cyrilzakka/clinical-trials huggingface dataset:
Differential Diagnosis Between Parkinson's Disease and Multiple System Atrophy Using Digital Speech Analysis

Parkinson's disease (PD) is the second most common neurodegenerative disease. Multiple system atrophy (MSA) is a relentlessly progressing rare neurodegenerative disease of unknown etiology. In early stages of the disease, PD and MSA symptoms are very similar, particularly MSA-P where Parkinsonism predominates. The differential diagnosis between MSA-P and PD can be very challenging in early disease stages, while early diagnostic certitude is important for the patient because of the diverging prognosis. Voice disorders are a common early symptom in both diseases and of different origin. The ambition and the originality of this project are to develop a digital voice-based tool for objective discrimination between PD and MSA-P.

Given the clinical similarity between PD and MSA-P in early disease stages and the severity of the prognosis of MSA-P, it would be very useful to have objective tools to assist in the differential diagnosis between both disorders. Since dysarthria is a common early symptom in both diseases and of different origin, the innovative goal of this project is to use dysarthria, through a digital processing of voice recordings of patients, as a vehicle to distinguish between PD and MSA-P in early disease stages.

The team will build a corpus of voice samples of patients with both diseases and a recent diagnosis (less than 4 years) and controls. This corpus will consist in sustained vowels, utterances of a standard text and spontaneous speech. The recordings will be performed using a high quality digital recorder (H4n) and the DIANA and EVA-2 workstations. DIANA is a state-of-the-art system dedicated to pathological voice recording and analysis.

An electroglottograph (EGG), a non-invasive device, will be also used in conjunction with the recordings to provide the ground truth of glottal opening and closure instants during utterances. The use of an EGG can be very useful given that OGI and GCI provide valuable information about the voice short-time dynamics.

Eligibility Criteria:
Inclusion Criteria:

* Patient with Parkinson's disease :

  * Diagnosis of idiopathic Parkinson's disease (PD) according to criteria (Hughes et coll., 1992)
  * Patient in early stage of PD : Hoehn\&Yahr stage between 1 and 2, and the onset of symptoms ≤ 4 years
  * Patient with or without mild to moderate speech troubles: UPDRS III item 18 ≤ 2
* Patients with MSA-P (Parkinsonian form) :

  * Diagnosis of Multiple Atrophy System (MSA) Parkinsonian form possible or probable according to Gilman et coll 's criteria (2008)
  * Patient in early stage of MSA-P: score of part IV of the UMSARS (Unified Multiple System Atrophy Rating Scale) ≤ 3 points and the onset of symptoms ≤ 4 years
  * Patient with or without mild to moderate speech troubles: UMSARS II item 2 ≤ 2
* Controls :

  * Absence of neurologic and oto-rhino-laryngologic disease

Exclusion Criteria:

* The deaf and/or mutes
* Patient with speech troubles which are not related to the MSA or PD
* Person under safeguard justice, guardianship
Provision of a Mobile Geriatric Team Extra-Community Hospital

The purpose of this study is to demonstrate the effectiveness of the mobile unit to reduce the geriatric hospital inappropriate (especially for emergencies) to 1 month.

The primary endpoint: survival without hospitalization through the emergency inappropriate to 1 month.

The purpose of this study is to assess the effectiveness of the Mobile Geriatrics on the management of complex situations in retirement homes and in ambulatory care of frail elderly patients, reported by the generalist doctor, in terms of improving the conditions of use technical support hospital follow-up recommendations given by the mobile team and their impact on outcomes of care.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged 75 and over living in complex medical or psycho-social complex or at risk of hospitalization
* Patient affiliated to social security or beneficiary of such a regime
* Patient available for follow-up to 6 months with a caregiver or accompanying social duly appointed.

Exclusion Criteria:

* Patient residing outside intervention sector
* Life-threatening emergency (ambulance)
* Lack of complexity of the situation, supported by routine care
Treatment of Chronic Fatigue Syndrome and Fibromyalgia With D-ribose- a Multicenter Study

To determine whether adding Ribose 5 grams 3 x day would improve quality of life, energy, sleep and cognitive function and decrease pain in patients with CFS and/or fibromyalgia (CFS/FMS).

Chronic Fatigue Syndrome and Fibromyalgia (CFS/FMS) are debilitating syndromes affecting \~ 2-4% of the population. Although they are heterogeneous conditions associated with many triggers, including infections, autoimmune illnesses, hormonal dysfunctions and other processes, they appear to have the common pathology of being associated with impaired energy metabolism.

As D-ribose has been shown to increase cellular energy synthesis in heart and skeletal muscle, and was shown to significantly improve clinical outcomes in CFS/FMS in an earlier pilot study, we conducted a larger, community based, multicenter trial to see if these findings could be generalized to a broader patient population. We hypothesized that giving D-ribose would improve function in CFS/FMS patients.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with Fibromyalgia (FMS) (by American College of Rheumatology \[ACR\] criteria) and/or Chronic Fatigue Syndrome (CFS- by Centers for Disease Control \[CDC\] criteria) by a health practitioner.

Exclusion Criteria:

* pregnant or nursing women, or
* any participants with known severe medication or nutrient sensitivities, or
* previous ribose use.
A Phase II, Open Label, Multiple Arm Study of AUY922, BYL719, INC280, LDK378 and MEK162 in Chinese Patients With Advanced Non-small Cell Lung Cancer

The purpose of this study was to evaluate the anti-tumor activity of single agent BYL719, INC280, LDK378 and MEK162 in advanced NSCLC patients carrying specific molecular alterations.

There is a great unmet medical need in NSCLC patients with advanced or metastatic disease. Novel approaches using targeted therapeutic agents for these patient populations with molecular characterization could potentially identify subsets of advanced NSCLC patients who would benefit from targeted kinase inhibition. Study treatments, BYL719, INC280, LDK378 and MEK162, which target PIK3CA, c-MET, ALK/ROS1 and MEK respectively, have shown promising data in either preclinical or clinical lung cancer settings.

To enter the screening phase of the study, the subjects' molecular alterations were determined using locally validated methodologies from a newly obtained tumor sample (preferred) or the most recent archival tumor sample available. Based on the molecular alterations of the tumor, subjects were assigned to one of the treatment arms. Subjects with multiple molecular alterations in epidermal growth factor receptor (EGFR) and the relevant pathways were excluded, except under the conditions described in Inclusion criteria.

The treatment period began on Cycle 1 Day 1 and continued in 28-day cycles until disease progression, unacceptable toxicity, withdrawal of informed consent, death or the subject transferred to another Novartis study that could continue to provide the study drug.

All subjects were required to be followed up for 30 days for safety after receiving the last dose of study treatment. Subjects who discontinued study treatment for any reason other than disease progression were followed up for progression of disease. All subjects were required to be followed for survival. For subjects transferred to another Novartis study, an end of treatment visit (EOT) was required to be performed and the subject would not enter the follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Advanced (stage IIIB or stage IV) NSCLC
* Must have specific molecular alterations

Exclusion Criteria:

* Symptomatic central nervous system (CNS) metastases which are neurologically unstable or requiring increasing doses of steroids within the 4 weeks prior to study entry to control their CNS disease
* Radiation therapy within ≤ 4 weeks prior to study entry, with the exception of limited field palliative radiotherapy for bone pain relief.
* Any other malignancies within the last 5 years before study entry
* Major surgery ≤ 2 weeks prior to study entry or who have not recovered from side effects of such therapy
An Open Label Phase II Study Combining Nivolumab and Celecoxib in Patients With Advanced " Cold " Solid Tumors

This is an open-label study to evaluate the safety and the anti-tumor activity of the combination of nivolumab and celecoxib.

The total numbers of participants to be enrolled will be up to 68 participants, depending on the investigated dose of celecoxib during the safety run-in phase.


Eligibility Criteria:
Inclusion Criteria:

* Men and women ≥ 18 years of age.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
* Measurable disease as per RECIST 1.1.
* Adequate renal, hepatic and hematologic functions as defined by laboratory parameters within ≤ 7 days before treatment initiation.
* Metastases biopsiable on two occasions
* Recently acquired (within 90 days prior to treatment) tumor tissue from an unresectable or metastatic site of disease must be provided for biomarker analyses. In order to include only IDO1 positive (≥5% expression of tumor cells) and non T-cell infiltrated tumors (\<1% T cells infiltrating the tumor bed)
* Cancer types with an indication of treatment with anti-PD1 antibodies such as

  * Melanoma non BRAF mutated in first line of treatment
  * Melanoma BRAF mutated in first or second line of treatment
  * Lung cancer (NSCLC) in second line of treatment
  * Renal cell Cancer (RCC) in second line of treatment
  * Head and Neck squamous carcinoma (HNSC) after platinum salt based chemotherapy
  * Bladder cancer after platinum salt based chemotherapy

Exclusion Criteria:

* Active brain metastases or leptomeningeal metastases.
* Ocular melanoma.
* Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement therapy, psoriasis not requiring systemic treatment, or other autoimmune condition not expected to recur in the absence of an external trigger are permitted to enroll.
* Subjects must also meet other study criteria including exclusions for medical history, positive Hep B/C, HIV, and pregnancy tests, and other laboratory criteria.
Intraoperative Hyaluronic Acid Gel Injection for Improvement of Scar Quality Following Reduction Mammaplasty

The purpose of this study is to determine the efficacy of hyaluronic acid gel injections compared to saline injections in improving scar quality in patients undergoing breast reduction surgery. Hyaluronic acid has been implicated in scarless fetal healing, and the investigators therefore hypothesize that injections of hyaluronic acid gel into breast reduction incisions will improve their appearance compared to injections of saline.


Eligibility Criteria:
Inclusion Criteria:

* adequate organ function (BUN \< 4.0 mmol/L; serum creatinine \< 120 micromol/L; Hgb \> 100 g/L; WBC \> 4,000/mm3 and \< 12,000/mm3; platelets \> 100,000/mm3)
* age 18 years or older, with a minimum life expectancy of 2 years
* current non-smoker
* American Society of Anaesthesiology score of 1 or 2
* ability to provide informed consent

Exclusion Criteria:

* previous history of breast surgery; known allergy to polyglactin, poliglecaprone, or injectable hyaluronic acid gel (Restylane or Prevelle)
* history of current or recent (\<2 months) immunosuppression
* documented hypersensitivity to streptococcal products
* acute or chronic skin diseases such as folliculitis or psoriasis
* history of bleeding dyscrasia or active anticoagulation (INR\>2.0)
* pregnancy or active breast-feeding
* any additional surgical procedures performed in the same surgical session in the same anatomical region
* personal or family history of susceptibility to keloid or hypertrophic scar formation
* Fitzpatrick skin type 5 or 6.
Photo-Activated Disinfection Versus Triple-Antibiotic Paste for Management of Necrotic Young Permanent Anterior Teeth

This study aims to compare regenerative endodontics for necrotic young permanent anterior teeth using oral photo-activated disinfection versus triple antibiotic paste in terms of:

1. Clinical success in terms of absence of any complication such as spontaneous pain, sinus or swelling.
2. Radiographic success in terms of healing of periapical radiolucency or increase root thickness, length or apical closure.

Disinfection of the root canal system is thought to be critical to the success of Regenerative Endodontic Procedures (REPs) as infection prevents regeneration, repair and stem cell activity . A suitable material for using as intra-canal medicament seems to be antibiotic. Triple antibiotic paste (TAP) containing metronidazole, ciprofloxacin and minocycline has been reported to be a successful regimen in controlling the root canal pathogen and in managing necrotic young permanent tooth .

Recently, new disinfection methods have been developed to overcome the limitations of conventional disinfecting protocols that they may neither reduce the number of bacteria to a satisfactory level nor minimize the toxicity to periapical stem/progenitors . Other concerns regarding the use of TAP are tooth discoloration after treatment and bacterial resistance. Photo-activated oral disinfection is a novel disinfection method which present a great solution for the problem associated with triple antibiotic paste

Eligibility Criteria:
Inclusion Criteria:

* Healthy children with no physical, mental or systemic conditions.
* Developmental age of the child is the most important factor so periapical x- ray will be taken first to assure apex immaturity.
* No sex predilection.
* Restorable necrotic young permanent anterior teeth

Exclusion Criteria:

* Root fracture.
* Internal or external root resorption.
* Parents or guardians refuse to participate in the study.
Efficacy and Tolerability CVI (A 12-week, Double-blind, Randomised, Placebo-controlled, Multicentre Trial (CVI)

To determine efficacy and tolerability of Antistax 360 mg tablets in chronic venous insufficiency linked to edema (swelling) and subjective symptoms


Eligibility Criteria:
Efficacy, Safety and Tolerability of ATH3G10 in Patients With ST-elevation Myocardial Infarction

Patients with ST-segment elevation myocardial infarction (STEMI) that have suffered a major anterior wall infarction or where coronary blood flow is less than normal in spite of successful percutaneous coronary intervention (PCI) have a poor prognosis. There are today no medical treatments that specifically reduce risk in these patients. The acute inflammatory reaction in conjunction with a STEMI and reperfusion by PCI determines the final size of the infarction and the signals leading to left ventricular remodelling.

This study is designed to assess the efficacy and safety of single intravenous injection with ATH3G10, a fully human IgG1 antibody against phosphorylcholine, in high-risk subjects with STEMI. ATH3G10 aims to reduce inflammation and thereby infarction size and remodeling.


Eligibility Criteria:
Inclusion Criteria:

* Acute myocardial infarction with ST elevation at the J-point in two contiguous leads
* Start of PCI less than 4 hours after symptom onset.

Exclusion Criteria:

* Cardiogenic chock, non-compensated acute heart failure and/or pulmonary edema.
* Previous major vascular intervention within the last 4 weeks.
* History of an infarct in the same artery that is currently affected.
* Conditions contraindicating MRI
A Study to Examine Health Behavior Change Strategies for Primary Care

Prescription for Health is a national program of The Robert Wood Johnson Foundation (RWJF) in collaboration with the Agency for Healthcare Research and Quality (AHRQ). A major goal of Prescription for Health is to measure the extent to which comprehensive strategies are effective in changing patient behavior and quality of life relative to four target health risk behaviors: diet, smoking, alcohol use, and physical activity. The funded projects will use a common set of survey instruments to help measure outcomes and draw overarching conclusions across projects. This study will only be analyzing aggregated data and does not have responsibility for recruitment of patients, randomization (if applicable), or interventions. Individual project designs may differ.

The data will be collected by and submitted from up to 10 practice-based research networks over a two-year period. We will: 1) aggregate de-identified data and 2) analyze the aggregated data. We will not identify or recruit study subjects, administer surveys to patients, or conduct any interventions with patients or practices. The individual research networks will submit only de-identified data to a central data repository for subsequent analysis by us. Individual research networks will submit their own protocols for review by their IRBs in order to collect patient-specific data, conduct interventions, and submit de-identified data to our central repository.

By combining data from funded projects we will be able to answer questions that individual projects would not be able to answer. The analysis will use the combined set of data to gain statistical power sufficient to test hypotheses of interest, determine the distribution of responses to the selected measures in patients in primary care practices, assess the impact of types of interventions, compare the impact of different types of interventions, determine if these measures can be used routinely, and conclude how useful, if at all, the selected measures were in Prescription for Health projects. Statistical analysis will include basic descriptive statistics and distributions of scores at baseline and follow-up and more complex hierarchical linear modeling, which seeks to understand effects in multi-site studies (across sites or groups of sites). We will not directly evaluate specific research network interventions, but will assess them as part of larger groups. This study will report only aggregated results and will not name individual primary care practices or research networks.

Eligibility Criteria:
Inclusion Criteria:

* varies by project

Exclusion Criteria:

* varies by project
Autoimmune Encephalitis With Anti-NMDA Receptor Antibodies Following Herpetic Encephalitis

Herpes Simplex Virus encephalitis is the most common infectious encephalitis, with an estimated annual incidence of 1 / 250,000 to 1 / 500,000 in industrialized countries. Despite a widely used antiviral treatment, the prognosis remains poor with a mortality of 5 to 20% and a considerable morbidity rate.

One of the contributing factors of bad prognosis is the development of encephalitis mediated by autoantibodies, most often directed against NMDA receptors, in the weeks following viral encephalitis.

The description of this pathology is recent, the pathophysiology of this process remains poorly understood, and the management of these patients is not yet codified.


Eligibility Criteria:
Inclusion Criteria:

* Clinical autoimmune encephalitis with anti-NMDA antibodies and documented by CBA in the CSF
* After a herpetic encephalitis documented by a positive viral PCR for HSV in the CSF
* Without age limit

Exclusion Criteria- No respect of inclusion criteria
Effects of Whole Sprouts on Airway Allergic Inflammation

The primary objective of this study is to determine if broccoli sprouts (BS) improves airway inflammatory, oxidative stress (OS), and symptoms among asthmatic adults with aeroallergen sensitization.

The study is a double-blind, placebo-controlled, randomized trial to compare BS to placebo in 40 adults with asthma. 40 adults (age 18-50) who meet these eligibility criteria will be randomized to receive either: (a) BS or (b) placebo (alfalfa sprouts). Subjects will eat a sprouts sandwich daily for three days, and then undergo repeat measurement of outcomes.


Eligibility Criteria:
Inclusion Criteria:

* doctor diagnosis of asthma
* aeroallergen sensitization
* Non-smoker
* Negative pregnancy test
* Not breastfeeding
* Normal TSH
* For women, abstinent or using reliable birth control
* Age 18-50 years
* No other major pulmonary disease such as cystic fibrosis or COPD
* Willingness to participate in study and sign consent form

Exclusion Criteria:

* Severe or unstable asthma defined as requiring hospitalization in the previous 6 months or intubation in the previous 2 years, or on high-dose inhaled corticosteroids or chronic oral corticosteroids
* Uncontrolled asthma defined as short-acting beta agonist use 3 or more days a week in the previous 4 weeks
* Other significant medical issues such as heart disease or poorly controlled hypertension, type 1 diabetes, poorly controlled type 2 diabetes, or hypothyroidism
* Pregnancy or nursing/breastfeeding mothers
* On beta-blocker therapy
* On reserpine, clonidine, imipramine, or related tricyclic drugs
* Taking anti-oxidant supplements
* Planned dietary changes during the study period
* Unable to stop antihistamines prior to skin testing
* Food allergy to Broccoli Sprouts or Alfalfa Sprouts
* Omalizumab use within the last 12 months
* Nasal polyps
Transpulmonary Gradient After Cardiac Surgery Under Cardiopulmonary Bypass

Get a better understanding of the pathophysiological processes of acute respiratory failure following cardiopulmonary bypass to initiate timely therapies targeted on a cell line.

Demonstrate that there is a relationship between increased transpulmonary gradients of inflammation biomarkers (sRAGE, sICAM-1, SPB, PAI-1, ROS) and pulmonary vascular resistance on the one hand and alveolo-capillary gas exchange on the other hand after cardiac surgery under cardiopulmonary bypass.


Eligibility Criteria:
Inclusion Criteria:

* Patient man or woman \> 18 y.o.
* Patient has signed informed consent prior to the study
* Patient affiliated to a social security administration
* Patient operated on for cardiac surgery at the University Hospital of Strasbourg.
* Patient at high risk for postoperative respiratory failure defined by a SLIP score (Kor et al.) ≥ 22 Kor:

  * High-risk cardiac intervention under cardiopulmonary bypass (19 pts)
  * COPD (10 pts)
  * Diabetes (6 pts)
  * gastroesophageal reflux (7 pts)
  * Alcohol abuse (11 pts)
* Scheduled use of a pulmonary artery catheter and a left atrial catheter

Exclusion Criteria:

* Inability to obtain informed consent from the patient and / or unable to give informed patient information (difficulty understanding ...)
* Urgent surgery (\<24h)
* Acute heart failure
* Patient ventilated preoperatively
* Allergy to Latex
* Persons deprived of liberty or under judicial protection
* Patient placed under guardianship
* Pregnancy
* Breastfeeding