cyrilzakka/clinical-trials huggingface dataset:
Effect of Sub-mental Sensitive Transcutaneous Electrical Stimulation on Pharyngeal Muscles Control : TENSVIRT Study

Swallowing is a complex phenomenon that allows oral feeding while protecting the airway. It involves many brain areas, including primary motor and sensory areas. Its dysfunction, called oropharyngeal dysphagia is present in approximately 60% of patients with a stroke. In this case, it is conventionally translated by a swallow response time delay of the swallowing reflex.

Pathophysiology of dysphagia is explained by impairment of the dominant swallowing, function that representation center is bi-hemispheric but asymmetric (Hamdy, 1997). Half of patients with a stroke supra-tentoriel with oropharyngeal dysphagia (about 55 % of strokes) regain normal swallowing in a few weeks ( Barer, 1989). Mechanisms that determine the recovery appear to be related to a reorganization of the motor cortex intact. Patients who retain disorders are those who have not cortical reorganization.

With this in mind a team used different methods known to modulate brain plasticity, which electrotherapy with an application endo- pharyngeal sensory threshold. This stimulation increases the excitability of the cortico- bulbar reflex, which improves swallowing function in the clinical application.

The hypothesis of this work is that the transcutaneous electrical stimulation applied submental, noninvasive technique, would also have an impact on cortical plasticity may explain the improved coordination of swallowing observed in earlier studies (Verin , 2011) ( Gallas , 2010).


Eligibility Criteria:
Inclusion Criteria:

1. Subjects aged over 18 years
2. Affilitation to social security scheme
3. Registration in National register of people who participate in biomedical research
4. Healthy volunteers who provided written informed consent

Exclusion Criteria:

1. Subjects with swallowing disorders
2. Presence of psychiatric disorders
3. Skin disorders
4. Cardiac disorders (non controlled arrythmia, severe heart failure, presence of heart valve)
5. Submental tumor
6. Epilepsia, treated or untreated
7. Presence of neurosurgical clip
8. Suspicion of digestive fistula
9. Presence of metal, pacemaker, defibrillator, pump treatment or neurostimulation
10. Cannabis user, regular use of benzodiazepines
11. Presence of chronic respiratory, neurological disease, ENT or gastroesophageal disease (cause potentially change swallowing)
12. Contra-indication to MRI (claustrophobia, metal fragment, cardiac/ENT/neurological implantable device not MRI compatible, osteosynthesis prior to 1980)
13. Subject reported against the use of Micropaque®
14. Pregnant or nursing woman, or absence of contraception
15. Poor understanding of French langage
16. Person under judicial protection
17. Person deprive of their liberty by judicial or administrative decision
18. Participating in a clinical trial within 4 weeks before the pre-inclusion visit
PARK-FIT. Treadmill vs Cycling in Parkinson´s Disease. Definition of the Most Effective Model in Gait Reeducation

PARK-FIT Treadmill vs Cycling in Parkinson´s Disease Rehabilitation. Non-pharmacological Clinical Trial for the Definition of the Most Effective Model in Gait Reeducation.

Treadmill vs Cycling in Parkinson´s Disease Rehabilitation. Non-pharmacological Clinical Trial for the Definition of the Most Effective Model in Gait Reeducation.

Eligibility Criteria:
Inclusion Criteria:

* Patient is diagnosed with idiopathic Parkinson's disease according to criteria from the United Kingdom Parkinson's Disease Society Brain Bank (UK-PDSBB)
* H\&Y less than or equal to 2
* Stable drug treatment in the six weeks prior to the start of training and during the study.
* Signature of informed consent.

Exclusion Criteria:

* Diagnosis of other neuro-degenerative disease
* Cardiovascular disease or other systemic condition that contraindicates the moderate physical exercise
* Need for ambulation support
* Frequent freezing of gait events.
* Mni- Mental State Examination (MMSE) \<26
Helicobacter Pylori Sample Collection Protocol Post Therapy Subjects

The primary objective is to obtain stool samples from post-therapy subjects already undergoing evaluation for an H. pylori infection by upper esophagogastroduodenoscopy (EGD) and gastric biopsy.

Stools will be collected and tested, at a later date, in a clinical performance study with an investigational H. pylori antigen assay. This study will be coordinated by the Sponsor.

Eligibility Criteria:
Inclusion Criteria:

* Adult ≥ 22 years, either gender
* Subject previously diagnosed with H. pylori infection
* Subject received and completed FDA approved treatment option
* Minimum of 4 weeks to one year has lapsed after completion of FDA approved treatment option
* Subject with a post therapy positive result from a FDA cleared UBT or FDA cleared Fecal Antigen Test
* Subject will undergo EGD and gastric biopsy as part of routine care to measure H. pylori post-therapy response
* Biopsy is obtained from antrum and/or corpus and is tested by CRM
* At least two of the three CRM tests are performed
* Subject whose EGD with biopsy occurred ≤ 7 days prior to stool collection
* Willing and able to sign the IRB approved Informed Consent form for this study project

Exclusion Criteria:

* Subject with current severe H. pylori infection
* Subject ingested compounds that may interfere with detecting of H. pylori, e.g. 4 weeks for antibiotics and 2 weeks for Bismuth preparations or proton pump inhibitors prior to collection
* Pregnant or lactating
* Inability or unwilling to perform required study procedures
* Subject is unable or unwilling to provide informed consent
Immune Responses to COVID-19 Vaccination in Lymphoma Patients

This prospective observational study aims to evaluate the robustness and persistence of immune responses to vaccination, define factors associated with impaired immune responses and assess the incidence of COVID-19 infections in vaccinated individuals. To do this, we will collect peripheral blood from patients with lymphoid cancers before and after their COVID-19 vaccination. The blood will be explored in the laboratory for antibodies to SARS-CoV-2 and T-cell responses to the spike protein. Detailed clinical information will also be collated on about their cancer and treatment.


Eligibility Criteria:
INCLUSION CRITERIA

1. Patients having a confirmed diagnosis of either:

   A) Hodgkin lymphoma B) Aggressive B-cell lymphoma (e.g. Burkitt's lymphoma, diffuse large B-cell lymphoma, grade 3b follicular lymphoma, de novo transformed follicular lymphoma) C) Indolent B-cell lymphoma (e.g. all grades of follicular lymphoma except grade 3b, marginal zone lymphoma, lymphoplasmacytic lymphoma, chronic or small lymphocytic lymphoma, mantle cell lymphoma) D) Mature T/NK-cell malignancy (any subtype)
2. Patient must be ≥ 18 years.
3. Patients will have provided written Informed Consent.

EXCLUSION CRITERIA

1) Serious medical or psychiatric illness likely to affect participation or that may compromise the ability to give informed consent.
GLS-1027 for the Prevention of Severe Pneumonitis Caused by SARS-CoV-2 Infection (COVID-19)

This clinical trial will evaluate the safety, tolerability and efficacy of GLS-1027 in the prevention of severe pneumonitis caused by SARS-CoV-2 infection

This Phase II randomized, double-blind, placebo-controlled, study will assess 2 different doses of GLS-1027 in the prevention of severe pneumonitis among those hospitalized with PCR confirmed SARS-CoV-2 infection. Subjects will be randomized at a 1:1:1 ratio to either Standard of Care (SOC) plus placebo, or SOC plus GLS-1027 at either 120 mg or 360 mg daily. Clinical status will be monitored through 56 days from the initiation of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Able to provide consent
* Able and willing to comply with study procedures
* Diagnosis of PCR confirmed SARS-CoV-2
* Enrollment within 72 of hospitalization
* WHO COVID-19 classification level 3 or 4

Exclusion Criteria:

* Pregnant or lactating
* Need for mechanical ventilation, non-invasive ventilation (NIV), or high-flow O2 (≥60%) via face mask
* Calculated GFR \< 60 (Cockcroft-Gault)
* Meets treatment algorithm criteria for treatment with a non-study immune modulator
* Pre-study or planned treatment with a non-study immune modulator
* Participation in a COVID-19 clinical trial that includes prescription of a drug with anti-cytokine activity
* Status post transplantation of an organ, bone marrow, or body part
* Treatment within the past 60 days with a chemotherapeutic agent
* Diagnosis of leukemia or lymphoma
* WHO COVID-19 classification level of 5 or greater
* Unable to take oral medication
* Grade 3 or greater laboratory abnormalities as characterized by CTCAE v5
Inspiratory Muscle Training in Patients Receiving Allogenic Stem Cell Transplantation

The study is a monocentric, controlled randomized trial. Its an interventional method study. There is a control and an interventional group. The interventional group is receiving a specific inspiratory muscle training with "Respifit" (special device for inspiratory muscle training) during the first 30 days after allogenic stem cell transplantation.

The investigators want to show that the training group gets stronger inspiratory muscles. The investigators measure the change of PIMAX values and MVV values.


Eligibility Criteria:
Inclusion Criteria:

* Patients receiving allogenic stem cell transplantation
* Age 17 - 80 years old
* Informed consent

Exclusion Criteria:

* Actual pneumonia at the beginning of the trial
* Impaired vision
* Patient is not able to handle "Respifit"
UNN-RADS Scale for Diagnosing Lymph Node Metastasis in Patients With History of Thyroid Cancer

In 2020, Sarda-Inman et al., developed the Ultrasound Neck Node Reporting and Data System (UNN-RADS) scale that allows decision-making about when it is appropriate to perform FNA of a cervical lymph node, evaluating seven ultrasonographic descriptors (shape, margins, echogenicity, echogenicity of the hilum, vascularity and the presence/absence of calcifications, and cystic degeneration), features that have been associated with metastatic lymph nodes, with scores ranging from 0 to 3 points, which allows categorize into 5 different risk groups. Thus, the objective of this study is to evaluate the ultrasound characteristics of metastatic LN in patients undergoing TC follow-up and to validate the UNN-RADS scale for the diagnosis of LN Metastasis in Patients with a history of TC.

This study enrolled consecutive patients in follow-up for differentiated thyroid cancer (DTC) history who underwent US-guided fine needle aspiration (FNA) of the LNs for suspicious metastatic cervical lymph nodes. Patients were included if they 1) had previous history of DTC, 2) both sexes with age over 18 years old, and 3) underwent FNA of the LNs for any suspected features corresponding with at least UNN-RADS 1. Patients were excluded if they underwent FNA of the LNs for persistent or recurrent disease after surgery for thyroid cancer, had previous bilateral cervical lymph node dissection as initial treatment, or the FNA results were not concluded.

UNN-RADS 1 y 2 and UNN-RADS 3, 4 and 5 were grouped for analysis purpose. Diagnostic performance of UNN-RADS scale were assessed in terms of sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV), positive likelihood ratios (+LR), negative likelihood ratios (-LR) and accuracy, as well as with a receiver operating characteristic (ROC) curve.

Eligibility Criteria:
Inclusion Criteria:

* 1) had previous history of DTC 2) both sexes with age over 18 years old 3) underwent FNA of the LNs for any suspected features corresponding with at least UNN-RADS 1

Exclusion Criteria:

* 1) underwent FNA of the LNs for persistent or recurrent disease after surgery for thyroid cancer 2) had previous bilateral cervical lymph node dissection as initial treatment 3) FNA results were not concluded
Renin Angiotensin System Blockade in Renal Transplant Patients With Presence of PECs in Urine

By means of a personalized medicine strategy, investigators are going to evaluate if the treatment with an angiotensin II receptor antagonist (ARAII) in renal transplant patients with the presence of renal progenitor cells (PECs) in the urine is able to prevent the expected loss of glomerular filtration (GFR) observed in this subgroup of patients. In addition, investigators intend to deepen the mechanisms of glomerular damage and glomerular repair involved in the process of chronic allograft damage.

A randomized, double-blind clinical trial will be performed in renal transplant patients in month 6 post-transplant, at the time of protocol renal biopsy. After verifying the inclusion and exclusion criteria, informed consent will be obtained. Patients with urinary PECs will be randomized to 80 mg of valsartan vs. placebo (sample size calculated for a superiority study, 45 patients per group). Patients without PECs in urine will be followed according to usual clinical practice. The follow-up will be up to 2 years post-transplant. At baseline (6 m post-transplant) and at 2 years the GFR will be measured by means of iohexol clearance (main variable) and, in addition, we will analyze safety variables such as patient and graft survival and RAGIs. By means of morphometry techniques on renal biopsy and by measuring the renal cortical volume by high resolution CT, the number of glomeruli will be determined, which in turn, will allow to calculate the SN-GFR. Finally, in 5 patients per study group and in 5 controls, PECs of renal tissue will be isolated by means of laser microdissection techniques to perform single-cell RNA sequencing techniques to assess the molecular pathways involved in the glomerular damage and repair process and how the RAAS blockade modifies such molecular pathways.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Stable renal function understood as a variation of eGFR of less than 15% in the last 3 months
* Immunosuppression maintenance based on tacrolimus and MMF / MPA

Exclusion Criteria:

* Chronic active infection by HCV, HBV, HIV.
* Treatment with inhibitors of the renin angiotensin system.
* Double kidney transplant or combined with another organ.
* Immunosuppression of maintenance other than tacrolimus and MMF / MPA.
* eGFR \<20 ml / min / 1.73m2.
* History of allergy or intolerance to inhibitors of the renin angiotensin system.
* Physically fertile women who plan to become pregnant, are pregnant and

  / or breast-feeding, or who do not want to use effective contraception during their participation in the study.
* Any other medical condition that, in the opinion of the investigator, based on the counting or review of clinical records, could affect the completion of the study, including, but not limited to, visual problems or cognitive impairment.
Specimen Stability Study

To collect and process urine samples from critically ill subjects for use in assessing the effects of various urine sample freezing and storage conditions on biomarker test results.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females 21 years of age or older
2. Subjects must be enrolled (first study-specific sample collection) within 24 hours of ICU admission

   * Subjects enrolled from ED or Floor must be admitted to the ICU within 24 hours of enrollment
   * Subjects enrolled in the ICU must have been admitted to the ICU or transferred into the study ICU from another ICU no more than 24 hours prior to enrollment
3. Expected to remain in the ICU for at least 48 hours after enrollment
4. Use of indwelling urinary catheter as standard care expected for at least 48 hours after enrollment
5. Subject (or authorized representative)able and willing to provide written informed consent for study participation

Exclusion Criteria:

1. Special populations including children, pregnant women, and prisoners
2. Previous renal transplantation
3. Already receiving dialysis (either acute or chronic) or in imminent need of dialysis at the time of enrollment
4. Known infection with human immunodeficiency virus (HIV) or active hepatitis (acute or chronic)
5. Subjects with a history of chronic kidney disease (CKD) without a baseline serum creatinine value (baseline within 6 months of enrollment)
6. Previously provided a urine sample and enrolled in this study
Neoadjuvant Treatment of Upper Urinary and Muscular Invasive Bladder Urothelial Carcinoma

Few previous studies focused on the neoadjuvant treatments of upper urinary or bladder cancer, especially chemotherapy combined with immunotherapy, however, available data of retrospective studies showed this neoadjuvant treatment model might benefit patients. So This prospective Phase II clinical trial was designed to explore the efficacy of chemotherapy combined with PD-1 inhibitor as neoadjuvant therapy in upper urinary and muscle-invasive bladder urothelial carcinoma, then to improve the rate of complete pathological remission, survival and provide medical evidence.


Eligibility Criteria:
Inclusion Criteria:

1. bladder cancer of T2-4aN0M0
2. upper tract urinary carcinoma of T1-3N0M0 and high grade
3. ECOG 0-1
4. good organ function
5. no previous chemotherapy or immunotherapy
6. Informed consent form signed

Exclusion Criteria:

1. unable to receive chemotherapy or surgery due to physical abnormalities
2. previous cancer history
3. active tuberculosis
4. HIV
5. autoimmune disease
6. anticipating other clinical studies
The HeartSpare Plus 1B Trial

This study aims to compare the resource impact, acute toxicity and feasibility of different pan-lymph node radiotherapy techniques. Radiotherapy using wide tangents with the patient in breath hold will be compared against volumetric modulated arc therapy (VMAT) in free breathing in the main trial. A parallel study will asses the accuracy of VMAT treatments using voluntary deep inspiratory breath hold compared to an active breathing controlled breath hold device.

Following publication of results of two large randomised clinical trials, pan-lymph node radiotherapy (pan-LN RT) (including treatment of the internal mammary chain) is set to become standard treatment in patients with lymph-node positive breast cancer. Traditional pan-LN RT techniques deliver high radiation doses to the heart and lungs which can cause long-term side-effects in women many years after their treatment. Modern techniques including breath-holding and volumetric-modulated arc therapy (VMAT) can reduce doses to heart and lungs but the investigators do not yet know which technique(s) are best in terms of resource costs, short to medium-term side-effects, and day to day accuracy. This study will compare the time taken to deliver pan-LN RT using breath-holding versus VMAT and will collect side-effect data up to one year following treatment as well as modelling long-term cardiac risks based on heart doses delivered. The results of the main study will help guide clinicians and departments in selecting the best pan-LN RT techniques for their patients. A parallel study will evaluate the combination of breath-hold and VMAT using a machine-based technique called the active-breathing controlled (ABC) device against a more simple voluntary breath-hold technique were patients simply take a breath in and hold it for up to 20 seconds at a time. These techniques will be compared in terms of their day-to-day accuracy. If the simpler technique proves as accurate as the ABC-technique, this will establish the simpler technique as a less resource-intensive standard of care adoptable by other radiotherapy departments.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Female or male
* Invasive carcinoma of the breast (left or right-sided)
* Breast conservation surgery or mastectomy
* Axillary staging and/or dissection
* pT1-T4,N1-2,M0 disease
* Histological involvement of axillary lymph nodes
* Indication for radiotherapy to the IMC, axillary levels I-III and/or level IV
* Patient able to tolerate breath hold
* Performance status 0-1

Exclusion Criteria:

* Contralateral and/or previous ipsilateral breast cancer, irrespective of date of diagnosis
* Past medical history of malignancy except (i) basal cell skin carcinoma, (ii) CIN cervix uteri, (iii) non-breast malignancy allowed if treated with curative intent and at least 5 years disease free
* Previous radiotherapy to any region above the diaphragm
Morphological Pancreatic Features in Diabetes Mellitus Type 2

Hypothesis: Type 2 diabetes mellitus is associated with pancreatic fibrosis that can be evaluated by minimally invasive imaging techniques. That fibrosis is associated with alteration of exocrine pancreatic function, defined as a reduced secretion of pancreatic enzymes and the development of nutritional deficiencies.

To test that hypothesis, a prospective, observational, cross-sectional, comparative, case-control study has been designed.

Pancreatic fibrosis will be evaluated by endoscopic ultrasound and quantitative elastography in cases (type-2 diabetes) and age-gender-matched controls without diabetes.

Pancreatic function will be explored by fecal elastase test and nutritional evaluation.

Calculated sample size is 94 patients (47 cases and 47 controls). Study period is 2 years.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years.
* Undergoing an upper endoscopic ultrasound for any indication other than pancreatic disease.
* Signed informed consent-
* Patients: Previous diagnosis of type-2 diabetes mellitus.
* Controls: Nondiabetic subjects, matched by age, gender, alcohol consumption, and smoking with patients.

Exclusion Criteria:

* History of pancreatic disease or surgery.
* History of upper gastrointestinal surgery.
* Diabetes type other than type-2.
* Severe cardiovascular or respiratory disease.
* Lack of informed consent.