cyrilzakka/clinical-trials huggingface dataset:
Longitudinal Study of Ultra-rare Inherited Metabolic and Degenerative Neurological Diseases.

General aim of the study is the improvement of the clinical knowledge of ultra-rare inherited metabolic and degenerative neurological diseases (prevalence less than 5:100,000) in adulthood through the systematic longitudinal collection of clinical, laboratory and instrumental data.

The study provides a collection of retrospective data from adult patients with ultra-rare inherited neurological diseases followed at "Carlo Besta" Neurological Institute from 1st January 2004 until March 2021. Further, prospective data will be collected starting from March 2021 (date of protocol approval) and spanning the next ten years. Normal clinical practice will be followed for collection of the prospective data. Follow-up assessment will be performed at least once a year to evaluate the disease course. Based on their clinical manifestations, patients will be assessed by using quantitative functional tests (clinimetric tests such as Timed Up and Go Test) and traditional ordinal scales (such as the scale for the assessment and rating of ataxia (SARA). Moreover, a varying of laboratory and instrumental tests (e.g., neuroimaging, neurophysiological investigations, etc.) will be used according to clinical practice in selected patients.

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years
* Subjects with ultra-rare inherited degenerative and metabolic neurological diseases
* Subjects with undiagnosed neurological diseases (when supposed to be inherited)

Exclusion Criteria:

* none
Effects of Phytonutrients Upon Muscle Perfusion in Response to Feeding

This is a random order cross over design trial to evaluate the efficacy of select nutritional ingredients on enhancing muscle perfusion in response to an acute meal stimulus.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) 18-30 kg/m2
* Free from active metabolic disease
* Normotensive

Exclusion Criteria:

* Habitual gym use or formal exercise (more than once a week) or other routine strenuous physical activity
* Smokers
* Surgery within past 3 months
* Active cardiovascular disease
* Taking beta-adrenergic blocking agents
* Cerebrovascular disease:
* Active respiratory disease
* Active metabolic disease
* Active inflammatory bowel or renal disease
* Active Malignancy or until confirmed remission
* Clotting dysfunction
* History of DVT
* Significant musculoskeletal or neurological disorders
* Family history of early (\<55y) death from cardiovascular disease
* Known sensitivity to Sonovue contrast agent
* Known allergy or intolerance to any of the study ingredients
* Current use of any of the study ingredients
Nurses Ability to Assess Visual Acuity in Geriatric Consultation

Nurses participate to geriatric evaluations for falling patients. For these patients, it is recommended to evaluate,especially, visual acuity but this is not currently done because it is difficult to systematically combine with an ophthalmologic consultation.

The HAS french recommendations propose to detect visual acuity deficiency using Monoyer and Parinaud scales, without specifying the professional qualification. According to the nurse competence decree of State Graduates, "sensory disorders" screening is a "non-vulnerable" examination, and can be performed by nurses. Therefore, they can use these scales, after training.

We propose to evaluate the correlation between visual acuity scores obtained by nurses in geriatric consultations and an ophthalmologist.

This study should include 204 patients over 65 years, who have fallen at least twice in the last 12 months. These patients will benefit from an evaluation by an ophthalmologist, after the geriatric consultation.


Eligibility Criteria:
Inclusion Criteria:

* at least 2 falls in the last 12 months,
* applied in geriatric evaluation
* talking French
* affiliated to the social security system

Exclusion Criteria:

* not communicating
* illiterate
* Total blindness
Role of the Renin Angiotensin Aldosterone System in the Mechanisms of Transition to Heart Failure in Abdominal Obesity

R2C2 study has shown that abdominal obesity is associated with a cardiac and vascular remodelling in healthy volunteers. This remodelling is correlated with renin-angiotensin aldosterone system (RAAS) activation and/or systemic fibrosis. R2C2 II study is designed to confirm the hypothesis that RAAS is associated with an early remodelling and implicated in the transition to cardiac failure in abdominal obesity.

Follow up of abdominal obesity patients from the R2C2 cohort study.

Eligibility Criteria:
Inclusion Criteria:

* Being a former member of R2C2 study, abdominal obese group.
* Having signed the informed consent (refusing to participate to the genetic study is not an exclusion criteria).
* being affiliated to health insurance scheme.

Inclusion Criteria of R2C2 study:

* Men and women aged between 40 and 65 year's old
* Caucasian
* Born or living in France for at least 10 years
* Presenting an abdominal obesity defined by a waist circumference \>94 cm in men and ≥ 80 cm in women, associated or not with untreated hypertension or hypertension treated for less than one year
* Having signed the informed consent

Exclusion Criteria:

* Subjects unable to understand the information letter
* Subjects under supervision or guardianship
* pregnant or lactating woman
* A contraindication to perform MRI is not an exclusion criteria.
Effects of Inspiratory Muscle Fatigue and Warm-up on Respiratory Variables, Handgrip Strength, and Walking Capacity in Sedentary Older Adults

Respiratory muscle training represents an effective method increasingly utilized in both sports and healthcare domains, employing various devices, among which threshold devices are prominent. The aim of this study is to determine the relationship between inspiratory muscle fatigue or warm-up and muscular strength in upper and lower limbs, in sedentary older adults, as well as the association between such fatigue and other variables, including maximal inspiratory pressure, diaphragmatic ultrasonography, functionality and handgrip strength.

According to our hypothesis, the execution of a protocol inducing inspiratory muscle fatigue or activation in sedentary older adults could influence muscular strength, respiratory function and exercise capacity.

In this study, subjects will be divided into three groups: the fatigue group , the activation group and the control group.

Measurements of variables, such as maximal inspiratory pressure, diaphragmatic strength (ultrasound image) and functional capacity, will be conducted.

This is a randomized control trial. The fatigue group (EG) will perform the inspiratory muscle fatigue protocol using a specific inspiratory endurance test, in which volunteers, one-on-one, and in a single session, will breathe against submaximal inspiratory loads equivalent to 60% of their Maximum Inspiratory Pressure (MIP) through a threshold valve device. The participants will follow a free pattern of breathing until they are unable to establish flow during at least 3 maximum inspiratory efforts.

The activation group (AG) will perform the protocol of 2 sets of 30 repetitions at 15% of their MIP, one-on-one, and in a single session, using a threshold valve device.

The control group will do a seat and wait.

The interventions will be supervised by a physiotherapist. The primary outcomes will be

Walking capacity will be assessed using the 6 minutes walking test (6MWT) immediately before intervention and immediately after intervention Respiratory muscle strength will be assessed using a respiratory pressure meter or manometer designed, and with ultrasound image measuring the cross sectional area of the diaphragm at 8-9th rib level and speed of contraction with a deep and fast inspiratory manoeuver. This will be done immediately before intervention and immediately after intervention Handgrip strength will be assessed using a handgrip dynamometer. This will be done immediately before intervention and immediately after intervention.

Eligibility Criteria:
Inclusion Criteria:

* Being over 60 years old.
* Physical independence in terms of gait and transfers
* Engaging in less than 150 minutes of physical activity per week.

Exclusion Criteria:

* Having any pathology that prevents the performance of physical activity.
* Subjects with impaired cognitive abilities.
* Subjects with tympanic perforation or middle-inner ear pathology.
* Subjects with chronic respiratory, cardiac, renal, or metabolic pathology..
* Subjects who have undergone lower limb surgery within the past 12 months.
Safety and Efficacy of Different Add Powers With a New Presbyopic Lasik Treatment Algorithm

This is a prospective, comparative, randomized, controlled, open-label, single-surgeon, single-center PMCF clinical study whereby presbyopic patients undergoing refractive surgery will receive a SUPRACOR treatment for the correction in the non-dominant eye and a PROSCAN refractive treatment in the dominant eye to correct for ametropia.

The participants will be randomized to either a SUPRACOR regular (100%) or SUPRACOR strong (130%) treatment with a 1:1 ratio.


Eligibility Criteria:
Inclusion Criteria:

* presbyopia
* willingness for a refractive presbyopia correction
* signed informed consent form

Exclusion Criteria:

- ocular comorbidity
A Pilot, Randomized Controlled Trial of Group Visits for Persons With Parkinson's Disease

To determine patient satisfaction with group visits versus standard of care delivery for patients with Parkinson's disease.

To establish the feasibility and to estimate the benefit of group visits for individuals with PD and their caregivers. The feasibility will be assessed by the ability to enroll and retain (measured by number of individuals who complete the 12-month study and at least half the study visits) \~40 individuals in the pilot trial. The responsiveness of the following different outcomes to group visits will be assessed during the pilot trial: quality of life, patient satisfaction, depression, caregiver burden, resource utilization, and disease progression. The primary outcome measure for efficacy will be a comparison of the change in the Parkinson's Disease Questionnaire-39 from baseline to 12 months in the control (routine care) and intervention (group visit) groups.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of idiopathic Parkinson's disease as determined by having two of the four cardinal features of PD (rest tremor, bradykinesia, cogwheel rigidity, and gait instability) and no alternative explanation for the etiology of the symptoms
* Willing and able to provide informed consent and to participate actively in group visits and complete study activities

Exclusion Criteria:

* Cognitive impairment, psychiatric disorder, or history of or current clinically significant substance abuse that in the investigator's judgment could interfere in the conduct of group visits or with study participation.
Evaluation of an Algorithm to Detect Sleep and Wake in Continuous Positive Airway Pressure (CPAP)

The purpose of this engineering trial is to develop and validate an algorithm that will deliver Paced Breathing as a ramp feature to obstructive sleep apnea (OSA) subjects using Continuous Positive Airway Pressure (CPAP) therapy. In this trial the investigators will be evaluating the algorithm's ability to correctly distinguish between sleep and wake.


Eligibility Criteria:
Inclusion Criteria:

* Age 21-70
* Diagnosis of obstructive sleep apnea (OSA)
* Current adherent CPAP user (has been using CPAP nightly for at least 2 weeks).
* On CPAP pressures of 5-10cm.
* Subjects wishing to complete a day or evening appointment need to have significant daytime sleepiness (Epworth Sleepiness Scale score of 8 or above)
* Able and willing to provide written informed consent
* English speaking

Exclusion Criteria:

* Participation in another interventional research study within the last 30 days
* Major controlled or uncontrolled medical condition such as congestive heart failure, neuromuscular disease, renal failure etc.
* Inability to tolerate nasal CPAP mask due to problems breathing solely through their nose.
* Chronic respiratory failure or insufficiency with suspected or known neuromuscular disease, moderate or severe chronic obstructive pulmonary disease (COPD), or any condition with an elevation of arterial carbon dioxide levels while awake (PaCo2≥55mmHg)
* Severe oxygen desaturation on the polysomnography (PSG), i.e. Sa02 \< 70% for 10% of the study.
* Surgery of the upper airway, nose, sinus or middle ear within the past 90 days
* Currently using supplemental oxygen
* Regular use of sleeping pills or stimulants (\> 3 nights a week)
* Currently working night shift or rotating day/night shift
* Drowsy Driving or near miss accident in the past 6 months
* Inability to tolerate or track to Paced Breathing device during initial habituation session in lab
* Chronic insomnia, Restless legs syndrome, or severe periodic limb movement disorder (PLMD - PLMAI\>20/hr).
Paclitaxel in Treating Women With Recurrent Solid Tumors

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating women who have recurrent solid tumors.

OBJECTIVES: I. Evaluate the relationships between body surface area (BSA) and toxic effects, BSA and pharmacokinetics, and pharmacokinetics and toxic effects in women with recurrent solid tumors who receive a fixed total dose of paclitaxel. II. Determine the toxic effects of paclitaxel in these patients. III. Assess the pharmacokinetics of paclitaxel in these patients.

OUTLINE: Patients receive single fixed dose intravenous paclitaxel over 3 hours on day 1. Blood samples must be drawn prior to the first paclitaxel infusion and then at 1, 6, and 24 hours after the start of the infusion during course 1 only. Treatment courses of intravenous paclitaxel are repeated every 3 weeks at the discretion of the treating physician. Patients are evaluated for response after the second course. Patients are followed at the discretion of the physician.

PROJECTED ACCRUAL: A total of 50 patients will be accrued over 13 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven recurrent adult solid tumors Must have measurable or evaluable disease No known bone marrow metastasis

PATIENT CHARACTERISTICS: Age: 18 and over Sex: Women Performance Status: Zubrod 0-2 Life Expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL SGOT less than 2.0 times upper limit of normal Renal: Creatinine no greater than 1.5 times upper limit of normal Other: Concurrently active secondary malignancies are allowed

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior paclitaxel therapy No more than 1 prior chemotherapy regimen for metastatic disease At least 4 weeks since chemotherapy Greater than 6 weeks since nitrosoureas, melphalan, or mitomycin Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since radiotherapy No prior whole pelvic radiation Surgery: At least 4 weeks since major surgery
ESKETamine for FIBromyalgia Treatment

Fibromyalgia is a cause of chronic pain, classified by the Internal Classification of Diseases (ICD) as a primary chronic pain with specific diagnostic criteria established by the American College of Rheumatology (ACR). No treatment to its complete cure is available at this time, all treatments having as purpose pain relief and an improvement of quality of life by combining pharmacologic and nonpharmacologic treatments. One of the mechanisms proposed in fibromyalgia is the central sensitisation phenomenon, by which the central nervous system becomes "hypersensitive" to nociceptive or non-nociceptive stimuli. The receptor involved in this phenomenon is the N-methyl-D-aspartate receptor to which ketamine binds. Ketamine has therefore been proposed as a co-treatment in chronic pain with central sensitization phenomena, such as fibromyalgia.

Ketamine is a drug used for anesthesia since the 1970s, acting as an antagonist to the N-methyl-D-aspartate receptor located in the central nervous system. It has two stereoisomers : R +ketamine and S - ketamine, the latter being about two to four times more potent. S-ketamine also has the advantages of producing less psychotropic effects, less tiredness and a lower temporary cognitive impairment than the racemic mixture at equianalgesic doses. Being first used as an anesthetic, in the last twenty years, ketamine's indications expanded to other domains, such as treatment of depression or off label use for chronic pain relief. Chronic pain is a multidimensional syndrome that touches 17-44% of the population of western countries. Fibromyalgia is a cause of chronic pain, classified by the Internal Classification of Diseases (ICD) as a primary chronic pain with specific diagnostic criteria established by the American College of Rheumatology (ACR). No treatment to its complete cure is available at this time, all treatments having as purpose pain relief and an improvement of quality of life by combining pharmacologic and nonpharmacologic treatments (as given by the European League Against Rheumatism (EULAR) guidelines). One of the mechanisms proposed in fibromyalgia is the central sensitisation phenomenon, by which the central nervous system becomes "hypersensitive" to nociceptive or non-nociceptive stimuli. The receptor involved in this phenomenon is the N-methyl-D-aspartate receptor to which ketamine binds. Ketamine has therefore been proposed as a co-treatment in chronic pain with central sensitization phenomena, such as fibromyalgia.

Eligibility Criteria:
Inclusion Criteria:

* patients suffering from chronic pain (as defined by International Association for the Study of Pain) being diagnosed as fibromyalgia according to the American College of Rheumatology 2016 criteria
* patients qualified for the treatment by S-ketamine as established by our latest clinical practice
* patients aged 18-65 years old
GLP-1 Receptor Targeting in Diabetic and Healthy Individuals

The purpose of the study is to determine whether there are differences in pancreatic uptake of the radiotracer between healthy individuals and patients with type 1 diabetes. If T1D patients have a markedly reduced uptake, the compound may be suitable for estimation of pancreatic beta cell mass, i.e. the cells in the pancreas that produce insulin.


Eligibility Criteria:
Inclusion Criteria:

* type 1 Diabetes

Exclusion Criteria:

* breast feeding
* pregnant
Examining the Effects of Regular Brief Internet-based Meditation Practice on Mental Health and Well Being

The study will examine the effects of online meditation training on stress and anxiety in healthy participants. It will also examine the dose-response relationship between the amount of daily focused attention meditation practice and established mental health outcome measures.

This is a 16-week study with an 8-week meditation intervention, with a requirement of a minimum of 10 minutes of meditation practice each day. This study will recruit \~200 healthy subjects (18+ years) with no current or previous diagnosis of psychiatric or neurological disorders who are interested in learning about meditation but don't have long-term experience with meditation. Half of the participant pool will be randomly assigned to the meditation intervention, and the other half will get the wait-list control assignment. The control group will later receive its intervention, likely a few weeks after the completion of the active group's intervention. A focused-attention meditation technique (SOS meditation) will be used to train participants.

Changes in participants' physiological markers (e.g., HRV, physical activity, respiration rate, sleep quality) will be evaluated using passive activity monitoring devices (e.g., Fitbit). Intervention-related changes in mental health will be assessed using web-based mental health and well-being surveys. Improvements in cognitive functioning will be assessed using web-based psychological tasks.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Able to follow basic instructions for prescreening and scheduling
* Compliant with investigator instructions during the consent process and participation in the study
* Is not already a regular meditation practitioner

Exclusion Criteria:

* Age \<18
* People with a current diagnosis of psychiatric or neurological disorders
* Be in current psychiatric treatment or medications
* Hospitalized for psychiatric disorders in the past year or so.
* Regular and long-term meditation practitioners
* Non-English speaking
* Non-USA mailing address to receive the activity tracker device
* Vision or hearing impairment severe enough to interfere with study participation
Using Direct Molding Socket Technology for Trans-tibial Prosthesis in Developing Regions

The study aims to understand how well CPOs and amputees can adapt to using the Amparo socket technology. CPOs at the APDK and The Cure will be trained to use the Amparo socket technology then use it with their consenting patients for a span of 7 months. Survey information will be collected along the way to assess how well the product is adapted by CPOs and patients.

Objective:

The objective of the trial is to ascertain the benefits and the implications of using the Amparo socket technology within the context of two pre-existing prosthetic services in Eastern Africa.

Design:

The trial is a phase one, exploratory single group trial. 4 Certified Prosthetist Orthotists (CPOs) will be trained to use the Amparo socket technology. Over a 7-month period, 40 lower limb amputees will be recruited to participate in the study where they will be fitted with the Amparo socket technology. Follow-up after one month of using the product will help build understanding their experience with the new prosthetic leg.

There will be a beginning and end surveys and interviews with each of the 4 CPOs.

Video and written observations will be taken of both the traditional socket making method and the Confidence Socket method for comparison.

Amputee participant surveys and assessments will be collected at each fitting, and follow-up visit.

Intervention:

The intervention for the study is to introduce a new fitting method and product for lower limb prosthetic, namely the Amparo Confidence Socket consisting of the socket and liner components. All other components of the prosthesis should remain the same as what is typically used in the respective organizations.

Population:

Professionals who craft prosthesis for amputees (CPOs) and Below-knee amputees who are able to and desire to use a prosthesis who reside in Kenya.

Outcome Measures:

CPO comfort level, perceived competence, and acceptance of the Confidence Socket Technology.

Patient quality of life measure Patient mobility measures Comparative task model between traditional method and the Amparo socket technology

Duration and follow-up:

The trial will last approximately 7 months. Starting from the first introduction of the new technology until the final interview with each CPO has been completed.

Eligibility Criteria:
Inclusion Criteria:

Below-Knee amputees 18 years of or older Individuals who would normally receive prosthetic care from the respective organization Minimum of 4 weeks after amputation Able to read and communicate in English User must be able to use a passive valve suspension system with a knee sleeve (Donning the LLP with suspension system require moderate level of hand strength and dexterity)

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Exclusion Criteria:

Users who have a known complication e.g. infection, open wounds, etc... Users who weigh more than 125kg (the max usage weight for the product) Users' residual limb cannot be longer than 25cm (MPT to stump end measurement) Users' residual limb cannot have distal circumference larger than 45cm (measured circumference with liner 4cm from end of stump)

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