cyrilzakka/clinical-trials huggingface dataset:
Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis

The purpose of this research is to support the clinical value of the Cionic Neural Sleeve for individuals diagnosed with multiple sclerosis (MS).

The randomized within-participants crossover study aims to demonstrate the clinical impact of the Cionic Neural Sleeve for individuals diagnosed with MS.

Physical measurements, performance-based tests, and questionnaire responses will be recorded. These include physical activity recorded by an Actigraph; in-person tests measuring disability, spasticity and balance; and questionnaires gauging perceived walking ability, quality of life, and physical and psychological impact of MS.

All participants will be assigned a hip-worn Actigraph activity monitor, a Cionic Neural Sleeve on the most impacted leg, and prescribed a home-based intervention of 15 minutes of walking for 5 days a week for 12 weeks. The Actigraph will be worn for the duration of the 12-week walking intervention, while the Cionic Neural Sleeve will be worn for 6 weeks of the study.

Participants will be randomized to one of two groups: A or B. Group A will wear the Actigraph and receive stimulation assisted walking from the Neural Sleeve (intervention), while group B will only wear the Actigraph while walking. After 6 weeks, participants in each group will cross over to the other group.

Eligibility Criteria:
Inclusion Criteria:

* Persons with relapsing-remitting or progressive forms of MS between the ages of 22 and 75
* Ability to ambulate at least 15 minutes throughout the day for five days per week, with or without assistive device
* Adequate cognitive and communicative function as assessed via Telephone Interview for Cognitive Status (TICS) to identify persons with dementia
* Able to tolerate the Neural Sleeve device for up to 8 hours per day
* T25FWT time between 8 and 45 seconds
* No recent change in medication or recent exacerbation of symptoms over the last 60 days
* Patient-determined Disease Steps score between 3 and 5 or EDSS score between 4 and 6.5

Exclusion Criteria:

* Lower motor neuron disease or injury (e.g. peripheral neuropathy) that may impair response to stimulation
* Absent sensation in the impacted or more impacted leg
* Inadequate response to stimulation, defined by inability to achieve muscle contraction or unable to tolerate stimulation
* Inability to ambulate with the sleeve in place of an ankle foot orthosis (AFO)/knee ankle foot orthosis (KAFO) if utilized
* History of falls greater than once a week
* No use of FES devices in the past year
* Demand-type cardiac pacemaker or defibrillator
* Malignant tumor in the impacted or more impacted leg
* Existing thrombosis in the impacted or more impacted leg
* Fracture or dislocation in the impacted or more impacted leg that could be adversely affected by motion from stimulation
Longitudinal Analysis of Spirometry in Black Children

To conduct a longitudinal investigation of early childhood lower respiratory illness (LRI) and patterns of lung growth using an existing electronic dataset generated by an 18-year study (1972-1990) of a population of 102 Black children followed from birth at the Frank Porter Graham Child Development Center.

BACKGROUND:

The study should improve knowledge of the patterns of functional lung development during childhood and factors that influence both relative level and growth rate of lung function in Black children and should offer new understanding of the predictive value of spirometric tests of lung function performed at an early age.

DESIGN NARRATIVE:

The study used a previously existing database which was of unique value because it included comprehensive respiratory illness data collected on-site during the children's tenure in the Frank Porter Graham Child Development Center's daycare facility and spirometric data collected longitudinally from three to 13 years of age. Furthermore, the measurements were for children in a racial group for whom limited cross-sectional or longitudinal spirometric data were available.

The longitudinal analyses had two primary objectives. The first was to characterize patterns of functional lung development in Black children from three to 13 years of age and relate these patterns to potentially influential factors such as (a) wheezing and non-wheezing associated LRI experience during the infant (ages 0 to two) and preschool (ages two to five) years, (b) ages of occurrence of first and subsequent LRI episodes, and (c) respiratory syncytial virus etiology of LRI. Potentially confounding factors included prenatal and childhood exposure to environmental tobacco smoke and allergies. The second objective was to determine the degree to which spirometric parameters 'track' for individual children and for populations of children over the interval from three to 13 years of age. This objective required assessment of the degree to which spirometric evaluations during the preschool years were predictive of later lung function.

The statistical analyses for achieving these objectives used recently developed statistical methods based on the general linear mixed model. By design, these methods for longitudinal data handled unbalanced data with missing values, incorporated time-varying covariates, and provided more exactly the extent to which the level of lung function of individual children was maintained relative to that of other study children and determined the value of preschool spirometric measurements as predictors of levels of spirometric performance during later childhood and adolescence. These analyses utilized methods developed by Stewart, Pekow, Burchinal, and Helms in 1991 that were unique in that they were designed to handle incomplete, inconsistently-timed data as well as complete, balanced data.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Effects of Acute Dietary Sodium on Cerebrovascular Reactivity and Blood Pressure Reactivity

Americans eat more salt than is recommended by the American Heart Association. This is important because consuming a high-salt diet is associated with an increased risk of cardiovascular events, like strokes and heart attacks. In fact, consuming one high-salt meal temporarily reduces blood vessel function and it is not uncommon for Americans to consume high-salt meals. Therefore, our laboratory is interested in determining if a single high-salt meal affects 1) brain blood vessel function at rest and 2) blood pressure responses during exercise.

Excess dietary salt increases the risk of cardiovascular events like strokes and heart attacks, independent of resting blood pressure. Recent data found that consuming one high-salt meal temporarily reduces endothelial function in the periphery. This decrease in endothelial function can lead to an exaggerated blood pressure response during exercise and may also attenuate cerebrovascular reactivity at rest. This is essential, because an exaggerated cardiovascular response to exercise and a decrease in brain blood vessel function at rest are risk factors for future cardiovascular events. The long-term goal is to determine how dietary salt adversely affects BP and cerebrovascular regulation. The objective of this proposal is to evaluate the impact of an acute dietary salt meal on BP response during exercise and cerebrovascular reactivity at rest. The investigators have 2 specific aims: 1) Aim 1 will test the hypothesis that high dietary salt will reduce cerebrovascular reactivity, 2) Aim 2 will test the hypothesis that high dietary salt will augment blood pressure reactivity during exercise. The findings of this project will shed light on how acute dietary salt affects the risk of cardiovascular events during a bout of exercise and long-term risk for cardiovascular disease and stroke.

Eligibility Criteria:
Inclusion Criteria:

* normal blood pressure
* males, females, minorities

Exclusion Criteria:

* high blood pressure
* body mass index (BMI \> 30 kg/m2)
* smokers or nicotine users
* those who are pregnant or planning to become pregnant
* allergy to the tomato soup
Interest of Bilateral Basic Tongue Mucosectomy Assisted by Robot or Laser in Combination with Tonsillectomy in the Assessment of Prevalent Cervical Lymphadenopathy

We are proposing a randomized phase II study to assess the benefit of bilateral robot-assisted or laser basal tongue mucosectomy in combination with tonsillectomy in the assessment of prevalent cervical lymphadenopathy


Eligibility Criteria:
Inclusion Criteria:

* Patient with a prevalent head and neck lymphadenopathy with positive or non-contributory fine needle aspiration, or having had an adenectomy revealing a metastasis of squamous cell carcinoma, a PET examination, an injected cervico-thoracic CT and an ENT work-up (nasofibroscopy) not finding a primary tumor
* Performance Status \< 2
* Patient aged 18 or over
* Patient affiliated with social security system
* Informed consent signed

Exclusion Criteria:

* History of squamous cell carcinoma of the VADS or skin of the face.
* History of cervico-facial radiotherapy
* Primary tumor discovering during pan-endoscopy
* Inexposable patient lead not to possible mucosectomy
* Uncontrollable hemostasis disorders (contraindication to tonsillectomy and basic bilateral mucosectomy of language)
* Distant metastases
* Lymphadenopathy inoperable
* Patient with a contraindication to radiotherapy
* Pregnant or breastfeeding woman
* Women of childbearing potential without effective contraception
* Patient under guardianship or unable to give informed consent
* Patient unable to undergo the trial follow-up for geographic, social or psychopathological reasons
A Study of Onartuzumab (MetMAb) in Combination With Tarceva (Erlotinib) in Participants With Met Diagnostic-Positive Non-Small Cell Lung Cancer Who Have Received Chemotherapy For Advanced or Metastatic Disease (MetLung)

This randomized, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of onartuzumab (MetMAb) in combination with Tarceva (erlotinib) in participants with incurable non-small cell lung cancer identified to be Met diagnostic-positive. Participants will be randomized to receive either onartuzumab (MetMAb) or placebo in combination with erlotinib. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.


Eligibility Criteria:
Inclusion Criteria:

* Adult participants, greater than or equal to (\>/=) 18 years of age
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Histologically or cytologically confirmed incurable Stage IIIb/IV NSCLC tumor
* Met diagnostic-positive status tested by immunohistochemistry (IHC)
* Results of endothelial growth factor receptor (EGFR)-activating mutation testing
* Radiographic evidence of disease
* Prior treatment with at least one platinum-based line of treatment (for stage IIIb/IV) and no more than one additional line of chemotherapy treatment; the last dose of chemotherapy must have been administered \>/= 21 days prior to Day 1
* availability of tissue sample for diagnostic testing is required

Exclusion Criteria:

* More than 30 days of exposure to an investigational or marketed agent that can act by EGFR inhibition, or a known EGFR-related toxicity resulting in dose modifications (EGFR inhibitors including but not limited to gefitinib, erlotinib and cetuximab)
* Brain metastases or spinal cord compression not definitively treated with surgery and/or radiation, or previously treated central nervous system (CNS) metastases or spinal cord compression without evidence of stable disease for \>/= 14 days
* History of another malignancy in the previous 3 years, unless cured by surgery alone and continuously disease free for at least 3 years; participants with prior history of non-invasive cancers are eligible
* Inadequate hematological, biochemical or organ function
* Significant history of cardiac disease
* Serious active infection at time of randomization or other serious underlying medical conditions that would impair the ability of the participant to receive protocol treatment
* Any inflammatory changes of the surface of the eye
* Clinically significant gastro-intestinal disease, including uncontrolled inflammatory gastro-intestinal diseases
* Pregnant or lactating women
* Positive for human immunodefinciency (HIV) infection
Post-Trial Tuberculosis Case Finding: A Substudy of CoVPN 3008

This substudy aims to identify cases of tuberculosis after the CoVPN 3008 clinical trial is completed.

This observational substudy will involve participants from the CoVPN 3008 trial, regardless of their HIV status, to study tuberculosis (TB). At the start, all participants will be screened for TB, even if they have no symptoms. They will receive chest x-rays and provide sputum samples for TB testing using Xpert Ultra, smear microscopy, and culture.

The study has two main groups. Group 1 includes participants with confirmed TB, and Group 2 includes participants without TB who will act as controls.

Participants with confirmed TB will start treatment and have a first follow-up visit on Day 4 to reassess TB symptoms and collect blood samples. A second follow-up visit will take place at week 26 to evaluate their treatment progress, clinical outcomes, and TB status, ensuring they receive the necessary care.

Participants without TB will have a single follow-up visit on Day 4 to reassess TB symptoms and collect blood samples. The study aims to identify potential biomarkers of TB by analyzing blood samples from both cases and controls, focusing on gene expression linked to TB, including hidden (subclinical) TB.

Eligibility Criteria:
Inclusion Criteria:

* Enrollment into the CoVPN 3008 clinical trial.
* Able and willing to complete the informed consent process: Volunteer demonstrates an understanding of this substudy.
* Willingness to discuss TB status, undergo related testing/monitoring labs, and receive referrals for TB care.

Exclusion Criteria:

* Investigator's concern for difficulty with venous access based on clinical history and physical examination.
3D Instrumentation Versus Rotary Instrumentation

enrollment of the patient after diagnosis, radiographic evaluation, and signing the informed consent.

allocation of the patient to either intervention or control group. After anaesthesia and access cavity, the first root canal sample will be taken. Endodontic treatment will be completed in one visit. The second root canal sample will be taken. Patients will be asked to evaluate their postoperative pain level using VAS scale at 6, 12, 24 hours, and daily up to 5 days. Patients will record the number of analgesics if any taken.

After diagnosing the case as asymptomatic pulp necrosis and confirming that the patient conforms to all eligibility criteria, (R.S) will enroll the patient in the study.

the operator will complete treatment of all cases in single visit as following:

1. Anesthetizing the tooth using inferior alveolar nerve block technique
2. Removal of Caries and/or coronal restorations completely with sterile bur and rubber dam will be applied.
3. Preparation of access cavity using another sterile round carbide bur size 3 and Endo-z bur .
4. (R.S) will take the preinstrumentation root canal sample (S1)
5. Confirming the patency of the root canals using stainless steel hand K-files size #10 and #15 . Working length will be determined .
6. In the intervention group, (R.S) will perform mechanical preparation in a 3D manner using Xp-endo Shaper single file in an endodontic motor at a speed of 800 rpm and a torque of 1 Ncm.
7. In the control group, mechanical preparation will be done using rotary iRace files (#25/0.04, #30/0.04, and #40/0.04) at a speed of 600 rpm and a torque of 1.5 Ncm. The canal will be irrigated and recapitulated after the use of each instrument.
8. EDTA gel will be used as a lubricant. The canals will be thoroughly irrigated using 3ml of 2.5% sodium hypochlorite.
9. The canal will then be dried by using sterile paper points and then flushed with 5 ml of 5% sodium thiosulfate to inactivate the NaOCl. The postinstrumentation sample (S2) will be taken from the canals.
10. Master cones will be fitted to the working length and a radiograph will be taken to ensure proper length.
11. (R.S) will complete obturation using AdSeal resin-based root canal sealer .

Eligibility Criteria:
Inclusion Criteria:

1. Healthy Adult patients.
2. Age between 20-40 years old.
3. Males \& Females.
4. Asymptomatic necrotic mandibular premolars with or without periapical radiolucency.
5. Normal occlusal contact with the opposing teeth.
6. Patients accepting to participate in the study.

Exclusion criteria:

1. Medically compromised patients
2. Pregnant women
3. If analgesics or antibiotics have been administrated by the patient during the past 12 hours preoperatively
4. Patients reporting bruxism or clenching
5. Teeth that shows:

   * Association with acute periapical abscess and swelling
   * Greater than grade I mobility or pocket depth greater than 5mm
   * No restorability
Safety Study of Tenapanor for the Treatment of Pediatric Patients (6 to Less Than 18 Years Old) With IBS-C

Open-label long-term safety study of tenapanor in pediatric patients with IBS-C.

Open-label long-term safety study of tenapanor in pediatric patients with IBS-C. Eligible patients who complete the parent study will have an option to enroll in this study.

Patients from the parent study will continue tenapanor at the same dose assigned in the parent study which can be titrated to either 50 mg BID or 25 mg BID per guidance in protocol after a patient's first week on the assigned dose. Patients will also return for study visits approximately every 6 weeks for safety assessments.

Eligibility Criteria:
Inclusion Criteria:

1. ≥6 and \<18 years old at enrollment of either parent study
2. Patient completed the parent study immediately with adequate compliance with study procedures in the opinion of the Investigator
3. Females of child-bearing potential must have negative pregnancy test at the last visit of the parent study and confirm the use of appropriate contraception (including abstinence).
4. Subject is ambulatory
5. Written informed consent by parent/guardian/ Legally Authorized Representative (LAR) and a willingness of both subject and parent/guardian/LAR to participate in the study as it is described

Exclusion Criteria:

1. Patient discontinued prematurely from the parent study.
2. Any surgery on the stomach, small intestine or colon, excluding appendectomy or cholecystectomy
3. Pregnant or lactating women
4. If, in the opinion of the Investigator, patient is unable or unwilling to fulfill the requirements of the protocol
RAS Peptide Profiles in Patients With Treatment-resistant Arterial Hypertension

This study evaluates RAS peptides profiles in patients with treatment resistant arterial hypertension.

Selective quantification of RAS peptides in human plasma triggered investigations evaluating whether RAS peptides could be used as clinical biomarkers in patients receiving antihypertensive treatment.

Drug-specific RAS profiles first characterized in healthy normotensive subjects (EKBB 255/12; ClinicalTrials.gov ID NCT01771783) are presently investigated in patients with newly diagnosed arterial hypertension (EKNZ 2015-081; clinicaltrials.gov identifier (ID) NCT02449811). With this observational study RAS peptide profiles will be characterized in patients with treatment resistant hypertension. Data generated by this study will show whether RAS peptide profiles merit further evaluation as clinical biomarkers in this complex patient group.

Eligibility Criteria:
Inclusion criteria

* Office blood pressure ≥ 140/90 mmHg and mean 24 hour blood pressure \>130/80 mmHg on average, or \>135/85 mmHg during the day, or \> 120/70 mmHg during the night, despite concurrent use of 3 antihypertensive agents at optimal doses, including one diuretic OR
* Office blood pressure and 24 hour mean blood pressure controlled with four or more medications

  * Age ≥ 18 years
  * Ability to understand research procedures and to provide written informed consent

Exclusion criteria

* Known secondary arterial hypertension at time of inclusion or diagnosis of secondary hypertension after study inclusion during routine work-up of treatment resistant hypertension
* Known obstructive sleep apnea at time of inclusion
* History of, or clinically relevant or uncontrolled cardiovascular disease (other than arterial hypertension), namely myocardial infarction within last 3 months or valvular heart disease with clinically relevant reflux or heart failure
* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the research project or compliance with the research plan.
Fellow-eye Study (FE) of LX101 in Subjects With Inherited Retinal Dystrophy

Up to nine subjects who have participated in the earlier LX101 clinical study, and who meet all study eligibility criteria, will receive LX101 administration in the previously uninjected, contralateral eye to evaluate the safety of bilateral, sequential subretinal administration of LX101.


Eligibility Criteria:
Inclusion Criteria:

Prior subretinal administration of LX101 (unilateral)

≥ 6 years old Signed written informed consent

Exclusion Criteria:

Prior gene therapy except LX101 Active intraocular or periocular infections Lacking of sufficient surviving retinal cells Prior ocular surgery within six months Retinoid like compounds or precursors were taken within three months Complicating systemic diseases Clinically significant abnormal baseline laboratory values Using of any retinal toxic compounds
Effect of Ferrlecit® Versus Oral Iron on Iron Deficient Chronic Kidney Disease (CKD) Patients Receiving Erythropoietic Agents

This study compares the effect of Ferrlecit® (a form of intravenous iron) to ferrous sulfate (a form of oral iron) in treating anemia and iron deficiency in chronic kidney disease patients who are receiving erythropoietic agents, such as Procrit® and Aranesp®.


Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe anemia
* Iron deficiency
* Moderate to severe chronic kidney disease
* Receiving therapy with erythropoietic agent

Exclusion Criteria:

* Receiving dialysis
* Known sensitivity to Ferrlecit® or any of its components
* Clinically unstable
Level of Concordance Between Patients Perception and Physicians Evaluation of Cardiovascular Risk

This is a national, non interventional, prospective study performed in the general practice setting.

The study has been designed :

* to assess the level of concordance between patients' cardiovascular risk perception and the cardiovascular risk evaluated by the physicians,
* and to evaluate the impact of patients' exposure to a medical information leaflet on patients' cardiovascular risk perception.

LEVEL OF CONCORDANCE BETWEEN PATIENTS PERCEPTION AND PHYSICIANS EVALUATION OF CARDIOVASCULAR RISK

Eligibility Criteria:
Inclusion Criteria:

* Currently in primary prevention for a cardiovascular event (patient with no known history of acute cardiovascular or cerebrovascular event)
* Usually treated by the GP
* Having signed the information and consent form

Exclusion Criteria:

* Patient with a pathologic vascular ultrasound exam (atheromatous plaque or stenosis)
* Patient unable to read and complete the study documentation