cyrilzakka/clinical-trials huggingface dataset:
Saccharomyces Boulardii in Irritable Bowel Syndrome

Various studies have been conducted in past using different strains of probiotics in evaluating IBS symptoms. The results are by no means consistent and the overall impact of probiotics in IBS remains unclear. However, recently O'Mahony L et al have shown that Bifidobacterium infantis 35624 alleviates symptoms in IBS; this symptomatic response was associated with normalization of the ratio of an anti-inflammatory to a proinflammatory cytokine (IL-10/IL-12 ratio), suggesting an immune-modulating role for this organism, in this disorder.Saccharomyces boulardii is a probiotic yeast that has been successfully used for the antibiotic induced diarrhea, prevent relapse of Clostridium difficile and Crohn's disease. It ameliorates intestinal injury and inflammation caused by a wide variety of enteric pathogens.We therefore plan a Double-blind, randomized, placebo-controlled study to assess the effects of Saccharomyces boulardii in improving symptomatology of diarrhea predominant IBS and its effect on quality of life. We also plan to assess the changes in the relative production of anti-inflammatory interleukin (IL)-10 to proinflammatory cytokines (IL-12, IL-8 and TNFα).


Eligibility Criteria:
Inclusion Criteria:

1. Diarrhea-predominant IBS satisfying ROME III criteria.
2. Adults aged 18-70

Exclusion Criteria:

1. Pregnant and lactating females
2. Inflammatory bowel disease and other systemic disease
3. Patients on anti-diarrheal and antibiotics drugs
4. Patients with any ongoing infection
5. Not willing to participate
6. Allergy to any of Saccharomyces boulardii components
7. Central venous catheter carriers
8. Other probiotics e.g., Lactobacillus and Bifidobacterium
Use of Polysomnography for Non-Invasive Ventilation Settings' Optimization

The aim of this randomized controlled trial is comparing the improvement of diurnal PaCO2 in OHS patients after one month of NIV treatment depending upon the tools used for adjusting settings. In one arm settings will be adjusted using only nocturnal oxygen SaO2 and PaCO2 at awakening whereas in the other arm patients will benefit from a complete polysomnography under NIV.

Initiation of NIV treatment implies technical adjustments (choice of mask and ventilator), but also patient education by the nurses and medical staff. The settings are generally adjusted during the daytime in awake patients. The appropriateness of these settings is generally not optimal during sleep as many respiratory events (hypopnoea, apnea, leaks, desynchronization, and glottic closure) may occur under NIV then reducing the effectiveness of treatment. These nocturnal abnormalities are routinely evaluated by measuring their consequences, i.e. oxygen desaturation and the level of PaCO2 after wake up. Some teams are now proposing to better characterize what happens when using NIV during sleep using polysomnography (PSG). The precise characterization of residual events under treatment may allow optimizing ventilator settings.

Eligibility Criteria:
Inclusion Criteria:

* Patient male or female, aged 20 to 75 years
* Patient with a OHS in stable condition, with a BMI\> 32 kg/m2 and a PaCO2\> 6 kPa in diurnal spontaneous breathing without other cause of alveolar hypoventilation
* Patient affiliated to a social security insurance
* Having given its written informed consent to participate to the study

Exclusion Criteria:

* Patients with inherent chronic obstructive pulmonary disease (COPD) with FEV1 on Forced Vital Capacity (FVC) ratio less than 70%
* Patients suffering from heart failure with periodic breathing
* Associated Neurological Diseases, evolving rapidly, leading to a dependency in daily activities
* Unbalanced Psychiatric Diseases
* Patients with a respiratory decompensation the month preceding the study
* Patients not autonomous in the use of the NIV
* Pacemaker patients, constituting a contraindication to magnetic stimulation
* Sensitive subjects, in accordance with article L 1121-6 of the French Public Health Code
* Patients with long term by steroids or other anti-inflammatory drugs
Exploring the Landscape of Injury and Repair in the Human Oesophagus

The goal of this study limited to working with human tissue samples is to delineate the mechanisms defining appropriate oesophageal injury and repair and to use this information to understand how these rules are dysregulated and result in cancer formation in adult patients undergoing endoluminal vacuum therapy (EVT therapy) for the treatment of perforations to the oesophagus.

The main question\[s\] it aims to answer are:

* to gain a deeper understanding of the processes underlying tissue regeneration and repair in the oesophagus and upper gastro-intestinal tract following physical injury
* to identify the similarities in the processes of regeneration and early carcinogenesis

Participants will take part in the study during their usual EVT therapy schedule. Tissue brushings and pinch biopsies will also be taken.

Tissue injury activates a number of cellular responses to initiate wound healing, resulting in the formation of new tissue within a short span of time and in a controlled fashion. In contrast, cancer results when a tissue mass forms in an unregulated process. Understanding the molecular mechanisms behind appropriate wound healing enables us to delineate how this process goes askew in the context of cancer. The goal is to delineate the mechanisms defining appropriate oesophageal injury and repair, and to use this information to understand how these rules are dysregulated and result in cancer formation.

In this study, the researchers wish to recruit adult patients undergoing endoluminal vacuum therapy (EVT therapy) for the treatment of perforations to the oesophagus in order to collect the discarded EVT sponge, biopsies from endoscopies, resected surgical specimens and additional blood samples. The researchers will request consent for access to archived tissue samples from any previous related surgery and some associated clinical metadata. The samples and associated clinical metadata will then be pseudonymised and sent to the Wellcome Sanger Institute.

Once samples are received at the Wellcome Sanger Institute, they will undergo a number of procedures including but not limited to genome sequencing, this will enable the researchers to gain a better understanding of the wound healing process, specifically how it can sometimes go wrong and lead to the development of cancer.

Eligibility Criteria:
Inclusion Criteria:

* Male and Female patients 18 years old and over who are having elective upper gastro-intestinal surgery where a leak is a recognised complication (but has not occurred)
* Male and Female patients 18 years and over who present acutely with an upper gastro-intestinal leak.

Exclusion Criteria:

* patients who do not have a good understanding of the English Language
Diagnosis of Acute Rejection in Renal Transplant Patients by Urine Mass Spectrometry

Reliable and timely detection of acute rejections in renal transplant patients is important to preserve the graft function and to prevent premature graft failure. The current gold standard for the rejection diagnosis is a renal biopsy which is usually performed upon an unexplained decline in the graft function (determined by serum creatinine or clearance). Because of the insensitivity of creatinine determinations and the invasiveness of renal biopsies, non-invasive tests have been suggested to diagnose acute rejection including mass spectrometry (MS) analysis of urine samples.

The ability of MS analysis to detect acute rejection has been demonstrated in small studies on selected patients but evidence is lacking that this test is efficacious in the routine setting of the post-transplant patient care. Based on our previous work that established urine peptide sets for acute rejection by MS, a prospective, multicentre diagnostic phase III study will be executed.

The aim of the study is to prove that this test is as equally effective as the allograft biopsy to detect acute rejection in patients that undergo a biopsy for unexplained renal dysfunction. The perspective of this approach is that the test could be used either in place of the biopsy or as decision guidance whether a biopsy is necessary to confirm the presence of rejection. Another perspective is that the MS test (respectively, a simplified test system derived from this method) could be used in the regular post-transplant surveillance for acute rejection, in place of the relatively insensitive procedure with periodic monitoring of the graft function by creatinine determinations.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with a kidney or combined kidney/pancreas transplantation
* Unexplained renal allograft dysfunction within the first year of transplantation
* Renal allograft biopsy, which is clinically indicated to verify or exclude an acute rejection

Exclusion Criteria:

* Lacking consent of the patient to participate in the study
Blood Collection for Development and Validation of Point-of-Care Diagnostic Liver Function Tests

This is an observational study exploring the performance of a novel point-of-care diagnostic testing platform designed to quantitate the presence of liver function biomarkers such as bilirubin. Blood samples will be collected from participants to further development and validation of the testing platform to support FDA review. The diagnostic device is intended to provide rapid in-office test results using a finger stick of blood, a reaction test device, and a smartphone app.

The nature of outpatient diagnostics delays diagnosis and proper treatment due to the need to travel to a sample collection site that is designed for volume testing adding the individual's sample to the testing que. The physical and temporal separation of diagnostic testing from medical office or virtual care visits delays physician decision-making until results are available. Many patients even skip the recommended testing due to time and financial costs.

Many acute and chronic conditions result in disruption of normal liver function. Common prescription and over-the-counter medications also affect liver function when taken over extended periods or at elevated doses. Having multiple rapid, easy-to-use diagnostic tests on a single platform could improve condition diagnosis and medication monitoring by ensuring current test results are available every time and anywhere they could be useful for immediate medical decision-making.

This study will provide fresh blood samples for further development and validation of a novel point-of-care diagnostic testing platform. Tests for liver function biomarkers such as bilirubin, ALT (alanine transaminase), and AST (aspartate aminotransferase) will be characterized and validated using fresh whole blood, freshly prepared serum, and frozen serum. Enrolled participants will have a standard venous and a standard finger stick blood collection. Enrolled participants can return once weekly for blood draws or can chose to have only a single study visit. The study will continue until sufficient data has been generated to support review of the tests by the FDA.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older
* Able to read and understand an informed consent form written in English

Exclusion Criteria:

* Pregnancy
* Participated in the present study within the last 6 days
* Subject is subjectively unwell at the time of enrollment visit
* Subject previously participated and has asked to be withdrawn from the study
Comparison of Blood Loss in Using vs Not Using Placental Cord Drainage After Spontaneous Vaginal Delivery

Comparison of effectiveness of placental blood drainage after spontaneous vaginal delivery in decreasing the duration, blood loss,and complications of the third stage, against no drainage of placental blood.

The patients will prospectively randomized equally into two groups (100 each in the study and control groups).

Group-A (Study group)-Placental blood was drained.

Group-B (Control group)-Placental blood was not drained.

In all the patients detailed medical and obstetric history will taken. In each patient, the pre-delivery pulse rate, blood pressure, and Hb gm% will noted. Immediately after vaginal delivery, after clamping and cutting the cord-the cord will unclamped and the blood will drained until the flow ceased. In the control group, the clamped cord will not released. Blood lost in the third stage of labour will measured by collecting the blood measuring bag.

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy
* Vertex presentation
* Gestational age of 37 weeks (or) more
* No major medical (or) obstetric complications
* Spontaneous vaginal delivery

Exclusion Criteria:

* Hb\\7 gm/dl
* History of APH
* Instrumental delivery
* Multiple pregnancy
* Malpresentations
* Large baby (more than 3.5 kg)
* Polyhydramnios
* Known coagulations disorders
* Previous surgeries on the uterus
A Study to Investigate the Effect of Protein in Infant Formula on Insulin Response in Adults

It has been established that the consumption of a diet that causes a low rise in blood insulin levels is beneficial in terms of risk for diabetes and heart disease. Furthermore, it is known that certain nutrients contained within a food play an important role in the insulin response of that food. For example, the type and quantity of protein has been shown to affect the insulin response to particular foods.

Different types of infant formula exist, containing different levels and types of protein, yet the impact of these different infant formulas on blood insulin levels is not known.

Using a randomized, double blind, cross-over study design, the insulin response to four test milks was compared in healthy adults. The four test milks were as follows: i) infant formula containing partially hydrolyzed protein; ii) infant formula with intact protein; (iii) infant formula with a higher energy and protein content compared to (i) and (ii); and (iv) human breast milk (in a small sub-group). The aim of the study was to show that the insulin response to the partially hydrolyzed formula is similar to that of an infant formula with intact protein.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males and females aged 20-50 years at time of the enrollment
* Normal body weight. BMI 19-25 kg/m2
* Having obtained his/her signed informed consent

Exclusion Criteria:

Chronic or acute diseases affecting metabolism (diabetes, renal insufficiency, CVD, liver disease), dyslipidemia, as checked using the medical questionnaire and based on a biochemical blood analysis (glucose, triglycerides, cholesterol, transaminases and Gamma-GT, CRP in fasting

* Anemia (Erythrocytes \< 4,6 T/l (male) or \< 4,2 T/l (women); Hemoglobin Hb \< 13 g/dl (male) or Hb \< 12 g/dl (women); Hematocrit Ht \< 40% (male) or Ht \< 37% (women); sera iron \< 0,6 mg/l or plasma ferritin \< 120 μg /l (male) or \< 60 μg/l (non menopaused women)
* Recent major surgery (3 months)
* History of cancer within the past year
* Significant weight loss during the last 3 months (more than 5% of BW)
* Regular intensive physical activity of more than 3 times of 45 min per week
* Food allergy, lactose intolerance
* Under chronic medications (except contraceptive pills) Have a regular higher alcohol consumption than 1 drink/day or occasional 1-2 drinks during week end
* Consumption of illicit drugs, as checked by a urinary testing
* Smoking (more than 5 cigarettes a day)
* Women pregnant or lactating
* Special weight reduction program /diet
* Blood donation of at least 300mL during the last 3 months or planned blood donation before the end of the study
* Subject who cannot be expected to comply with the study procedures, including consuming the test products (600 mL of milk within 10 minutes)
* Currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study
Echocardiographic Assessment of Volume Variation Secondary to Preoperative Fasting

The primary objective of this study is to demonstrate that preoperative fasting does not increase the rate of lowered blood volume (defined by a variation of 15% ΔITV during a leg lift) in patients undergoing surgery.


Eligibility Criteria:
Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient is ASA (American Society of Anesthesiologists) class I, II or III
* The patient has not been fasting for more than 6 hours at the time of inclusion
* The patient is schelduled for a gynecological or visceral surgery

Exclusion Criteria:

* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient is pregnant
* The patient is breastfeeding
* The patient is ASA class IV
* The patient has insulin dependent diabetes
* The patient has a cardiac or respiratory dysfunction
* The patient has a heart rhythm disorder
* The patient has renal insufficiency with dialysis
* The patient is being treated with diuretics
* The patient has had a bowel preparation
* Emergency surgery
* Outpatient surgery
Performance of Tampons as a Biospecimen Collection Tool for the Detection of Human Papillomavirus in a Colposcopy Setting

Evaluation of the clinical performance of the Daye Diagnostic Tampon (DDT) for the detection of Human Papilloma Virus (HPV) infection associated with high grade cervical disease. Cross sectional design with comparison to a clinician taken biospecimen. Performance will be measured relative to the presence/absence of histologically confirmed disease

Type of Study: Clinical Trial

Goal: The goal of this clinical trial is to evaluate the clinical performance of the Daye Diagnostic Tampon (DDT) for the detection of HPV infection associated with high-grade cervical disease.

Main Questions:

What is the sensitivity and specificity of molecular HPV assays in detecting high-grade cervical disease (CIN2+) using the DDT compared to a clinician-taken, liquid-based cytology (LBC) sample?

How does the relative sensitivity and specificity of HPV detection in the tampon compare to the LBC sample for the detection of CIN2+?

Participants:

Women attending routine colposcopy clinics as part of standard care.

Main Tasks:

Provide informed consent. Undergo routine colposcopy. Use the DAYE Diagnostic Tampon (DDT). Provide a clinician-taken liquid-based cytology (LBC) sample. Complete a short questionnaire.

Comparison Group:

Researchers will compare the performance of the DAYE Diagnostic Tampon (DDT) to a clinician-taken, liquid-based cytology (LBC) sample to determine if there are differences in sensitivity and specificity for the detection of high-grade cervical disease (CIN2+). The comparison will assess the relative sensitivity and specificity of HPV detection in the tampon versus the LBC sample for the presence/absence of histologically confirmed disease.

Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 25-65 years (inclusive)
* Ability to understand patient information sheet
* Ability to provide informed consent
* Natal female
* Referred to colposcopy for routine indications
* In-tact cervix

Exclusion Criteria:

* \<25 years of age or over 65 years of age
* Hysterectomised
* Known allergy or sensitivity to tampons
* Pregnancy (current) or within last 3 months
* History of toxic shock syndrome
* Concurrent participation in other interventional research project
Safety and Efficacy Study of Antiviral Local Application to Treat High Grade Cervical Intraepithelial Lesions (CIN2/3)

The purpose of this phase-II study is to evaluate the efficacy and safety of an aqueous gel containing an antiviral, administered directly on cervix exhibiting high grade squamous or glandular intraepithelial lesion (CIN 2 and 3) in comparison with a placebo treatment.

Human Papilloma Virus (HPV) infections induce cervical intraepithelial neoplasia (CIN) of cervix. To reduce incidence of invasive tumor associated with high grade CIN lesions, the standard treatment is the conisation of cervix (surgical act). A local treatment with antiviral would preserve the cervix of young subjects and reduce obstetrical morbidity induced by the conisation.

This clinical study is aimed at:

* to evaluate the efficacy of a gel with antiviral directly applied on the cervix exhibiting high grade CIN lesions (CIN2/3): conisation is still indicated?
* to evaluate the safety and tolerance after local application.

Eligibility Criteria:
Inclusion Criteria:

* Women aged between 18 and 50 years old
* Informed consent signed
* Cervical lesion classified CIN 2 or 3, on a biopsy made during the 60 days before inclusion
* No sexual activity, or proved sterility, or use of effective mechanical, hormonal or intrauterine contraception during 30 days following inclusion (except vaginal ring Nuvaring, diaphragm and spermicide)

Exclusion Criteria:

* Invasive or microinvasive cervical neoplasia
* Pregnancy or breast feeding
* Subtotal hysterectomy
* Current renal impairment
* Current immune disorder including serology HIV +
* Current use of drugs interfering with renal function
* Current use of oncologic treatment
* Current use of immune treatment
* Current use of anti-viral treatment
* Current vaginal application of drugs or cosmetics
* Prior treatment with the antiviral on the cervix
* Local or general condition incompatible with the experimental treatment in the opinion of the principal investigator
* Current or recent participation to another experimental study during the last 3 months before the screening visit