cyrilzakka/clinical-trials huggingface dataset:
BE1 Study Spain - CAPSULE SYSTEM FOR COLOSTOMATES

A comparative study on the improvement of quality of life of colostomized patients using the new Be1 device with capsule system.

The primary objective is to demonstrate improvement of quality of life (difference of at least 5 points in the StomaQoL questionnaire) among descending colostomy patients, establishing the following comparisons:

1. Patients with recent surgery who after one month using a current two-piece mechanical device switch to the new Be1 device with capsule system versus patients who after one month continue to use the same current two-piece mechanical device during four months.
2. Patients who have been using a current two-piece mechanical device during more than 6 months after an ostomy and agree to switch to the new Be1 device with capsule system during four months.

The following secondary objectives have been defined:

* Assessment of patient satisfaction with the new Be1 device with capsule system versus a current two-piece mechanical device.
* Demonstration that the new Be1 device with capsule system improves the microbiota of the colostomized patient.

Eligibility Criteria:
Inclusion Criteria:

- Inclusion criteria groups 1 and 2

* Patients of at least 18 years of age.
* Recently operated patients with a descending colostomy.
* Patients with a non-retracted stoma measuring no more than 1.5 cm in height.
* Patients agreeing to participate in the study and who have signed the informed consent in accordance with the legal requirements.
* Patients who in the opinion of the stoma therapist are candidates for a two-piece mechanical device.

Inclusion criteria group 3

* Patients of at least 18 years of age.
* Patients with a descending colostomy for over 6 months and who carry a two-piece mechanical device.
* Patients with a non-retracted stoma measuring no more than 1.5 cm in height.
* Patients agreeing to participate in the study and who have signed the informed consent in accordance with the legal requirements
* Patients who in the opinion of the stoma therapist are candidates for use of the Be1 device with capsule system.

Exclusion Criteria:

Exclusion criteria groups 1 and 2

* Patients with cognitive impairment which in the opinion of the investigator would not allow completion of the questionnaire or could pose problems.
* Patients who are participating in another study.
* Patients with multiple stomas.
* Vulnerable patients or subjects under legal tutelage.
* Patients with known allergy to any of the components of the study product.
* Patients with a retracted stoma.
* Patients with a prolapsed stoma or a stoma measuring more than 1.5 cm in height.

Exclusion criteria group 3

* Patients with cognitive impairment which in the opinion of the investigator would not allow completion of the questionnaire or could pose problems.
* Patients who are participating in another study.
* Patients with multiple stomas.
* Vulnerable patients or subjects under legal tutelage.
* Patients with known allergy to any of the components of the study product.
* Patients with a retracted stoma.
* Patients with a prolapsed stoma or a stoma measuring more than 1.5 cm in height.
Dietary Intervention to Mitigate Adverse Consequences of Night Work

The goal of this clinical trial is to test whether our dietary intervention can prevent or lessen the negative health effects of night shift work in healthy participants.

Participants will:

* complete 2 inpatient stays
* be provided with identical meals
* have frequent blood draws
* provide urine, saliva, stool and rectal swab samples

Shift work increases the risk for diabetes possibly due to the adverse metabolic effects of circadian misalignment. As shift work is not foreseen to disappear, the development of individually-targeted therapies for metabolic health in these vulnerable shift workers is urgently needed. This research will determine whether our dietary intervention can mitigate the adverse metabolic effects of circadian misalignment, which may help in the design of evidence-based dietary interventions to improve the metabolic health in shift workers.

Eligibility Criteria:
Inclusion Criteria:

* 18-45 yr old
* BMI 20.0-29.9
* European/Hispanic/African-American ancestry
* No acute, chronic or debilitating medical conditions (e.g. metabolic, cardiovascular, respiratory, neurological, cancers, etc.)

Exclusion Criteria:

* Currently smoking/vaping or 5 or more years of smoking/vaping
* History of drug or alcohol dependency
* History of psychiatric illness or disorder
Caregiver as Navigator: Develop Skills Online (CAN-DO)

This study is designed to learn more about ways to promote caregiver mastery online. 270 dementia family caregivers will be enrolled and randomized to take the CAN-DO online course immediately or after a waiting period. They will participate in interviews before and after the course; total time of study participation is 6 months.

Family members and friends are the core of the uncoordinated system of care that tenuously maintains persons living with dementia in their community settings and delays their placement into more costly settings of institutional care, providing more contributed and out of pocket care support than Medicare and Medicaid combined.

The CAN-DO program fills a significant gap in caregiver psychoeducation programming by focusing not principally on day-to-day care management but on the many substantial system navigation tasks that caregivers assume. Supported by preliminary efficacy data, CAN-DO will employ state-of-the art asynchronous interactive learning methods to enhance caregivers' mastery of skills and confidence to navigate healthcare and other (legal, financial, social service, and family) systems that are crucial to the continued community living of persons affected with dementia illnesses.

This study will enroll 270 dementia family caregivers who will be randomized to take the CAN-DO course immediately or after a waiting period. They will participate in interviews before and after the course; total time of study participation is 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Family member or friend providing at least 4 hours per week of informal care for a community-dwelling person living with ADRD
* 18 years or older
* Has internet access
* Does not have to co-reside with the individual
* Understands, speaks, and reads English

Exclusion Criteria:

* Family caregiver plans to move care recipient to an institutional setting within the next six months
* Care recipient currently enrolled in hospice
A Study of Viekira/Exviera for Korean Hepatitis C Patients According to the Standard for Re-examination of New Drugs

Post-marketing surveillance study to evaluate the real world safety and effectiveness of Viekira/ Exviera (paritaprevir/ritonavir/ombitasvir and dasabuvir) administered under a normal, routine treatment practice by Korean patients with Hepatitis C.


Eligibility Criteria:
Inclusion Criteria:

* Participants with type C hepatitis
* Participants prescribed Viekira/Exviera in accordance with approved local label

Exclusion Criteria:

* None
Low Dose Thrombolysis, Ultrasound Assisted Thrombolysis or Heparin for Intermediate High Risk Pulmonary Embolism

Open label clinical randomized trial comparing three strategies for managing acute intermediate-high risk pulmonary embolism

Trial acronym: STRATIFY Background: Intermediate-high risk pulmonary embolism (PE) is associated with a significant risk of death or hemodynamic deterioration. The optimal treatment strategy should balance efficacy in reducing thrombus burden and hemodynamic compromise with risk of complications, in particular bleeding. Previous studies have investigated conventional high-dose, short term thrombolysis by (rtPA), finding a reduction in risk hemodynamic deterioration, but no reduction in mortality and a substantial increase in significant bleeding complications.

Catheter based techniques and low dose thrombolysis may offer lower risk of complication with reasonable efficacy. Such studies have not been performed in RCTs with a reasonable sample size, and no study have compared low dose intravenous thrombolysis and catheter based techniques.

The current trial addresses this paucity of data by randomizing patients to one of three treatment modalities:

Intervention: 1:1:1 randomization, stratified for site to

* UltraSound Assisted Thrombolysis (USAT) with low dose thrombolysis (20 mg of rtPA, Alteplase) over 6 hours plus unfractionated heparin (UFH) or low molecular weight heparin (LMWH) within 12 hours of randomization
* Intravenous low dose thrombolysis (20 mg of rtPA, Alteplase) over 6 hours plus UFH or low molecular weight heparin (LMWH).
* UFH or low molecular weight heparin (LMWH) only (with option for conventional thrombolysis according to local protocols for hemodynamic deterioration) Design: Regional collaborative, randomized trial with 1:1:1 allocation of 210 patients with acute intermediate-high risk PE with no absolute contraindications to thrombolysis

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Informed consent for trial participation
3. Intermediate high-risk PE according to ESC criteria
4. Thrombus visible in main, lobar or segmental pulmonary arteries on CT angiography
5. 14 days of symptoms or less

Exclusion Criteria:

1. Altered mental state (GCS \< 14)
2. No qualifying CT angiography performed (\> 24 hour since CT angiography)
3. Females of child bearing potential, unless negative HCG test is present
4. Thrombolysis for PE within 14 days of randomization
5. Thrombus passing through patent Foramen Ovale (risk of paradoxical embolism)
6. Ongoing oral anticoagulation therapy (heparins, aspirin, antiplatelet therapy and NOAC allowed)
7. Comorbidity making 6 months survival unlikely
8. Absolute contraindications for thrombolysis

   1. Hemorrhagic stroke or stroke of unknown origin at any time
   2. Ischemic stroke in the preceding 6 months
   3. Central nervous system damage or neoplasms
   4. Recent major trauma/surgery/head injury in the preceding 3 weeks
   5. Gastrointestinal bleeding within the last month
   6. Known bleeding risk
Effects of Physical Therapy on Improving Disc Height, Postural Stability, Pain and Function in Persons With Discogenic Low Back Pain

Lumbar degenerative disc disease and discogenic low back pain is comparatively common and disabling musculoskeletal condition, however there is no conclusive evidence regarding the positive effects of conservative physical therapy management in terms of radiological changes and improvement in disc height. For this reason, the current study will not only look into the positive effects of conservative physical therapy on postural stability, pain and function, but also in terms of disc height in persons with discogenic low back pain.


Eligibility Criteria:
Inclusion Criteria:

* Both male and female participants
* Aged 18-50 years old
* low back pain intensity less than 80/100mm on visual analogue scale
* positive centralization phenomenon
* low signal intensity of IV disc on T2 - weighted MRI
* high intensity zone towards the posterior aspect of the disc on MRI

Exclusion Criteria:

* Individuals with and any musculoskeletal, metabolic, or neurological disorders that may impair gait, postural stability or sensory integrity will be excluded from the study.
Phase 2 Study of Association Gemcitabine-Cisplatin to Treat Penis Epidermoid Carcinoma

The purpose of this study is to determine whether association Gemcitabine-Cisplatin is effective in the treatment of penis epidermoid carcinoma loco-regionally advanced or metastatic.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* OMS ≤ 2
* Penis epidermoid carcinoma histologically proved. Tumor with ganglionic loco-regional injury inextirpable and/or metastatic (M1, all T , all N), at initial diagnostic or at relapse after first treatment with curative aim (surgery and / or radiotherapy)
* Disease measurable with RECIST criteria
* Absence of all former chemotherapy during 5 years between inclusion.
* If former radiotherapy, necessity to have appreciated targets outside the irradiation fields. If former radiotherapy, it must have been done more than 4 weeks before inclusion in the study.
* Biologicals values required : polynuclear neutrophils ≥ 1500/mm3, blood-platelets ≥ 100000/mm3, Hb ≥ 10 g/dl, Transaminases \< 3N, TP ≥ 70%, total bilirubin \< 1,5 N, creatinine in the blood ≤ 110 micromoles/l.
* Normal clearance of creatinine, according to Cockroft and Gault's formulae.
* Calcemia : normal or anomaly without clinical meaning.
* Well-informed written consent, signed by the patient.

Exclusion Criteria:

* Uncontrolled cerebral known metastasis
* All former chemotherapy administration during 5 years between inclusion
* Other cancer (except baso-cellular cancer of skin correctly treated, or cancerous disease considered with good prognosis and on remission until 5 years at least)
* Uncontrolled cardiac insufficiency or all other severe and uncontrolled pathology.
* Peripheric neuropathy ≥ grade 2 OMS
* Anormal audiogram
* Patient difficult to follow for geographical, psychological or family reasons.
* Persons protected by law.
Non-Interventional Study on Safety of Liraglutide in Subjects With Type 2 Diabetes

This trial is conducted in Asia. The aim of this trial is to investigate the safety profile of liraglutide under normal conditions of use.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with type 2 diabetes mellitus, including newly-diagnosed subjects or those already receiving other anti-diabetic medications including GLP-1 analogues other than Liraglutide, who require treatment with liraglutide according to the clinical judgment of their treating physician
* Subjects who are capable of giving study-specific signed informed consent before any collection of information

Exclusion Criteria:

* Subjects with type 1 diabetes
* Subjects who are or have previously been on liraglutide
* Subjects who are participating in another clinical trial
* Subjects with a hypersensitivity to liraglutide or to any of the excipients (Disodium phosphate dihydrate, propylene glycol, phenol, water for injections)
* Subjects who are pregnant, breast feeding or have the intention of becoming pregnant within the following 6 months
Airway Navigation Database Asia for Diagnosis of Peripheral Pulmonary Nodules

The study is designed to evaluate the efficacy and safety of Augmented Reality Navigation System through intra-airway navigation system to guide bronchoscopy in the diagnosis of peripheral pulmonary nodules and explore the factors of diagnosis yield.

This is a single-arm, prospective, Asian multicenter, Real World case Registry study. Recruitment is expected to last up to 12 months, and each subject may be followed up for 12 months at most after surgery which depends on certain factors. The total duration of the study is about 24 months.The research is planned to be carried out at more than 10 sites.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18;
2. Chest thin-layer CT show that the peripheral pulmonary nodule (maximum diameter ≤3 cm) is not clearly diagnosed, and planned to be sampled and diagnosed by Augmented Reality Navigation System guided bronchoscopy;
3. The target nodule is evaluated as being able to be reached via bronchoscope under the guidance of Augmented Reality Navigation System before procedure;
4. Patients can understand the study and sign informed consent form.

Exclusion Criteria:

-

1. Contraindications for bronchoscopy:

1. Myocardial infarction whithin 1 month.
2. Active massive hemoptysis.
3. Coagulation dysfunction.
4. Pregnancy.
5. Malignant arrhythmia, severe cardiac insufficiency, extreme systemic failure, etc.

2. Severe cardiopulmonary dysfunction and other diseases that may significantly increase the risk of procedure; 3. The situations in which the investigators consider that patients are not suitable for this study.
Telephone Versus In-person Post-test Cancer Genetic Counseling

The purpose of the GEO-STAR randomized non-inferiority trial is to compare the outcome of post-test telephone cancer genetic counseling with standard in-person cancer genetic counseling. We hypothesize that telephone counseling is non-inferior by outcome if compared to standard in-person counseling.

Consecutive patients undergoing pre-test cancer genetic counseling and cancer genetic testing, during the study period, will be eligible to participate. During the pre-test genetic counseling, demographic data, family and personal medical history will be collected and pedigree will be drawn. Available participants will provide written informed consent. They will be then randomized in blocks of ten participants using an online system (http://wwwservizi.regione.emilia-romagna.it/generatore/).

The study is open label; thus, patients and investigators will not be blinded to treatment allocation due to the study nature intervention.

After randomization, participants will be scheduled for post-test genetic counseling session. Participants randomized to usual care will receive standard in-person result disclosure. Participants randomized to telephone counseling will be scheduled for telephone post-test counseling sessions. One-week after completing the post-test genetic counseling session, the survey package will be sent by email to participants to assess impact and satisfaction with post-test counseling.

Genetic counselors delivering post-test genetic counseling will complete the questionnaire immediately after the post-test session.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age inclusive at the time of the study;
* Patients must have undergone an in-person pre-test genetic counseling session;
* Patients must have undertaken cancer genetic testing;
* Patients must be able to speak Italian fluently;
* Patients must have got an email address.

Exclusion Criteria:

* Patients unable to provide informed consent, for example due to mental incapacity or active psychotic illness.
Large Scale ICU Data Sharing for 1000 Critically Ill Patients With Severe Acute Respiratory Distress Syndrome Coronavirus (SARS.COV19) in Three Distinct Isolation Centers

Cohort study of patients with severe respiratory distress syndrome coronavirus2 in three different isolation hospitals recording data about outcome.


Eligibility Criteria:
Inclusion Criteria:

* All COVID positive candidates

Exclusion Criteria:

* patient refusal
Single Dose Crossover Study of Patient Preference for Unscented Nasonex® Nasal Spray Versus Scented Flonase® Nasal Spray (Study P04208)

This was a one-day single dose trial conducted to compare patient's preference for Nasonex® (mometasone) versus Flonase® nasal spray. Each patient was randomized to take one dose (2 sprays in each nostril) of Nasonex or Flonase. Thirty minutes later, each patient was to take one dose of the opposite medication. Questionnaires were given to each patient after each drug dose to evaluate patient product preference.


Eligibility Criteria:
Inclusion Criteria:

* Subject must have been 18-65 years of age, of either sex and any race.
* Subject must have had symptomatic allergic rhinitis with a total nasal symptom (congestion, rhinorrhea, sneezing, itching) severity score of \<6 but \>2; congestion must have been \<2.
* Subject must have been free of any clinically significant disease (other than allergic rhinitis) that would interfere with study evaluations.
* Subject must have understood and been able to adhere to the dosing and visit schedule.

Exclusion Criteria:

* Subject had used any investigational product within 30 days prior to enrollment.
* Subject was in a situation or condition that, in the opinion of the investigator, may have interfered with optimal participation in the study.
* Subject was participating in any other clinical study(ies).
* Subject was using any nasal lavage fluid or spray.
* Subject was using any perfume during the study day.
* Subject was using any oral rinse during the study day.
* Subject had used topical or oral nasal decongestants in the past 1 week.
* Subject had used a nasal corticosteroid in the previous 2 weeks.
* Subject had anosmia or ageusia (absence of the sense of smell or taste).
* Subject had been using medications which are associated with anosmia or ageusia in the 2 weeks prior to testing.
* Subject had a respiratory infection in the 2 weeks prior to testing.
First-in-Human Single Ascending and Multiple Dose of GLPG0778

The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) and multiple (MD) oral doses of GLPG0778 compared to placebo (with and without food).

Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0778 after single and multiple oral administration will be evaluated, and, if applicable, the maximum tolerated dose determined.


Eligibility Criteria:
Inclusion Criteria:

* healthy male
* body mass index (BMI) between 18-30 kg/m², inclusive.

Exclusion Criteria:

* any condition that might interfere with the procedures or tests in the study
* smoking
* drug or alcohol abuse
Beat Childhood Cancer Specimen Banking and Data Registry

This is an observational data registry study of pediatric cancer patients at participating Beat Childhood Cancer Consortium sites involving specimen banking and data collection.

This observational registry and banking study is being performed on a large cohort of patients who have been identified to receive molecular testing to better understand the relationship between genomic and molecular information and clinical outcomes, enabling timely and informed treatment decisions by physicians for cancer patients. We hypothesize that large gene panels, sequencing (DNA/RNA), and epigenetics of tumors can identify molecular aberrations in tumors that can be leveraged to offer more effective treatment. Findings may suggest additional research will be required to better understand the molecular underpinnings of the relationship between molecular abnormalities and disease. Banked specimens and the creation of tumor cell lines and xenograft models will enable this research to be performed.

Eligibility Criteria:
Inclusion Criteria:

* No age restrictions
* Patients with suspected or confirmed pediatric tumors
* Subject or his/her legally authorized representative (where applicable) signs the study consent.

Exclusion Criteria:

* Patient or his/her legally authorized representative (where applicable) did not consent for specimen banking and data collection for this study.
Inhaled Ibuprofen to Treat COVID-19

The study aims to evaluate the reduction in severity and progression of lung injury with inhaled ibuprofen in patients with severe acute respiratory syndrome due to SARS-CoV-2 virus.


Eligibility Criteria:
Inclusion Criteria:

1. Provision of written informed consent by the patient OR by the patient's Legal Representative.
2. Confirmed or suspected SARS-CoV-2 infection;
3. Pneumonia without criteria of severity.
4. With some of the following conditions:

   * Diabetes.
   * Cardiovascular disease.
   * Chronic kidney disease.
   * Chronic obstructive pulmonary disease.
   * Structural diseases of the lung
   * Immunocompromise.
5. Patient who presents negative results by rtPCR for SARS CoV-2, in case of being highly suspicious, the patient may receive it empirically until the results are obtained.
6. No unstable bronchial asthma

Exclusion Criteria:

1. The doctor considers that participation in the Program is not the best for patients or for any condition that prevents the Program from being followed safely.
2. Patients with a history of unstable bronchial asthma
3. The patient is allergic to ibuprofen or any of the compounds in the preparation.
4. Hypersensitivity to the drug, nasal polyps syndrome, angioedema or bronchospasm against aspirin or other NSAIDs.
5. Pregnant or lactating woman, or positive pregnancy test on a pre-dose exam.
6. Patient who is expected to be transferred to another place other than the place where the Program starts, within 7 days of starting it.