cyrilzakka/clinical-trials huggingface dataset:
Impact of Adrenal IncidenTalomas and Possible Autonomous Cortisol Secretion on Cardiovascular and Metabolic Alterations

The investigators hypothesize that cardiovascular and metabolic alterations can occur in patients with adrenal adenomas and possible Autonomous Cortisol Secretion (pACS). Investigators hypothesize that adrenalectomy in selected patients, following the 2016 European Congress of Endocrinology (ECE) guidelines, can improve metabolic parameters and cardiovascular risks and features.

Adrenal incidentalomas are clinically silent masses discovered inadvertently during diagnostic imaging procedures performed for unrelated reasons. Depending on the criteria applied, up to 50% of patients with adrenal incidentalomas may have biochemical evidence of cortisol excess. Possible autonomous cortisol secretion (pACS), as defined in the 2016 European Society of Endocrinology Guidelines, is characterized by a partial, incomplete suppression of the hypothalamic-pituitary-adrenal (HPA) axis without the typical signs of overt cortisol hypersecretion.

Investigators will perform a prospective longitudinal study in patients with adrenal incidentalomas associated with possible autonomous cortisol secretion, aiming to assess the effect of surgical and conservative management on cardiovascular and metabolic features.

Data will be detected at baseline, at 1 and at 5 years follow-up to quantitatively identify the different cardiovascular and metabolic alterations in: (1) patients with non-functioning adrenal adenoma; (2) patients with possible autonomous cortisol secretion receiving conservative management; (3) patients with possible autonomous cortisol secretion receiving adrenalectomy according to the 2016 European Society of Endocrinology guidelines; (4) patients without adrenal masses.

Eligibility Criteria:
Inclusion Criteria:

* Incidentally detected adrenal mass

Exclusion Criteria:

* Patients with overt Cushing's syndrome, pheochromocytoma, Conn syndrome, adrenocortical carcinoma, late-onset congenital adrenal hyperplasia, adrenal metastasis and adrenal hemorrhage
* Patients taking medications influencing glucocorticoid production or metabolism
* Patients with psychiatric diseases or alcohol abuse
* Pregnancy
Flavored Intravenous Ondansetron Administered Orally for the Treatment of Persistent Vomiting

The purpose of this study is to give children with gastroenteritis with persistent vomiting flavored intravenous ondansetron orally. The investigators test the palatability of the drug and check the serum level of ondansetron at 4 hours .

This is a prospective pilot study for children,3-8 years of age presented to the Pediatric Emergency Department in the state of Qatar between September 2014 and January 2015, with acute gastroenteritis with mild to moderate dehydration, more than 2 episodes of vomiting in the last 24 hours, and who had failed oral rehydration trial in the department as per the department oral hydration protocol. Acute gastroenteritis was defined as diarrhea and vomiting for less than a week period.

Hydration level was assessed for all patients on arrival, and eligible patients were enrolled after obtaining an informed written consent.Enrolled patients received intravenous ondansetron form orally after being flavored 1:1 with ORA-sweet, the dose of ondansetron was determined based on the patient presenting weight. Palatability was evaluated by the primary investigator within one minute fom drug administration applying taste scores for children and recorded according to a specific scoring system. All patients were kept nil per oral for 30 minutes and then oral rehydration trial was started as per the department rehydration protocol. If the drug was vomited within 30 min of administration, a similar second dose was given. Blood level for ondansetron was collected 4 hours after the successful drug administration and was sent to the department laboratory within 5 min. Patients were sent home when they were ready for discharge as per the treating physician discretion. All patients were followed by a telephone call after 24 hours to assess the safety and efficacy of the orally taken ondansetron.

Eligibility Criteria:
Inclusion Criteria:

* children 3-8 years of age.
* acute simple gastroenteritis with mild to moderate dehydration.
* more than 2 episodes of vomiting in 24 hours period.

Exclusion Criteria:

* known hypersensitivity to ondansetron.
* seizure disorder.
* chronic liver or kidney diseases.
* on any chronic medication.
Development of a Multi-attribute Health Index: to Measure the Quality of Labour Analgesia: The QLA Index

The findings of this research will be used to develop a scale for measuring the quality of epidural pain relief achieved during labour and vaginal delivery.

The current lack of a tool to measure the overall quality of neuraxial pain relief provided in labour analgesia trials has produced studies unable to provide clear direction to clinical care and research. Our previous work explored and described the underlying dimensions and attributes of quality neuraxial analgesia from the perspectives of labouring women as the initial phase of development of an Index to measure this as an outcome in research. We now seek to confirm our findings as well as to generate additional items (descriptors) of quality neuraxial analgesia from the perspectives of parturients and experts (obstetrical anesthesiologists and experienced labour nurses). Once generated, the full list of items will be used to in a subsequent study involving only parturients (Item Reduction phase) to develop a scale permitting global measurement of quality neuraxial labour analgesia. The resulting scale, once validated, will provide researchers with a simple global measure for quality in labour analgesia research. This scale will be used later in our program of research to assist with validation studies of the larger Multi-attribute Health Index we are developing.

Eligibility Criteria:
Inclusion Criteria:

1. Use of neuraxial labour analgesia during the current pregnancy
2. Native English-speakers
3. Term pregnancies (\>37-42weeks)
4. The ability to read and write in English
5. Provision of written informed consent.

Exclusion Criteria:

1. Women who received IM or IV narcotics within 4 hours of epidural/ combined spinal epidural (CSE) placement
2. Women with evidence or history of maternal cognitive impairment
3. Women who experienced a neonatal death during the current pregnancy
Corneal Ulcer Prevention Through Health Education

A community-randomized trial comparing villages randomized to receive an intervention consisting of a trained community health volunteer who brings patients to the nearest Vision Centers or Primary Health Care Centers for treatment after diagnosing a corneal abrasion to control villages receiving no additional intervention. The primary outcome of corneal ulcer will be measured by baseline and annual population-based census performed in both intervention and control villages by masked examiners from baseline to 24 months. Each resident in the village will be asked about their ocular history and, if suspected of having a corneal ulcer, will be examined for evidence of a corneal opacity. Annual visits will occur, coinciding with the end of the harvest season. In villages randomized to intervention, an active promotion campaign will be undertaken to urge residents to notify the village eye health worker within 24 hours of ocular trauma. In control villages, abrasions and ulcers will be treated if they present to a clinic or are found during the annual monitoring visits, but active promotion of corneal abrasion care will not be offered.

Research Question: Can the investigators prevent corneal ulcers on a mass scale?

Aim 1: To determine whether diagnosis and prophylaxis of corneal abrasions by village health workers will reduce the incidence of corneal ulceration in rural South India. The investigators hypothesize that communities in which village eye health workers are available to diagnose and prophylax corneal abrasions will have a significantly lower incidence of corneal ulceration compared to communities without this service.

Aim 2: To determine the cost-effectiveness of a village eye worker program to prevent corneal ulcers. The investigators hypothesize that preventing corneal ulcers through a village eye worker program will be more cost-effective than the current standard of treating corneal ulcers after patients present at health care facilities.

Aim 3: To determine the incidence of corneal ulceration in this South Indian population. The investigators anticipate that the incidence of ulcers is lower than estimated in our 1995 incidence survey, but still far higher than that observed in the developed world.

Eligibility Criteria:
Inclusion Criteria:

* Presence of a corneal abrasion
* Willingness to be treated with topical antibiotic and antifungal ointments 3 times a day for 3 days
* Appropriate consent

Exclusion Criteria:

* Evidence of a corneal ulcer
* Evidence of other acute eye disease requiring urgent care
* Known allergy to study medications
* Not willing to participate
Magnetic Resonance Imaging (MRI) Fat Quantification of the Liver

Fatty liver in the obese is a common finding; some cases develop steato-hepatosis which in the long-term can lead to liver cirrhosis. The effect of bariatric surgery on fat distribution in the liver has so far been studied with liver biopsies and single voxel MR techniques. With this trial investigators present a new, whole organ MR-quantification of liver fat and describe changes after bariatric surgery in visceral and subcutaneous fat.

Currently, liver biopsy is still regarded as the gold-standard in the diagnosis of non-alcoholic fatty liver disease and monitoring of progression. However, accuracy of diagnosis is not perfect with a certain risk of sampling error depending on biopsy quality and a more or less homogeneous distribution of liver tissue alterations. Complications are rare; however, the method is invasive and carries the risk of bleeding. Therefore, non-invasive methods (such as serum biomarkers or imaging techniques) are sought for accurate diagnosis and safe monitoring of disease progression. Unidimensional transient elastography (TE; FibroScan®) is a non-invasive technique, which can be a helpful tool here: however, accuracy of diagnosis is depending on the stage of fibrosis and lower grades of fibrosis (stage 1 and 2) are difficult to assess. Moreover, in obese patients this method cannot be applied.

In recent years, the development of fat-water magnetic resonance imaging has enabled non-invasive assessment of fat and water content in tissues. In addition, modern MRI devices allow brief breath holding, which reduces motion artifacts and provides us with excellent data and therefore MRI has become an important tool for fat quantification.

Up to date only a few studies have focused on fat quantification before and after bariatric surgery: patients treated with laparoscopic gastric banding (a purely restrictive procedure) and patients undergoing metabolic surgery such as sleeve gastrectomy and gastric bypass have been examined pre- and postoperatively by means of MRI fat quantification. However, in these studies single voxel spectroscopy was used. In contrast, in this current trial investigators aim to assess full organ volume, which hopefully will provide more accurate data.

Eligibility Criteria:
Inclusion Criteria:

* morbidly obese patients with BMI over 35, scheduled for bariatric surgery (either sleeve gastrectomy or gastric bypass)

Exclusion Criteria:

* Smoking
* substance abuse
* Diabetes
* history of gastrointestinal disorders
* pace-maker
* claustrophobia
Evaluate the Safety and Therapeutic Effects of Transplantation of MNV-201 in Pediatric Patients With Pearson Syndrome

Primary Mitochondrial diseases are a clinically and genetically heterogeneous group of disorders caused by mutations in genes encoded by nuclear Deoxyribonucleic Acid (DNA) or by mutations and/or deletions in the mitochondrial DNA (mtDNA). While some mitochondrial disorders only affect a single organ (e.g., the eye in Leber hereditary optic neuropathy \[LHON\]), many involve multiple organs. Mitochondrial disorders may present at any age and a frequent feature is the increasing number of organs involved in the course of the disease.

Minovia Therapeutics Ltd. ("Minovia") is a biotech company developing novel therapeutics based on its mitochondrial augmentation technology (MAT). MNV-201 is a cell therapy produced by MAT that consists of the participant's autologous CD34+ hematopoietic stem and progenitor cells (HSPCs) enriched with allogeneic placental-derived mitochondria, manufactured in Minovia's GMP facility.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female participants aged from 1 to 18 years old.
2. Diagnosis of Pearson Syndrome
3. Body weight ≥ 10 kg.
4. Participant has anemia and/or thrombocytopenia, and/or leukopenia and/or blood transfusion dependent (receives blood transfusions every 6 weeks or less).
5. Participant is medically able to undergo the study interventions, as determined by the investigator.
6. Participant's living parent(s) and/or legal guardian(s) able to understand and provide voluntary written informed consent.

Exclusion Criteria:

1. History of infection with HIV-1, HIV-2, and HTLV I/II.
2. Current active infection with HBV (including HBcore and HBsAg positive), HCV, HTLV I/II, Treponema Pallidum and HIV I-II
3. Participant has been diagnosed with Myelodysplastic Syndrome, by FISH and/or karyotype.
4. Participant is unable to undergo leukapheresis.
5. Total number of CD34+ cells collected is lower than 20x106 cells
6. Participant has known hypersensitivity to murine proteins or iron-dextran.
7. Participant has chronic severe infection.
8. Participant has disease or condition that may risk the participant or interfere with the ability to interpret the study results.
9. History of malignancy
10. History of treatment with gene therapy, bone marrow or allogeneic cord blood transplantation.
11. Currently participating in another clinical trial, or participation in another clinical trial within 1 year prior to study enrollment.
12. In the opinion of the Investigator, the participant is unsuitable for participating in the study for any reason.
Evaluation of Lung Volume Under Nasal High Flow With a Time of Flight Camera

The effectiveness of Nasal High Flow therapy (NHF), in comparison with conventional oxygen therapy, is based on Positive Expiratory Pressure (PEP) and washout of dead space.

Many authors have shown that peak expiratory pressure, expiratory plateau pressure, mean upper airway pressure and lung volume were significantly increased. It depends mainly on gas flow and mouth closure.

First, "Groves"showed in 2007 that mouth opening could vary nasopharyngeal pressure from 2.7 to 7.4 cmH20 to 60 L / min, like Parke did in 2009, with a pressure of 1.2 at 2.7 cmH2O at 35 L / min.

Then, "Parke" showed in 2011 and 2015, a nasopharyngeal pressure changing from 2.7 to 11.9 cmH20 by varying the flow rate from 30 to 100 L / min. "Bräunlich" also showed concordant results in 2018, from 1.6 to 2.3 cmH2O, changing flow rates from 20 to 40 L / min. "Corley" in 2011 found a pressure from -0.3 to 2.7 by passing from ambient air to high flow. "Okuda and Mauri's" work in 2017 on oesophageal pressures also contributed to this.

In addition, it has been proved that the Tidal Volume (TV) is proportional to the flow delivered. These measurements were carried out by impedancemetry, the results of which were extrapolated to Vt. Thus "Okuda" evaluated it at 685mL in ambient air and 968mL at 50L / min. In 2016, "Fraser" highlighted a TV increasing from 400 to 500 mL by increasing the flow rate to 30 L / min. "Parke" in 2015 described an exponential End Expiratory Lung Impedence (EELI) proportional to the flow rate, as did "Riera" in 2013 with a ratio of 1.26 between ambient air and NHF at 40 L / min, and "Corley" in 2011 (ratio of 1.25).

Actualy, Time-of-Flight (ToF) cameras, such as Kinect v2®, are increasingly used in the medical field, particularly to characterize respiratory movement.

Various authors have shown a good correlation between the values of TV obtained by spirometry (reference method) and those obtained with ToF camera. A study led in 2018, by "S. Nazir" in the Department of "Réanimation Médicale" at the University Hospital of Brest, evaluated the average errors less than 46mL, with 76% of measurements having an error less than 50 mL, which corresponds to the clinical limit.

Now having a non-invasive, safe, simple, reproducible, inexpensive, and allowing evaluation in clinical situations method ; the use of a Time-of-Flight camera to evaluate the breathing and its various parameters, is indicated.

In this innovative study, never performed in different respiratory conditions in vigilant patients with NHF, the lung volume will be evaluated by a Time-of-Flight camera.

Different clinical situations, and the different parameters influencing it, will be observed and compared with the results of previous studies.

These situations will be simulations ranging from a physiological state to an acute respiratory distress.


Eligibility Criteria:
Inclusion Criteria:

* Healthy and Major Volunteers

Exclusion Criteria:

* Nasopharyngeal obstruction, facial trauma, or other contraindication to the use of Nasal High Flow, pregnant woman, major incompetent, lack of consent.
Interventricular Cardiac Septal Thickness in Fetus of Diabetic Mother Correlated to Postnatal Outcome

Good glycemic control is superior to poor glycemic control in reducing risk of interventricular septal thickness among fetuses of diabetic mothers.

Thick Interventricular septum is thought to be related to poor glycemic control during pregnancy, and it causes variable degree of left ventricular outflow obstruction and hypertrophic cardiomyopathy.

Hypertrophic cardiomyopathy requires specific management as digoxin and inotropic agents usually used in heart failure are contraindicated.

So high index of suspicion is required in fetus of diabetic mother having thick Inter ventricular septum.

Eligibility Criteria:
Inclusion Criteria:

* above 35 weeks pregnancy
* diabetic mothers
* single intrauterine pregnancy

Exclusion Criteria:

* any other medical disorder
Dissecting the Biology of Early-onset Colorectal Cancer

Contrarily to late-onset (LO) colorectal cancer (CRC), early-onset (EO) CRC incidence is increasingly growing. Several factors, such as obesity, chronic inflammation, and intestinal dysbiosis, can increase the general risk of CRC. However, little is known about the biology of EO-CRC. To evaluate whether such selective rise in the incidence of EO-CRC patients mirrors a distinct transcriptomic profile, the investigators will first dissect EO-CRC's transcriptomic landscape.

Then, the investigators will investigate the colorectal cancer stem cell (CSC) compartment by in vitro functional assays and RNA-seq analysis. Because our preliminary data indicate an increased aggressiveness of the tumor microenvironment (TME) in EO-CRC,the investigators propose to investigate the CSC niche and the interaction with the TME to dissect the molecular and cellular pathways occurring in EO-CRC.

A cohort of 30 EO-CRC patients (\<50 years old) will be enrolled and fully characterized. About 10 EO-CRC-derived CSCs in the form of organoids and spheroids will be generated. Since the relevant differences between CR-CSCs isolated from EO-CRC vs LO-CRC patients are still unknown, the investigators will gain information about their specific features such as clonogenic activity, tumorigenic/invasive capacity, and about differences in the mechanisms regulating their cross-talk with TME components.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 and \< 50 years ;
* Written informed consent

Exclusion Criteria:

* Non-availability of informed consent.
Trial of IMO-3100 in Patients With Moderate to Severe Plaque Psoriasis

The purpose of this study is to evaluate different dose levels of IMO-3100 compared to placebo administered for 4 weeks to patients with moderate to severe plaque psoriasis.

To evaluate the safety, tolerability and treatment effect of different dose levels of IMO-3100 compared to placebo administered for 4 weeks to patients with moderate to severe plaque psoriasis.

Eligibility Criteria:
Inclusion Criteria:

* Is age 18 to 70 years, inclusive;
* Completes the informed consent procedure (see Section 15.3), including signing and dating the informed consent form;
* Has moderate to severe plaque psoriasis meeting the criteria specified above;
* Female subjects must have a negative pregnancy test at screening and on Day 1 prior to start of treatment;
* Female subjects of childbearing potential (see Section 8.4.1) and male subjects who have partners of childbearing potential must agree to use effective birth control (contraception; see Section 8.4.1) from Screening through the treatment period and for four (4) weeks after the last injection of study drug.

Exclusion Criteria:

* Has known hypersensitivity to any oligodeoxynucleotide;
* Is nursing;
* Has body weight \< 50 kg;
* Has BMI \> 34.9 kg/m2;
* Regularly consumes \> 3 drinks of alcoholic beverages (beer, wine, or distilled spirits) per day;
* Has a positive test for antibody to human immunodeficiency virus (HIV-1 or -2) or hepatitis C virus;
* Has a positive test for hepatitis B surface antigen (HBsAg);
* Has at screening safety laboratory tests meeting one or more of the following criteria:
* hemoglobin \< 10.5 g/dL
* white blood cell count \< 4,000 cells/mm3
* absolute neutrophil count (ANC) \< 1500/mm3
* platelet count \< 100,000/mm3
* alanine transaminase (ALT; SGPT) \> 1.5x ULN
* aspartate transaminase (AST; SGOT) \> 1.5x ULN
* serum total bilirubin \> 1.4x ULN
* serum creatinine \> 1.3x ULN;
* Has a history of allogeneic organ transplant (including bone marrow or stem cells);
* Has, within the past 10 years, had evidence of or required treatment for cancer (except treated basal or squamous cell carcinoma of the skin or cured cervical carcinoma-in-situ);
* Has had within the past three months or is expected to have during the study period any of the following treatments:
* surgery requiring general anesthesia
* hematopoietic stimulating agents (e.g., erythropoietin, G-CSF, GM-CSF)
* another investigational drug;
* Has other significant medical disease (chronic or active within the past 6 months), including, but not limited to: cardiac disease (e.g., unstable angina, myocardial infarction, congestive heart failure, ventricular arrhythmia); uncontrolled seizure disorder; liver disease; chronic infection (e.g., tuberculosis); uncontrolled diabetes;
* Has any other condition that would, in the opinion of the Investigator, potentially compromise the safety or compliance of the patient or may preclude the patient's successful completion of the clinical trial.