cyrilzakka/clinical-trials huggingface dataset:
Testing Whether Brief Use of a Virtual Reality Device Improves Gait

A virtual reality device has already been successfully used for improving gait in adults who have neurological conditions. We will evaluate if it is feasible to study the brief use of this device in older adults who have had falls.

Older adults are at risk for recurrent falls.

This study will involve a single study session (lasting two hours) in the controlled setting of a research laboratory. This study will evaluate whether older adults who have had unintentional falls are willing to enroll in this kind of study, use the device briefly, and undergo research assessments. The study will also test whether using the virtual reality device leads to detectable changes in gait, balance, and mobility confidence. This study will lay the groundwork for more comprehensive studies in the future that will assess the clinical impact of using the device.

Twenty-four subjects will be recruited. They will include equal numbers of older adults who: (1) have fallen without a significant injury (e.g. only minor contusion, lacerations) or (2) have fallen with a significant injury (e.g. dislocation, strain/sprain, or fracture) which has healed prior to enrollment.

Each subject will complete baseline measures of gait, balance, and confidence. Then she or he will be introduced to the virtual reality device and will use it for a brief period. Gait and balance will be tested again, first with the virtual reality device and then, finally, without the virtual reality device.

The device (GaitAid®), developed by co-investigator Yoram Baram, Ph.D., has already been used for the rehabilitation of neurological patients (e.g. Parkinson's Disease). The device is a training tool and NOT a continuous walking aid.

Eligibility Criteria:
Inclusion Criteria:

1. Age 60+.
2. English-speaking.
3. One or more unintentional falls in past year.
4. Able to ambulate for at least 10 minutes without continuous assistance, i.e., without human physical assistance and without an assistive device such as a walker, or a cane.
5. A moderate or high level of concern about falling (determined by phone screening by PI).
6. Community dwelling.

   Exclusion Criteria:
7. Diagnosed with any neurological disease, i.e., sensory ataxia, cerebellar ataxia, or spasticity of the lower limbs.
8. Diagnosed with Parkinson's Disease.
9. Diagnosed with Multiple Sclerosis.
10. Diagnosed with Cerebral Palsy.
11. Marked cognitive impairment.
12. Uses large eyeglasses to walk.
13. Vision conditions that reduce ability to use the device.
14. Severe hearing loss.
15. Unstable medical condition or terminal illness.
16. Inability to otherwise comply with the study procedures (determined by PI/study clinician).
Erector Spinae Plane Block in Liver Transplantation Donors

Living donor liver transplantation has become a common treatment option for patients with end-stage liver disease. Donor hepatectomy is associated with significant postoperative pain due to inverted L-shaped incision. Therefore adequate analgesia is important for recovery.

Erector Spinae Plane Block (ESPB) is a safe anesthesia technique used to provide postoperative analgesia. This study aimed to compare the novel ultrasound-guided ESPB technique with controls in terms of postoperative opioid consumption and postoperative pain control on donor patients.


Eligibility Criteria:
Inclusion Criteria:

* Donor patients scheduled for elective hepatectomy in liver transplantation surgery
* ASA I-II
* Patients who are aged between 18-65

Exclusion Criteria:

* Patients who do not accept the procedure
* Skin infection at the site of Erector Spina Plan Block area
* Coagulation disorder or using anticoagulant drugs
* Known local anesthetics and opioid allergy
* Severe pulmonary and/or cardiovascular problems
* Substance addiction or known psychiatric or mental problems
* Chronic painkiller usage
* Pregnancy or lactation
Phase I Study of Intravenous Artesunate for Solid Tumors

This is a Phase One study to determine the safety, tolerability, and maximum tolerated dose of intravenous artesunate in patients with solid tumors. A rapid dose escalation design will be used, in which single patients will be enrolled to escalating dose levels until a grade 2 or higher toxicity occurs during cycle 1. Enrollment will then continue using 3 to 6 patients at each dose level until a dose is reached at which 2 or more patients out of 6 experience a treatment-related toxicity.

A rapid dose escalation design will be used, in which single patients will be enrolled to each dose level until a grade \>/= 2 treatment-related toxicity occurs during cycle 1; enrollment then will proceed using a classic 3+ 3 dose escalation design. If the toxicity was grade 2, then enrollment will continue on that dose level. If the toxicity was grade 3 or 4, then enrollment will continue on one dose level below that dose. Dose escalation with the 3+3 design will continue until \>/= 2 patients out of 6 experience a treatment-related dose-limiting toxicity. Then, the maximum tolerated dose and recommended Phase II dose of intravenous artesunate will be one dose level below the level at which the toxicities occurred.

Eligibility Criteria:
Inclusion Criteria:

* At least one measurable lesion by RECIST criteria
* Willing to undergo pharmacogenetic testing
* Over the age of 18 years and able to provide informed consent
* No standard of care therapy available which has a proven overall survival benefit
* Adequate kidney, liver, and bone marrow function
* Life expectancy of greater than 3 months
* ECOG performance status less than or equal to 2

Exclusion Criteria:

* Chemotherapy or surgery within 4 weeks of treatment start
* Radiation treatment within 3 weeks prior to treatment start
* Untreated brain metastases or neurologically unstable CNS metastases
* Any severe or uncontrolled medical condition or other condition which could affect participation in the study including: unstable angina, serious uncontrolled cardiac arrhythmia, uncontrolled infection, or myocardial infarction \</= 6 months prior to study entry
* Previous diagnosis of alpha- or beta-thalassemia
* Patients on a medication or herbal therapy known to inhibit CYP2A6, UGT1A9, or UGT2B7
* Female patients who are pregnant or breast feeding, or adult patients who are of reproductive potential and are unwilling to refrain from conceiving a child during study treatment
* Patients unwilling or unable to comply with the protocol, or provide informed consent
Cognitive Behavioural Therapy of Early Dementia

A randomized, controlled, parallel-group trial to evaluate the efficacy of a cognitive behavioral therapy for patients with early dementia.

The KORDIAL study is a randomized, controlled, parallel-group trial evaluating the efficacy of a cognitive behavioral therapy for patients at the early stage of Alzheimer's disease. The 3-month experimental intervention consists of 12 individual sessions with regular involvement of carers or other patient proxies. Strategies for improving the patient's coping ability and for enhancing their psychological well-being are combined. The primary outcome criterion is functioning in the everyday context after completion of the intervention and after another 6 months. The control condition will be treatment as usual. The study will be conducted in 5 university outpatient units and in 5 specialist offices.

Eligibility Criteria:
Inclusion Criteria:

* Mild dementia (MMSE \> 21) in Alzheimer's disease (ICD-10), proxy available

Exclusion Criteria:

* Acute of unstable psychiatric or physical disease, proxy unavailable
* Participation in another trial
Improving Geriatric Drug Safety in Underserved Practices

The purpose of this study is to determine whether a CRM (adapted Crew Resource Management approach proven successful in aviation as well as some inpatient medical settings) intervention is effective for reducing medication errors among older adults in primary care settings.

Adverse drug events (ADEs) are among the most common and serious medication use concerns among older patients in primary care practices, yet they are often preventable. This translational research into practice (TRIP) pilot study uses a randomized trial to evaluate the effect of a site-level intervention in a sample of practices in medically underserved communities within the Upstate New York Practice Based Research Network (UNYNET). These sites are located in rural and urban areas and include an over-sample of minority patients. The specific aims of this study are to:

1. Examine the feasibility of objectively assessing the impact of a CRM (adapted Crew Resource Management approach proven successful in aviation as well as some inpatient medical settings) intervention on reducing medication errors among geriatric patients in primary care settings; and
2. Assess office staff internalization and application of CRM principles for reducing geriatric medication errors in primary care settings by examining changes in safety attitude constructs achieved

   1. with a practice enhancement assistant (PEA) and
   2. without a PEA.

Outcomes measured for Aim #1 will be change in number, severity, consequence, and stage of process of preventable ADEs. Outcomes for Aim # 2 will be change in safety climate, teamwork climate, stress recognition, and working conditions.

Fifteen sites will be randomized into one of three intervention arms: usual care, CRM only, or CRM plus a PEA. A random sample of charts of older adults (aged \>64) with cardiovascular disease will be reviewed for adverse drug events over prior-year periods at baseline and post-intervention endpoints. Participatory research methods will be used to assess provider- and staff-identified barriers to implementation. This study will test the feasibility of incorporating PEA's into the practice setting to improve geriatric medication safety. The information gathered will serve as a basis for an ongoing translational research program that will lead to an RO1 application.

Eligibility Criteria:
Practice Inclusion Criteria:

* Practice must located in Health Professional Shortage Area or Physician Scarcity Area.
* Practice must be a member of the Western New York Practice-Based Research Network

Practice Exclusion Criteria:

* None

Patient Inclusion Criteria (for chart review):

* Aged \>64
* Cardiovascular disease
* Seen at the practice within the past year

Patient Exclusion Criteria (for chart review):

* None
Oasis Donor Site Wounds Post-Market Study

The purpose of this study is to demonstrate the safety and performance of Oasis extracellular matrix (ECM) when used as a treatment for donor site wounds in the United Kingdom. Oasis ECM is commercially available for the treatment of partial and full-thickness skin wounds, including chronic wounds, wounds from trauma, and wounds that occur during surgery, such as donor site wounds. The ability of the Oasis ECM to promote the healing of donor site wounds will be evaluated in this study.

About 40 patients (20 in each arm) over 16 years old will be involved in this study at one center in the United Kingdom.


Eligibility Criteria:
Inclusion Criteria:

1. Has a split thickness skin graft (STSG) donor site wound no greater than 14 x 20 cm in size requiring placement of a covering material.
2. Has at least 24 hours to consent to study participation.

Exclusion Criteria:

1. Age \< 16 years
2. Patients who, in the opinion of the investigator, have co-morbidities that impair wound healing, such as:

   1. Chronic inflammatory skin condition
   2. Chronic liver failure
   3. Chronic renal failure
   4. Blood-borne viruses (Hep B, Hep C, HIV)
   5. Peripheral vascular disease
   6. Clinically significant anaemia
   7. Uncontrolled diabetes
3. Need for use of the same harvest site (re-cropping)
4. History of radiation therapy to proposed donor site
5. Chronic use of medications known to impair wound healing
6. Chronic use of opioids or neuropathic pain agents
7. Suspected cellulitis, osteomyelitis or septicaemia
8. Patients undergoing haemodialysis
9. Patients requiring spinal/regional block
10. Patients on current anti-coagulant therapy
11. Unable or unwilling to provide informed consent
12. Unable or unwilling to comply with the study follow-up schedule, and procedures
13. Simultaneously participating in another investigational drug or device study (patient must have completed the follow-up phase for the primary endpoint of any previous study at least 30 days prior to enrolment in this study)
14. Allergy or hypersensitivity to materials that are porcine-based
15. Cultural or religious objection to the use of pig or porcine products
16. Known intolerance/allergy to standard wound care products
17. Presence of a local infection at the donor site and/or systemic infection
Cluster Headache and SPINK-1 Gene

Cluster headache (CH) is a rare, excruciating primary headache disorder. A genetic basis has been suggested by family and twin studies, but the mode of transmission seems to vary and the amount of heritability is unclear.

The number of genetic association studies investigating variants implicated in the pathophysiology of CH is limited. The HCRTR2 1246G \> A and the ADH4 925A \> G polymorphisms have been associated with CH. The former has been confirmed and may affect the hypothalamic hypocretin system. The aim of the present study was to investigate the possible link between SPINK 1 gene and cluster headache.


Eligibility Criteria:
Inclusion Criteria:

* People aged 18 or over
* Patient consulting in Marseille's or Nice's Pain departments
* Patient agreeing to participate to the research study
* Patient with health insurance

Exclusion Criteria:

* People aged under 18
* Patient refusing to participate to the research study
* Patient with deprivation of liberty
A Phase 2a Multicenter Clinical Trial of TB006 in Participants With Parkinson's Disease

The primary objectives of this study are to assess the efficacy of TB006 in improving motor function and to assess the safety of TB006 in participants with Parkinson's Disease (PD).


Eligibility Criteria:
Inclusion Criteria:

1. Participants voluntarily agree to participate in this study and sign an Institutional Review Board (IRB)-approved informed consent form (ICF) prior to performing any of the screening procedures.

   Parkinson's Disease Related Criteria:
2. Diagnosis of Parkinson's disease (PD) with motor symptom improvement from levodopa, if applicable.
3. Less than 5 years from the initial PD diagnosis, at the time of ICF.
4. Early-stage PD, with mild symptoms based on standard clinical staging in OFF state.
5. Participants who are on immediate-release levodopa-carbidopa/benserazide.

   Other Health Related Criteria
6. No active cancer, unless in remission for ≥10 years without ongoing treatment, except fully removed basal cell carcinoma.
7. Free of significant health issues that might interfere with study participation.

   Other Criteria/Social Circumstances
8. Negative screening for illegal drugs (excluding cannabis), with willingness to abstain during the study and avoid cannabis or alcohol effects during visits.

Exclusion Criteria:

Parkinsons's Disease Related Criteria

1. History of sudden, unexpected PD medication OFF episodes.
2. Severe motor complications or disabling symptoms that may impact study involvement.

   Other Health Related Criteria
3. Any condition or health concern deemed a safety risk or likely to interfere with study results.
4. Severe psychiatric disorders, including psychosis or substance addiction.
5. Allergies or sensitivities to specific study-related treatments or substances.
6. Any prior history of a severe infusion reaction.

   Other Criteria/Social Circumstances
7. Pregnancy, breastfeeding, or plans for pregnancy or ova donation during or shortly after the study.
8. Recent use of investigational drugs or therapeutic antibodies.
Lacrimal Drainage System Obstruction Associated to Radioactive Iodine Therapy for Thyroid Carcinoma

The radioactive radioiodine therapy (Na131I) for the treatment of differentiated thyroid carcinoma is a procedure used for ablation of remaining thyroid tissue after thyroidectomy and metastases. Although serious complications are uncommon after treatment, there are well-documented adverse reactions secondary to the involvement of the salivary glands, such as dry mouth, pain in the parotid glands and dysphagia, even after administration of low doses of radioiodine. However, ocular complications of such treatment are scarcely reported in literature.

Among them the investigators can mention recurrent and chronic conjunctivitis, keratoconjunctivitis sicca and dry eye, affecting 23% of patients undergoing radioactive iodine therapy. Dysfunction of the lacrimal gland is described in recent studies, especially after high cumulative dose of the drug. Likewise, epiphora and nasolacrimal duct obstruction have been reported as complications associated with the use of radioiodine, although studies are not available to assess its true incidence through the systematic evaluation of patients.

It can be seen in routine practice that these patients would normally be referred for ophthalmological examination only if a complaint, what happens in the process of OVL already installed after the use of high doses of radioiodine. With the early evaluation of these patients, the investigators focused on detecting the process of ongoing obstruction in order to study interventions that prevent its final installation.


Eligibility Criteria:
Inclusion Criteria:

* Thyroid carcinoma
* Previous thyroidectomy

Exclusion Criteria:

* Potential causes of dry eye (autoimmune diseases, contact lens wearers or drugs that alter tear production, such as antihistamines and psychotropic)
* Use of other anti-neoplastic, such as 5-fluorouracil and docetaxel, which can cause epiphora and OVL
* Lacrimal gland / ocular trauma
* Radiation therapy for other diseases or radiotherapy of head and neck
* Patients with diseases that alter the neural control of tear secretion, hormone therapies, pterygium, Graves' disease with or without ophthalmopathy, blepharitis and other conditions that may reduce tear production or result in rapid evaporation.
Diabetes eConsult Non-Inferiority Study

Flash glucose monitoring is an FDA-approved and widely clinically available, glucose monitoring technology that is worn on the body and measures glucose values every 15 minutes, storing this data for up to 14 days. The Freestyle Libre Pro is already used as a diagnostic technology in clinical care. It provides a full 24-hour glucose profile for each day that the sensor is worn and that can be correlated with daily activities, medication administration, food intake, and other factors that are contextually relevant in meeting glycemic goals for an individual patient.

In this study, patients referred to Endocrinology for specialty diabetes care will be randomized to an in-person visit as is typically done or to wear the Freestyle Libre Pro placed by staff at their primary care clinic. Patients who wear the Freestyle Libre Pro will have a professional interpretation of their glucose data completed by an endocrinologist as well as a remote eConsult completed using this glucose data and information from their medical record. The recommendations from the eConsult regarding medication and lifestyle adjustment as well as potential referral on to see Endocrinology will be implemented by the primary care physician at their clinical discretion.

The investigators will utilize glycemic measures including hemoglobin A1c, number of clinical visits (outpatient, inpatient and emergency department) for diabetes care, patient reported outcomes including self-efficacy, and patient and provider assessments of burden to determine if eConsults utilizing flash glucose monitoring technology are non-inferior to in-person visits with a diabetes specialist.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects age 18-80, inclusive
* Diagnosed with type 2 diabetes at least 6 months prior to screening
* Not previously seen within the prior three years in the endocrinology clinic for diabetes management
* Referred to endocrinology for diabetes care directly from primary care
* Willing to wear an Abbott® FreeStyle Libre Pro for 7-14 days
* English speaking
* Able and willing to complete questionnaires

Exclusion Criteria:

* Planned travel or surgery during the time of libre wear
* Patients without a diagnosis of type 2 diabetes, including individuals with type 1 diabetes and gestational diabetes
* Women referred for diabetes care during pregnancy, or while breastfeeding or who intend to become pregnant during involvement in this trial
* Currently using real time CGM or FGM system
* Concurrent involvement in another clinical trial using diabetes pharmacotherapy
* Individuals with active malignancy undergoing treatment with chemotherapy and/or high dose glucocorticoids
* Individuals with rheumatic disease undergoing treatment with high dose glucocorticoids
* Planned magnetic resonance imaging (MRI), computed tomography (CT) scan, or high-frequency electrical heat (diathermy) treatment during the time of Libre wear
* Any cognitive or other disorders, in the investigator's opinion, that may interfere with participation or ability to follow the study protocol