive outcomes of metroplasty via office hysteroscopy in unexplained infertile women with dysmorphic uterus with comparing a group of unexplained infertile women performing 6 months spontaneous cycles plus 3 cycles controlled ovarian hyperstimulation and intrauterine insemination by randomized trial.

A dysmorphic uterus is a second-class (Class U1) uterine anomaly in the The European Society of Human Reproduction and Embryology (ESHRE) and the European Society for Gynaecological Endoscopy (ESGE) (ESHRE/ESGE) consensus on the classification of congenital genital tract anomalies, which was formerly known as "T-shaped uterus" in the American Fertility Society (AFS) Classification of Anomalies of the Müllerian Duct that leads to poor reproductive and obstetric outcomes.

The reproductive performance of dysmorphic uterus is not well-known issue. We designed a randomized trial in unexplained infertile couples women with dysmorphic uterus. After allocation of properly selected women, hysteroscopy group will be undertaken metroplasty procedure and 9 months follow-up period with natural conception. Second group will be undertaken to six months spontaneous coitus and three cycles clomiphene citrate and intrauterine insemination cycles. After nine months of follow-up of both groups, the pregnancy and reproductive outcomes will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

Unexplained infertile couples with;

1. Dysmorpic uterus in hysterosalpingography
2. Normal spermiogram

2. Bilateral patent tubes in hysterosalpingography 3. Normal ovarian reserve (AMH \>1.5 ng/dl and/or total bilateral antral follicle count \>8)

Exclusion Criteria:

1. Women with history of pelvic surgery including endometriosis and/or tubal surgery
2. women with endometrioma which was visualised/suspected on transvaginal ultrasonography
3. Women with anovulation
4. Women with diminished ovarian reserve (AMH \< 1.5 ng/dl and/or total bilateral antral follicle count \<8)
5. Couples with abnormal spermiogram parameters (oligospermia, oligoasthenospermia, oligoasthenoteratozoospermia, azospermia)
6. Women with alive children
7. Obese women (BMI\>30 kg/m2)
Infant Crying, a Bioacoustic Prognostic Signal for Neurodevelopment

Crying is a vital communication signal for the baby. Product of a complex physiological process, it reflects not only the organization and functioning of the cortical central nervous system and the function of sympathetic and parasympathetic autonomic regulation but also the integrity of three entities: the lungs responsible for ventilatory mechanics and respiratory rhythm, the larynx and its vocal cords as a phonatory organ, and the oropharyngeal tract guaranteeing the resonance of the sound emitted by the vocal cords.

Crying is usually caused by pain, discomfort, hunger, or separation from parents or other caregivers. Crying carries essential information from birth, the expression of which depends closely on the neuroanatomical and functional brain integrity of the child. On a bioacoustic level, crying consists of sequences of complex acoustic signals produced by the vocal folds and filtered by the vocal tract. The vibration frequency of the vocal cords determines the cry's fundamental frequency f0 (and the harmonic frequencies), which is responsible for its more or less low or high pitch. Other acoustic cues also characterize each baby's cry.

The objective of the Baby's cry 1000/100 study is to evaluate the acoustic characteristics of crying at birth, of term and premature babies and to correlate them with neurodevelopmental outcomes at 2 years of age to see if the bioacoustic characteristics of crying at birth could be predictive of the baby's neurofunctional integrity.

To achieve this objective, the investigators wish to document a large bank of recordings of the crying of term or premature babies by relying on deep learning and artificial intelligence approaches, making it possible to process large databases quickly, evaluate the links between acoustics of crying and clinical data at the birth of full-term babies who will benefit from systematic neurodevelopmental monitoring at 2 years (Bayley scale).

Eligibility Criteria:
Inclusion Criteria:

* For a full-term baby \> 37 weeks
* For a premature baby \< 37 weeks
* Born in the maternity ward of the Saint-Etienne University Hospital
* Holder of parental authority having received informed information about the study and their right to object
* Holder of parental authority affiliated to or beneficiary of a social security system
* Eutrophic between the 10th and 90th percentile on the neonatal curves)

Exclusion Criteria:

* Refusal of participation by the holder of parental authority
* Antenatal pathology, nor perinatal asphyxia
* Holder of minor parental authority
* Holder of parental authority under curatorship or guardianship
* Abnormal T1 audiological screening test.
Impact of HLA Evolutionary Divergence and HLA Donor-recipient Molecular Mismatches on Kidney Allograft Rejection

The Human Leucocyte Antigen (HLA) system is pivotal in kidney transplant rejection. In-silico methods such as HLA eplet mismatches and PIRCHE-II scores have emerged to refine HLA immunogenicity assessment and stratify patients for immunological risk. However, large-scale studies in unselected large kidney transplant cohorts are lacking to support their broader clinical applicability. Additionally, recent studies on HLA evolutionary divergence (HED), quantifying HLA polymorphism, highlight its potential impact on rejection. Yet, the association of HED with kidney allograft rejection or de novo DSA occurrence remains unexplored in kidney transplantation.

The complexity introduced by diverse in-silico methods for assessing HLA immunogenicity necessitates further research to comprehensively understand their role in relation to kidney allograft rejection.

This project thus aims to investigate the association between various aspects of HLA immunogenicity, including HLA molecular mismatches and HLA evolutionary divergence, along with standard immunological and clinical parameters assessed at the time of transplantation, with the occurrence of antibody-mediated rejection and de novo DSA formation post-transplant in a large, comprehensively annotated kidney transplant cohort.


Eligibility Criteria:
Inclusion Criteria:

* Living or deceased donor kidney recipient transplanted after 2004
* Kidney recipient older than 18 years of age
* Written informed consent at the time of transplantation for the center database

Exclusion Criteria:

* Combined transplantation
Anesthesia for Loop Electrosurgical Excision Procedure (LEEP).

The goal of this prospective, randomized controlled study study is to investigate the efficacy and safety of propofol combined with different doses of esketamine (ESK) for anesthesia during loop electrosurgical excision procedure (LEEP).Ninety female patients undergoing LEEP were randomly allocated to three groups.It aims to answer :1.The effect of esketamine combined with propofol in respiration, circulation, etc,during LEEP. 2.The appropriate dosage of esketamine when combined with propofol in LEEP anesthesia.

To investigate the efficacy and safety of propofol combined with different doses of esketamine (ESK) for anesthesia during loop electrosurgical excision procedure (LEEP). Ninety female patients undergoing LEEP were randomly allocated to three groups: group P (2 mg/kg propofol + saline), group propofol + esketamine(PK)1 (1.5 mg/kg propofol + 0.5 mg/kg ESK), and group PK2 (1.5 mg/kg propofol + 0.25 mg/kg ESK). Parameters including mean arterial pressure (MAP), heart rate (HR), respiratory rate (RR), oxygen saturation (SPO2), and venous carbon dioxide (PvCO2) were recorded. Additionally, the need for supplemental propofol, jaw thrust maneuver or ventilation, postoperative awakening time, and adverse reactions were assessed.

Eligibility Criteria:
Inclusion Criteria：

* Patients who will undergo Loop Electrosurgical Excision Procedure
* The age of the patients ranged from 20 to 60 years old
* Paients had a BMI of 18-30 kg/m2
* ASA physical status grade of I or II

Exclusion Criteria:

* Patients who refused to participate
* History of hypertension, hyperthyroidism, or neurological or mental disorder
* Currently taking or has taken opioids and non-steroidal anti-inflammatory drugs within 48 h before surgery
* Participated in other drug clinical trials within 4 weeks
* Allergy to esketamine or propofol
* History of opioid or esketamine addiction
Selective Internal Radiation Therapy With 90Y Resin Micropheres for Refractory Colorectal Cancer Liver Metastases

Observational, feasibility study investigating biological aspects in patients with liver metastasis from colorectal cancer undergoing treatment with SIRT, by translational analysis of biological samples.

In this study, the investigators seek to investigate biological aspects in patients with colorectal cancer liver metastasis undergoing treatment with Selective Internal Radiation Therapy, by translational analysis of biological samples.

SIRT will be conducted as per standard procedure at Aarhus University Hospital. Translational blood samples will be drawn pre-treatment and during follow up.

The total cell free DNA level will be quantified in all samples. The samples will be analysed for tumour specific mutations such as the KRAS, BRAF and NRAS oncogenes.

The investigators expect to include up to 30 patients.

This is a purely observational translational study. Results will be analysed in relation to outcome data.

The study is conducted in collaboration with:

Department of Gastroenterology and Hepatology, Aarhus University Hospital Department of Radiology, Aarhus University Hospital Department of Nuclear Medicine, Aarhus University Hospital

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of metastatic colorectal adenocarcinoma with liver dominant disease
* Diagnosis of liver metastasis may be made by histo- or cyto-pathology, or by clinical and imaging criteria.
* The Liver metastasis are not eligible for resection, RFA or SBRT
* All patients must be off all chemotherapeutic regimens for 14 days prior to SIRT treatment
* All patients must be off vascular endothelial growth factor inhibitors for 6 weeks prior to SIRT treatment
* Progressive disease, severe intolerance during or following all standard lines of chemo-therapy
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Age 18 years or older
* Able to understand written information
* Consent to samples for translational research

Exclusion Criteria:

* Pretherapeutic work-up procedure with Tc-99m macroaggregated albumin (MAA) scintigraphy showing extrahepatic foci in GI-tract
* Evidence of any detectable Tc-99m macroaggregated albumin deposition in the stomach or duodenum, after application of established angiographic techniques to stop such deposition
* Previous radiation therapy to the lungs and/or to the upper abdomen overlapping with dose to the liver at interventionist´s decision
* Lung shunt greater than 20% or \> 30 Gray radiation absorbed dose to the lungs, at estimated by Tc-99m-MAA
* Pregnancy
* Symptomatic lung disease precluding SIRT at interventionist´s decision
* Active uncontrolled infection
* Any pre-treatment laboratory findings within 30 days of treatment demonstrating: alanine aminotransferase level greater than 5 times upper normal limit and/or serum bilirubin greater than 2 mg/dl (\>34 umol/l)
* Current or previously evidence of ascites on CT-scan or physical examination
* Tumour volume greater than 50% of liver volume
* Conditions precluding translational samples
Improved Estimation of GFR by Cystatin C in Preventing Contrast Induced Nephropathy by NAC or Zn

Background Prevention of contrast media (CM) induced nephropathy (CIN) by pharmacological prophylaxis (e.g. N-acetylcysteine; NAC) is controversially discussed. So far, in all interventional studies assessment of kidney function was based on measurements of serum creatinine although this surrogate biomarker has several limitations. We investigated the antioxidants NAC and zinc (Zn) for the prevention of CIN by monitoring concomitantly serum levels of creatinine and cystatin C.

In a prospective, placebo-controlled, double blind trial patients with moderate impaired kidney function receiving hypoosmolar, nonionic contrast medium were randomly assigned to an oral treatment for 2 days with 1.2g/day of NAC (n=19), for 1 day with 60mg/day of Zn (n=18) or placebo (n=17). All patients were periprocedural hydrated with 1ml/kg/h of 0.45% saline for 24h. At baseline (before hydration), prior to exposure of CM as well as 2 and 6 days after CM serum levels of creatinine and cystatin C have been measured.

Eligibility Criteria:
Inclusion Criteria:

1. older than 18 years of age,
2. serum creatinine \> 1.2 mg/dl or a creatinine clearance \< 50 ml/min (measured by a 12 or 24 hour urine collection).

Exclusion Criteria:

1. acute inflammatory disease,
2. medication with NSAID or metformin until 3 days before entering study,
3. abnormal findings in physical examinations, e.g. signs of dehydration or decompensated heart failure.
Pilot Study of cNEP for the Treatment of Snoring

This pilot study will examine the efficacy and safety of continuous negative external pressure ("cNEP") for the treatment of chronic snoring in people without obstructive sleep apnea.


Eligibility Criteria:
Inclusion Criteria:

* sleep test within the previous six months that shows snoring of at least 30 dB for at least 30% of total sleep time
* AHI \< 10/hr

Exclusion Criteria:

* previous neck surgery or radiation
* carotid artery disease
* serious medical or psychiatric illness
* pregnancy
* silicone allergy
* excessive use of alcohol or sedating drugs