cyrilzakka/clinical-trials huggingface dataset:
Integrative Study of Vestibular Pathology

Exploratory posturological, neurosensory, cognitive, emotional, personality and general evaluations (quality of life).

The investigators will characterize a sensory profile quantified by one or more scores from a multi-parameter baysian approach. Each parameter and these scores will be correlated to the type of vestibular damage and its recovery in order to establish diagnostic, prognostic and therapeutic follow-up markers.

This is an exploratory neurophysiological work that aims to identify diagnostic, prognostic and therapeutic markers in vestibular pathology.

Theinvestigators wish to characterize the neurosensory profile of individuals using new exploration paradigms provided by a new posturology platform coupled with virtual reality scenarios and by proposing a complete transversal approach in terms of evaluation of the subjects: personality, cognition, emotion including the depressive state, sensory strategy, general data.

Baysian statistical approaches and linear mixed model will be used to determine markers of sensory profile correlated to the vestibular damage for diagnostic, prognostic and therapeutic follow-up.

The investigators aim to be able to better characterize the cognitive-emotional and sensory deficits expressed by the vertiginous and unstable patients, to integrate it into the evaluation of the vestibular pathology, to use these markers to better discriminate the underlying physiopathological mechanisms, and to improve at the same time the diagnosis of the functional attack and the rehabilitation follow-up of the patients.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patient (18-80 years old)
* Patient with an acute or chronic vestibular pathology according to ENT diagnostic criteria

Exclusion Criteria:

* Subjects under 18 years of age
* Pregnant or breastfeeding women,
* Persons in an emergency situation or unable to give their consent, including adults under guardianship
* Person under legal protection
* Patient presenting a vertigo or postural disorders of non vestibular etiology
* Persons deprived of liberty, minors, protected adults,
* Patients with an intercurrent neurological pathology including cerebellar pathology
* Inclusion of the subject in another interventional research protocol with pharmacological aim during the present study
Doppler Flow Wires in Cerebral Angiography

The purpose of this study is to use a wire with a Doppler tip to measure blood flow in vessels in the brain and determine hemodynamic factors associated with treatment success or failure. Many neurological diseases cause abnormal blood flow in the brain in specific vessels. The special wire used in this study is place into brain blood vessels during standard of care procedure to treat such diseases, and blood flow parameters (such as velocity and pressure) are measured to gain better understanding of these neurological diseases.

Current treatments of cerebral aneurysms are imperfect, and aneurysmal hemodynamics is an important factor in treatment failure. The identification of hemodynamic factors that influence treatment success could predict outcome. Published studies show that the hemodynamic environment of aneurysms changes after treatment, and there is limited retrospective evidence that the degree of change affects treatment success. However, previous hemodynamic calculations did not have access to patient-specific measurements of blood flow, which substantially reduced their accuracy. In addition, no prospective studies of the predictive value of post-treatment aneurysm hemodynamics have been done.

Methods: Prospectively test new aneurysm patients for hemodynamic predictors of treatment outcome based upon the hypothesis long-term aneurysm treatment outcome can be prospectively predicted by measuring the immediate hemodynamic effects of aneurysm treatment with novel patient-specific modeling techniques. Task 1: In a new cohort of patients undergoing aneurysm treatment, the investigators will again use Doppler guidewire measurements to create patient-specific hemodynamic models of treatment effects. By prospectively applying the knowledge of crucial hemodynamic changes the investigators will use immediate post-treatment hemodynamics to predict long-term treatment outcome.

Eligibility Criteria:
Inclusion Criteria:

* Patient with an unruptured intracranial aneurysm ≥ 5mm in size undergoes endovascular treatment and subsequent angiographic follow-up

Exclusion Criteria:

-previously enrolled in the study
Effects of Exoskeleton-Assisted Gait Training on Bone Health and Quality of Life

This is a randomized clinical trial to quantify the effects of exoskeleton-assisted gait on the musculoskeletal system and health-related quality of life.

Investigators will test if exoskeleton-assisted ambulation confers skeletal benefits in a dose-dependent fashion. Investigators also will test if reintroduction of ambulation will be associated with improvements in quality of life due to improvements in mood, pain, and functional connectivity of emotional networks in the brain.

Eligibility Criteria:
Inclusion Criteria:

* 3 years or more after injury,
* Non-ambulatory AIS A-D spinal cord injury (C7-T12),
* 158-188 centimeters tall,
* Weigh less than 100 kilograms,
* Have a Modified Ashworth Scale (MAS) score of less than 3 in both lower extremities, and
* Have sufficient upper body strength to complete sit to sit transfers.
* Women of childbearing potential must agree to use contraceptive measures during participation in the study. They also will be required to have a negative pregnancy test (urine or serum) before receiving an imaging studies.

Exclusion Criteria:

* Current enrollment in another clinical trial
* Pregnancy
* Anyone with an initial blood pressure\>140/90 mmHg, orthostatic hypotension with symptomatic fall in blood pressure \>30 mmHg when upright,
* An active grade 2 or greater pressure ulcer that can be worsened by walking in the device,
* Lower extremity contractures that interfere with the ability to wear the device,
* An unhealed limb or pelvic bone fracture history of other neurological disease (e.g. stroke, peripheral neuropathy, myopathy),
* Active treatment for epilepsy,
* Current use of medications potentially affecting bone health (bisphosphonates, androgenic steroids, estrogenic steroids, lithium, glucocorticoid use for more than 3 months).
* Subjects with MRI-incompatible implants, pumps, or neurostimulators will be excluded.
Anthropometric and Biomechanical Analysis of the Infant Foot

In the era of science and technology, footwear has become not only an essential item of clothing, but also another tool for the optimal development of children, the improvement of work and sports performance or the prevention and treatment of pathologies.

The anthropometric characteristics of the child's foot differ considerably from those of the adult foot, in fact, it is not until the age of 18-19 years that the structure of the foot is finally consolidated. Therefore, it is essential that footwear manufacturers know these characteristics to achieve an adequate design.

Current scientific evidence highlights the importance of considering the unique morphology of the infant foot, as well as the high functional demands to which footwear is subjected at these ages. There is a lack of studies that analyze in detail the shape of the child's foot.

Given that the data we have so far comes from studies that are not very current and on small samples, there is a need to update these variables to transfer these results to the productive fabric.

Therefore, the objective of this research is to carry out an anthropometric and biomechanical analysis of the infant foot in order to use these data in the creation of a standard last that respects its morphology.

Subsequently, said last will be subjected to different fit tests to verify its correct adaptation to the foot in this population group.

Eligibility Criteria:
Inclusion Criteria:

* School-age boys and girls with foot sizes between 20 and 41
* Attending school and belonging to public, private or concerted schools, to guarantee the variability of the sample in terms of type of school.

Exclusion Criteria:

* Present a severe structural or functional alteration of the foot, which prevents an adequate digitization of the foot and ankle with the hardware and software used to collect the samples.
* Not having the signature of the informed consent or express authorization of the parents or legal guardians to carry out the measurement and the subsequent processing of the data.
* Inability to stand or walk independently.
* Present crying or fear, not being cooperative or engaging in inappropriate behavior.
Rifaximin in Minimal Hepatic Encephalopathy

The purpose of this study is to determine whether alteration of gut flora with rifaximin can lead to improvement in driving performance, psychometric test performance, and quality of life in patients with minimal hepatic encephalopathy (MHE) and cirrhosis in a randomized, blinded, placebo-controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years
* Cirrhosis diagnosed on clinical grounds
* MHE diagnosed by abnormalities in a psychometric battery (NCT-A, NCT-B, ICT BDT and DST impaired beyond 2 standard deviations of known control values on any of the above 3 tests will be considered to have MHE)
* Current drivers (valid driving license and driving at least 20 miles/week)
* All women of child-bearing potential will be required to use effective contraception

Exclusion Criteria:

* Current or recent (\< 6 month) use of alcohol (AUDIT questionnaire will be used; any cirrhotic with a value of \> 0 will be excluded) and a positive blood alcohol level
* Use of antibiotics within last 6 weeks
* Allergy to rifaximin, rifabutin, rifampin, or rifapentine
* Infection or gastrointestinal hemorrhage within the last 6 weeks
* Renal insufficiency
* Hepatocellular carcinoma
* Psychoactive drug use, including interferon concurrently
* Non-drivers and those who drive less than 20 miles/week
* Pregnancy and breastfeeding
* Excluding patients with OHE:

  * Detailed neurological examination to check for dysarthria, asterixis, ataxia and disorientation
  * Detailed history-taking from friends/relatives only after taking the patient's permission
  * Mini-mental status examination \> 25
  * Episode of overt (clinical hepatic encephalopathy) within 6 months
  * Current treatment with lactulose, rifaximin, zinc, or metronidazole
Echocardiography in Kids Intensive Care Decision Support

A study to determine if echocardiographically derived parameters, plethysmographic variability index and pulse pressure variation predict fluid responsiveness in children on PICU.

A study to determine if echocardiographically derived parameters, plethysmographic variability index and pulse pressure variation predict fluid responsiveness in children on PICU. These parameters will be measured pre and post fluid bolus in children prescribed fluid bolus therapy for clinical indications on the PICU. Children will be classified as responders (\>10% increase in cardiac output) and non responders (\<10% increase). Appropriate statistical tests will be performed to determine the most useful predictor of an increase in cardiac output following a fluid bolus.

Eligibility Criteria:
Inclusion Criteria:

* Any ventilated child requiring fluid bolus therapy on the PICU for clinical indications

Exclusion Criteria:

* Arrythmia
* Intracardiac shunt
Bindex for Osteoporosis Diagnostics

Osteoporosis is a disease that leads to impaired skeletal strength and increased fracture risk. Among 200 million osteoporotic patients most are diagnosed only after several fractures. Furthermore, the progressively aging population will increase the prevalence of osteoporosis. It is estimated that over 75% of osteoporotic patients are not diagnosed and does not receive treatment for their condition. Bindex ultrasound device has been developed and validated in Caucasian female population. In this study, diagnostic thresholds for density index as determined with Bindex will be evaluated in two different ethnic populations.

Currently, the diagnosis of osteoporosis is based on the measurement of bone mineral density (BMD), using axial dual energy X-ray absorptiometry (DXA) of the hip and/or the lumbar spine at special healthcare.

Application of diagnostic thresholds determined against BMD have been suggested by International Society for Clinical Densitometry (ISCD) for use with peripheral bone densitometry devices (90% sensitivity and 90% specificity). These thresholds have been determined and validated for Bindex in Caucasian female population.

This study focuses on clinical validation of the ultrasound device (Bindex®, Bone Index Finland Ltd., www.boneindex.com) device and Density Index (DI), a diagnostic parameter reported by Bindex. The predetermined thresholds for DI will be evaluated by measuring 70 osteoporotic and 70 healthy patients with Bindex and DXA in each selected patient groups. The feasibility of DI for diagnostics of osteoporosis in these groups will be assessed.

Eligibility Criteria:
Inclusion Criteria for all:

* Postmenopausal status
* Age at 50 years or over
* Caucasian or Hispanic race (number shall be controlled, 140 in each group)
* Body mass index (BMI \< 35)

Additional criteria for Osteoporotic group

- T-Score (NHANES database) -2.5 or lower at femoral neck or total femur

Additional criteria for non-osteoporotic group

- T-Score (NHANES database) \> -2.5 at femoral neck or total femur

Exclusion Criteria:

for non-osteoporotic groups (Hispanic or Caucasian)

* Previous osteoporosis diagnosis
* Previous or current use of anti-fracture medication
Impact Evaluation of a Targeted mHealth Intervention to Improve Uptake of Postpartum Contraception in Kenya

The goal of this study is to explore approaches to improve postpartum contraceptive counseling, information, and uptake through a collaboration between the Harvard Chan School, Rutgers School of Public Health, Jacaranda Health, Jhpiego, and IPSOS, leveraging an existing mobile health platform for intervention delivery and Jacaranda's established partnership with the Kenyan Ministry of Health, county health offices and public maternity hospitals.

Jacaranda's PROMPTS mHealth platform has reached over two million pregnant women and new mothers, providing them with needed, tailored information about prenatal and postpartum health along with access to a mobile helpdesk to triage users' questions. Using a targeted human-centered-design process with early postpartum mothers, we developed targeted messaging around family planning and contraceptive method options, with the goal of integrating this new content into Jacaranda's PROMPTS platform. We will conduct a randomized controlled trial with pregnant women engaged with the PROMPTS platform to determine the impact of the intervention package on information and utilization of postpartum contraception. If proven effective, the results of this intervention will be integrated into Jacaranda's PROMPTS system at full scale.


Eligibility Criteria:
Inclusion Criteria:

* Age 15 and over,
* Pregnant at 7-8 months gestation,
* Consented to be enrolled in the PROMPTS text-messaging platform and who have provided informed consent to be part of this research study
* Have access to a mobile phone

Exclusion Criteria:

* None
Mobility in Older People

The main aim of this study is to investigate whether increasing the amount of physical activity in frail older people during hospital based rehabilitation is associated with better mobility outcomes compared to usual care. A second aim is to investigate whether this physical activity intervention is associated with improvements in health related quality of life. Finally we plan to investigate whether increasing the amount of physical activity during rehabilitation is cost effective, measured from a health system perspective, compared with usual care.

Older people receiving inpatient rehabilitation will be randomly assigned to an intervention group, who will receive extra physical activity on weekdays and weekends or a control group, who will receive additional activities based on social interaction. The activity sessions will be individualized to the particular participant. Both groups of people will be assessed at baseline, discharge from hospital and at 6 months following discharge. The intervention group will be provided with one or two extra sessions on weekdays and two extra sessions on weekends for the duration of their rehabilitation stay. To account for the extra physiotherapy time that the intervention group receives, the people in the control group will spend the same amount of time performing other activities, such as cards, board games or reading, whilst seated. To ensure the safety of the participants in this study, each physical activity session will be supervised by either a physiotherapist or allied health assistant.

Hypothesis 1: The primary hypothesis is that, compared with usual care, increasing the amount of physical activity in frail older people during rehabilitation will lead to more optimal mobility at discharge, as measured by gait speed.

Secondary hypotheses are that, compared with usual care, increasing the amount of physical activity during rehabilitation will:

Hypothesis 2: lead to significantly greater improvements in mobility and function both at discharge and six months following discharge.

Hypothesis 3: lead to better quality of life six months following hospital discharge, measured using the EuroQol Health (EQ5D) Questionnaire and the EuroQol-Visual Analogue Scale (EQ-VAS).

Hypothesis 4: be cost effective compared to usual care


Eligibility Criteria:
Inclusion Criteria:

* over 60 years of age
* a goal of admission is to 'improve weight-bearing mobility or improve walking' as determined by either the admission referral or the treating therapist

Exclusion Criteria:

* specific medical restrictions that limit mobilisation (e.g. non weight bearing)
* if already enrolled in a different Randomised Controlled Trial
* previously enrolled in the current trial
* the primary reason for admission is awaiting a residential care placement
* the primary reason for admission is for carer training
North West London Pebble Pathway: Automated OSA Diagnosis

Patients with obstructive sleep apnoea (OSA) wait up to two years for a diagnostic test. Early diagnosis enables optimal treatment, mitigating risks including heart failure, lung disease, and stroke. Current diagnostic approaches are expensive (£391), time-consuming (\>1-hour interpretation), uncomfortable (cables/tubes/wires), and inequitable (multiple hospital visits). Overcoming all these limitations, we have designed and will investigate a straigh-to-test automated diagnostic pathway for OSA. This will use the AcuPebble, a miniature wearable acoustic sensor and the first regulated technology for automated, at-home diagnosis. The test is cheap (\< £100); time-saving; endorsed by patients, and accessible (posted directly to patients). This project will measure the impact of a potentially transformative, innovative, and scalable diagnostic pathway using AcuPebble technology.

The investigators are conducting a prospective implementation and health economic study of a novel straight-to-test (STT) clinical diagnostic pathway for OSA, using a novel, regulatory-approved wearable medical device for automated diagnosis of OSA in the home setting (AcuPebble SA100). The setting is real-world direct clinical care, with participation from three NHS sleep medicine centres servicing the North West London region.

Inclusion criteria is primary care referrals for OSA investigation were triaged onto the pathway based on predetermined criteria, compared to a historical cohort of patients undergoing STT using cardiorespiratory polygraphy (CR-PG) technology serving as a control group. The primary outcome is time-to-diagnosis. Secondary outcomes include NHS cost-saving per patient; surrogates for health equity (e.g. test completion rates, time/cost of journeys saved); and carbon footprint reduction from averted patient journeys (sustainability).

Eligibility Criteria:
Inclusion Criteria:

* OSA testing referral from primary care

Exclusion Criteria:

* Unable to follow test instructions
Prevalence of Ocular Surface Disease in Glaucoma Patients

Demographic information and a brief medical and concomitant medicine history will be obtained from the glaucoma patient's records. Qualified patients will be asked to complete a questionnaire about their symptoms. Patients will then be scheduled to undergo three standard clinical tests of the ocular surface.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of glaucoma;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Inability to understand trial procedures;
* Inability to understand Informed Consent;
* Current use or use within the last 3 months of Restasis, steroids, or topical ocular non-steroidal anti-inflammatory drugs;
* Punctal plugs;
* Previous glaucoma, corneal, or conjunctival surgery;
* Other protocol-defined exclusion criteria may apply.
Efficacy of Levocetirizine and Cetirizine in Reducing Symptoms of Seasonal Allergic Rhinitis in Ragweed Sensitive Subjects

Controlled conditions of the EEU allow a reliable assessment of the efficacy and a determination of the action onset, action intensity and duration of effect of levocetirizine and cetirizine in order to establish the relative efficacy of these two drugs available for the treatment of SAR.


Eligibility Criteria:
Inclusion Criteria:

* Male/Female, aged \>= 16 years
* seasonal allergic rhinitis that required pharmacologic therapy each year during the last 2 ragweed pollen seasons
* documented seasonal allergy to ragweed pollen
* total symptom score of at least 18 points.

Exclusion Criteria:

* nasal anatomic deformities ? 50% obstruction
* acute sinusitis within 30 days of Period 2
* initiated or advanced an immunotherapy regimen
* immunotherapy injections within 48 hours of pollen exposure
* impaired hepatic function
* history of malignancy
* intolerance to histamines
* asthma requiring medication more than occasionally