cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Reversibility of the Bronchial Obstruction by Impulse Oscillometry Technique in Chronic Obstructive Pulmonary Disease (COPD): Correlation With Functional Features Measured by Plethysmography and Dyspnoea

Limitation of expiratory flows is considered as the main determiner of dynamic distension and dyspnoea in chronic obstructive pulmonary disease (COPD). The analysis of proximal and distal resistances should allow to better appreciate the functional impact.

This study should also allow to specify the best parameters in respiratory functional explorations useful for the follow-up in COPD and to specify the relevance of functional indications other than the forced expiration volume at 1 second (FEV1) or the functional residual capacity (FRC) to estimate in a more relevant way the clinical improve with the increase of the therapeutic load (increase of posology, association of two bronchodilatators, addition of an anti-inflammatory drug, thus etc...) at already handled patients suffering from a persistent dyspnoea insufficiently relieved.


Eligibility Criteria:
Inclusion Criteria:

* COPD with dyspnoea with Medical Research Council scale (MRC) \>1,
* No exacerbation for 6 weeks
* No bronchodilatator short action(share) (ß 2 agonist or ipratropium) within 6 hours before the respiratory evaluation and the test of reversibility.
* Patient under current treatment (ß2 long-acting agonist (LABA) or anticholinergic long-acting (LLAMA(LAMA)) or LABA-corticoid association inhaled (CSI), or triples LABA-CSI-LAMA association) stable for at least 4 weeks, and taken for at least the 1 hour the day of the visit
* Having given a written consent

Exclusion Criteria:

* Patient Under 18
* Other respiratory illness
* Clinically significant left cardiac failure
* Obesity with BMI \> 35 kg / m2)
* Unable to perform respiratory evaluations
* Contraindication to the salbutamol or to the ipratropium bromide or to one of its components
* Pregnant or breast-feeding woman
* Unable to agree
* No social security scheme
Effects of Inspiratory Muscle Training in Addition to Pulmonary Rehabilitation in Patients With COPD Exacerbation

Inspiratory muscle weakness, limited functional exercise capacity and worse quality of life have been shown in patients with exacerbation of chronic obstructive pulmonary disease (COPD). Recommendations from clinical practice guideline state that promoting pulmonary rehabilitation after exacerbation can improve the conditions above. Inspiratory muscle training (IMT) has been proven to enhance inspiratory muscle strength and endurance in patient with stable COPD. However, there is less research on whether IMT in addition to pulmonary rehabilitation after exacerbation can benefit inspiratory muscle function, functional exercise capacity and quality of life in patients with COPD. The purpose of this study is to examine the effects of IMT in addition to pulmonary rehabilitation on respiratory muscle function, functional exercise capacity and quality of life in patients with exacerbation of chronic obstructive pulmonary disease.


Eligibility Criteria:
Inclusion Criteria:

* age \> 20 years old
* diagnosed as exacerbation of COPD
* maximal inspiratory pressure (MIP) \< 80 cmH2O

Exclusion Criteria:

* any clinical diagnosis that will influence the measurement, including any history of neuromyopathy
* angina, acute myocardial infarction in the previous one month
* pregnancy
* participated in inspiratory muscle training program in the previous three months
* any psychiatric or cognitive disorders, for example: Mini-Mental State Examination (MMSE) \< 24, that will disturb the communication and cooperation of the study
Clinical Efficacy of Different Revision Times in the Reulceration Rate in Persons with Diabetes and Remission

The goal of this three arms randomized clinical trial is to compare different revision times in persons with diabetes at high risk of suffering a diabetic foot reulceration (patients in remission). The literature suggests to clinically check the patients in a 4-12 weeks basis, despite this, this recommendation is based in expert opinions.

The main question it aims to answer is:

- Does different revision times could affect the reulceration rate in persons with diabetes in remission. Different revision time will be 2 weeks, 4 weeks and 6 weeks.

The planned RCT try to elucidate if there exist any difference in ulcer recurrence between different revisions times in persons with a previous healed diabetic foot ulcer and currently under remission.

There will exist three different groups for analyses after randomization:

* Group 1: patients revised every fourweeks.
* Group 2: patients revised every eightweeks.
* Group 3: patients revised every twelveweeks.

Main outcome measure will include:

- Recurrence: the outcome measure was based on recurrent events in the foot in a binary basis (patient with a recurrent event or patient without a recurrent event), as defined according to the IWGDF guidelines. Recurrent events were considered as breaks in the foot skin at the epidermis and part of the dermis level.

Secondary outcome measure will include:

* Minor lesions: defined as non ulcerative lesions of the skin on the plantar aspect of the foot and included abundant callus, hemorrhage, or a blister.
* Minor amputations: evaluated in a monthly basis during the 1-year prospective period

Follow-up period: all the sample will be followed-up depending on the randomization group up to a 1-year prospective period. In every visit de principal investigator will perform debridement of high-risk points, such as minor lesions or calluses.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older.
* Type 1 or type 2 diabetes.
* Presence of diabetic polyneuropathy (diagnosed as an inability to sense the pressure of a 10-g Semmes-Weinstein monofilament at three plantar foot sites and/or a vibration perception threshold \>25 V, as assessed using a bio-tensiometer.
* Patients classified as high-risk patients (risk 3 patients according to the IWGDF guidance). Previous healed diabetic foot ulcer.

Exclusion Criteria:

* Active diabetic foot ulcers during inclusion.
* Active Charcot foot process.
* Conditions other than diabetes also associated with foot ulcers were excluded from the study as well.
Walking Football as a Supportive Medicine for Patients With Prostate Cancer

Androgen deprivation therapy (ADT) is widely used in men with prostate cancer (PCa) to delay disease progression and enhance survival. The use of ADT is often associated with a vast spectrum of side effects that considerably reduce quality of life. Exercise has been proposed as a non-pharmacological strategy to counter some adverse effects of ADT among patients with PCa. Particularly, recreational football-based interventions have been suggested as an enjoyment approach to involve patients with PCa in regular exercise practice. Given its intermittent nature and vigorous efforts, adverse events associated with recreational football practice have been reported. To handle this issue and to involve patients with PCa in recreational football practice, walking football has emerged as a more suitable exercise modality

This study was design as a randomized controlled trial, with two study arms, which aims to analyse the feasibility, safety of a supervised walking football program in patients with PCa. Moreover, the effects on health-related quality of life; bone mineral density; body composition; physical fitness; physical activity levels; inflammatory and metabolic profile; cognitive function; and cost-effectiveness will be complementarily analysed.

Recruitment will be conducted by invitation of Centro Hospitalar de Vila Nova de Gaia/Espinho (CHVNG/E; Vila Nova de Gaia, Portugal, E.P.E) oncologists and urologists. Patients who agree to participate in this study will be referred to a study coordinator (medical oncologist) and will be randomly allocated (1:1 ratio) to one of the two study-arms.

In addition to standard PCa care, patients in the interventional group (IG) will perform 3 times per week a supervised Walking Football Program over 16 weeks and plus 16 additional weeks.

Patients allocated to control group (CG) will receive standard PCa medical care and will be instructed to maintain daily-life routines. After the first 16 weeks, the control group patients' will be invited to join and preform the exercise intervention (additional 16 weeks).

Walking football exercise sessions will be conducted on an indoor sports hall, supervised by one exercise physiologist and a football coach. Exercise intensity will be monitored through heart rate and rated perceived exertion.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with PCa
* Under castration therapy for more than 3 months
* Planned to be under castration for more than 6 months
* Follow-up at the Medical Oncology department and/or Urology department of the Hospital Center Vila Nova de Gaia/Espinho.

Exclusion Criteria:

* Medical or surgical contraindications for exercise.
* T-score \< -2.5
A 12-Week Treatment Study to Evaluate the Effectiveness of Albuterol Multidose Dry Powder Inhaler With Integrated Electronic Module Digital System (eMDPI DS) in Participants13 Years or Older With Asthma

This is a 12-week treatment, multicenter, open-label, randomized, parallel group comparison feasibility study to evaluate the effectiveness of the Albuterol eMDPI Digital System (DS), including inhaler, App, digital health platform (DHP) (Cloud solution), and dashboard, to optimize outcomes in participants at least 13 years of age or older with asthma.

The study will consist of a screening visit, a 12-week open-label treatment period, and a follow-up telephone call (2 weeks following treatment completion).

Participants with suboptimal asthma control will be enrolled in the study and randomized in a 1:1 ratio to 1 of 2 parallel groups stratified by investigational center: DS group participants utilizing the Albuterol eMDPI DS, including inhaler, App, DHP (Cloud solution), and dashboard, and CC group participants who will be treated with their standard of care albuterol-administering rescue inhalers and will not use the DS during the treatment period.


Eligibility Criteria:
Inclusion Criteria:

* The participant has a documented diagnosis of asthma
* The participant is currently on treatment with an inhaled corticosteroid (ICS) with a long-acting beta2 antagonist (LABA).
* The participant is currently using inhaled albuterol sulfate as rescue medication and is willing to discontinue all other rescue medications and replace them with the study provided Albuterol eMDPI.
* The participant can read and communicate in English and is familiar with and is willing to use his/her own smart device and download and use the App.

  * Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

* The participant has any clinically significant uncontrolled medical condition (treated or untreated) other than asthma.
* The participant was hospitalized for severe asthma in the last 30 days.
* The participant has a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) or Asthma-COPD Overlap (ACO).
* The participant is a current smoker or has a greater than 10 pack-year history of smoking.
* The participant is currently being treated with systemic corticosteroids (oral, intramuscular, or intravenous) or has been treated within the last 30 days.
* The participant has any treatment with biologics for asthma (for example, omalizumab, anti-IL5, anti-IL5R, anti-IL4R), or has had such treatment within the last 90 days.

  * Additional criteria apply, please contact the investigator for more information
Evidence-Based Tele-Emergency Network Grant Program

The purpose of this study is to determine the impact of an existing tele-emergency care network on quality of care, appropriateness of care utilization, patient safety (medication errors), and cost effectiveness compared to telephone consultations from a healthcare system prospective.

The investigators will use a novel cluster randomized unbalanced crossover trial design. When a new site is enrolled, the first approximately 6 months of the project will be a "ramp-up" period during which the protocol will be re-reviewed during a site visit to the participating EDs and random block assignments will be generated and delivered. The last 6 months will be reserved for data analysis, study closeout, and manuscript preparation. An intervening 2-year period will be divided into 4 six-month calendar time periods for carrying out the protocol and data collection. For each 6-month period, each ED will have a randomized treatment assignment for pediatric emergency and critical care consultations ("M" for telemedicine and "P" for telephone.) Participating EDs (the unit of randomization) will be stratified into two strata by size of ED and geographical location. EDs will then be randomized within-strata to one of the four unbalanced (3:1) crossover treatment assignment sequences, each consisting of a 6-month period: PMMM, MPMM, MMPM, or MMMP. During these assigned periods, the type of consultation being assigned will be strongly encouraged, but deviating from protocol (i.e., using telephone consultation when randomized to telemedicine, or the vice-versa) will be allowed as needed by the physicians. Data will be collected and abstracted through retrospective chart review.

Eligibility Criteria:
Inclusion Criteria:

* Children younger than or equal to 14 years of age at the time of their ED visit.

Exclusion Criteria:

* Children evaluated at the ED for non-medical reasons such as elective surgeries and social reasons (i.e., cases of possible endangerment) and other non-medical reasons.
* Children evaluated at the ED preoperatively, for elective surgical procedures.
* Children transferred to the ED from another hospital ED.
* Children transiently "held" in the ED in the process of a direct admission to the ward.
Presentation of First Time Attenders at Lymphedema Clinics

The first aim of this research project is to identify what factors motivate patients to seek assessment for early lymphedema and further, to gain insight into the signs and symptoms of developing lymphedema and the concurrent physical measurements.

The second aim is to identify other sensory signs and symptoms and changes in body perception which may be perceived by the patient as reflective of lymphedema, and to identify to which degree they contribute to the patients' motivation to seek referral to lymphedema clinics.

One of the most challenging morbidities after breast cancer treatment is lymphedema. Approximately 20% of women treated for breast cancer with axillary lymph node dissection will be diagnosed with lymphedema. Pre- and post-operatively, women are informed about changes suggestive of lymphedema and guided about seeking further assessment. The investigators presume that if symptoms occur, patients will seek assessment. However, it is unknown whether this is true or if those prospectively monitored present earlier for treatment, or whether other factors specifically drive patients to seek further assessment. Understanding the early experience and presentation of secondary lymphedema will improve patient education and detection programs.

Eligibility Criteria:
Inclusion Criteria:

* women after breast cancer (\> 18 years) with unilateral axillary lymph node dissection or sentinel node biopsy; mastectomy (with or without autologous reconstruction) or wide excision of the tumor
* able to give consent to participate in the research

Exclusion Criteria:

* patients under the age of 18 years
GLP-1: Acute Effects on Kidney Function in Healthy Men

The purpose of this study is to investigate how Glucagon-Like Peptide 1 (GLP-1) affects kidney function in healthy young men. The hypothesis is that GLP-1 induces a positive effect on kidney hemodynamics.


Eligibility Criteria:
Inclusion Criteria:

* Healthy young men

Exclusion Criteria:

* Any chronic diseases
Investigating Systemic and Local Vascular Responses to Apelin in the Context of Renin-angiotensin Upregulation

The apelin-APJ system is a relatively new discovery. It has generated interest in part due to it's apparent ability to counteract the renin-angiotensin system, which is frequently overactive in many cardiovascular disease.

Two of the main actions of apelin are to increase the pumping ability of the heart and cause blood vessels to relax. The investigators wish to assess if these actions are altered in the setting of normal renin-angiotensin activation and increased renin-angiotensin activity.


Eligibility Criteria:
Inclusion Criteria:

* \>18yr

Exclusion Criteria:

* Lack of informed consent
* Age \< 18 years,
* Current involvement in other research studies,
* Systolic blood pressure \>190 mmHg or \<100 mmHg
* Malignant arrhythmias
* Renal or hepatic failure
* Haemodynamically significant aortic stenosis
* Severe or significant co morbidity
* Women of childbearing potential.
* Any regular medication
* Previous history of any cardiovascular disease
Fabrication of Naso-alveolar Molding (NAM) Appliance in Cleft Lip and Palate (CLP) From Digital Magnetic Resonance Imaging (MRI) Face Scan

The purpose of this study is to fabricate a nasoalveolar molding (NAM) appliance that is digitally fabricated and 3 dimensionally printed utilizing an MRI face scan and to assess the fit of the NAM in new borns with cleft lip and palate.


Eligibility Criteria:
Inclusion Criteria:

* new born babies with cleft lip and/or palate
* will undergo treatment with UT Pediatric Dental Clinic with a NAM appliance

Exclusion Criteria:

* Patients without cleft lip and/or palate
* patients that cannot tolerate an intraoral appliance
* patients that are not able to be discharged from the hospital 2-3 days after birth.
Evaluation of Ocoxin®-Viusid® in Advanced Stomach Cancer and Gastric Esophagogastric Junction

Our main objective is to evaluate the effect of Ocoxin-Viusid on the quality of life of patients with advanced stomach cancer and esophagogastric junction. The Ocoxin-Viusid nutritional supplement is expected to improve quality of life and tolerance to treatment with Chemotherapy.

* To evaluate the effect of Ocoxin-Viusid on the quality of life of patients
* To evaluate the toxicity of Ocoxin-Viusid in combination with chemotherapy (QT).
* To assess the influence of Ocoxin-Viusid on tolerance to treatment with chemotherapy.
* Identify the changes that occur in the nutritional status of patients receiving the supplement.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with cyto-histological diagnosis of stomach adenocarcinoma and gastric esophageal junction in stages III and IV, which are tributaries of the FOLFOX chemotherapy scheme.
2. Patients of any sex with age ≥ 18 years.
3. Patients with clinical status according to Karnofsky index ≥ 70%.
4. Patients with life expectancy ≥ 3 months.
5. Clinically fit patients to receive the FOLFOX chemotherapy scheme.
6. Patients who have signed informed consent for the investigation.
7. Patients with laboratory parameters within normal limits that do not contraindicate the administration of chemotherapy: hemoglobin ≥ 90 g / l, total leukocyte count ≥ 3.0 x 109 / L, absolute neutrophil count\> 1.5 x 109 / L, platelet count\> 100 x 109 / L, total bilirubin ≤ 1.5 times the upper limit of the normal range established in the institution, TGO / TGP ≤2.5 times the upper limit of the normal range established in the institution, creatinine within the limits normal of the institution.
8. Patients of childbearing age with negative pregnancy test and use appropriate contraceptive methods such as intrauterine devices, barrier or tubal ligation methods, hormonal contraceptives. In the case of male sex (vasectomy, use of condoms) while the treatment lasts.

Exclusion Criteria:

1. Patients with stomach cancer and gastric esophageal junction in stages III and IV, tributaries of surgical treatment and / or radiotherapy.
2. Patients who are being treated with another product under investigation.
3. Patients with known hypersensitivity to any component of the investigational product.
4. Patients with known hypersensitivity to any component of the Chemotherapy (FOLFOX).
5. Patients with acute allergic states or history of severe allergic reactions.
6. Patients with acute, chronic, or inflammatory decompensated infectious diseases.
7. Patients with brain metastases.
8. Patients with psychiatric disorders that make it difficult to collect information, treatment or follow-up.
9. Patients in the period of breast-feeding or puerperium.
Effects of a Combination of Polyphenol-rich Extracts on the Protection of Retinal Cells Against Blue Light in the Prevention of Ocular Diseases

The aim of the study is to confirm that daily supplementation with a product containing a standardized combination of polyphenol-rich extracts has a protective effect against potential blue-light-induced damage to retinal cells.

Randomized, double-blind, parallel study conducted under medical supervision on a group of 54 volunteers exposed to blue-light for 6-8h a day. Patients receive one of the investigational products or placebo for 6 weeks. Study parameters: OCT (optical coherence tomography), Amsler test, Computerized Perimetry, Schirmer test. In addition, subjective symptoms will be assessed using the Visual Analog Scale (VAS) method and a Dry Eye-Related Quality-of-Life Questionnaire. The studied parameters will be measured before and after supplementation.

Eligibility Criteria:
Inclusion Criteria:

* Women and men, 25-45 years old.
* Signed informed consent.
* Volunteers who do not use glasses or contact lenses.
* Volunteers exposed to blue light for at least 6 - 8 hours a day.

Exclusion Criteria:

* Intake of supplements containing plant extracts, polyphenols or anthocyanins.
* Participation in another clinical trial.
* Oncological disease, autoimmune disease, severe liver dysfunction, tuberculosis, leukemia, multiple sclerosis, AIDS, rheumatoid arthritis, organ transplant and other gastrointestinal diseases that may affect the results of the study.
* Women who are pregnant, planning to become pregnant during the study, or breastfeeding.
* Use of drugs that cause impaired vision or impaired tear secretion (including digoxin, fluoroquinolones, metronidazole, hydrochlorothiazide, retinoids).
* Current use of eye drops in the treatment of ocular diseases.
* Ocular diseases.