cyrilzakka/clinical-trials huggingface dataset:
Effects of Nurse-led Telephone Based Service for Early Palliative Care (PALTEL)

Non-pharmacological, interventional, two-arm, randomized controlled trial. Early Palliative Care cancer patients will be randomized to active telephonic follow-up program by specialist nurses until end-of-treatment (28 days) (group A, research arm) or face-to-face visit at end of treatment (28 days) (group B, control arm).

There are few studies demonstrating the efficacy of nurse-led telephone service in advanced cancer patients but it's still quite unclear how they can affect quality of life, symptom burden and caregivers distress. In addition, the ideal structure, method and timing of telephone follow-up as well are often not considered and have not been articulated. Nurse-led management by phone to advanced cancer patients could, for some patients, dramatically improve their care experience, quality of life and symptoms control.

Investigators want to build an effective and sustainable approach for implementing the telephone service providing nurse-led telephone-based support to Early Palliative Care cancer patients. The aim is to investigate the feasibility of a proactive approach and measure the efficacy in terms of symptom management, satisfaction with care and impact on health care resources.


Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study;
* Patients having a defined Caregiver
* Cancer patients referred for the first time to the Early Palliative Care Outpatient Clinic;
* Both Female or Male, aged ≥ 18 years;
* Italian speaking patients.

Exclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) Performance Status score of 3 or higher
* Patients cognitively impaired or deaf;
* Patients not having a telephone or not capable of speaking/using a telephone;
* Patients referred to palliative Homecare or Hospice at the first visit Early Palliative Care Outpatient Clinic.
Gargling With Green Tea for Prophylaxis of Influenza Infection in Teenagers

Experimental and clinical studies in adults have reported that green tea catechins prevent influenza infection. In this clinical randomized study, the investigators aimed to determine the effects of gargling with green tea on the prophylaxis of influenza infection among high school teenagers.

Influenza infection is the principal cause of acute respiratory illnesses and occurs in epidemic or pandemic worldwide. It spreads easily among high school students and from them to the rest of the community; therefore the prevention of influenza is very important.

Experimental studies have revealed that some components of green tea can prevent influenza infection in vitro. In clinically, gargling with green tea catechins has been reported to have possibilities to preventing influenza infection in adults; however, little clinical evidence in teenagers has so far been existed. Based on this background, the investigators designed a randomized study to evaluate the clinical efficacy of gargling with green tea in preventing influenza infection among high school students.

Eligibility Criteria:
Inclusion Criteria:

* aged from 15 to 20 years
* obtained written informed consent from both the student and parent before participation
* possible to gargle during 90 days
* possible to fill in questionnaire

Exclusion Criteria:

* Possessing allergy to green tea
* Possessing history of influenza infection within 6 months before entering the study
* Possessing severe immune disease or whole body infection
* severe cardiac, respiratory, renal, or hepatic dysfunction
* diagnosed as inadequate to participate in the study by student doctor
Budesonide Capsules vs. Mesalazine Granules vs. Placebo in Collagenous Colitis

The purpose of this study is to determine whether budesonide or mesalazine is more active in the treatment of collagenous colitis.

This study will check the reproducibility of the results reported in trials with budesonide in patients with collagenous colitis. Efficacy of mesalazine was never tested in collagenous colitis by placebo-controlled trials. This trial will check the superiority of mesalazine over placebo using the common clinical symptom of collagenous colitis, which is chronic or recurrent non-bloody, watery diarrhea.

Eligibility Criteria:
Inclusion Criteria (main):

* \> 4 watery/soft stools on at least 4 days in the week prior to baseline
* \> 3 stools per day on average within the last 7 days prior to baseline
* Symptoms (chronic watery diarrhea) for at least 3 months before baseline
* Complete colonoscopy within the last 12 weeks before baseline
* Histologically confirmed diagnosis of collagenous colitis

Exclusion Criteria:

* Evidence of infectious diarrhea
* Celiac disease
* Endoscopic-histologic findings, which may have caused diarrhea
* History of partial colonic resection
* Diarrhea as a result of the presence of other symptomatic organic disease of the gastrointestinal tract
* Active colorectal cancer or a history of colorectal cancer
* Severe co-morbidity substantially reducing life expectancy
* Abnormal hepatic function or liver cirrhosis (ALT, AST or AP \>= 2 x ULN)
* Abnormal renal function (Cystatin C \> ULN)
* Active peptic ulcer disease, local intestinal infection
* Asthma, diabetes mellitus, infection, osteoporosis, glaucoma, cataract, or cardiovascular disease if careful medical monitoring is not ensured
* Hemorrhagic diathesis
Eliquis Regulatory Post Marketing Surveillance

The primary objective of this study is to examine the safety profile of Eliquis in Korean nonvalvular atrial fibrillation patients.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Patients ≥19 years of age
* Adult patients who are diagnosed with nonvalvular atrial fibrillation and are initiating Eliquis anticoagulation therapy for risk reduction of stroke and systemic embolism
* Patients with evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study

Exclusion Criteria:

* Receiving Eliquis treatment for an indication that is not approved in Korea
* Contraindicated for the use of Eliquis as described in the Korean label
A Multi-Site Clinical Evaluation of the ARIES Clostridium Difficile Assay in Symptomatic Patients

The ARIES C. difficile Assay is a real-time PCR based qualitative in vitro diagnostic test for the direct detection of C. difficile nucleic acid in stool specimens.

The ARIES C. difficile Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection of Clostridium difficile (C. difficile) nucleic acid in unformed (liquid or soft) stool specimens obtained from patients suspected of having Clostridium difficile associated disease (CDAD).

The objective of this study is to establish diagnostic accuracy of ARIES C. difficile Assay through a multi-site, method comparison on prospectively collected, left-over, stool specimens. Diagnostic accuracy will be expressed in terms of clinical sensitivity (or positive agreement) and specificity (or negative agreement).

Eligibility Criteria:
Inclusion Criteria:

* The specimen is from a patient suspected of having C. difficile associated disease (CDAD).
* The subject's specimen is an unpreserved, unformed (liquid or soft) stool submitted for testing at the site.

Exclusion Criteria:

* The specimen is preserved.
* The specimen was not properly collected, transported, processed or stored according to the instructions provided by the sponsor.
Multi-Centre, Retrospective, Open Label Study, to Validate ML-PrediCare by Patients With Melanoma Under 1st and 2nd Lines of Immunotherapy

This is a retrospective, open label study to establish and validate a prediction technology for advanced melanoma patients under the 1st, 2nd and later treatment lines, with the immunotherapeutic drugs Ipilimumab, Pembrolizumab \& Nivolumab, in order to predict response rate and disease progression

The aim of this project is to develop a technology application (termed ML-PrediCare), which is meant to be a predictive stand-alone software device, to support clinicians' decision-making, by predicting the individual patient's response to immunotherapy treatments, e.g., in terms of time-to-progression (TTP).

In Stage I of the study, data will be collected for establishing a training set and assess the predictive potential of the modelling technology for the response of melanoma patients to immunotherapy. In Stage II of the study, data will be collected in order to establish a validation set and test the predictive power of the modelling technology in an independent set of patients diagnosed with melanoma.

Eligibility Criteria:
Inclusion Criteria:

Patients who meet all of the following criteria are eligible for this study:

1. Gender: Female, Male.
2. Age: Eighteen years and older at the start of treatment.
3. Histologically confirmed unresectable Stage III or Stage IV melanoma, as per AJCC staging system.
4. Prior radiotherapy must have been completed at least 2 weeks prior to drug administration.
5. Measurable disease by CT, or PET-CT, or MRI per RECIST 1.1
6. Patient has at least one quantitative measurement of at least one target lesion (primary tumor or metastasis) before treatment.
7. Patient has at least one quantitative measurement of at least one target lesion (primary tumor or metastasis) during or after the treatment.
8. Patient has at least one recorded visit to the treating oncologist before treatment.
9. Patient has at least one recorded visit to the treating oncologist during or after the treatment.
10. Treatment as per SOC for melanoma.

Exclusion Criteria:

Patients meeting one or more of the following criteria are ineligible for this study:

1. History of another malignancy within the previous 2 years except for:

   • Adequately treated Stage I or II cancer currently in complete remission, or any other cancer that has been in complete remission for at least 2 years
2. Ocular melanoma
3. Active brain metastases or leptomeningeal metastases.
Physical Activity Guidelines for People With Spinal Cord Injury (SCI)

The first evidence-based physical activity guidelines for people with spinal cord injury were released in March, 2011. This project will evaluate the implementation of the new physical activity guidelines in a community exercise setting in Hamilton, Ontario. The investigators hypothesize that persons who follow the guidelines will experience increased aerobic fitness and muscle strength. The investigators also hypothesize that participants will find the guidelines easy to follow and that their self-efficacy for participating in physical activity will be improved following the study period.


Eligibility Criteria:
Inclusion Criteria:

* adults with spinal cord injury who have been given clearance to exercise by their primary care physician (or healthcare team)

Exclusion Criteria:

* ventilatory support
* inability to voluntarily participate in upper body exercises
* inability to communicate in English
* ongoing infection
* unstable autonomic dysreflexia
Transsphincteric Fistula Management Using LIFT and MAF

a study that detect the most suitable surgical techniques for treating transsphincteric fistula

we compared between LIFT and MAF in elderly with PAF

Eligibility Criteria:
Inclusion Criteria:

* elderly persons with PAF

Exclusion Criteria:

* recurrent fistula
* associated autoimmune diseases
Prognosis of a First-Ever Stroke in Persons Living With HIV

With aging of the persons living with HIV, cardiovascular diseases now account for substantial mortality and morbidity. Stroke frequency grows exponentially with aging and its incidence doubles every decade over 55 years of age.

The prognosis of ischemic stroke depends mainly on the care in Stroke Units in the acute phase of the disease (thrombolysis/thrombectomy). It is important that HIV patients are referred to these units in the first hours of a stroke and not to their infectious disease units which is a loss of chance.

It would also be important to know whether HIV patients need specific protocols for stroke emergency management.

The study aims to compare the functional prognosis after the first occurrence of an ischemic stroke, in patients admitted to a Stroke Unit, whether they are infected or not infected by HIV.


Eligibility Criteria:
Inclusion Criteria:

* Patients unexposed to HIV: HIV-1 seronegative OR patients exposed to HIV: HIV seropositive for over 6 months with or without antiretroviral treatment. Confirmed by Elisa and Western blot tests
* admitted for ischemic stroke, defined as a sudden cerebrovascular event confirmed by MRI
* at least 18 years of age
* paired with patients unexposed to HIV, admitted for ischemic stroke, same gender and age

Exclusion Criteria:

* antecedents of a symptomatic ischemic or hemorrhagic cerebrovascular event
* no social security benefits;
* Absence of signed informed consent for the study
* Patients currently pregnant or breast-feeding
Evaluating the Treatment in the MZEB Aachen

Evaluation of patient characteristics, involved physicians and therapists as well as therapies in a German University Center for the Treatment of patients with intellectual disabilities and severe multiple disability (MZEB Aachen)

In the MZEB Aachen, since 11/2018 patients with intellectual disabilities and/or severe multiple disabilities are diagnosed, treated and accompanied for many years in a multidisciplinary setting with physicians, nurses, physiotherapists, ergo therapists, speech therapists and Support by social workers. MZEBs are considered to have a pilot function in the health care system, cooperating with therapists and physicians in the surroundings. This concept is established as a new concept in Germany in order to optimise health care for patients with disabilities. Thus we want to investigate patient characteristics, diagnoses, involved physicians and therapists as well as proposed therapies and disease progress in this center.

Eligibility Criteria:
Inclusion Criteria:

* intellectual disability and/or severe multiple disability (disability degree GdB at least 70 and at least one noticeable sign
* willing to participate

Exclusion Criteria:

* housed in an Institution and/or prison
Ibrutinib in Combination With Lenalidomide and Rituximab in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

This Phase 1b/2 study is designed to assess the safety and efficacy of ibrutinib in combination with lenalidomide and rituximab in subjects with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) not eligible for transplant.

Phase 1b: In the dose escalation portion of the study, various cohorts with escalating doses of lenalidomide may be explored, using the 3+3+3 principle for dose determination.

Phase 2: This will be conducted as an international, multicenter, open-label study. Eligible subjects will receive ibrutinib, lenalidomide and rituximab.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed relapsed/ refractory DLBCL
* Must have previously received first line treatment regimen
* Must be ineligible for high dose therapy/ stem cell transplantation
* Measurable disease sites on computed tomography (CT) scan (\>1.5 cm in longest dimension)
* prothrombin time/international normalized ratio (PT/INR) \< 1.5 x upper limit of normal (ULN) and partial thromboplastin time (PTT; activated partial thromboplastin time \[aPTT\]) \<1.5 x ULN
* Men and women ≥18 years of age
* Eastern Cooperative Oncology Group (ECOG) \< 2
* Adequate hepatic and renal function
* Adequate hematologic function

Exclusion Criteria:

* Medically apparent central nervous system lymphoma or leptomeningeal disease
* History of allogeneic stem-cell (or other organ) transplantation
* Any chemotherapy, external beam radiation therapy, or anticancer antibodies within 2 weeks
* Radio- or toxin-immunoconjugates within 10 weeks
* Concurrent enrollment in another therapeutic investigational study or have previously taken ibrutinib and/or lenalidomide.
HVNI for Successful Weaning in Respiratory Failure

The goal of this randomized active-controlled study is to investigate the role of high velocity nasal insufflation (HVNI) in the immediate post-extubation period and compare it with non-invasive positive pressure ventilation (NIPPV) as regards to weaning success rate. The study will recruit those who have been on invasive mechanical ventilation for at least 3 days and with a high risk of weaning failure.

This is a single center prospective randomized controlled open label trial of high velocity nasal insufflation (HVNI) in the immediate post-extubation period versus noninvasive positive pressure ventilation (NIPPV). After at least 72 hours from intubation, for respiratoy failure, those who are considered to be eligible for weaning from mechanical ventilation based on the weaning protocol but are at high risk for extubation failure will be randomized to either HVNI or NIPPV. Data on the respiratory and cardiovascular status will be continuously monitored and recorded thereafter.

The primary outcome measure will be failure of either arm within 72 hours of initiation, leading to reintubation (or crossover only from a failed HVNI allocation to NIV based on clinical judgement to avoid reintubation in selected cases). Secondary outcomes to be investigated include: 1) Failure of HVNI or NIPPV after 72 hours from initiation, 2) hospital mortality, 3) length of ICU stay, 4) length of hospital stay, 5) incidence of ventilator associated pneumonia, 6) patient tolerance and comfort, and 7) ICU readmission or mortality at 28-days post hospital discharge.

Eligibility Criteria:
Inclusion Criteria:

High risk of extubation failure (one or more of the following):

1. Age \>65 years old
2. BMI \>30
3. APACHE II score at extubation \>12
4. ≥2 comorbidities
5. Endotracheal intubation \> 7 days
6. ≥1 failed attempts at disconnection from mechanical ventilation
7. Chronic lung disease e.g., COPD, OHS, etc.
8. Underlying left ventricular dysfunction
9. Non-minimal airway secretions

Exclusion Criteria:

1. Non-respiratory failure patients
2. Patients judged to need a tracheostomy (poor airway reflexes or copious secretions)
3. Patients who cannot tolerate an oral or nasal interface (facial trauma or perforated nasal septum)
4. Patients with increased risk of aspiration, agitation, or uncooperativeness
5. End stage disease with life expectancy less than 6 months
Novel INXN-4001 Triple Effector Plasmid in Heart Failure

To evaluate the safety of retrograde coronary sinus infusion (RCSI) of a novel triple-effector plasmid (INXN-4001) in outpatient LVAD recipients as assessed by incidence of all study intervention-related adverse events occurring up to 6 months post-RCSI (primary endpoints), and to evaluate general safety by assessing incidence of cardiac specific adverse events and the incidence of related serious adverse events at intervals up to 12 months post-infusion (or until cardiac transplantation or death).

This is a first-in-human, phase I, open label, safety study of INXN-4001 delivered via RCSI in patients with outpatient LVAD. Twelve stable patients with implanted LVAD for mechanical support of end stage heart failure have been allocated into 2 cohorts (6 subjects each) to evaluate the safety of infusing the same amount of INXN-4001 (80mg) in 2 volumes (40mL and 80mL) at 20mL/min rate. Ongoing safety assessments include clinical labs, physical exams, ECG and medical history collected during clinic visits at: pre-treatment, day 3, then 1, 3, 6, 9, and 12 months after dosing via RCSI. During visits, subjects complete the KCCQ questionnaire and are evaluated via 6-min walk test (6MWT) prior to and during an LVAD wean interval. Daily activity data is collected throughout the study using a wearable biosensor (Actigraph).

Eligibility Criteria:
Inclusion Criteria:

* Male and female adult patients with a stable LVAD implanted for end-stage heart failure
* Must be managed in an outpatient setting and on stable medication regimen

Exclusion Criteria:

* Women who are pregnant or nursing
* Patients who have been on another clinical trial for heart failure in the last 90 days, or have received any stem cell or gene therapy within the previous year.
* Patient is not able to complete a Six Minute Walk Test or unable to tolerate an LVAD wean in the past 3 months
* Patient has an active infection requiring systemic antibiotics or an autoimmune disease requiring systemic immunosuppressants
* Patient has a history of arrhythmia, uncontrolled diabetes, diabetic retinopathy, systemic lupus erythematosus, macular degeneration, hyper-coagulation, or stroke
* Patient has had a myocardial infarction related to ischemia within the past 30 days
* Patient has had certain prior surgeries such as organ transplant, cardiac transplantation, left ventricle reduction surgery, or cardiomyoplasty
* Patient has infectious disease, such as hepatitis B or C, or human immunodeficiency virus (HIV)
* Patient has a history of cancer within the past 3 years
Treatment of Skeletal Class II Malocclusion With Modified Twin-Block Appliance With Clear Plates

Patients with skeletal class II malocclusion who have a retracted lower jaw will be treated in this study. The efficacy of clear Plates in the treatment of Skeletal Class II Malocclusion will be assessed. The skeletal, dental and soft tissues changes resulted by this intervention will be studied and compared with the results of Traditional treatment with fixed appliances.

There are two group:

1. a group of patients in which participants will be undergo to Modified Twin-Block Appliance with Clear Plates.
2. a group of patients in which participants will be undergo to the traditional Twin-Block Appliance.

phase Intervention/treatment Condition or disease

Not applicable Other:

Modified Twin-Block Appliance with Clear Plates.

Other:

Traditional Twin-Block Appliance. Skeletal class II Malocclusion

Eligibility Criteria:
Inclusion Criteria:

* - Patients with mixed dentition at age 10.5-13 years.
* The patient has Skeletal class II malocclusion caused by mandibular retraction ANB \> 5, 8 mm \>O.J\> 5 mm, SNB\<78, angle (NSAr) ≥ ° 125 and normal placement of the upper jaw.
* The patient is willing to accept treatment with a removable device.
* No previous orthodontic treatment
* the growth model is within the normal or horizontal maxillary opening angle of 30 \>MM or angle of 400 \> Björk
* patients do not have an upper alveolar dental protrusion.

Exclusion Criteria:

* -Patients with periodontal disease.
* patients with a neuromuscular disorder.
* patients of class I or III of malocclusion.
* Patients with temporomandibular joint disorder.
* Patients with Skeletal open bite.
* Patients with poor oral and gingival health
* the presence of a unilateral or bilateral posterior crossbite.
* patients who have upper jaw stenosis and need to be prepared by expansion before functional treatment.
* any patient who does not meet one or more of the Inclusion criteria will be removed from the study.