cyrilzakka/clinical-trials huggingface dataset:
Remote Monitoring with Health-Coaching for Lifestyle Changes in Patients with Lung Cancer Related Fatigue

This clinical trial investigates the effectiveness of a remote monitoring program for lifestyle changes in patients with lung cancer related fatigue (CRF). Fatigue is a common symptom of lung cancer and a side-effect of cancer treatments. CRF has a negative impact on patients' quality of life, daily activities, employment, social relationships and mood. Health coaches enable patients to develop and achieve self-determined wellness goals and assist patients to use their insight, personal strengths, goal setting, action steps, and accountability toward achieving healthy lifestyle changes. Remote monitoring with health-coaching may help relieve lung cancer related fatigue and increase the quality of life in cancer patients.

PRIMARY OBJECTIVE:

I. To assess the effect of the remote-monitoring program on patient reported fatigue by administering the Brief Fatigue Inventory (BFI), Functional Assessment of Cancer Therapy Fatigue (FACT-F), Functional Assessment of Cancer Therapy- Lung (FACT-L) and the Modified Fatigue Impact Scale (MFIS).

OUTLINE:

Patients undergo routine exercise using a remote monitoring system (Garmin Vívofit activity monitor, Nonin 3150 WristOx2 pulse oximeter, and an Android tablet) over 30 minutes at least 6 days per week and complete daily questionnaires over 20 minutes for 12 weeks. Patients also receive health coaching telephone calls over 5-20 minutes once a week for 12 weeks. At the end of the 12 weeks, patients complete an audio taped telephone interview.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with advanced lung non-small cell carcinoma (NSCLC) being treated with any line of non-curative intent, systemic treatment.
* Eastern Cooperative Oncology Group (ECOG) Performance Status from 0 (asymptomatic) to 2.
* The ability to read and respond to questions in English or Spanish
* Receiving primary cancer care at Mayo Clinic, Rochester or Mayo Clinic Health System (MCHS).
* Age \> 18 years.
* Life expectancy at least 6 months.
* Moderate or higher fatigue (\>= 4) on a scale of 0-10 based on fatigue rating to question: Rate your average fatigue over the last week, where 0 is no fatigue and 10 is extreme fatigue.

Exclusion Criteria:

* They have cognitive or psychiatric conditions as determined by the treating oncologist to prohibit study consent or participation.
Safety and Limitation of the 2nd Generation Laryngeal Mask Airway in the Lithotomy Position: An Obsevational Study

Laryngeal mask airway is used in different types of surgery requiring different position, recommendation was raised regarding the use of LMA in Lithotomy position with pressure controlled mode of ventilation. This raise a concern whether the mode of ventilation is a limitation for the use of LMA in these position, especially with the use of the i-gel LMA with the characteristic non-inflatable jelly cuff, that provides an excellent seal.


Eligibility Criteria:
Inclusion Criteria:

* Aged over 18 years
* Both gender
* Surgery mandating lithotomy position

Exclusion Criteria:

* Patients' refusal
* Pregnant women
* Obesity (BMI \> 39)
* Trendelenburg position
* Moderate to severe GERD
* Lengthy procedures (more than 120 min)
A Study of the Safety and Efficacy of Memantine in Moderate to Severe Alzheimer's Disease

The objective of this study is to evaluate the safety, tolerability, and efficacy of memantine compared to placebo in outpatients diagnosed with moderate-to-severe dementia of the Alzheimer's type on a concurrent acetylcholinesterase inhibitor (AChEI).

Memantine is a therapeutic agent that represents a unique class of Alzheimer's disease (AD) treatment options. A once daily (QD) dosing regimen in an AD population would simplify administration for the caregiver. The purpose of this study is to evaluate the safety and efficacy of modified release memantine taken once daily in outpatients with moderate-to-severe AD on a concurrent AChEI.

Eligibility Criteria:
Inclusion Criteria:

* Ambulatory patients aged \>/= 50 years
* Diagnostic evidence of probable Alzheimer's disease consistent with criteria from the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) and the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)
* Confirmatory magnetic resonance imaging (MRI) or computed tomographic (CT) scan within the prior 12 months.
* Mini-Mental State Examination (MMSE) scores \>/= 3 and \</= 14 at Screening (Visit 1) and Baseline (Visit 2)
* Ongoing daily acetylcholinesterase inhibitor (AChEI) therapy at a stable dose for at least 3 months prior to Screening (Visit 1). It is preferred that patients continue to receive the same AChEI therapy for the duration of the study.

Exclusion Criteria:

* Patients with a modified Hachinski Ischemia Score greater than 4 at Screening.
* Patients who have taken memantine within one month of Screening (Visit 1)
* Patients who have a known hypersensitivity to memantine, neramexane, rimantadine, or amantadine.
* Patients whose AChEI therapy is likely to be interrupted or discontinued during the course of the study.
* Patients who are receiving therapy with more than one AChEI.
* Patients with computed tomography (CT) or magnetic resonance imaging (MRI) evidence of hydrocephalus, stroke, a space-occupying lesion, cerebral infection, or any clinically significant central nervous system disease other than Alzheimer's disease.
* Patients with a DSM-IV Axis I disorder other than Alzheimer's disease, including amnestic disorders, schizophrenia or schizoaffective disorder, bipolar disorder, current major depressive episode, psychosis, panic, or post-traumatic stress disorder.
* Patients who, in the clinician's judgement, are likely to be placed in a nursing home within the next 6 months.
* Patients who had evidence of other neurological disorders that included, but were not limited to, stroke, Parkinson's disease, seizure disorder, or head injury with loss of consciousness within the prior 5 years
* Patients who had dementia that was complicated by other organic disease
* Patients who had dementia complicated by the presence of predominant delusions
Percutaneous Irreversible Electroportion in Unresectable Liver Cancer Close to Diaphragmatic Dome

The purpose of this study is to evaluate the safety and efficacy of irreversible electroportion in unresectable liver cancer close to diaphragmatic dome.

Single-arm pilot clinical trial. Patients will be subjected to irreversible electroporation (IRE) as the sole treatment of liver cancer close to diaphragmatic dome.

This pilot study was designed to study the feasibility and safety of treatment as an alternative therapeutic IRE in the treatment of neoplastic nodules in the liver, with particular reference to close to diaphragmatic dome, where the current therapeutic arsenal is inadequate or counter-indicated.

To perform the IRE procedure the IRE NanoKnife™ System (AngioDynamics) will be used.

Eligibility Criteria:
Inclusion Criteria:

* Liver cancer diagnosed by positive biopsy or non-invasive criteria,
* Tumors from diaphragm is \<1 cm
* not suitable for surgical resection or transplantation,
* have at least one, but less than or equal to 3 tumors,
* of the tumour(s) identified, each tumor must be ≤ 5 cm in diameter,
* Child-Pugh class A,B
* Eastern Cooperative Oncology Group (ECOG) score of 0-1,
* a prothrombin time ratio \> 50%,
* platelet count \> 80x109/L,
* ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post NanoKnife procedure,
* are able to comprehend and willing to sign the written informed consent form (ICF),
* have a life expectancy of at least 3 months.

Exclusion Criteria:

* liver cancer developed on an already transplanted liver,
* cardiac insufficiency, ongoing coronary artery disease or arrhythmia,
* any active implanted device (eg Pacemaker),
* women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception,
* have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the NanoKnife™ LEDC System,
* are in the opinion of the Investigator unable to comply with the visit schedule and protocol evaluations.
CO2-Laser Treatment in Patients With Diabetic Infected Foot Ulcers

The study is aimed at comparing debridement either with CO2 laser or traditional surgery in patients with infected diabetic foot ulcers. The principal endpoint is bacterial load immediately after treatment.

The present study is designed to assess the antimicrobial effect of a single CO2 laser beam (DEKA SmartXide2 c80-El.En, Florence Italy) in the treatment of diabetic infected foot ulcers. CO2 laser debridement will be compared with standard surgical care. The primary efficacy endpoint will be the reduction of bacterial load between pre- and immediately after debridement. Secondary endpoints will be adverse events and pain during treatment. Two bacterial sample with a flocked nylon swab will be collected before and after debridement.

Eligibility Criteria:
Inclusion Criteria:

* Diabetes
* Infected foot ulcer (with clinical signs of infection)
* Ulcer area between 0.5 and 150 cm2
* More than 50% of ulcer area covered by fibrin and/or necrosis
* Texas score \<3

Exclusion Criteria:

* Need for revascularization
* Pregnancy or lactation
Low-dose Hydroxychloroquine and Bromhexine: a Novel Regimen for COVID-19 Prophylaxis in Healthcare Professionals

This study will investigate the security and efficacy of a daily low dose of hydroxychloroquine and Bromhexine, in preventing the development of the disease from COVID-19 in Health Care Workers at a National Institute of Health In Mexico City.

This study will combine two drugs (hydroxychloroquine and Bromhexine) to see if hydroxychloroquine is better in combination with Bromhexine in preventing the development of the disease from COVID-19 in Health Care Workers at a National Institute of Health In Mexico City. Hydroxychloroquine will be used in a low dose (200 mg every 24 hrs). Bromhexine will be 8mg every 8 hrs. The study groups will be the following: 1) HCQ 200mg/d + BHH placebo 2) HCQ placebo plus BHH placebo

Eligibility Criteria:
Inclusion criteria

* Health personnel working at INR LGII or INCMNSZ who wish to participate in the study and sign the informed consent.
* Over 18 and under 60 years of age, both genders.
* Contacting with suspected or confirmed SARS-CoV-2 infection.
* Normal electrocardiogram.

Exclusion criteria

* Positive quantitative reverse transcriptase-polymerase chain reaction (qRT-PCR) test for SARS-CoV-2 at the time of inclusion.
* Panel of IgG or IgM antibodies positive for SARS-CoV-2 at the time of inclusion.
* Development of respiratory symptoms suspicious of SARS-CoV-2 infection during the first 7 days after treatment is initiated, confirmed by qRT-PCR and IgG or IgM antibodies postiver for SARS-CoV-2.
* History of allergies to any hydroxychloroquine or bromhexine related compound or medication.
* Use of immunosuppressors for any reason.
* History of bone marrow transplant.
* Known glucose-6-phosphate dehydrogenase deficiency.
* Chronic kidney disease or glomerular filtration \<20ml/min.
* Use of other drugs with reported pharmacological interactions (i.e., digitalis, flecainide, amiodarone, procainamide, or propafenone).
* History of long QT syndrome.
* Electrocardiogram with QTc\>500 msec.
* Pregnant or breastfeeding personnel.
* Epilepsy.
* Known liver disease.
* Personnel who have received the Covid-19 vaccine

Elimination criteria

* Personnel who decide to leave the study for any reason not related to adverse events.
* Personnel with incomplete information on the primary outcome (qRT-PCR for SARS-CoV-2).
* Personnel who are relocated to work in another institution.
* Personnel who do not wish to participate in the study
Pilot Study of the eHealth Application "Cancer Patients Better Life Experience" (CAPABLE) - Italy

The purpose of the CAPABLE study is to compare health-related quality of life in renal cell carcinoma patients who use or do not use a mobile-based application to monitor adverse events for cancer treatment at home. As secondary objectives, the study investigates the usability of the system and its generalizability to other cancer types

The study is designed as a prospectively enrolling, quasi-experimental cohort study in cancer patients, eligible for systemic treatment.

The CAPABLE cohort will receive the smartphone application and a multi-sensorial smartwatch (ASUS VivoWatch 5 HC-B05). Patients will be asked to use the system for at least 6 months after enrollment. If, after 6 months, a patient wants to keep using the system, he will be allowed to do so, until the end of the study. Questionnaires on health-related quality of life will be administered to the patients on baseline (T0) and every three months (T1 and T2). Lost to follow-up data will be included in intention-to-treat analysis. Qualitative and quantitative user experience studies will be done at enrollment, after 3 months and at the end of the follow-up period with the CAPABLE system. Results of this interventional study will be compared with a control cohort consisting of renal cell carcinoma patients, recruited in 2021 with the same inclusion criteria as this study population, but receiving standard care (ICSM CE number 2546, dated 13/04/2021 and amended on 09/02/2022).

Eligibility Criteria:
Inclusion Criteria:

* Adults (age \>=18 years)
* Sufficient understanding of the Italian language
* Patients or their caregiver (upon patient's consent) can use a smartphone
* Histologically or cytologically confirmed diagnosis of RCC, lung, breast, thyroid o head and neck cancer
* Candidate to systemic treatment (targeted agents, immune checkpoint inhibitors, or a combination of the two)
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at the start of the treatment.

Exclusion Criteria:

* Recruitment and consent denial
* Not able of understanding and complying with the protocol requirements (including basic technological abilities)
* Given the fact that each subject involved in the clinical study must be able to understand and sign the informed consent presented by the researcher, lack of this capability represents a specific exclusion criterion in the study protocol.
Auricular VNS Following Intracerebral Hemorrhage

This study will evaluate whether non-invasive auricular vagal nerve stimulation lowers inflammatory markers, and improves outcomes following intracerebral hemorrhage.

Vagal nerve stimulation (VNS) has been studied as a novel method of reducing inflammation, and it has been successfully used in animal models of inflammatory conditions. The purpose of the proposed study is to determine if transcutaneous auricular VNS will impact inflammatory markers in the blood and cerebrospinal fluid (CSF) in patients with intracerebral hemorrhage, and how it impacts their clinical course and outcomes.

This study will involve randomizing patients to stimulation with VNS, or sham stimulation. Blood and CSF will be collected on admission, and serially throughout the patient's admission. Clinical events tracked during the hospital stay include the development of peri-hematomal edema, interventions for edema (medical or surgical), and intensive care unit and hospital stay. Outcomes following admission will include functional scores at discharge, and at follow-up visits for up to 2 years after discharge. No additional appointments will be made specially for the research study.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients who present with a spontaneous supratentorial intracerebral hemorrhage (ICH) to Barnes Jewish Hospital

Exclusion Criteria:

* Patients \< 18 years old
* Patients with a presumed traumatic etiology for their ICH, infratentorial location, ICH volume \> 60 ml or \< 10 ml, at risk of imminent death (e.g. Glasgow Coma Scale, GCS of 3 or one or more pupils unreactive), surgical intervention imminently planned (not including ventriculostomy)
* Patients undergoing active cancer therapy
* Patients with sustained bradycardia on arrival with a heart rate \< 50 beats per minute.
* Patients who cannot be enrolled within 48 hours of the initial bleed.
Physical Therapy vs Surgical Decompression for Lumbar Spinal Stenosis

This is a randomized controlled multicenter trail comparing physical therapy to surgical decompression in patients with lumbar spinal stenosis. The 0-hypothesis is that there is no difference in the efficacy of structured physical therapy compared to surgical decompression.

Our aim is to evaluate if physical therapy can serve as a nonsurgical alternative for patients with LSS, where the severity of symptoms indicates the need of surgical decompression.


Eligibility Criteria:
Inclusion Criteria:

* Patients describing intermittent neurogenic claudication when walking and symptoms revealed by flexion of the spine.
* MRI shows lumbar spinal stenosis in one or two levels measured.
* The duration of the symptoms is longer than six months
* The patient is a candidate for surgical treatment
* The patient is capable of physical exercise

Exclusion Criteria:

* Vascular intermittent claudication
* Lumbar spinal stenosis in more than two levels
* Previous low back surgery
* Symptomatic lumbar disc herniation
* Degenerative scoliosis with Cobbs angle 30 degrees or more
* Degenerative spondylolisthesis grade 2 or more
* Spondylolysis with spondylolisthesis
* Recent osteoporotic fractures in the spine (last 6 month)
* Severe symptomatic arthrosis in hip or knee
* Locally advanced or metastatic cancer
* ASA \>3
* Polyneuropathy recognized by neurography
* Insufficient Norwegian language skills
A Study to Evaluate the Efficacy and Safety of Mizoribine in the Treatment of Lupus Nephritis

To demonstrate that the treatment effect in lupus nephritis of MZR is non-inferior to that of standard therapy CTX through analyzing overall remission rate after treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patient has been diagnosed with SLE according to American College of Rheumatology (ACR) criteria in 1997;
* Patient who has had a kidney biopsy within 365 days prior to screening which was confirmed as class III, III+V, IV, IV+V, or V according to the pathologic classification of International Society of Nephrology/Renal Pathology Society (ISN/RPS) in 2003;
* Patient with 24hr-urine protein ≥ 1.0g;
* SLE-DAI \> 8 ;
* Male or female patient between 18 and 70 years (inclusive) at informed consent obtained date;
* Patient with body weight between 40kg and 80kg (inclusive) at screening;
* Patients who sign the informed consent form;

Exclusion Criteria:

* Patient who had history of allergy to any investigational product (MZR, CTX) or hormone;
* Patient who had received accumulated dosage of CTX \>3g within one year prior to screening.
* Patient who had received immunosuppressant or Chinese traditional medicine with immunosuppressive effect within 30 days prior to screening;
* Patient who had received prednisone\>1.0mg/kg/day or equivalent dose of other oral glucocorticoid therapies within 30 days prior to screening;
* Patient who received other investigational drugs within 30 days prior to screening;
* Patient who have received plasma exchange therapy or immunoadsorption therapy within 30 days prior to screening;
* Patient who require pentostatin or live vaccine (not including flu vaccine);
* Patient who is undergoing renal replacement therapy;
* Patient who received kidney transplantation;
* Patient with malignancy;
* Patient with severe hypertension (SBP \> 160mmHg or DBP \> 100mmHg) which has not been effectively controlled;
* Patient with white blood cell count \<3×109/L /L(=3.0 GI/L);
* Patient with SCr \> 176.8μmol/L;
* Patient who has a value that is \> 3 times of the upper limit of normal range for AST or ALT;
* Patient with hepatitis B, hepatitis C or HIV infection;
* Patient with other serious infections;
* Patient who is unsuitable for participating in this study in the opinion of investigators ( e.g. uncontrolled diabetes, central nervous system lupus , lupus encephalopathy, active psychosis,osteonecrosis of the femoral head, fulminant hepatitis, peptic ulcer, etc.);
* Female patient who is pregnant, currently breast feeding or willing to become pregnant;
* Patient with any other diseases that would affect the evaluation of efficacy or safety.
Polestriding Versus Walking for Subjects With Poor Leg Circulation

The purpose of this study is to compare the effects of polestriding (walking with poles) and traditional walking on physical endurance in subjects with poor circulation in their legs. Another goal is to evaluate the effectiveness of a walking program in increasing the amount of oxygen in the calf muscles and therefore improving overall physical activity and quality of life.

Peripheral Arterial Disease (PAD/PVD) is caused by decreased blood flow to the legs. The most common symptom is intermittent claudication pain during walking that is relieved by rest. Walking is the primary treatment prescribed for PAD rehabilitation. Polestriding uses muscles of the upper and lower body in a continuous movement. Walking with poles increases stride length, cadence and walking speed and decreases ground reaction forces on the joints. Subjects in this study will participate in a walking program with or without poles.

Dr. Collins' research focuses on physical activity interventions to improve the functional status of persons with chronic illness. Several rehabilitation studies have tested the efficacy of walking exercise for patients with PAD. Studies on polestriding indicate that it may be superior to traditional walking, but these two methods have never been compared. Approximately 30% of patients with coronary artery disease have PAD as their only symptom. As the population ages and more people are affected by this debilitating condition, nurse-initiated rehabilitative therapies, such as polestriding, need to be explored. The consent form explains the purpose of the study in addition to the procedures, risks, benefits, options, confidentiality, costs, and compensation. Participants are also asked to sign a HIPPA authorization.

Eligibility Criteria:
Inclusion Criteria:

* Peripheral Vascular Disease
* Cramping/Claudication Pain in legs while walking
* Ankle Brachial Index (measure of circulation by doppler) .90 or less

Exclusion Criteria:

* Ulcers or sores on feet or legs
* Unable to walk or confined to a wheelchair
* Amputations or severe arthritis pain in shoulders, knees, or hips
* Medical conditions which would exclude subject from participating in an exercise program
* Vascular Surgery within the last six months, or planning vascular surgery