cyrilzakka/clinical-trials huggingface dataset:
Study of gekoTM Interaction With Cardiac Pacemakers

The gekoTM device is a small disposable battery powered device that attaches to the lower leg near the knee and stimulates the common peroneal nerve, causing muscle contraction of the lower leg. This contraction increases blood flow and the device is used to treat several conditions including deep vein thrombosis and venous leg ulcers.

There is evidence that some powered muscle stimulators and related devices can affect Cardiac Demand Pacemakers. This study is to ascertain if there is any such interaction between the gekoTM device and permanently implanted cardiac pacemakers.

CFR.890.5850 requires that the labelling for powered muscle stimulators includes the contraindication 'Powered muscle stimulators should not be used on patients with cardiac demand pacemakers'.

Further, IEC 60601-2-10:2012 clause 210.7.9.2.101d, requires that the instructions for use provide: 'Advice that a PATIENT with an implanted electronic device (for example a cardiac pacemaker) should not be subjected to stimulation unless specialist medical opinion has first been obtained'. However, no details on what criteria the specialist should apply.

There is evidence that some powered muscle stimulators, and related devices can affect Cardiac Demand Pacemakers(1,2). Traditional powered muscle stimulators use pulse trains at a frequency of at least 30Hz(3) to elicit muscle contractions. The electrodes for these devices may be placed at number of sites on the body depending on the application, including the legs, arms and torso, often with well-spaced electrodes that may be attached to different limbs, sending electrical impulses through the torso.

The geko™ range of devices, however operate by delivering a single pulse at a frequency of 1Hz with electrodes placed topically, close together, at the knee. The nature of the stimulation pulse, and its location make it extremely unlikely that the geko™ devices could interfere with cardiac demand pacemakers. However, there is no direct evidence to support this assumption. This trial will determine if there are any adverse interactions between the geko™ and cardiac pacemakers.

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged ≥ 18 years and able to provide written informed consent.
* Intact healthy skin at the site of geko™ device application.
* Patient has a single, dual or bi-ventricular pacemaker implanted and is not pacing dependent.
* Patient understands and is willing to participate in the study and is able to comply with study procedures and visits.

Exclusion Criteria:

* Pregnancy or breast feeding.
* Use of any concurrent use of a neuro-modulation device.
* Any medication deemed by the Investigator to potentially interfere with the study treatment (e.g. systemic steroids.)
* Participation in any other clinical study that may interfere with the outcome of either study
Comparing Visual Acuity Measurements (How Well You Can See) Using a Standard ETDRS Chart & a Handheld ETDRS Chart

Comparing visual acuity measurements (measurements of how well you can see) using a standard ETDRS (Early Treatment Diabetic Retinopathy Study) chart and a handheld ETDRS chart

Prospective determination of agreement between standard ETDRS chart and handheld illuminated ETDRS equivalent chart in eyes with retinal pathology

Eligibility Criteria:
Inclusion Criteria:

1. Ability to provide written informed consent and comply with study assessments for the full duration of the study (one visit per patient).
2. Age greater than 18 years.
3. Clinical diagnosis of retinal disease (including age-related macular degeneration, macular degeneration, retinal vessel occlusion, among others).

Exclusion Criteria:

1. Presence of a significant cataract as determined by your doctor.
2. Presence of a significant posterior capsular opacity (haziness in your eyes) as determined by your doctor.
3. Diagnosis of uveitis (inflammation in part of the eye).
Genomic Profiling Assay in Phase I

The goal of this research study is to collect and test tumor tissue from patients with advanced cancers that may be enrolled in Phase 1 studies or other treatments. Researchers will study if the results from genetic testing can help researchers determine which therapy may prove more beneficial for a patient in the future.

If you agree to take part in this study, your tumor tissue collected previously from surgery or a prior biopsy (archived tissue) will be used for genetic testing. Genetic testing looks at whether specific genes are changed (mutated) in the tumor.

The results of the genetic testing will be documented in your medical record. Your doctor may use the results of the genetic testing to help decide which treatment you will have. While awaiting results of the genomic profile assay, you may be enrolled in another treatment either at MD Anderson or near your home. This will be decided by your treating physician.

Your samples will be given a code number when they are sent for genetic testing to Foundation Medicine. No identifying information will be directly linked to your samples. Only the researcher in charge of sending all tissue for testing will have access to the code numbers and be able to link the samples to you. This is to allow medical data related to the samples to be updated as needed. Foundation Medicine will not be able to link this data to you.

Researchers will also review your medical history from before and following the collection of tissue, to learn if the use of genetic testing had any effect on the outcome of your treatment.

This is an investigational study.

Up to 300 participants will take part in this study. All will be enrolled at MD Anderson.

Eligibility Criteria:
Inclusion Criteria

1. Patients with advanced cancer.
2. Consent for use of archival tissue from primary or metastatic cancer diagnosis. Note: Patients may currently be enrolled in other investigational protocol including treatment protocols.
3. Control Group #2 only: Control Group #2 will consist of 100 patients from MDACC/Phase I historical archives. Patients (cases no older than 2 years) will be selected based on clinical characteristics and genomic alterations similar to matched targeted therapy group.
4. Patients may have received prior 'matched' therapies; however, at the time of enrollment, patients may not currently be on a known 'matched' therapy, and may not have received a 'matched' therapy as the last treatment if not receiving treatment at the time of consent.
5. Patients who have a life expectancy of greater than 3 months.

Exclusion Criteria:

1. Patients with advanced cancer who are NOT likely to meet the additional enrollment criteria in matched targeted therapy protocols or treatments.
2. Patients who do not have archival tissue available.
3. Patients are excluded if their last treatment before enrollment included a targeted agent matched to a genomic alteration in the patient's tumor.
Vestibular Outcomes in Vestibular Schwannoma

Previous studies have shown that vertigo is the symptoms that mostly affect quality of life in patients with vestibular schwannoma. There is still limited knowledge as to why some patients with this disorder develop vertigo, while others with the same diagnosis do not. The purpose of this study is to measure symptom-related quality of life and to relate this to objective disease characteristics at baseline.

This is a longitudinal observational study with data collected at baseline and after treatment.

Variables collected at baseline include age, sex, tumor size, location, type (cystic/solid), tumor side, symptom variables including Dizziness Handicap Inventory, Vertigo Symptom Scale Short Form, Haukeland Dizziness Questionnaire, Visual analog scale, Hospital Anxiety and Depression Scale, RAND-12, dynamic posturography, video-based head impulse test, bithermal caloric tests, ocular and cervical vestibular evoked myogenic potentials.

Follow-up data after 1 year are the same patient-reported outcomes as at baseline.

Eligibility Criteria:
Inclusion Criteria:

* Patients living i Norway referred to Haukeland University Hospital due to newly diagnosed, untreated vestibular schwannoma

Exclusion Criteria:

* Inability to undergo test protocol due to physical or language barriers
Effects of Using Divided Mesh and Using a Non Divided Mesh on Testicular Blood Flow and Volume in Laparoscopic Hernia Repair

Laparoscopic inguinal hernia repair techniques has been compared with the open techniques in several studies. However, no one studied about the different uses of the same type of mesh on the same surgical technique, and effects of this different use on testicular volume and blood flow. The objective of this study is to investigate the effects at 6 months of the divided and non divided mesh in laparoscopic totally extraperitoneal hernia repair technique on testicular volume and blood flow by use of Doppler Ultrasonography


Eligibility Criteria:
Inclusion Criteria:

Patients with unilateral inguinal hernia Male patients

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Exclusion Criteria:

Patients have femoral hernia Patients have bilateral inguinal hernia Patients have recurrent inguinal hernia Female patients Patients with history of pelvic surgery Patients with history of pelvic major trauma Patients with history of pelvic radiotherapy Patients have previous scrotal trauma or surgery history Patients have heavy cardiac diseases, pulmonary diseases Patients have benign prostate hyperplasia Patients have history of incarceration of inguinal hernia

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Reduced Anti-Platelet Therapy With Pimecrolimus Drug Eluting Stent (RAPID)

Non-randomized, single arm, multi-center, clinical trial evaluating the Corio™ pimecrolimus-eluting stent with reduced anti-platelet therapy in patients with de novo lesions of the native coronary arteries.

The registry is designed to evaluate 6-month in-stent late lumen loss in patients receiving the Corio™ drug-eluting stent.

Eligibility Criteria:
Inclusion Criteria:

General Inclusion Criteria

1. Eligible for percutaneous coronary intervention (PCI).
2. Documented stable or unstable angina pectoris
3. Left ventricular ejection fraction (LVEF) ≥25%
4. Acceptable candidate for coronary artery bypass graft surgery (CABG).
5. Target Lesion \< 25 mm in length with RVD of 2.5 to 3.5 mm with visually estimated stenosis of \>= 50 and \< 100 %.

Exclusion Criteria:

General Exclusion Criteria

1. Known sensitivity to pimecrolimus, the polymer (PLGA) or cobalt chromium.
2. Planned treatment with any other PCI device in the target vessel(s).
3. MI within 72 hours prior to the index procedure
4. The patient is in cardiogenic shock.
5. Cerebrovascular Accident (CVA) within the past 6 months.
6. Acute or chronic renal dysfunction
7. Contraindication to ASA or to clopidogrel.
8. Thrombocytopenia
9. Active gastrointestinal (GI) bleeding within the past 3 months.
10. Any prior true anaphylactiod reaction to contrast agents
11. Patient is currently taking chronic systemic steroid therapy or systemic immunosuppressant therapy or topical pimecrolimus.
12. Female of childbearing potential.
13. Life expectancy of less than 24 months due to other medical conditions.
14. Co-morbid condition(s)
15. Currently participating in another investigational drug or device study
Comparative Effect of Vojta Therapy and Bobath Therapy on Lower Limb Spasticity and Motorcity Among HS

Background: Stroke is clinical defined as a neurological syndrome characterized by acute disruption of blood flow to an area of brain and corresponding onset of neurological defects related to the concerned area of brain. Hemiplegic patient primarily affects the upper limb and lower limb of one side and typically results in flaccidity and difficulties with motor control and function.

The aim of this study will compare the Effect of Vojta therapy and Bobath therapy on lower limb spasticity and motorcity among hemiparetic stroke patients. Methodology: Randomize clinical trials will be carried out on lower limb spasticity and motorcity among hemiparetic stroke patients. This study will include adult's stroke (1-4 months post- onset). Inclusion criteria in which diagnosed with hemiplegic patients, aged 25-75 years and willingness to participants.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Hemiparetic stroke.
* adult's stroke (1-4 months post- onset)
* Ability to follow instructions and participate in testing
* Aged 25-75 years.

Exclusion Criteria:

* Previous history of brain surgery.
* Pregnant women.
* Limitation in cognitive skills like Aphasia, deteriorated consciousness or dementia.
* Severe cardiovascular disease (unstable hypertension)"
Evaluate the Safety and Effectiveness of the Biotrue ONEday for Astigmatism

Comparing Test Lens for Astigmatism Soft Contact Lens (Test) to 1-Day Control for Astigmatism contact lenses (Control).

This is a multicenter, randomized 1:1, parallel-group, bilateral, Investigator-masked study at 13 investigative sites in the United States (US) in a population including Chinese subjects (maternal and paternal grandparents born in China)

Eligibility Criteria:
Inclusion Criteria:

* Subject must be of legal age (at least 18 or as defined by state law) on the date the ICF is signed and have the capacity to provide voluntary informed consent.
* Subject must be able to read, understand and provide written informed consent on the IRB approved ICF and provide authorization as appropriate for local privacy regulations.
* Subject must have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings (greater than Grade 1 and/or presence of infiltrates) and have clear central 6 mm corneas.
* Subject must be an adapted wearer of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.

Exclusion Criteria:

* Subject has worn gas permeable (GP) contact lenses within last 30 days or polymethylmethacrylate (PMMA) lenses within last 3 months.
* Subject has systemic disease affecting ocular health.
* Subject is using any systemic or topical medications that will affect ocular physiology or lens performance.
* Subject has an active ocular disease (for example but not limited to papillary conjunctivitis, any conjunctivitis: viral, bacterial, allergic), any corneal infiltrative response or are using any ocular medications.
* Subject has any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear
Longitudinal Assessment of Genomic Alterations and Clonal Evolution in ALK-positive NSCLC (Galileo Project)

The scope of GALILEO project (Genomic ALteratIons and cLonal EvOlution in ALK+ NSCLC) is to explore the feasibility of genomic longitudinal evaluation for ALK+ NSCLC patients in Italian routine practice and provide a detailed overview of resistance mechanisms and clinical outcomes according to current standard treatments.


Eligibility Criteria:
Inclusion Criteria:

* a) histologically confirmed diagnosis of advanced NSCLC with ALK rearrangement detection by NGS (ALK+ NSCLCs patients detected at diagnosis by in hybridization (FISH), immunohistochememistry (IHC), or reverse transcriptase-PCR (RT-PCR) can be included if adequate tissue for NGS is available)

  b) to have received upfront treatment with alectinib, brigatinib or lorlatinib for at least 28 days

  c) ECOG PS 0-2

  d) adult patients (aged ≥ 18 years) at the moment of diagnosis

  e) signing of informed consent approved by the local Ethic Committee

Exclusion Criteria:

a) Diagnosis of lung cancer without ALK rearrangement

a) early withdrawn of treatment due to toxicity without evidence of radiological disease progression cannot be eligible for the study
Effects of Manual Lumbar and Prone Traction in Patients With Low Back Pain

The study determined the effects of manual Lumbar traction and prone traction on some clinical variables of patients with long standing low back pain.

Traction therapy has been used in the management of low back pain (LBP) especially None Specific Low Back Pain. There are several recommendations on how lumbar traction should be performed, but the type of technique to be applied differs among the sources. Prone traction adapted from inversion therapy which is a form of gravitational traction has been reported to be effective in ameliorating disabilities of patients with low back pain as well reduce pain intensity. Manual lumbar traction is performed by the therapist, pulling at the patient's ankles and has been reported to be effective in relieving pain and reducing disability of patient with None Specific Low Back Pain (NSLBP). Documented evidences on the efficacy of traction in non-specific low back pain are still inconclusive. While manual lumbar traction seems more commonly used, probably owing to its positional advantage, its relative effectiveness compared with manual prone traction is still unknown, hence this study. Therefore, the aim of this study was to examine the efficacy of manual lumbar traction and prone traction on pain intensity, disability, spinal range of motion and quality of life in patients with None Specific Low Back Pain.

Eligibility Criteria:
Inclusion Criteria:

* Participants diagnosed with Non-Specific Low Back Pain of not less than 3 months duration who were referred by a physician.
* Participants between the ages of 40 years and older.

Exclusion Criteria:

* Low back pain patients with specific pathology, such as systemic inflammatory diseases, pregnancy, fractures of the spine, tumors, infections.
* Participants with pathology affecting the trunk or upper and lower extremities
Effect of Developmental Care on Very Low Birth Weight Infants

The goal of this clinical trial is to learn if developmental care works when implemented in very low birth weight infants. The main questions it aims to answer are:

* Does developmental care shorten the length of hospital stay in the very low birth weight infants?
* Does developmental care increase the opportunity of family centered care in the very low birth weight infants? The clinical trial will use a 36-month stepped-wedge cluster-randomised trial conducted across 40 Neonatal intensive care units . A developmental care bundle will be tailored to meet the identified needs of participating NICUs.

Developmental care in the NICU focuses on creating a nurturing environment that supports the physical, emotional, and developmental needs of premature infants. This approach includes strategies like minimizing unnecessary noise and light, ensuring appropriate positioning and handling of infants, promoting skin-to-skin contact, and facilitating parental involvement in care.

The clinical trial investigates the effectiveness of developmental care in very low birth weight (VLBW) infants. The primary objectives are to determine whether developmental care can (1) reduce the length of hospital stay and (2) enhance the opportunity for family-centered care in these infants. The study employs a 36-month stepped-wedge cluster-randomised trial design, involving 40 Neonatal Intensive Care Units (NICUs).

In this trial, all NICUs will eventually receive the intervention, but the order in which they start implementing the developmental care bundle will be randomized. This approach allows each NICU to serve as its own control, comparing outcomes before and after the intervention.

Data collection will occur at multiple time points before and after the implementation of the developmental care bundle, enabling a comprehensive analysis of its impact. By tailoring interventions to each NICU's specific context and needs, the study aims to generate robust evidence on the benefits of developmental care for VLBW infants and their families.

Eligibility Criteria:
Inclusion Criteria

1. Birth weights less than 1500 g
2. Admitted or transported to a level III NICU within 24h of birth
3. OI\>30

Exclusion Criteria:

1. Severe congenital malformations
2. various chromosomal disorders
3. genetic metabolic diseases,
4. severe neurological disorders
Biomarkers for Early Detection of Lung Cancer in Patients With Lung Cancer, Participants at High-Risk for Developing Lung Cancer, or Healthy Volunteers

RATIONALE: Collecting and storing samples of sputum and tissue to study in the laboratory may help doctors identify biomarkers related to cancer.

PURPOSE: This research study is looking samples of sputum and tissue from lung cancer patients, participants at high risk for developing lung cancer, and from healthy volunteers (both smokers and non-smokers).

OBJECTIVES:

* To test and make a preliminary assessment of the sensitivity and specificity of Fourier transform infrared technology (FTIR) for use in the early detection of lung cancer in sputum samples from patients who have or participants at high risk for developing lung cancer and from non-high-risk smoking and non-smoking volunteers.
* To permit identification of specific metabolic biomarkers within FTIR spectra that can distinguish between lung cancer, high-risk, and non-high-risk cases.

OUTLINE: This is a multicenter study.

Sputum samples and endobronchial biopsy tissue specimens are collected prior to routine bronchoscopy as part of a standard clinical assessment for the early detection of lung cancer. Sputum samples are examined for levels of bronchial and non-bronchial cells using established cytological and immunohistochemical procedures. Samples are also examined for metabolic biomarkers using Fourier transform infrared spectroscopy (FTIR) to generate complete metabolic fingerprints (i.e., spectra) that can distinguish metabolic differences between cancer, non-cancer, and early disease (i.e., dysplasia or metaplasia). These molecular biomarkers, which are detected within FTIR spectra, may be further analyzed in matched endobronchial biopsy tissue samples for histological confirmation. Additional clinico-pathological data is collected for each participant to allow development of predictive statistical models from the data.

All study participants are followed annually.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Meets 1 of the following criteria:

  * Diagnosis of lung cancer
  * At high risk for developing lung cancer
  * Non-high-risk smoking or non-smoking volunteer (control)

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified