cyrilzakka/clinical-trials huggingface dataset:
The Effect of Plantar Vibration on the Progression of Peripheral Neuropathy

The purpose of this study is to assess the effect of vibration of the plantar surface of the foot on peripheral neuropathy.

Background: Peripheral neuropathy has a prevalence approaching 10% in the general population. The pathophysiology of peripheral neuropathy is poorly understood or undetermined. While many causes of peripheral neuropathy are known, a significant number of cases are idiopathic. The most common cause of neuropathy relates to glucose intolerance or overt diabetes. Exogenous factors such as smoking constrict small cutaneous blood vessels, thereby inhibiting small nerve fiber nutrition. Symptoms of neuropathy include numbness, pain, difficulty with balance, lack of temperature perception, and weakness which can lead to significant disability. Classification of neuropathies can be made based on nerve fiber size: large fiber, small fiber and mixed large and small fiber types. Plantar vibration which affects large fibers has been demonstrated to enhance peripheral and systemic blood flow, peripheral lymphatic and venous drainage (Stewart, Karman, Montgomery, \& McLeod, 2005). Since fluid retention in axons, nerve sheaths and surrounding connective tissues may contribute to neuropathy, it is hypothesized that plantar vibration may repair the small peripheral fibers, thereby improving the symptoms of neuropathy.

Purposes:

1. To assess the effect of plantar vibration on regeneration of small peripheral nerve fibers, peripheral neuropathy and quality of life in patients with diagnosed peripheral neuropathy.
2. To assess the correlation of health history, demographic variables, diet, alcohol and smoking history with small fiber neuropathy analysis by skin biopsy and plantar vibration.

Design: The study will employ a cross-over experimental design with subjects acting as their own controls. Independent variables are the plantar stimulation (intervention), and the characteristics of the subjects that include health history, demographic variables, self reported diet, alcohol, and smoking history, as well as urinary cotinine (a quantitative measure of smoking history). The dependent variables are the assay of intraepidermal nerve fibers in small-fiber neuropathy, clinical assessment of peripheral neuropathy, serum levels of Hgb A1C, and quality of life measurement.

Eligibility Criteria:
Inclusion Criteria:

* Clinical evidence of neuropathy
* Normal to moderate evidence of neuropathy on nerve conduction studies

Exclusion Criteria:

* Currently on medications with a known risk of neuropathy
* Pregnant
* Evidence of peripheral vascular disease
Real-world Outcomes of Patients With HER2+ Metastatic Breast Cancer After Treatment With Trastuzumab Deruxtecan

This study will explore treatment patterns and clinical outcomes using the US-based Flatiron Health database to describe patients with HER2+ mBC who were previously treated with T-DXd to better characterize this population and inform internal decision making in this rapidly changing therapeutic landscape.

This study will utilize a longitudinal, demographically and geographically diverse database derived from Electronic Health Record data. No study medication will be supplied or administered for this protocol. The primary research objective is to describe the real-world progression-free survival (rwPFS) in HER2+ mBC patients who initiated a subsequent line of therapy (LOT) after a T-DXd-containing LOT in the metastatic setting.

Secondary research objectives include describing the real-world overall survival (rwOS), patient demographics and clinical characteristics, real-world time to next treatment (rwTTNT), and real-world time to treatment discontinuation (rwTTD) in HER2+ mBC patients who initiated a subsequent LOT after a T-DXd-containing LOT in the metastatic setting. Treatment patterns and sequencing in HER2+ mBC patients for subsequent LOTs following initial treatment with T-DXd will also be assessed.

Eligibility Criteria:
Inclusion Criteria

Patients must meet all the inclusion criteria below to be included in the study population:

1. Patients with evidence of stage IV or recurrent mBC with a metastatic diagnosis date on or after January 1, 2011.
2. Patients aged ≥18 years old at mBC diagnosis date.
3. Patients with ≥1 T-DXd-containing LOT in the metastatic setting.
4. Patients with evidence of a subsequent LOT following the first T-DXd-containing LOT in the metastatic setting. The LOT subsequent to the first T-DXd-containing LOT in the metastatic setting will be the index LOT. Index date will be the index LOT start date.
5. Patients whose closest HER2 test result (defined as immunohistochemistry \[IHC\] 3+ or in situ hybridization \[ISH\]+) recorded prior to or on the index date was a HER2+ test result.
6. Patients with index date occurring at least 90 days prior to end of study period (March 31st, 2024).

Exclusion Criteria No exclusion criteria will be imposed.
Demonstrating Effective Salvage of Inadequate Colonoscopies

The aim of this study is to demonstrate that the use of the Pure-Vu EVS System can salvage inadequately prepared optical colonoscopies (OCs) to adequate OCs.

The primary objective of this study is to demonstrate the reduction of inadequate colonoscopies when Pure-Vu EVS System is used to salvage inadequately prepped colons as defined by the multi-society guidelines (USMSTF).

Eligibility Criteria:
Inclusion Criteria:

1. Eligible adults aged between 40-80
2. Elective outpatient colonoscopy by participating gastroenterologist

Exclusion Criteria:

1. Not competent to consent
2. Known or suspected bleeding disorders such as, but not limited to hemophilia and von Willebrand disease
3. History of colonic resection
4. Prior incomplete colonoscopy due to patient anatomy
5. Diverticulitis
6. Active Inflammatory bowel disease (Crohn's, Ulcerative Colitis, or Indeterminate)
7. Known or suspected colon stricture
8. Hereditary Colorectal Cancer Syndrome
9. Subject is pregnant or suspected pregnant
Echocardiographic Characterization of Cardiac Amyloidosis

This is a mono-center observational ambispective study in which patients with cardiac amyloidosis evaluated at the Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Rome, Italy) will be enrolled.

The primary aim is to investigate echocardiographic findings, particularly using advanced echocardiographic techniques, such as two- and three-dimensional speckle-tracking analysis, that may be helpful in the differential diagnosis between cardiac amyloidosis and other cardiomyopathies with hypertrophic phenotype.

Secondary aims are: 1) to evaluate the reversibility of myocardial damage, assessed by echocardiography, in response to a newly available specific treatment for patients with transthyretin-related cardiac amyloidosis (tafamidis) and its correlation with the clinical response 2) to investigate potential novel echocardiographic predictors of adverse cardiovascular outcomes.


Eligibility Criteria:
Inclusion Criteria:

* patients with cardiac amyloidosis, defined according to the recommendations provided by the working group of the european society of cardiology, with clinical, electrocardiographic ed echocardiographic data and with at least one follow-up visit.

Exclusion Criteria:

* missing data
* decline to the study participation
The Effect of Cannabis on Pain and Related Quality Of Life Outcomes In Chronic Pain: A Prospective Open-Label Study

The objective of the current study is to prospectively assess the effect of cannabis on pain and functional outcomes in a large group of patients with chronic pain.

This is a prospective, observational, open-label study carried out at the ambulatory pain clinic of Hadassah-Hebrew University Medical Center Pain Relief Unit.

Study population: Patients suffering from chronic pain that has not been relieved with other analgesic medications, who are eligible for treatment with medical cannabis (cigarettes, oil or cookies) following approval of Israeli Ministry of health.The patients will receive a prescription to be dispensed at pre-approved cannabis distribution points by a certified provider.

In this study, the efficacy of the cannabis treatment on pain and related quality of life (QoL) outcomes will be assessed by administering the S-TOPS questionnaire (Haroutiunian, Pain 2012), and the Brief Pain Inventory (BPI) before the treatment (baseline), and on expected follow-up visits at approximately 6 and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years old
* Chronic pain, with duration of 3 months or longer
* Lack of satisfactory analgesic response or intolerable adverse effects with at least two analgesics from 2 different drug classes at full dose.

Exclusion Criteria:

* Inability to read and understand the informed consent form.
* History of drug abuse/dependence
* Psychiatric co morbidity (or history) of schizophrenia or acute psychosis.
* Family history of schizophrenia.
* Psychologist evaluation of high abuse risk.
Clinical Outcomes of Patients Implanted With the RxSight Light Adjustable Lens (LAL)

The objective of this investigator initiated study (IIT-002) is to collect data on commercial patients implanted with the RxSight Light Adjustable Lens (LAL).


Eligibility Criteria:
Inclusion Criteria:

* Sign a written Informed Consent Document
* Implanted commercially with the LAL and completed LDD light treatments

Exclusion Criteria:

* Previous corneal or intraocular surgery other than removal of cataract and implantation of the LAL
Topical Application of Tranexamic Acid and Postoperative Blood Loss in Femoral Neck Fractures

Tranexamic acid (TA) is a synthetic antifibrinolytic agent. It prevents degradation of fibrin and delays the breakdown of hemostatic clots. It has been demonstrated in multiple studies and meta analyses to decrease blood loss in elective hip and knee arthroplasty. However, concerns about the prothrombotic side effects of systemic administration of TA has hindered the widespread adoption of this medication in orthopaedic patients due to their high risk for thrombotic complications such as deep venous thrombosis and pulmonary embolism Topical application of tranexamic acid has been proposed as a way to mitigate the potential prothrombotic effects of TA. Topical application of TA has been demonstrated to be beneficial in oral and cardiac surgery. Plasma levels of TA have been found to be minimal following topical application, minimizing its potential systemic thromboembolic side effects. TA has been used topically in total knee arthroplasty, with significant reductions in blood loss and no increase in thromboembolic complications8,10. Data on the use of TA in hip fracture surgery is limited, and there are no studies examining topical use of TA in hip fracture surgery.

Our study question is: Does topical tranexamic acid decrease blood loss following hemiarthroplasty of the hip for femoral neck fractures? The type of information collected by the research assistant will consist of estimated blood loss during surgery, length of stay in hospital, any wound infections as well as any thromboembolic side effects (blood clots in legs and/or heart) that may occur. The number of units of red blood cells transfused will be recorded up to and including postoperative day 8. Preoperative hemoglobin and lowest postoperative hemoglobin levels up to and including post-op day 8 will also be collected as well as any use of ambulatory aids will be recorded on presentation to hospital, discharge and 6 weeks post operatively.

Eligibility Criteria:
Inclusion Criteria:

* hip fracture patients
* aged 65 and older.

Exclusion Criteria:

* bilateral femoral neck fracture patient and/or one that is not suited to a hemiarthroplasty repair.
Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-1117568 in Adults With Schizophrenia

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, multi-arm, multi-stage inpatient study designed to assess the efficacy, safety, tolerability, and pharmacokinetics (PK) of NBI-1117568 compared with placebo in adult subjects with a primary diagnosis of schizophrenia, who are experiencing an acute exacerbation or relapse of symptoms.


Eligibility Criteria:
Key Inclusion Criteria:

* Completed informed consent.
* Subject has a primary diagnosis of schizophrenia.
* The subject is experiencing an acute exacerbation or relapse of symptoms and currently requires hospitalization.
* Subjects taking prohibited medications, including antipsychotics, must discontinue before study participation
* Subject is willing and able to remain in an inpatient setting for the study duration, follow instructions, and comply with the protocol requirements.

Key Exclusion Criteria:

* An unstable medical condition, chronic disease, or malignancy.
* Considered by the investigator to be at imminent risk of suicide or injury to self or others.
* Diagnosis of moderate or severe substance use disorder (with the exception of nicotine or caffeine dependence) within 6 months prior to screening.
* Positive alcohol test or drug screen for disallowed substances.
* Have a history of poor or suspected poor compliance in clinical research studies and/or in the investigator's opinion, the subject is not capable of adhering to the protocol requirements.
Group Exercise in Cancer Patients Under Active Treatment: Feasibility Pilot Study.

The aim of this study to investigate the feasibility in hospital reality, of a group exercise program for oncology patients under active treatment and evaluate its impact on some outcomes considered relevant from both clinical and subjective point of view.

The intervention will consist of EFG sessions lasting 45 minutes each, twice a week for 12 weeks to be carried out in the gym of the Rehabilitation Day Hospital.

Each 45-minute session includes an initial relaxation/stretching phase, simple aerobic exercises, muscle strengthening exercises, balance exercises, and will be led by a physiotherapist. The exercises proposed to the group with ECOG 2 will be less intense and of less difficulty with the aim of adapting the activity to patients with a lower performance status (see appendix 4.5, V2, 07/10/2024). The groups will consist of a minimum of five patients and a maximum of ten. Patients will also be stimulated to perform physical activity at home to a total of 150 minutes per week. Patients will be assessed at baseline (T0), at the end of the intervention (T1,12 weeks) and 6 months after the start of the intervention (T2).

Eligibility Criteria:
Inclusion Criteria:

* neoplastic tumor
* age\>= 18
* prognosis\> 12 months
* ECOG \<=2
* Walking with/ without aids
* clinically stable
* signed informed consent
* Patients with bone metastases with ECOG from 0-1 suitable results

Exclusion Criteria:

* sensory deficits who cannot perform physical exercise
* cognitive impairment that compromises collaboration and questionnaire filling
* patients with pathologies (e.g. neurological, psychiatric) that do not allow the obtaining of valid informed consent
Fluorescence Detection of Adult Primary Central Nervous System Tumors with Tozuleristide and the Canvas System

The purpose of this study is to examine the use of a single dose of tozuleristide (24 or 36 mg) and the Canvas imaging system during surgical resection of primary central nervous system (CNS) tumors: Primary gadolinium enhancing (high grade) CNS tumors, primary non-gadolinium enhancing CNS tumors, and primary vestibular schwannoma.

The primary objectives of the study is to see how well tozuleristide and the Canvas imaging system during surgical resection will show fluorescence among primary enhancing/high grade CNS tumors; and among the tumors that demonstrate tozuleristide fluorescence, to estimate the true positive rate and true negative rate of fluorescence in tissue biopsies, as well as sensitivity and specificity of tozuleristide fluorescence for distinguishing tumor from non-tumoral tissue.

The secondary objectives of the study include evaluating the safety of tozuleristide and the Canvas imaging system, and to determine if the presence of remaining fluorescence at the time of surgery corresponds to remaining tumor evident on post-operative MRI images, or if the absence of fluorescence corresponds to evidence of no gross residual tumor on post-operative magnetic resonance imaging (MRI).


Eligibility Criteria:
Inclusion Criteria:

* MRI obtained within 30 days of study enrollment documents a measurable lesion consistent with a primary malignant central nervous system tumor for which maximal safe resection is indicated OR MRI obtained within 30 days of study enrollment documents a measurable lesion consistent with a primary schwannoma enhancing tumor in the cerebellopontine angle for which maximal safe resection is indicated.
* Adequate renal and liver function
* Subjects with prior therapy are eligible provided they have recovered from any acute toxic effects of prior therapy and have sufficient time interval prior to enrollment.

Exclusion Criteria:

* Pregnant, breast-feeding, or planning to conceive a child within 30 days
* Ongoing serious medical conditions such that participation in the study could put the subject at increased risk of worsening their condition
* Subjects planned to undergo only a diagnostic biopsy procedure, without intent to resect tissue for therapeutic purposes
* Subjects for whom radiographic evidence suggests a non-intra-axial primary brain tumor
REGN5381 in Adult Participants With Heart Failure With Reduced Ejection Fraction

This study is researching an experimental drug called REGN5381 (called "study drug"). The study is focused on patients with heart failure with reduced ejection fraction (ie, the heart is not functioning as well as it should).

The aim of the study is to see how safe, tolerable, and effective the study drug is.

The study is looking at several other research questions, including:

* What side effects may happen from taking the study drug
* How much study drug is in the blood at different times
* Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)


Eligibility Criteria:
Key Inclusion Criteria

1. Body mass index (BMI) between 18 and 45 kg/m2, inclusive, at initial screening visit
2. Diagnosis of chronic heart failure
3. Left ventricular ejection fraction 20-49% by echocardiogram performed within 3 months of screening
4. Plasma NT-proBNP ≥800 pg/mL (or ≥1000 pg/mL if in atrial fibrillation) at screening (visit 1) and NT-proBNP ≥600 pg/mL (or ≥800 pg/mL if in atrial fibrillation) approximately 30 days prior to randomization (visit 5)
5. Receiving optimized standard of care therapy for heart failure as described in the protocol
6. Sacubitril-valsartan cohort only: treatment with sacubitril-valsartan at screening and at baseline
7. Low eGFR cohort only: eGFR of 30-45 mL/min/1.73 m2 at screening and within approximately 30 days of randomization

Key Exclusion Criteria

1. Hospital discharge within 180 days of anticipated randomization
2. Resting SBP that remains out of range after two repeated measurements prior to randomization as described in the protocol
3. Estimated glomerular filtration rate (eGFR) of \<45 mL/min/1.73 m2 according to locally used formula (Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] preferred), at screening (eGFR of 30-45 mL/min/1.73 m2 required for participants in the low eGFR cohort)
4. Current or recent diagnosis of acute coronary syndrome or myocardial infarction as described in the protocol
5. History of symptomatic autonomic dysfunction as evidenced by orthostatic hypotension and/or syncope
6. Unexplained syncope \<12 months prior to initial screening or during the Run-in period
7. History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disease, as assessed by the investigator that may confer unreasonable risk to the participant's participation in the study
8. Uncorrected congenital heart disease
9. Cardiac surgery within 6 months prior to screening or any planned surgery during the study
10. Implantation of a cardiac resynchronization therapy device in the prior 90 days, or planned during the study, or planned device optimization 30 days prior to randomization or during the study
11. Current chronic lung disease requiring long-term oxygen therapy

Note: Other protocol-defined inclusion/ exclusion criteria apply
Prospective Study to Validate Ablation Parameters with MRI Based Scar for Left Atrial Ablation

One of the goals of an ablation procedure is to create scarring of cardiac tissue. Not all ablations result in scar tissue. Advances in technology have improved scarring but ideal parameters that result in scar tissue are still not completely clear and there is great variability in the parameters used. Theoretically, intense ablation can always create scar tissue but is also likely to create more complications such as cardiac perforations. The investigator recently published another retrospective study looking at ablation parameters that reliably result in scar tissue but it had its limitations as it was retrospectively done.

This is a prospective study to validate the parameters that result in long term scarring. MRI has long been used to visualize ablation scar tissue. So in this study patients undergoing, initial left atrial ablation for atrial fibrillation as standard of care will undergo a 3 month post ablation MRI and that will be used to validate the ablation parameters.

A critical step to improve atrial fibrillation (AF) ablation broadly is to minimize interoperator variability. VISITAG SURPOINT calculated a marker tag index value by combining contact force, power setting, and duration of energy delivered. Use of VISITAG SURPOINT has accurately predicted sites of pulmonary vein reconnection and regional changes in late gadolinium enhancement (LGE) and T2 (edema) intensity 24 hours post ablation. Prospective use of the ablation index improves first pass pulmonary vein isolation and 1-year freedom from atrial tachyarrhythmias compared to conventional treatment.

There remains a paucity of data regarding if ablation guided by index values and VISITAG SURPOINT results in durable scar formation in humans in general and compared to conventional approaches. In addition, the relative contribution of the components of VISITAG SURPOINT impact scar formation in-vivo and across a broad diversity of atrial anatomies. Such data are critical in patients that present with various degrees of atrial myopathies, arrhythmia substrate, and anatomies.

Eligibility Criteria:
Inclusion Criteria:

* Paroxysmal or early Persistent AF (continuous AF duration less than 3 months and CHADSVASC great than or equal to 2).
* First time ablation for AF
* Agreeable to a 3 month MRI

Exclusion Criteria:

* Claustrophobic (unable to undergo MRI)
* Having undergone prior left atrial ablation including AT or atypical flutter
* Metal implants that preclude getting an MRI
* eGFR \< 30
A Survey to Evaluate Diabetes Management, Control, Chronic Complications, Psychosocial Aspects of Diabetic Subjects in Singapore

This study is conducted in Asia. The aim of this observational study is to evaluate current status of diabetes management, control and complications in diabetic subjects in Asia.


Eligibility Criteria:
Inclusion Criteria:

* Diabetic patients registered in the particular centre for more than 12 months
* Patients should have visited the centre at least once in the last 3-6 months apart from the initial visit
* Patients willing to sign informed consent form

Exclusion Criteria:

* Repetition of any patient as patients should not be included twice for any reason
* Unwilling to participate or unable to comply with protocol requirements