cyrilzakka/clinical-trials huggingface dataset:
Case Series to Evaluate the Identification of Anatomical Markers Using the KANGAROO™ Feeding Tube

This is a prospective, single-center, open label, within-subject clinical trial to evaluate the identification of anatomical markers in the gastrointestinal tract using the IRIS feeding tube. The trial will evaluate hospitalized subjects who require short-term enteral feeding with an anticipated duration of at least 3 days while in an intensive care unit (ICU) or step-down unit. Eligible men and women at least 18 years of age who give voluntary, written informed consent to participate in the clinical investigation will be included as subjects. If a potential subject is incapacitated and unable to provide informed consent, a designated legally authorized representative will be allowed to provide the informed consent on behalf of the subject to allow their participation in the study. Study entry will be defined as the point of signed informed consent. A Prospective, Single-Center, Open Label, Within-Subject Case Series to Evaluate the Identification of Anatomical Markers in the Gastrointestinal Tract Using the KANGAROO™ Feeding Tube with IRIS Technology


Eligibility Criteria:
Inclusion Criteria:

1. Hospitalized male and female patients in a monitored setting (i.e.; ICU or Step-Down Unit) who require and are eligible for short-term enteral (nasal or oral) feeding per standard of care with an expected duration of at least 3 days.
2. The subject or a legally authorized representative is able to understand and willing to give written informed consent.
3. Be a man or woman of 18 years or older
4. Have uncomplicated naso- and oropharyngeal anatomy based upon a focused physical examination

Exclusion Criteria:

1. Women and men under the age of 18 years
2. Female patients who are known to be pregnant or lactating
3. Incarcerated or imprisoned individuals
4. Hemodynamic instability with an inability to maintain a MAP \> 65 mm Hg on vasopressors
5. Patients who are currently enrolled in an investigational or interventional drug or device clinical trial
6. Patients who have been previously enrolled into this study
7. Individuals, who, in the opinion of the Principal Investigator, have any medical, social or psychological condition that would compromise their participation and follow-up in this clinical investigation
8. Known basal skull fractures
9. Unrepaired known GI perforation or leak
10. Recent adequate upper GI bleed that may obscure images
11. Esophageal varices \> Grade 2
12. Subjects with known anomalies precluding gastric or intestinal insertion (via either nasally or orally)
13. Known obstruction of the gastrointestinal tract
14. Known bowel ischemia or any other contraindication for enteral feeding
Study to Evaluate the Performance of the Therma COVID-19 Rapid Antigen Test for Detection of SARS-CoV-2

The Therma COVID-19 Rapid Antigen Test is an in vitro rapid, lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in human saliva specimens. This test is intended for near-patient use at the point-of-care or lay person, self-use in a non-laboratory or home setting using saliva samples from individuals with or without symptoms of COVID-19.

The Therma COVID-19 Rapid Antigen Test will be compared to a Health Canada approved RT-PCR COVID-19 test. Nasopharyngeal (for RT-PCR) samples will be collected at a COVID-19 Testing centre and saliva (for the rapid antigen test) samples will be collected and compared.

The prospective, observational, feasibility study will test 300 participants to establish the performance characteristics of the test on saliva specimens.


Eligibility Criteria:
Inclusion Criteria:

1. Participant is willing to sign verbal informed consent form
2. Age 12 or older and parents or legal guardians must consent for children as required by law.
3. Participant is attending COVID-19 testing centre for a nasopharyngeal swab sample
4. Participant is willing to provide a self-collected saliva sample

Exclusion Criteria:

1. Participant has previously tested positive for COVID-19 within the past 90 days
Screening Study for Cervical Pre-cancer and Cancer Prevention in South African Women.

Nearly 8 000 new cervical cancer cases are diagnosed in South Africa per year; many are still undiagnosed and about 50% of diagnosed cases succumb per year. Although the current prevalence of pre-cancer cervical disease is largely unknown, data from local studies suggest regional differences and an increase in the prevalence of cytological abnormalities when compared with historical data. Low frequency in cytology screening is the primary factor attributable to development of invasive cervical cancer and almost one-third of all cervical cancer patients had previous negative cytology. Due to the low sensitivity of cytology it can be assumed that the true prevalence of pre-cancer disease is underestimated by all available data. One round of optimal cervical cytology will detect around 50% of existing pre-cancer cervical disease as identified and proven using colposcopy and directed biopsy. It is now widely accepted that primary screening with a human papilloma virus (HPV) test can improve the sensitivity of screening and that even a single round of HPV screening can rapidly reduce the incidence of invasive cervical cancer and related mortality within a few years.

South Africa has a high prevalence of HIV infection and a delay in or failure to initiate antiretroviral therapy (ART). These facts, together with the largely unscreened status of the female population and the high incidence of cervical cancer all suggest that HPV infection and precursors to cervical cancer are both unusually common among South African women. Accurate current knowledge of the performance of newer generation HPV based screening tests in HIV-infected and general female population are essential for cost-analysis and planning for national prevention and screening programs. This study will aim to demonstrate the feasibility and efficacy of new generation HPV deoxyribonucleic acid (DNA) based screening assays in a South African setting.

The investigators hypothesize that HPV testing followed by normal and special cytology tests will be a successful screening model for a South African population.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent accepted and signed
* Health seeking behaviour or request for a cervical cancer screening test
* Willing and able to receive test result by automated text message or clinic visit

Exclusion Criteria:

* Current pregnancy
* Hysterectomy
* Current or previous treatment for gynaecological cancer
* Hesitant or unable to undergo screening and treatment if indicated
Children Severe Traumatic Skin Lesions and Functional Outcome

Traumatic skin lesions require an adapted and early patient care management

Traumatic skin lesions and in particular the burns which happen to growing children are complex and require an adapted and early patient care management. A child presents physical, psychological, and physiological characteristics which involve a specific functional prognosis. The aim of the study was to evaluate the functional outcome after a mid-term period from a severe skin traumatism occurring during childhood and which had required an initial graft.

Eligibility Criteria:
Inclusion Criteria:

* children who were hospitalized for an extensive and deep skin lesion on at least one joint, at CHU Amiens, from April 1999 to December 2014, in the Physical and Rehabilitation Pediatric activity center.
* And with a serious skin lesion:

  * What the total dermal area is estimated to be less than 25%
  * Taking at least one articulation
  * Dont a part is at least 2nd degree deep or third degree

Exclusion Criteria:

* First degree burns or superficial second degree Burns resulting in death in the acute phase
* A history of pre-burn disorders affecting growth
* Escarres
Evaluation of DD-25 Topical Cream for the Treatment of Psoriasis Vulgaris : Proof of Concept Study

The purpose of this study is to determine the efficacy of DD-25, a new topical drug, on plaque Psoriasis Vulgaris.

The study will include subjects at plaque stage from 5-20% body area involvement. A total of 30 subjects will be treated with cream application on affected areas twice daily for three weeks.The efficacy of the preparation will be documented by PASI score, Global physician assessment and photos.

Psoriasis Vulgaris remains a widespread clinical entity with chronic outflares and various regimens of treatment, none of them definitive. A new safe and efficacious, external treatment is required for.

Eligibility Criteria:
Inclusion Criteria:

1. Subject age 18-60
2. Diagnosis of PS by a dermatologist with lesions on arms, legs or trunk
3. Subjects have stable plaque PS, mild to moderate form, Body Surface Area of 5-20%.
4. Subject understood and signed an informed consent form

Exclusion Criteria:

1. Guttate, erythrodermic, palm-plantar or pustular psoriasis as sole or predominant form of psoriasis.
2. Hypersensitivity to sunlight; history of Lupus, PMLE, or any disease known to be worsened by UV light exposure
3. Pregnancy, breast feeding
4. History of cancer, excluding non-melanoma skin cancer.
5. Patients with history of ischemic heart disease (e.g. angina pectoris, myocardial infarction); cerebrovascular syndromes, peripheral vascular or uncontrolled hypertension. Subjects with known severe hepatic and/or severe renal insufficiency.
6. Any medical condition that, in the opinion of the Investigator, would jeopardize the health of the patient during the course of this study.
7. Systemic treatment with biological therapies with a possible effect on psoriasis vulgaris within 4 months or 5 drug half-lives prior to checkup.
8. Systemic treatments with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, vitamin D analogues, retinoids, immuno-suppressants) within the 8-week period prior to randomization. Subjects using within the 8 week period prior to randomization PUVA or Phototherapy. Use of SSRI or MAO inhibitors.
9. Subjects using one of the following TOPICAL drugs for the treatment of PS within 2 weeks prior to randomization: e.g. WHO group I-II corticosteroids, retinoids, Vit. D analogues, immunomodulators, Anthracene derivatives, Salicylic acid.
10. Subjects with current participation in any other interventional clinical or subjects with any concomitant dermatological disorder(s) which might preclude accurate evaluation of the psoriasis
Exacerbations and Their Outcomes International (EXACOS International)

Observational, cross-sectional study with retrospective data collection from medical records. During the cross-sectional study visit, data will be captured through the use of electronic Case Report Forms (eCRFs). As there will be only one study visit, no prospective data collection will take place, nor collection of data that are not part of the routine clinic visit.

For understanding the burden of severe exacerbations of COPD and the association between frequency of severe exacerbations and clinical and health-care utilization outcomes in less well-resourced countries

Observational, cross-sectional study with retrospective data collection from medical records. During the cross-sectional study visit, data will be captured through the use of electronic Case Report Forms (eCRFs). As there will be only one study visit, no prospective data collection will take place, nor collection of data that are not part of the routine clinic visit.

For understanding the burden of severe exacerbations of COPD and the association between frequency of severe exacerbations and clinical and health-care utilization outcomes in less well-resourced countries

Patients, treated by pulmonologists, with an investigator-confirmed diagnosis of COPD for at least 5 years from the index date (the date that signed Informed Consent was obtained) and who meet all of the inclusion and none of the exclusion criteria

Eligibility Criteria:
Inclusion Criteria:

* Patients will be included if they meet the following inclusion criteria:

  1. have an investigator-confirmed diagnosis of COPD of at least 5 years and are over the age of 40 years old;
  2. are smokers or ex-smokers (quit smoking no longer than 15 years before the study visit);
  3. have COPD-related data recorded in (electronic) medical records for at least 5 years, including spirometry and medication data;
  4. have signed a written Informed Consent Form

Exclusion Criteria:

* Patients will be excluded from participation if they meet any of the following exclusion criteria:

  1. have a diagnosis of bronchiectasis, sarcoidosis, Interstitial Lung Diseases, or Idiopathic pulmonary fibrosis. This is because differentiating deteriorations in symptoms/exacerbations in these individuals at attributing them to COPD is impossible
Multicenter Asthma Research Collaboration

To study the epidemiology of emergency asthma by focusing on three Multicenter Asthma Research Collaboration (MARC) databases collected over a two-year period in adult and pediatric emergency departments.

BACKGROUND:

The Multicenter Airway Research Collaboration (MARC) was created by 12 emergency physicians in May 1996 to determine the best management of acute asthma in the emergency department. The principal investigator of MARC, Dr. Carlos Camargo, formed the MARC Steering Committee to help guide this collaboration. The MARC Coordinating Center is based at the Massachusetts General Hospital (Boston, MA). Financial support for MARC has come from a variety of sources, including government, foundations, and industry. The NHLBI study used MARC databases.

DESIGN NARRATIVE:

Five representative aims were to: 1) characterize acute asthma management in urban emergency departments (EDs) and then compare current practice with that recommended in the 1997 national guidelines; 2) examine gender differences in acute asthma; 3) identify reasons why minority patients with asthma go to (and possibly prefer) the ED for their asthma care; 4) characterize important clinical subgroups, such as acute asthma among pregnant women and patients with sudden-onset severe acute asthma; and 5) examine risk factors for asthma hospitalization and for relapse after ED discharge.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Effects of a Community-based Group Rehabilitation Program for Dynamic Balance and Mobility Post Stroke

Stroke patients clearly benefit from intensive and coordinated inpatient care. While inpatient rehabilitation care is the preferred form for many patients post-stroke, due to access and financial barriers, many patients do not have this option. Community, outpatient rehabilitation programs will allow the patients with moderately disabling strokes the opportunity to maintain or augment gains achieved during inpatient stroke rehabilitation , while allowing some patients with mild disability to avoid inpatient rehabilitation completely.

Objective: Phase 1 randomized control trial to test the efficiency and effectiveness of treating adults who have suffered a single stroke using the following essential treatment components; a) community setting, b) group activity program, c) flexible, task-specific, computer-based exercise regime This program is designed to allow an extension of the in-patient rehabilitation experience to a community-based setting, in a cost-effective manner using paraprofessional staff and rehabilitation specialists, to provide a challenging, functional program to promote recovery and independence from physical impairments affecting balance and walking.

The specific objectives are to:

1. assess the benefits and feasibility of the multi-functional group exercise intervention for balance and mobility in a community setting. Secondary objectives
2. identify effective combinations of exercises \& activities that translate to increased abilities and participation levels.

Hypothesis: Intense training targeting standing balance, and walking will significantly improve stroke clients' functional mobility. Training in a group setting and incorporating interactive and engaging computer gaming further provides the benefits of motivation and peer support while providing treatment in a cost effective manner.


Eligibility Criteria:
Inclusion Criteria:

1. community dwelling individuals, who have suffered a single stroke of thrombic -embolic or hemorrhagic origin in the last 3-12 months and are waiting for outpatient rehabilitation ,
2. Aged 50-70 years,
3. Montreal Cognitive Assessment score greater than 26,
4. English-speaking and possess the ability to understand the nature of the study and provide informed consent,
5. Independent in sit to stand transfer and ambulatory functions, with or without an assistive device (cane or walker), f ) Gait speed (average over 25 meters) between 0.3 and 0.8 m/s and Berg Balance Scale score of less than 45.

Exclusion Criteria:

Any medical condition or disability that prevents participation in an exercise program. For example, a reported medical history of current treatment for cancer, kidney disease, recent fracture, uncontrolled diabetes or seizure disorder, uncontrolled cardiovascular-related problems .

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Mobile-based Positive Psychological Support for Smoking Cessation Via "Quit to Win" Contest 2021 (QTW 2021)

This study aims to explore the effectiveness of a combined intervention using brief cessation advice and personalized chat-based positive psychological support compared with the control group on current smokers who join the Quit to Win Contest.

Smoking is a leading cause of many diseases and deaths globally. Although Hong Kong has a relatively low overall smoking rate of 10.2% (in 2019), health and economic burdens due to smoking are still substantial. The practice of smoking might predispose smokers to COVID-19 infection and poor prognosis. Growing evidence has also suggested that smokers are at higher risk of developing serious respiratory and cardiovascular symptoms in the COVID-19 pandemic than non-smokers. Smoking cessation in the post-COVID-19 era is the key priority to meet the HKSAR Government's target of reducing smoking prevalence to 7.8% by 2025.

Mental health problems are commonly comorbid with smoking and related problems. Our population-based survey amidst the COVID-19 pandemic found current smokers were at higher risk of suffering from anxious symptoms (adjusted OR 1.84 95% CI 1.27, 2.67), depressive symptoms (adjusted OR 2.04 95% CI 1.40, 2.96), and stress symptoms (adjusted β 0.54 95% CI 0.26, 0.82) compared with non-smokers. We also observed mental health burden increased during the COVID-19 pandemic with approximately doubling of the prevalence of anxious symptoms (15.8 vs. 9.3) and depressive symptoms (14.8 vs. 6.3) compared with the pre-COVID-19 pandemic (2017). Mental health can be both precursors and consequences of smoking. Previous studies have suggested that depressive symptoms and low positive affect during and after SC attempts are associated with poor cessation outcomes. This implies that a combined intervention of behavioral and psychological SC intervention is needed, particularly under the circumstance of worsening mental health problems.

Therefore, our study aims to test the effectiveness of a combined intervention using brief cessation advice and personalized chat-based positive psychological support compared with the control group on current smokers who join the Quit to Win Contest.

Eligibility Criteria:
Inclusion Criteria:

* Hong Kong residents aged 18 or above
* Smoke at least 1 tobacco stick (includes HTP) per day or use e-cigarette daily in the past 3-month
* Able to communicate in Chinese
* Saliva cotinine 30 ng/ml or above
* Intent to quit/reduce smoking
* Able to use the instant messaging tool (e.g., WhatsApp, WeChat) for communication

Exclusion Criteria:

* Smokers who have communication barrier (either physically or cognitively)
* Smokers who are currently participating in other SC programmes or services
Implementation of A Patient Centered Self-Management Program for Patients With Type 2 Diabetes

Translational study based on the American Association of Diabetes Educators 7 behaviors to manage Type 2 diabetes

The Primary Investigator will meet with patients that attend routine visits for Diabetes 2 in the primary care office on a monthly basis to set behavior goals. Behavior goals will be set by patient's choice of 4 out of 7 of the AADE7 recommendations. The goals are health eating, being active, monitoring,taking medications, problem solving, healthy coping, and reducing risk. Once the goal is chosen, the PI and patient will make a plan to address the goals on a monthly basis for four months. There will be pre and post questionnaires that will evaluate diabetes knowledge and self-efficacy. There will also be a pre and post measure of the patient's Hemoglobin A1c which is a measurement that helps determine the extent of glycemic control over a three-month period.

The goal of the study is to determine if translation of the AADE7 behavioral goals into the primary care setting will make a difference in diabetes knowledge, self efficacy, and Hemoglobin A1c.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 with Hemoglobin A1c 7 mmol/mol or higher will be included in the study
* Patients willing to attend minimum of 4 monthly appointments for diabetes treatment
* Patients who give written consent to participate

Exclusion Criteria:

* Patients below age 18, children are not treated in the facility for type 2 diabetes
* Patients who attend less than 4 monthly appointments for diabetes,
* Patients who do no give written consent to participate
Observational Study on Safety and Efficacy of Biphasic Insulin Aspart in Type 2 Diabetes Patients

This study is conducted in Asia. The aim of this observational study is to evaluate the safety profile and clinical effectiveness of using various pre-mixes of Biphasic Insulin Aspart under routine clinical practice conditions in Israel in Type 2 Diabetes patients.


Eligibility Criteria:
Inclusion Criteria:

* Any patient with type 2 diabetes who has HbA1c greater than 7% on insulin with or without OAD and who needs intensification of treatment with either NovoMix® 30 or NovoMix® 50 or NovoMix® 70 or combinations, will be eligible

Exclusion Criteria:

* Subjects with a hypersensitivity to biphasic insulin aspart or to any of the excipients. Particular attention should be paid to the drug interactions that are listed within the product local label.
* Women who are pregnant, breast feeding or have the intention of becoming pregnant within the next 12 months.