cyrilzakka/clinical-trials huggingface dataset:
The Effect of Random Vibrations on Perception and Balance

The purpose of this study is to investigate the effects of vibrating insoles on vibration perception threshold (VPT) and balance of people with diabetic neuropathy.

Rationale: People with diabetes mellitus often suffer from polyneuropathy. Reduced somatosensation of the feet due to polyneuropathy is one of the major risk factors for ulceration at the plantar side of the feet and may often cause problems in balance. It has been shown that the application of a mechanical noise signal to the feet (a vibration with a random frequency) can reduce the sensation threshold and improve standing balance. However, techniques used in research so far have several problems that limit applicability in daily practice. New vibrating insoles have been developed that overcome these problems, but it is unknown if these insoles have the same effects.

Study population: Two samples of 20 consecutive patients with diabetes mellitus will be included. Patients will be included if their VPT is between 25 and 45V. Patients with a history of ulceration on MTP, halllux or heel region will be included in the first sample group. In the second sample group patients with no history of ulceration will be included. Patients with an ulceration or (a history of) amputation will be excluded in both groups.

Intervention: First, participants will be standing on vibrating insoles placed on a platform for the measurement of VPT. Secondly, participants will be standing on a force platform while wearing standardized shoes in which vibrating insoles are placed. The insoles are either turned on (i.e. random vibrations applied) or off (i.e. no random vibrations applied).

Main study parameters: Vibration perception threshold and centre of pressure displacements.

Eligibility Criteria:
Inclusion Criteria:

* Diabetes mellitus, type I or type II
* Aged 18 years or older
* Diagnosed with neuropathy
* VPT between 25-45V
* Understand Dutch or English
* Is able to detect the stimulus at full power

Exclusion Criteria:

* A history of neuropathic conditions other than diabetes mellitus
* Problems with the somatosensory or motor system that affect balance or plantar sensation, not related to DM (for example: CVA)
* Severe visual problems
* Current ulcer
* (a history of) amputation
Kinetic Study of Lp(a) and PCSK9 in Humans

The aim is to study the relationship between lipoprotein(a) \[Lp(a)\] and PCSK9 (Proprotein Convertase Subtilisin/Kexin type 9) in humans with a kinetic study of lipoproteins in patients with dramatic increase of Lp(a) and controls.

Elevated plasma levels of lipoprotein(a) \[Lp(a)\] are independently associated with an increased risk of cardiovascular diseases (CVD). Recently an unexpected and significant 15 to 30 % reduction of Lp(a) was reported with PCSK9 (Proprotein Convertase Subtilisin/Kexin type 9) inhibitors. The relation between Lp(a) and PCSK9 are unclear and debated.

Kinetic studies of lipoprotein are an important tool to decipher the complexity of apolipoprotein metabolism in human. The comparison of apoprotein(a) and PCSK9 kinetic parameters of patients with extreme lipid disorder link to PCSK9 and apo(a) will allow to better understand the impact of PCSK9 on apo(a). From one previous in vitro study, the hypothesize is that PCSK9 increases the production rate and the assembly of Lp(a).

The objectives are to explore the relationship between the plasma concentration of PCSK9 and apo(a) production rate as well as the impact on the catabolic rate. Patients with extreme Lp(a) levels and healthy controls will be explored by performing a continuous infusion of deuterated leucine for 14 hours. LC/MS-MS will be used to analyze the samples and kinetic data of apo(a) and PCSK9 will be generated from a compartmental model. Tracer enrichment analysis could be complicated for proteins with low plasma concentrations as PCSK9. This issue will be solved with SPE and/or immune affinity concentration techniques. Non-parametrical test and multivariate analysis will be use to describe the relationship between these two variables.

This study will provide new knowledge on Lp(a) and PCSK9 metabolism and their interactions in humans.

Eligibility Criteria:
Inclusion Criteria:

* age: 18 to 75 years
* For subjects in the "Control" group: Patients with no major LDL-cholesterol deficiency (patients eligible for LDL-apheresis, eg LDL-C\> 200 mg / dL for secondary prevention and 300 mg / dl in primary prevention)) and a level of Lp (a) \<50 mg / dl or
* For subjects in the "high-dose" group: Patients with no major LDL-cholesterol abnormalities (LDL-apheresis eligible patients, eg LDL-C\> 200 mg / dL for secondary prevention and 300 mg / dl in primary prevention)) and a level of Lp (a)\> 80 mg / dl Whenever possible, groups will be balanced for age, sex, familial forms of hypercholesterolemia and their major groups of mutations.

Exclusion Criteria:

* Patients treated with PCSK9 antibodies.
* Patients with acute illness and considered incompatible by the investigator
* Uncontrolled diabetes (HbA1c\> 8.5%)
* Severe hepatic insufficiency
* Creatinine clearance \<30 ml / min
* Patients not covered by a social security scheme or beneficiary of such a scheme
* Patients unable to understand and / or sign consent
* Pregnant or lactating women
* Minors
* Majors under guardianship or trusteeship or safeguard of justice
Efficacy of AFL-assisted PDT With Short Incubation Time in Actinic Keratosis

Photodynamic therapy (PDT) using methyl aminolevulinate (MAL) is an effective first-line treatment for actinic keratosis (AK). Erbium: yttrium-aluminium-garnet (Er:YAG) ablative fractional laser-assisted MAL-PDT (AFL-PDT) has shown significant benefit for the treatment of AK. However, knowledge on the optimal photosensitizer incubation time for AFL-PDT is limited

Photodynamic therapy (PDT) is widely used in the treatment of superficial skin cancer. It has an excellent cosmetic outcome, and it could be considered the first-line therapy for Actinic keratosis (AK). In PDT incubation time is required so that the photosensitizer can be converted to PpIX. The recommended treatment regimen of PDT requires a relatively long incubation time with ALA (4 hours) and MAL (3 hours) before illumination. Theoretically, ablative fractional laser (AFL) pre-treatment may facilitate the penetration and distribution of topically applied drugs, since the ablated laser holes extend into the dermis, thereby possibly acting as channels for drug uptake. However, knowledge on the optimal photosensitizer incubation time for AFL-PDT is limited. The objectives of this study were to compare the efficacy, recurrence rate, cosmetic outcome, and safety between AFL-PDT with 2 and 3hours of incubation vs. conventional MAL-PDT in patients with facial and scalp AK.

Eligibility Criteria:
Inclusion Criteria:

* age \>18 years
* the presence of 2-10 facial AK lesions

Exclusion Criteria:

* lactating or pregnant women
* patients with porphyria
* a known allergy to any of the constituents of the MAL cream and lidocaine
* patients with systemic disease
* history of malignant melanoma
* tendency for melasma development or keloid formation
* any AK treatment of the area in the previous 4 weeks
* any conditions associated with a risk of poor protocol compliance
* patients on immunosuppressive treatment
The Effects of MBSR on Patients With TBI and Chronic Insomnia

To evaluate the effects of Mindfulness Based Stress Reduction (MBSR) as an adjunct to usual clinical care for treatment of stress and chronic insomnia for patients with mild to moderate traumatic brain injury (MTBI). MBSR is a standardized protocol of meditation and yoga that has been studied extensively in other populations, however the effects of MBSR have not yet been well studied in the proposed population of service members with a Traumatic Brain Injury (TBI) who are experiencing insomnia.

Randomized, controlled trial with 1:1 randomization (n=50). The control group will receive the usual care for TBI through the clinical program with standard providers based on usual patient evaluation and needs. The intervention group will receive MBSR in addition to the usual care through the TBI program.

The usual care pathway will include physician visits, rehabilitation therapies (PT/OT/ST/et al), and other providers as needed based on recommendations by his or her providers. Some variability will exist, but withholding standard of care would be unethical and standardizing care would be impossible. However, providers will be asked that medications, et al that could affect sleep remain unchanged during the trial period (maximum 12 weeks), which is reasonable given that patients have a chronic injury and no emergent/acute needs based on inclusion/exclusion criteria.

Subjects in a control group will be offered complimentary MBSR after 6 month follow up visit is completed.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with mild-to-moderate TBI (as defined by the DoD criteria)
2. Right-handedness
3. Insomnia Severity Index ≥15
4. DEERS eligible at the time of enrollment
5. Not pregnant
6. Male and female subjects 18 to 60 years old
7. Insomnia disorder per DSM-V criteria

Exclusion Criteria:

1. Inability to speak or understand English (because this is a group intervention, it requires a common language)
2. Patients who require assistance with activities of daily living (ADLs)
3. Active practice of meditation and/or yoga or participation in meditation/yoga classes in the last 6 months prior to enrollment
4. Signs or symptoms of upper motor neuron syndrome, any major systemic illness or unstable condition which could interfere with protocol compliance
5. Active psychiatric disease that would interfere with participation in the trial, psychotic features, agitation, or behavioral problems within the last 3 months that could interfere with protocol compliance
6. A history of alcohol/substance abuse or dependence within the past 6 months
7. Any neurosurgical intervention affecting brain parenchyma
8. Unstable seizure activity
9. Concurrent participation in another clinical research trial with investigational drug or previous participation with the last investigational drug administered less than 4 weeks prior to screening
10. Females who are pregnant or planning to become pregnant in 6 months following screening.
Education Intervention in Patients with Rash Due to Epidermal Growth Factor Receptor (EGFR) Treatment.

The main adverse reaction of EGFR seen in patients is rash. EGFR treated patients have a 24-95% incidence of rash depending on the type of treatment they receive. Skin toxicity may occur in more than 80% of patients treated with cetuximab.

If a severe rash (Grade 3 or 4) occurs, a dose reduction or discontinuation of treatment may be required. Also, infections are the main secondary side effect caused by the rash.

The aim of the study is through a randomized clinical trial feasibility study to investigate the effectiveness of an educational intervention in patients receiving EGFRI therapy.

It will be randomly selected which patients will belong to the intervention group and who in the control group. The type of program involves educational intervention.

In recent years, EGFRI (Epidermal Growth Factor Receptor Inhibitor) have evolved as effective anti-cancer drugs. They are distinguished in monoclonal antibodies (cetuximab and panitumumab) and EGFR (TKIs) kinase inhibitors gefitinib, erlotinib and lapatinib, where they are used in the treatment of colon, rectal, head and neck, lung, pancreas and of breast.

According to studies, the usual treatment for the prevention and treatment of skin rash refers to the use of antibiotics such as doxycycline, tetracycline and cortisone products such as hydrocortisone. It is also recommended to use moisturizing cream.

The study of Carmine P. et al., 2011 mentions the need to investigate educational measures for the rash due to EGFR treatment.

Eligibility Criteria:
1. Adult cancer patients (\>18).
2. Patients who suffered with pruritus, or rash or photosensitivity, in the onset of the symptoms.
3. Willing to participate.
4. Ability to complete the questionnaires.
5. A performance status of two or less on the Eastern Cooperative Oncology Group (ECOG).
6. Patients with no pre-existing dermatological condition that may limit the interpretation of results.
Skeletal Muscle Wasting and Insulin Resistance Following Surgical Stress

Background: Skeletal muscle wasting or decrease in muscle mass occurs as a result of alteration in the body's mechanisms to make or break muscle protein. In animal models, the pathway termed as 'ubiquitin-proteasome pathway' (UPP) is primarily responsible for the regulation of skeletal muscle protein loss in wasting conditions and during infection(sepsis). Skeletal muscle wasting is noticed in patients having major surgery due to the inflammatory reaction triggered by special group of proteins called cytokines (inflammatory proteins), resulting in reduced muscle strength, impaired capacity to fight infections, change in bowel function, increased clinical complications and prolonged recovery. Major surgery also leads to decreased sensitivity to hormone known as insulin, resulting in 'diabeteslike'state.

We hypothesize that susceptibility of patients undergoing major abdominal surgery, to skeletal muscle wasting and insulin resistance, is determined by stress response to surgery over time, leading to changes in the pathways that make or break muscle protein, namely the Akt/Foxo signalling and UPP. Therefore, the aim of this study is to establish the underlying mechanisms of skeletal muscle wasting and insulin resistance in patients undergoing major abdominal surgery.

Experimental plan Fifteen adult patients undergoing major open elective abdominal surgery will be included in this nonrandomized study.

Objectives:

1. To study the expression proteins and metabolites involved in UPP mediated protein degradation, in blood and muscle biopsy samples.
2. To correlate the effects of surgery on the release of bacteria in blood from the bowel.

The analysis of the samples will include the following techniques, namely, RTPCR, ELISA, western blotting and metabolomics.

Establishing the association between these signaling mechanisms and expression of the individual proteins secondary to inflammation following surgery and infection would enable application of suitable therapeutic strategies that could reduce the inflammatory response to benefit all patients undergoing surgery.

Eligibility Criteria:
Inclusion Criteria:

* All adult patients undergoing major open elective gastrointestinal surgery lasting 3 hours or more will be eligible for the study.

Exclusion Criteria:

* Patients who are:

  1. undergoing emergency surgery
  2. suffering from chronic illness, (e.g. diabetes) or other debilitating diseases
  3. on long term anti-inflammatory drugs, (e.g. NSAIDS, Steroids, immunosuppressant)
  4. on long term antibiotics
  5. on statins
  6. on full therapeutic dose of anticoagulants, or aspirin \> 325 mg/day, clopidogrel \> 75 mg/day
  7. suffering from bleeding diathesis
  8. unable to give consent
  9. pregnant or breastfeeding
Role of Novel ILR in the Management of PVCs

This prospective, observational study is a single center clinical registry of patients referred for management of symptomatic or asymptomatic Premature Ventricular Contractions (PVCs). Subjects will be followed through 12 months. The study will enroll approximately 50 patients.

This study is intended to monitor patients presenting with Premature Ventricular Contractions (PVCs) and ventricular arrhythmias using implantable loop recorders (ILRs) from the time of their initial presentation of PVCs to assess for the incidence of all cardiac arrhythmias detected with long term monitoring in this population. It is also intended to evaluate for clinical, biomarker and radiological evidence of myocarditis in this cohort to understand association with incident arrhythmias and understand the role of implantable loop recorders (ILRs)in managing these patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years of age
* Have a Medtronic LINQ II ILR
* Willing and able to give written informed consent

Exclusion Criteria:

* History of myocardial infarction
* Significant flow-limiting coronary artery disease (≥50% stenosis) on invasive coronary angiography or Computed tomography angiography (CTA).
* History of cardiac arrest
* With existing implantable defibrillators
* Currently pregnant
Mental Health Status and Related Factors Among Physical Medicine & Rehabilitation Physicians in the Covid-19 Pandemic

In December 2019, a highly infectious disease caused by a novel coronavirus (SARS-CoV-2) emerged in Wuhan, China. On March 11th 2020, the World Health Organization (WHO) declared COVID-19 a pandemic. Facing this critical situation, health care workers on the front line are at risk of developing psychological distress and other mental health symptoms. Physical medicine and rehabilitation (PM\&R) physicians works both in specialty outpateint/inpatient clinic and pandemic outpatient/inpatient clinics during the outbreak. Accordingly, PM\&R physicians are expected to be mentally affected by COVID-19 pandemic. In this study we aimed to evaluate mental health status of PM\&R physicians and related factors during COVID-19 pandemic. This study is a cross-sectional survey which is conducted on an online platform. Demographic data, working conditions of PM\&R physicians and factors that may be related to mental health status is questioned in the survey. The Depression, Anxiety and Stress Scale - 21 (DASS-21) is used to measure the emotional states of depression, anxiety and stress.The Insomnia Severity Index (ISI) is used to assess the severity of both nighttime and daytime components of insomnia.


Eligibility Criteria:
Inclusion Criteria:

* Being a physical medicine and rehabilitation physician
* Worked during COVID-19 pandemic in specialty outpatient/inpatient clinic or pandemic outpatient/inpatient clinic.

Exclusion Criteria:

* Being a specialist in a branch other than physical medicine and rehabilitation
A Study of Olezarsen (ISIS 678354) in Participants With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease, or With Severe Hypertriglyceridemia

The purpose of the study is to evaluate the effect of olezarsen on percent change in fasting triglyceride (TG) levels compared to placebo in participants with hypertriglyceridemia and atherosclerotic cardiovascular disease, or with severe hypertriglyceridemia.

This is a Phase 3, multi-center, placebo-controlled study in approximately 1475 participants with hypertriglyceridemia and atherosclerotic cardiovascular disease. The study consists of 3 periods: 1) Screening Period: Week -12 to Week -1 (up to 12 weeks); 2) Treatment Period up to Week 53; and 3) Post-Treatment Follow-up Period: Week 54 to Week 66 (13 weeks). Participants enrolled will receive olezarsen or placebo once every 4 weeks during the 53-week Treatment Period.

The Screening Period was extended with no impact to overall study timelines.

A coronary computed tomographic angiography (CTA) sub study will be performed to assess whether triglyceride lowering through inhibition of apoC-III protein synthesis may reduce coronary plaque progression.

Eligibility Criteria:
Inclusion Criteria:

* Participants must fall into 1 of the following groups (a or b):

  a. Hypertriglyceridemia with fasting TG ≥200 mg/dL (2.26 millimoles per liter \[mmol/L\]) and \<500 mg/dL (5.65 mmol/L) with either
* Clinical diagnosis of atherosclerotic cardiovascular disease (ASCVD) or
* At increased risk for ASCVD

  b. Severe hypertriglyceridemia with fasting TG ≥500 mg/dL (5.65 mmol/L)
* Participants should be on standard of care (SOC) lipid-lowering medications per local guidelines. Lipid-lowering medications should be optimized and stabilized for at least 4 weeks prior to Screening to minimize changes in these medications during the study.

Exclusion Criteria:

* Hemoglobin A1c (HbA1c) ≥ 9.5% at Screening
* Alanine aminotransferase or aspartate aminotransferase \> 3.0 × upper limit of normal
* Total bilirubin \> 1.5 upper limit of normal unless due to Gilbert's syndrome
* Estimated GFR \< 30 mL/min/1.73 m\^2

NOTE: Other Inclusion/Exclusion criteria may apply.
Study of TelmisartanFor the Prevention of Acute GVHD Post Allogeneic Hematopoietic Stem Cell Transplantation

This is single-center, open-label, prospective study of telmisartan for the prevention of acute GVHD in approximately 60 subjects undergoing allogeneic HCT for treatment of a hematologic malignancy.

This is single-center, open-label, prospective study of telmisartan for the prevention of acute GVHD in approximately 60 subjects undergoing allogeneic HCT for treatment of a hematologic malignancy. Subjects will receive 160 mg Micardis brand telmisartan once daily, starting 2 days prior to HCT (day -2). Once the patient is discharged post-HCT, treatment will continue through Day +98 post-HCT for a total of 101 days. After treatment discontinuation on or before day +98 post-HCT, subjects will be followed for up to 6 months for primary and secondary endpoints.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of:

  * Acute myeloid or lymphoid leukemia in remission,
  * Myelodysplastic syndrome,
  * Chronic lymphoid leukemia,
  * Non-Hodgkin lymphoma,
  * Hodgkin lymphoma,
  * Chronic myeloid leukemia in chronic or accelerated phase,
  * Myeloproliferative disorder, or
  * Multiple myeloma
* Undergoing allogeneic HSC transplantation from a related or unrelated donor matched at least at 7 of 8 of the HLA-A, -B, -C, and DR loci ("8/8" or "7/8" match)
* Undergoing allogeneic HSC transplantation after a myeloablative TBI-, busulfan-, or (non-myeloablative) melphalan-based pre-transplant conditioning regimen. Regimens for transplantation will include at one of the following agents, given in conjunction with fludarabine or cyclophosphamide:

  * Busulfan 130 mg/m2 iv daily x 2 (reduced intensity) or 4 days
  * TBI 150 cGy bid x8 doses (1200 Gy)
  * Melphalan 140 mg/m2. (Although melphalan is not a myeloablative regimen, it results in clinically significant mucositis and patients receiving this medication will be of considerable interest in the analysis of these data.)
* Male or female patient age 18 years or older
* Karnofsky performance status \> 70% at time of initiation of pre-transplant conditioning
* Transplantation-specific co-morbidity score of \<5 at time of initiation of pre-transplant conditioning
* Patients taking antihypertensive medications (including telmisartan) are eligible but the patient must discontinue treatment at least 48 hours prior to first dose of study medication
* Capable of giving informed consent and having signed the informed consent form

Exclusion Criteria:

* Inability to provide informed consent
* Subjects with known heart failure, advanced renal impairment requiring renal replacement therapy, or liver failure although these patients would most likely not be eligible for HCT.
* Subjects taking ACE inhibitors, potassium supplements, or spironolactone (or any other potassium-sparing diuretics) who cannot discontinue use prior to initiation of study treatment OR who require a high-potassium diet
* Patient unable to discontinue current hypertension medication for medical or other reasons for two days prior to starting telmisartan
* Chronic symptomatic hypotension, volume depletion.