cyrilzakka/clinical-trials huggingface dataset:
Epley Manoeuvre in Participants With Multiple Sclerosis Diagnosed From Benign Paroxysmal Positional Vertigo

Vertigo, dizziness and control postural disturbance are one of the most disabling symptoms in Multiple Sclerosis. These could be caused by a peripheral or central vestibular disorder. Although, central vestibular damage is more prevalent, peripheral vestibular disturbance aetiology is significantly common in this disease. Within peripheral vestibulopathy, benign paroxysmal positional vertigo is the most common syndrome. Impairments of posterior semi-circular canals in benign paroxysmal positional vertigo represent among the 60-90 % of the cases. Gold standard treatment in this syndrome is the canalith repositioning procedure, called Epley manoeuvre. This manoeuvre has been deeply investigated in previous studies for participants who only suffer from benign paroxysmal positional vertigo. Any randomized clinical trials have been carried out to assess the effectiveness of Epley manoeuvre. However, a retrospective research and a case study reported encouraging results for the resolution of posterior semi-circular canal benign paroxysmal positional vertigo, through the Epley manoeuvre. The main objective of the study is to assess the effectiveness of the Epley Manoeuvre for the improvement of the benign paroxysmal positional vertigo of participants with multiple sclerosis, compared to a passive control group.

After given oral and written information to participants, they will be freedom to decide their wish to participate. After the invitation, those participants who desire to be part of study will sign the written informed consent.The study describes a two-arms, parallel groups design and double-blind randomized clinical trial. A prospective study with randomized and conceal allocation will be performed to prevent possible bias. Participants and evaluators will be blinded to group allocation. The randomized controlled trial have 3 evaluations of the sample, that will be carried out at baseline, immediately after intervention and 48 hours later

Eligibility Criteria:
Inclusion Criteria:

* Adults of both genders aged from 18 to 65 years old.
* clinically diagnosed of any MS subtype (relapsing-remitting, primary progressive and secondary progressive),
* with an Expanded Disability Status Scale (EDSS) ranging from 1 to 5 points,
* diagnosed of posterior semi-circular canals benign paroxysmal positional vertigo by an otolaryngologist and a physical therapist expert in vestibular rehabilitation.

Exclusion Criteria:

* Changes in MS pharmacotherapy within the last 3 months,
* BPPV treatments as vestibular sedatives, corticosteroids, morphic and antihistamines, at least 72 hours before intervention,
* alcohol consumption in the last 72 hours,
* severe visual impairments,
* participants who have received vestibular rehabilitation within the last 3 months,
* existence of any other neurologic disease.
Assessment of a Diagnostic Medical Device for the INR (International Normalized Ratio) Measurement

The purpose of this study is to assess the measurement conformity of an in vitro diagnostic device measuring the INR (International harmonized Ratio).

The investigators will assess the performance of an in vitro diagnostic device for assessing the INR.

The evaluation will consist of make several INR measurements using the device and compare these measures to the reference value.

The INR will be measured using the study device on capillary blood drops taken from the fingertip. In the same way a venous blood sampling will be carried out to measure a reference INR.

A total of 20 healthy subjects and 180 patients treated with vitamin K agonist will be enrolled in the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients treated with vitamin K agonist or healthy volunteers
* For healthy volunteers : Body Mass index between 18 ans 29 kg/m²
* No acute disease in the previous month

Exclusion Criteria:

* Pregnant woman
Study of LY573636-Sodium in Patients With Metastatic Non-Small Cell Lung Cancer

The primary objective is to estimate the time to progressive disease for patients who receive LY573636-sodium (hereafter referred to as LY573636) after two previous treatments for metastatic non-small cell lung cancer. Patients will receive an intravenous infusion of study drug once every 21 days. Computed tomography (CT)-scans will be done before the first dose and then after every other treatment.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of metastatic non-small-cell lung cancer
* At least 18 years of age
* Have received 2 previous treatment regimens for metastatic non-small-cell lung cancer

Exclusion Criteria:

* Serious pre-existing medical conditions
* Previous cancer (except skin cancer, excluding melanoma)
* Have received 3 or more previous treatment regimens for metastatic non- small-cell lung cancer
* Active treatment with Coumadin
Automated Documentation of Vital Parameters Using Mobile Stations and Activation of the Rapid Response Team

The documentation of vital signs is traditionally performed manually when the patient is not admitted in intensive care units, which can lead to documentary errors, long time for data acquisition and, consequently, impairment in the early identification of possible clinical deterioration. In-bed technology solutions are available to automate the collection of vital data and transfer information to a medical record or central electronic monitoring and its role in the health value chain needs further investigation. The investigators propose to evaluate the impact of the Connex Spot Monitor solution Welch Allyn (CSM / Hillrom) in conjunction with the Hillrom Connecta solution in a real world situation, conducting a cluster randomized trilal in wards of a tertiary hospital. In addition, this study aims to estimate the clinical effectiveness of a technological solution that performs an analysis of vital signs and automatically activates the rapid response team (RRT) when the pre-defined criteria are met, comparing it with the traditional manual method. The primary outcome is the number of times that the RRT fires in a timely manner.


Eligibility Criteria:
Inclusion Criteria:

- All patients with activated RRT during the study recruitment period.

Exclusion Criteria:

- Individuals who need blood pressure measurement in lower members.
CRP-Apheresis for Attenuation of Pulmonary, MYocardial and/or Kidney Injury in COvid-19

The 'CAPMYKCO' study is a randomized controlled, open-label, single center proof of concept trial. The aim of this study is to evaluate whether a CRP-apheresis in addition to the current standard therapy is intended to mitigate the severity of the disease course of SARS-CoV-2, especially with regard to tissue injury in the lungs, heart and kidneys and their consequences.

CRP-apheresis should reduce the necessity and duration of non-invasive/invasive ventilation requirements compared to the control group.

The influence of CRP-apheresis on the attenuation of pulmonary, myocardial and/or kidney tissue injury as well as the course of the COVID-19 disease will also be demonstrated by evaluating various biomarkers, several clinical scoring systems, and the duration of intensive care medical treatment.

The prognostic value of C-reactive protein (CRP) in assessing disease progression in COVID-19 is well known: The steeper the CRP rise in the days after infection and the higher the CRP concentration at hospitalization, the worse the prognosis. It is believed that CRP concentration not only reflects tissue damage but also causally contributes to the severity of the damage that occurs. CRP apheresis effectively limits CRP rise, which may lead to improved prognosis. CRP apheresis is a therapeutic hemapheresis procedure that selectively removes C-reactive protein from the patient's plasma. Other causal therapies for immediate selective reduction of CRP in the acute phase of disease are not currently available.

In the planned 'CAPMYKCO' study, CRP-apheresis in addition to current standard COVID-19 therapy is expected to mitigate the severity of disease progression, particularly with regard to tissue injury in the lungs, the heart and/or the kidneys and their respective clinical consequences.

CRP-apheresis treatment in COVID-19 patients should reduce the necessity and duration of non-invasive / invasive ventilation compared to the control group.

The influence of CRP-apheresis on the course of the COVID-19 disease will also be demonstrated by evaluating different organ biomarkers and the duration of intensive medical treatment.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed SARS CoV-2 infection (PCR-test)
* Oxygen therapy (maximum 'high-flow' therapy)
* CRP plasma concentration ≥ 50 mg/l and/or
* CRP increase ≥ 15 mg/l within 24 h after admission.
* Completed informed consent and written informed consent.
* Legal capacity

Exclusion Criteria:

* Age \< 18 years
* Pregnancy / lactation period
* Invasive, mechanical ventilation
* Extracorporeal membrane oxygenation (ECMO)
* Participation in other interventional trials
* Extracorporeal membrane oxygenation (ECMO) support
* Participation in other interventional trials
Contribution of the Evaluation of Body Composition by Connected Scale in the Effectiveness of a Reconditioning Program Through Physical Activity Adapted for Patients Suffering From Chronic Diseases

The goal of this interventional study is to evaluate the impact of the use of a connected impedance scale on the physical and mental quality of life of patients suffering from chronic diseases and participating in a physical activity rehabilitation program. The main objective is to know if a regular monitoring of the evolution of body composition parameters recorded by the connected scale would allow patients participating in the Physical Activity rehabilitation program at Hôtel-Dieu to follow in real time the effects of such program, not on weight itself but on body composition, and that this would contribute to a better perception of physical and mental quality of life at the end of the program 90 Participants will be randomized in two groups :

* Control group (N = 45) : routine care
* Interventionnal group (N=45) : routine care + use of connected scale All participants will undergo physical activity rehabilitation program during 6 weeks.

Patients will be see again at 6 months, and the following parameters will be comparer between the two groups :

* SF-36 questionnaire
* Ricci \& Gagnon questionnaire
* 6MWT
* 30 sec sit-to stand test
* Ito-Shirado test
* Sorensen test
* Handgrip test
* MaxV02


Eligibility Criteria:
Inclusion Criteria:

* Patient (male or female) aged 18 and over
* Patient able to express free, informed and written consent
* Patient participating in the physical activity rehabilitation program at the CIMS of the Hôtel Dieu
* Patient suffering from a known, stable and diagnosed chronic disease
* Patient autonomous in taking treatments for their ALD
* Patient affiliated to a social security system

Exclusion Criteria:

* Patient under legal protection (guardianship, curatorship)
* Patient deprived of liberty by a judicial or administrative decision
* Patient with functional limitations that do not allow a physical assessment or result in a walking distance \< 350 m during the HDJ for admission to the program
* Patient with suspected cardiac pathology during the HDJ for admission to the program
* Patient with episode of decompensation or exacerbation
* Patient with a pacemaker or implantable automatic defibrillator
* Pregnant women
Effect of Administration of Rifaximin on the Portal Pressure of Patients With Liver Cirrhosis and Esophageal Varices

The purpose of this study is to assess whether the add of Rifaximin in patients with liver cirrhosis and esophageal varices treated with a standard therapy with beta blockers, leads to a significant reduction of portal hypertension.

It is well recognized that the gut flora may play an important role in the development of complications of liver cirrhosis, such as hepatic encephalopathy (HE), spontaneous bacterial peritonitis (SBP) and variceal bleeding, which are are directly caused or aggravated by the translocation of enteric bacteria or their products into the blood of cirrhotic patients.Preliminary studies have shown that selective intestinal decontamination appears to ameliorate the hyperdynamic circulatory state of cirrhosis. The investigators hypothesize that a modulation of gut microbiota by administering a non-adsorbable antibiotic, in addition to beta-blockers, can be a safe strategy to reduce the portal pressure, influencing favorably hemodynamics of portal circulation. Thus, the purpose of this study is to evaluate if in patients with liver cirrhosis and esophageal varices at high risk of bleeding, Rifaximin, administered in addition to standard therapy with beta - blockers (propranolol), for a time of 60 days: leads to a significant reduction of Hepatic Venous Pressure Gradient (it will be assessed by hepatic vein catheterization), 2) modify the intestinal flora in favor of specific families of bacteria (it will be assessed by fecal microbiota analysis), 3) change systemic inflammatory responses (it will be assessed by serum pro-inflammatory cytokines) 4) change in cognitive functions (it will be assessed by neuropsychological and electroencephalogram evaluations).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of liver cirrhosis (based on clinical, biochemical and radiological criteria with or without liver biopsy)
* Presence of esophageal varices at high risk of bleeding
* Hepatic Venous Pressure Gradient \> 12 mmHg.
* 19≤ age ≤75
* Informed Consent

Exclusion Criteria:

* Patients already treated with beta blockers
* Treatment with systemic antibiotics and/or non-absorbable intestinal antibiotics in the previous two weeks
* Bacterial infection, spontaneous bacterial peritonitis
* overt hepatic encephalopathy in the last week
* active gastrointestinal bleeding, or in the last week
* active alcoholism or drug abuse in last 3 weeks
* Acute Alcoholic Hepatitis
* Hepatocellular carcinoma or other neoplasm
* significant coronary artery disease (angina NYHA III/IV), congestive heart failure (NYHA III/IV), relevant cardiomyopathy, history of myocardial infarct within the last 12 months
* Contraindications to the administration of beta blockers; allergy to Rifaximin
* Pregnancy or breastfeeding
* Refusal to participate
A Study of Onartuzumab (MetMAb) in Combination With Bevacizumab (Avastin) Plus Platinum And Paclitaxel or With Pemetrexed Plus Platinum in Patients With Non-Squamous Non-Small Cell Lung Cancer

This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of RO5490258 (MetMab) in combination with either of two backbone chemotherapy regimens in the first-line setting in patients with incurable Stage IIIB or IV non-squamous non-small cell lung cancer. In Cohort 1, patients will be randomized to receive 4 cycles of bevacizumab (Avastin) 15 mg/kg iv, paclitaxel 200 mg/m2 iv, platinum (cisplatin/carboplatin) iv plus either MetMab 15 mg/kg iv or placebo on Day 1 of each 21-day cycle. In Cohort 2, patients will be randomized to receive pemetrexed 500 mg/m2 iv, platinum (cisplatin/carboplatin) iv plus either MetMAb 15 mg/m2 iv or placebo on Day 1 of each 21-day cycle. Patients who have not progressed after 4 cycles will be offered maintenance therapy with their assigned treatment of bevacizumab plus either MetMAb or placebo (Cohort 1) or pemetrexed plus either MetMAb or placebo (Cohort 2). Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Histologically or cytologically confirmed Stage IIIB or Stage IV non-squamous non-small cell lung cancer (NSCLC)
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* For patients who received prior adjuvant chemotherapy or chemoradiotherapy: a treatment-free interval of at least 12 months since last chemotherapy or chemoradiotherapy cycle
* Adequate tissue for central immunohistochemical (IHC) assay of Met receptor, and epidermal growth factor receptor (EGFR) testing if EGFR status is unknown
* Radiographic evidence of disease

Exclusion Criteria:

* Prior systemic treatment for Stage IIIB or IV non-squamous NSCLC
* Evidence of mixed NSCLC with a predominance of the squamous cell type
* Prior exposure to experimental treatment targeting either the hepatocyte growth factor (HGF) or Met pathway
* Patients with tumors confirmed to have EGFR-activating mutations who are suitable for anti-EGFR therapy (e.g. gefitinib or erlotinib), as determined by the investigator, unless that treatment is unavailable or refused by the patient
* Known central nervous system (CNS) disease, other than stable, treated brain metastases
* History of another malignancy in the previous 3 years, except for history of in situ cancer that was treated surgically with curative intent, localized prostate cancer that has been treated surgically with curative intent, or basal or squamous cell skin cancer
* Uncontrolled diabetes
* Pregnant or lactating women
* Impaired bone marrow, liver or renal function (as defined by protocol)
* Significant history of cardiovascular disease
* Positive for HIV infection
Human Microbiome Research and Development for Overcoming Pediatric Diseases

Prediction and treatment of pediatric diseases and long-term outcomes through microbiome and multi-omics analysis by life cycle: We aim to demonstrate that a wide range of diseases are associated with gut microbiome dysbiosis and to investigate the subsequent recovery (restoration) or further deterioration of the gut microbiome over time. This study seeks to offer a novel perspective on changes in the gut microbiome, particularly in the context of the gut-lung and gut-brain axes.

Fecal samples are collected and analyzed from birth through childhood, including those from both preterm and term infants. Based on these collected samples, groups are categorized into disease groups commonly observed in children. Genomic DNA is extracted from the fecal samples, followed by high-throughput 16S rRNA amplicon sequencing to analyze the microbial composition. Additionally, multiomics analyses, including metabolomics, are conducted to provide a comprehensive understanding of gut microbiome dynamics. The impact on the microbiome is further investigated in vitro using a fermenter-based intestinal microbiota model system.

Eligibility Criteria:
Inclusion Criteria:

* children (including newborns) who have obtained their consent from their guardians

Exclusion Criteria:

* subjects who did not obtain consent
Home-based Exercise for Management of HIV-associated Cardiovascular Disease Risk

Because of advances in drug treatment, people living with HIV/AIDS (PLWHA) are living longer, but are also at greater risk for cardiovascular disease (CVD) and diabetes. Exercise and increased physical activity can reduce the risk factors for these diseases in PLWHA, but no studies have tested an at-home exercise program that would benefit low income people and others who do not have access to exercise facilities. This study will test the feasibility of an at-home exercise program for PLWHA and prepare for a full-scale intervention study, which may lead to a reduction in CVD risk among PLWHA.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and older
* Medical diagnosis of HIV-1 positive serostatus
* Sedentary lifestyle: not actively exercising ≥ 3 d•wk-1 for 20 min per session
* 18.5 kg/m2 \< BMI \< 40.0 kg/m2
* Stable, DHHS-approved ART regimen for previous 3 months, with HIV viral load below 75 copies/mL
* Capable of performing the required exercise regimen
* Have daily access to a telephone for approximately 10 months
* Capacity and willingness to provide informed consent and accept randomized group assignment

Exclusion Criteria:

* Individuals who have a clinical history strongly suggestive of Type 1 diabetes.
* History of serious arrythmias, cardiomyopathy, congestive heart failure, stroke or transient ischemic cerebral attacks, peripheral vascular disease with intermittent claudication, myocardial infarction, or CABG.
* Malignancies in the past 5 years, except therapeutically controlled skin cancer.
* Plans to be away \> 4 weeks in the next 9 months
* Score of 5 or greater on the DAST or MAST (signifying excessive use of drugs or alcohol).
* Weight loss in excess of 10% body weight in previous 12 weeks.
* Chronic or recurrent respiratory, gastrointestinal, neuromuscular, neurological, or psychiatric conditions.
* Inflammatory-related conditions such as collagen disorders.
* Any other medical condition or disease that is life-threatening or that can interfere with or be aggravated by exercise.
Study of Coronary Artery Disease by Two Types of Angiography

The purpose of this study is to test the ability of a new X-ray technique called CT angiography to identify significant narrowing of the coronary arteries compared to traditional coronary angiogram.

Objective:

In patients with newly diagnosed cardiomyopathy it is the standard of care to perform coronary angiography. This procedure can separate ischemic from non-ischemic cardiomyopathy and identifies patients who may be eligible for revascularization as a therapeutic modality. With the advent of multidectector row-computed tomography technology, it is becoming possible to non-invasively identify significant atherosclerotic stenoses with acceptable sensitivity and specificity. The goal of this study is to compare non-invasive computed tomography (CT) angiography with traditional coronary angiography to identify proximal, and hence revascularizable, coronary artery disease in patients with cardiomyopathy. Revascularizable is defined a 3 vessel proximal disease, left main disease, or left main equivalent disease (ostial left anterior descending and ostial left circumflex).

Research Design:

This study is prospective, interventional, single site with the interpreting radiologists blinded to the results from previous angiography.

Methods:

Subjects will be patients with cardiomyopathy, defined as an ejection fraction less than 40%. Exclusion criteria include known allergy to contrast medium, previous anaphylaxis, and renal insufficiency (serum creatinine greater than 1.5). We would like to enroll 30 patients. After giving informed consent, all eligible patients will undergo CT angiography, performed using new multi-slice technology. The results of previously obtained transthoracic echocardiography and standard coronary angiography will be reviewed. Following CT angiography all patients will have a repeat measurement of serum creatinine to screen for contrast induced nephropathy. Results of the CT angiography will be analyzed to determine sensitivity and specificity for identifying revascularizable coronary artery disease, compared to coronary angiography as the gold standard.

Eligibility Criteria:
Inclusion Criteria:

* Congestive heart failure with EF\<40%
* Age\> 18 years

Exclusion Criteria:

* Contrast allergy
* Renal insufficiency
* Inability or unwillingness to sign a consent
* Diabetes Mellitus
LGG/BB12-pastille Study

We want to study the effect of short-term consumption of probiotics (a mixture of L. rhamnosus GG and B. lactis BB-12)on the composition of the oral flora.


Eligibility Criteria:
Inclusion Criteria:

* Subjects healthy, 20-30 yrs of age

Exclusion Criteria:

* Subjects not healthy, too old/young