cyrilzakka/clinical-trials huggingface dataset:
Omission of Axillary Lymph Node Dissection in Case of Tumor Spread to Lymph Nodes in the Armpit in Breast Cancer

SENOMAC-ULTRA enrols patients with breast cancer that has spread to lymph nodes in the armpit, and that have been detected already prior to surgery by imaging, e.g. ultrasonography. In this situation, a full axillary lymph node dissection, removing more than 10 lymph nodes from the arm pit, is unnecessarily extensive in about half of the patients. More extensive surgery leads to a risk for arm lymphedema and functional problems with the arm and shoulder region, which should be avoided if not beneficial for diagnosis or prognosis. This trial seeks to ascertain that less extensive surgery, performed by only removing the first lymph node/s in the armpit (the sentinel lymph node/s) and the known metastatic lymph nodes, offers non-inferior survival outcomes to a full axillary lymph node dissection.


Eligibility Criteria:
Inclusion Criteria:

* Patients with primary invasive breast cancer cT1-T3
* Axillary metastases detected by ultrasound (other imaging accepted if confirmatory ultrasound is performed)
* Axillary metastasis confirmed by fine needle or core biopsy
* Written informed consent
* Age ≥ 18 years

Exclusion Criteria:

* Distant metastases
* Nodal metastases in ipsilateral axillary levels 3 or 4
* Preoperative suspicion of extensive nodal involvement, i.e. locally advanced disease
* Clinically N2-3 disease on palpation or imaging (i.e. nodes fixed to each other or to neighbouring structures)
* History of prior invasive breast cancer
* Bilateral invasive breast cancer
* Pregnancy or breast-feeding
* Neoadjuvant systemic treatment (short course of neoadjuvant endocrine therapy \<three months is allowed)
* Medical contraindications for radiotherapy or the recommended adjuvant systemic treatment which complies with standard of care, taking age and comorbidity into consideration
* Inability to absorb or understand the meaning of the study information; for example, through disability, inadequate language skills or dementia
AusCADASIL: An Australian Cohort of CADASIL

The aim of this project is to establish an Australian cohort of patients diagnosed with Cerebral Autosomal Dominant Arteriopathy with Subcortical Infarcts and Leukoencephalopathy (CADASIL). This study will examine the clinical features and longitudinal course of CADASIL. Outcome measures include neuropsychological profile, neuroimaging, genetics, blood biomarkers, and retinal imaging.

Using clinical examination, questionnaires, neuropsychological evaluation, brain MRI, blood sample evaluation and retinal imaging, we aim to characterise the clinical profile and progression of CADASIL in an Australian cohort.

This is multi-centre observational cohort study currently based at six sites (clinics, hospitals and universities) across three states in Australia (New South Wales, Victoria and Queensland). The multidisciplinary team aims to be the first to develop an Australian cohort of CADASIL which will contribute to global efforts and understanding of the disease.

Eligibility Criteria:
Inclusion criteria:

1. Adults ≥18 years old
2. Ability to provide written informed consent

   * A large-print version is available for individuals with visual impairment
   * An easy-to-read version is available for individuals with cognitive difficulties who may require extra support
3. Ability to attend a testing site
4. Ability to complete minimum dataset (medical examination and medical history questionnaire, blood test to determine genetic status and a short (20 minute) neuropsychology assessment).
5. CADASIL participants according to one of the following categories:

   1. confirmed diagnosis via genetic testing (NOTCH3 pathogenic variant), OR
   2. suspected diagnosis based on medical history and brain MRI, OR
   3. first degree relative of participant who is positive for NOTCH3 pathogenic variant

OR 6. Unrelated individual who is negative for the NOTCH3 pathogenic variant, and has no cognitive complaints (i.e. control participant)

Exclusion criteria:

1. Significant cognitive impairment leading to an inability to provide informed consent.
Efficacy of Changing to DUOTRAV® From Prior Therapy

The purpose of this study was to assess the efficacy and tolerability of changing to DUOTRAV® from prior bimatoprost 0.03%/timolol 0.5% pharmacotherapy in subjects with open-angle glaucoma or ocular hypertension having uncontrolled intraocular pressure (IOP).


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of ocular hypertension, open-angle or pigment dispersion glaucoma in at least one eye.
* Stable IOP-lowering regimen of bimatoprost 0.03%/timolol 0.5% therapy (either administered concomitantly or in a fixed combination) within 4 weeks prior to the screening visit.
* IOP considered to be safe (in the opinion of the investigator), in both eyes, to assure clinical stability of vision and the optic nerve throughout the study period.
* IOP between 19 to 35 mmHg (at any time of the day) in at least one eye (which would be designated as the study eye).
* Willing to discontinue the use of all other ocular hypotensive medication(s) prior to receiving the study medication for the entire course of the study.
* Able to follow instructions and willing and able to attend all study visits.
* Best corrected visual acuity of 6/60 (20/200 Snellen, 1.0 LogMAR) or better in each eye.
* Sign informed consent.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Known medical history of allergy, hypersensitivity or poor tolerance to any component of DuoTrav® that is deemed clinically significant in the opinion of the Principal Investigator.
* Corneal dystrophies in either eye.
* Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator's best judgment.
* Bronchial asthma or a history of bronchial asthma, bronchial hyper reactivity, or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker.
* History of severe allergic rhinitis.
* A condition, which in the opinion of the Principal Investigator, would interfere with optimal participation in the study, or which would present a special risk to the subject.
* Participation in any other investigational study within 30 days prior to the Screening Visit.
* Other protocol-defined exclusion criteria may apply.
Airway Clearance for Prevention of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation

The purpose of this study is to show that one form of mechanical airway clearance techniques, High Frequency Chest Wall Oscillation (HFCWO)using a pneumatic vest, will diminish exacerbations of COPD which will improve respiratory health status.

Approximately 60 to 70% of people with COPD have chronic cough and phlegm, the cardinal symptoms of chronic bronchitis or chronic mucus hypersecretion (CMH). Once thought to be a relatively benign condition, recent evidence shows that CMH in patients with established COPD is associated with greater decline in lung function, more frequent respiratory infections, more frequent exacerbations and increased mortality.Using mechanical airway clearance techniques (The Vest) will diminish exacerbations of COPD which will improve respiratory health status.

Comparison: Patients randomly assigned to the vest will have fewer exacerbations of COPD,better quality of life and less health care use compared to patients assigned to a sham vest.

Eligibility Criteria:
Inclusion Criteria:

* Physician Diagnosis of COPD,chronic bronchitis and/or emphysema
* Forced Expiratory Volume in 1 second (FEV1)/ Forced Vital Capacity (FVC) \< or = 70%
* FEV1 \< or = 65%
* Current or former smoker \> or = 20 pack years
* History of 1 or more COPD exacerbations in past 6 months necessitation hospitalization, Emergency Department (ED) visit, antibiotic or steroid prescription

Exclusion Criteria:

* Other lung diseases
* Co-morbid illnesses such as cancer, liver disease, cardiomyopathy
* Recent chest wall or abdominal trauma or surgery that would preclude using the vest
Safety and Efficacy of CKDB-501A in Subjects With Post-stroke Upper Limb Spasticity

Multicenter, randomized, double-blind, active-controlled, parallel-design study to evaluate the safety and efficacy of CKDB-501A in Subjects with Post-stroke Upper Limb Spasticity


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients ≥ 19 years
* History of stroke more than 24 weeks prior to screening
* ≥ 2 points in the focal spasticity of wrist flexor and ≥ 1 point at least one of finger flexor and elbow flexor as measured on MAS(0 to 4)
* ≥ 2 points in one of the targeted functional disability item (i.e. hand hygiene, clothing, upper extremity, or pain for evaluation on DAS

Exclusion Criteria:

* Neuromuscular disorders such as Lambert-Eaton syndrome, myasthenia gravis, or amyotrophic lateral sclerosis
* Fixed joint/muscle contracture in the target limb
* History(within 24 weeks of screening visit) or planned(during study period) treatment with phenol or alcohol injection(chemodenervation) or surgery in the target limb
* History(within 4 months of screening visit) or planned(during study period) treatment with tendon lengthening in the target limb
* History(within 12 weeks of screening visit) treatment with Botulinum Toxin
* Concurrent treatment with an intrathecal baclofen
* Known allergy or sensitivity to the study medication or its components (Clostridium botulinum toxin type A, albumin, Sodium chloride, etc.)
* Male and Female who are not willing to take any appropriate means of contraception during the study period
* Patients who are not eligible for this study at the discretion of the investigator.
Microfinance Institutions as a Platform for Global Health

This study will analyze data from a program run by an microfinance institution (MFI) in Haiti from 2011-2012 where the MFI delivered health goods to some of the villages where it operates. By comparing health indicators among children who were in villages targeted by the program initially to children who were in villages that were not targeted by the program until later, the investigators hope to understand if the MFI successfully delivered the intervention and offer a practical platform for delivery of basic health goods.

Two-thirds of child deaths could be prevented with increased coverage of existing health products and services; however, effectively delivering health products and services to rural populations in low-income countries remains a practical challenge. This study investigates whether microfinance institutions (MFIs), having invested in community-based infrastructure to deliver financial services to 200 million rural poor households globally, offer a practical platform for delivery of basic health goods.

The investigators intend to analyze data from a pilot program implemented by an MFI in Haiti during 2011-2012 that distributed an evidence-based health good, micronutrient powders (MNPs), to 526 children in 34 villages where the MFI operates. Micronutrient deficiency is estimated to be responsible for over 1 million deaths of children under five per year. MNPs are one form of micronutrient supplementation proven to effectively combat micronutrient deficiency.

Published cost estimates indicate that leveraging existing supply chains could cut the total cost of mass MNP delivery by 25%. Given MFIs reach 200 million households globally, MFI-based delivery of health goods may be a promising route to improving health outcomes efficiently.

Eligibility Criteria:
Inclusion Criteria:

* Lives in a household where the head of household was an microfinance client.

Exclusion Criteria:

* Severely anemic (Hgb \< 70 g/L)
* Severely malnourished (Mid Upper Arm Circumference \< 110 mm)
NECROtizing Soft Tissue Infections and Their Scoring System

Primary Objective:

The primary objective of this study is to develop and validate a clinical risk index score for identifying NSTIs in emergency general surgery patients being evaluated for a severe skin and soft tissue infection.

Secondary Objectives:

To describe the contemporary microbiology of NSTIs and explore the effects on outcomes and to identify predictors of amputation and mortality.

This study is designed as a multicenter, prospective, observational study. There will be no direct interaction with subjects and involves no interventions; study is conducted completely via review of electronic health records. Our site will only collect data from the Methodist Dallas Medical Center. We plan to complete the data collection and analysis by 12/30/2021.

Eligibility Criteria:
Inclusion Criteria:

* All adult patients (age ≥18 years old and ≤89 years old) with suspected or confirmed NSTI

Exclusion Criteria:

* Age \<18 years old and age \> 89 years
* Pregnancy
* Prisoners
* Below ankle diabetic foot infections complicated by peripheral vascular disease
* Burn wounds
Exploratory Study to Evaluate the Efficacy of RUTI® Against SARS-COV-2 Infection (COVID-19) in Healthcare Workers

The aim of this study is to explore potential for reduction of incidence and/or morbidity of SARS-CoV-2 infection in healthcare personnel. The study will include a comparison between placebo and RUTI® vaccine in a 2:1 design.


Eligibility Criteria:
Inclusion Criteria:

1. Sign the Informed Consent before initiating the selection procedures.
2. Population:

   1. Healthcare system workers working in contact with subjects potentially infected with SARS-CoV-2
   2. People between 18 years and 59 years
3. Willingness to meet the requirements of the protocol.
4. Negative Rapid Serological Test of SARS-CoV-2
5. The participant must agree to use effective contraceptive methods during the study period, in case of childbearing age.

Exclusion Criteria:

1. Previous SARS-CoV-2 infection
2. Pregnancy. Pregnancy test will be performed in case of doubt.
3. Breastfeeding.
4. Suspected of active viral or bacterial infection.
5. Symptoms compatible with COVID-19, despite a negative polymerase chain reaction (PCR) test.
6. Vaccination in the last 4 weeks or planned vaccination during the study period, except for influenza vaccine.
7. Participation in a research that requires experimental intervention (does not include observational studies) in the previous month before signing the Consent or during the study.
8. Severely immunocompromised people. This exclusion category includes:

   * Subjects with human immunodeficiency virus (HIV-1).
   * Neutropenic subjects with less than 500 neutrophils / mm3.
   * Subjects with solid organ transplantation.
   * Subjects with bone marrow transplantation.
   * Subjects undergoing chemotherapy.
   * Subjects with primary immunodeficiency.
   * Severe lymphopenia with less than 400 lymphocytes / mm3.
9. Malignancy, or active solid or non-solid lymphoma from the previous two years.
10. Soy allergy.
11. Direct involvement in the design or execution of the RUTICOVID19 clinical trial.
12. Retirement, transfer, long-term leave (\> 1 month) due to scheduled surgery or any other event that makes it impossible to work in person at your health center during the months following the recruitment to the study.
13. Do not have a smartphone.
14. Detection by the researcher of lack of knowledge or willingness to participate and comply with all requirements of the protocol.

16. Any other findings that, at the discretion of the researcher, may compromise compliance with the protocol or that may influence significantly the interpretation or the results of the effects of the vaccine.
Micro-abrasive Blasting vs Acid Etching of Orthodontic Bracket Bases

To describe a method of acid etching the base of a bracket, and to compare the bond failures between micro-abrasive blasted (sandblasted) brackets and acid etched brackets over an eighteen month period

The aims of this randomized control trial are:

1. To describe a method to chemically etch the bases of stainless steel orthodontic brackets.
2. To observe the changes in the micro-structure of the brackets with sandblasted bases and acid-etched bases under an electron microscope.
3. To compare the failure of orthodontic brackets with a chemical etched base versus a sandblasted base bonded with composite using the conventional acid etch technique, over a follow-up of 18 months

Eligibility Criteria:
Inclusion Criteria:

* Patients about to undergo fixed orthodontic therapy

Exclusion Criteria:

* Patients with cavities, history of fixed orthodontic therapy, recent bleaching
Community Health Worker Assisted Task Specific and Cognitive Therapy At Home with Exposure After Stroke

CATCHES is a novel intervention for preliminary testing, integrating Task Specific Therapy at home guided by Community Health Workers (CHW) under supervision of a licensed Physical Therapist (PT) guided by telehealth based Cognitive Behavioral Therapy (CBT) to reduce task specific fears through repetitive exposure and adaptive behavioral activation strategies and facilitate engagement in physical activity.

1. To integrate and establish feasibility of CATCHES intervention. Hypothesis: A multidisciplinary team providing home based TST with exposure therapy tailored to an underserved urban setting will inform a patient-centered behavioral intervention to reduce fear of falling (FOF) among post-acute stroke patients returning home. Feasibility outcomes will include recruitment, retention, and fidelity of implementation.
2. Test effects of the intervention on hypothesized treatment mechanism of fear of falling. Hypothesis: Therapy will reduce task specific fear of falling Primary outcome will be change in Activities-specific Balance Confidence Scale.
3. Explore physical activity measures subjectively and objectively. Exploratory outcomes include pre and post Timed Up and Go test, patient reported outcome surveys and activity as measured by wearable devices.

Stroke is a leading cause of disability in the country, and ethno-racial inequities are persistent. Almost two thirds of stroke patients are discharged home without effective rehabilitation or community-based support. Falls can occur at home, and associated fear of falling leads to avoidance behaviors that limit physical activity and community reintegration. Here the investigators propose a novel intervention in a feasibility study for preliminary testing, integrating Task Specific Therapy at home guided by Community Health Workers (CHW) under supervision of a licensed Physical Therapist (PT) in conjunction with telehealth based Cognitive Behavioral Therapy (CBT) with reduce task specific fears through repetitive exposure and adaptive behavioral activation strategies to facilitate engagement in physical activity. The main objective is to assess the feasibility of this intervention. The secondary objective is to explore the underlying behavioral mechanism for behavior change and explore physical activity.

Eligibility Criteria:
Inclusion criteria:

* Aged over 18 years
* Plan for discharge home after stroke and ability to provide consent
* Low balance confidence (Activities-specific Balance Confidence \< 80)

Exclusion criteria:

* Modified Rankin Scale \> 2 at time of enrollment
* Severe Stroke (NIH Stroke Scale \> 14 and/or significant aphasia, dysarthria, or cognitive impairment precluding ability to complete study questionnaires as determined by interviewer)
* Legal blindness precluding ability to view infographic or education materials
* Terminal non-cardiovascular illness (life expectancy \< 1 year)
* Co-morbid mental illness requiring hospitalization
* Unavailable for follow-up
* Non-English and non-Spanish speaking
Educational Impact of the NLM/National Area Health Education Center Organization (NAO) Project-SHARE Based Teen Health Information Literacy Curriculum

Background:

The Teen Health Information Literacy Project is an after-school program for high school students. It gives them skills to access valid and reliable health data. It also aims to grow young health advocates. Researchers want to find out more about the impact the program has had on students. They want to use this feedback to improve the program.

Objective:

To gain feedback about the Teen Health Information Literacy Project.

Eligibility:

Young people who participated in the Teen Health Information Literacy Project. The project was run by Area Health Education Centers (AHECs) and sponsored by the National Library of Medicine (NLM).

Design:

The study will be explained to students during a program session. They will take consent forms home to their parents.

Participants will split into 6 focus groups. Each one will be conducted at an AHEC project site.

The focus group will be a 90-minute discussion between participants and an evaluator from the NLM. The evaluator will be present either in person or by video conference.

The evaluator will ask participants questions, which may include the following. What did they like and dislike about the program? Why did they decide to participate? What have they learned? Would they recommend this program to another student? How has the program affected their interest in health-related careers?

The discussion will be audio-recorded. The evaluator will use an automated tool to convert recordings into text. After that, she will destroy the audio.

The objective of the study is to evaluate the impact of the National Library of Medicine (NLM)/ National Area Health Education Center Organization (NAO) Teen Health Information Literacy Curriculum (based on an earlier Project SHARE curriculum) on the participants : understanding of health disparities in their communities; leadership, health advocacy, and communication skills; sense of self and connectedness with the community; and interest in health-related careers. Study population: The study population consists of program participants at the five participating sites, which include local AHEC chapters of Boston, Brooklyn-Queens-Long Island, Colorado, Eastern Connecticut, and Montana. The program participants are middle and high school students, ranging in ages from 13 to 18 years old. All participants will be invited to participate. Design: The study will involve moderated focus groups at each participating site. Outcome measures: participants understanding of health disparities in their communities; leadership, health advocacy, and communication skills; sense of self and connectedness with the community; and interest in health-related careers.

Eligibility Criteria:
* INCLUSION CRITERIA:
* Participation in the NLM / NAO Teen Health Information Literacy Project

EXCLUSION CRITERIA:

-NA