cyrilzakka/clinical-trials huggingface dataset:
INtegrated Colonoscopy Improvement Program in Italy

The Italian Society of Digestive Endoscopy (SIED) and the Italian Association of Gastroenterologists and Hospital Digestive Endoscopists (AIGO) want to develop an effective training program for endoscopists to improve the quality of colonoscopies through careful evaluation of quality indicators and how they can be improved with an appropriate educational program. Primary objective of this study is to evaluate the variation of "Polyp Detection Rate (PDR) and Adenoma Detection Rate (ADR)" obtained by operators at high and low volume of colonoscopy before and after a training period. Secondary objectives are to compare high and low volume endoscopists' performance before and after training comparing by evaluation of withdrawal time; Number polyps / patient and Number adenomas / patient; the percentage and time of intubation of the cecum, ; patient's pain perception based on the Nurse Assessed Patient Comfort Score (NAPCOMS) scale. The study is structured as follow:

* A first phase when all endoscopists collect the results of 200 colonoscopies in an electronic Case Report Form (eCRF) is formed(maximum enrollment period 4 months).
* A second phase of training through an e-platform in which the endoscopists are offered with an online refresh reviewing the international standard parameters to perform a quality colonoscopy. Once the final training exam have been passed, the endoscopist will be able to access the third phase
* A third phase in which the endoscopists will collect prospectively the colonoscopies they perform in an eCRF (maximum enrollment period 4 months).


Eligibility Criteria:
Inclusion Criteria:

* patients between 50 and 75 years old
* colonoscopy for cancer screening program, post polypectomy follow up, patients with abdominal symptoms suggestive for colonic pathology.

Exclusion Criteria:

* patients aged \< 50 or \> 75 yrs

  * presence of alarm symptoms
  * American Society of Anesthesiologists (ASA) Classification ≥ 3
  * presence of colonic stenosis
  * previous colonic resection
  * Presence of diverticulitis
  * history of Inflammatory Bowel Disease (IBD)
  * History of polyposis syndrome
  * Pregnancy or breastfeeding
  * inability to provide informed consent
  * Severe cardiovascular illness
  * contraindication to undergo to sedation
  * Anticoagulant therapy
  * Melanosis coli
Clinical Decision Support Tools to Increase Human Papillomavirus (HPV) Vaccination in Adolescents in Pharmacies

This clinical trial develops and tests how well a clinical decision support (CDS) tool works to increase human papillomavirus (HPV) vaccination of children between the age of 9-17 (adolescents) in pharmacies. HPV vaccination rate in eligible adolescents remains low even though over 90% of the cancers in adults caused by HPV can be prevented by the HPV vaccine. The National Vaccine Advisory Committee recommends HPV vaccinations to be given in pharmacies to increase access to vaccines, but pharmacy processes and lack of awareness of the service among parents impact the use of local pharmacies for HPV vaccinations. Using a focus group may be an effective method to develop a CDS tool and create a process that may be more convenient for parents to get their adolescent's vaccine at their local pharmacy. A CDS tool may make it easier to obtain HPV vaccines, and as a result increase the adolescent HPV vaccination rate and reduce the incidence of cancer caused by HPV.

OUTLINE: Participants are assigned to 1 of 3 groups.

Group I: Staff participate in facilitated planning discussions to develop CDS tools on study. (Aim I)

Group II: Staff receives CDS tools training and implements CDS tools to facilitate HPV vaccination on study. (Aim II)

Group III: Parents complete survey post-intervention on study. (Aim II)

Eligibility Criteria:
Inclusion Criteria:

* AIM I: \>= 18 years
* AIM I: Pharmacy staff: Employed at the partnering community pharmacies in Washington state
* AIM I: Scientific Technologies Corportation (STC)Health staff: Employed at STCHealth
* AIM I: PioneerRx staff: Employed at PioneerRx
* AIM II: \>= 18 years
* AIM II: Parents: English speaking parent or guardian of at least one child, ages 9-17, living in Washington state and obtained an HPV vaccination for their child at a participating pharmacy and have access to a telephone or computer with internet access.
* AIM II: Pharmacy staff: Employed at community pharmacies recruited into the study located in Washington state

Exclusion Criteria:

* Pharmacy staff: Floaters/per diem. Those who object to having the focus group discussions audio recorded. Those who object to participating in implementation evaluation surveys
* STCHealth staff: Those who object to having the focus group discussions audio recorded
* PioneerRx staff: Those who object to having the focus group discussions audio recorded
* Parents: Those who decline to provide feedback on their experiences with getting their children vaccinated at the pharmacy
Nilotinib and LDE225 in the Treatment of Chronic or Accelerated Phase Myeloid Leukemia in Patients Who Developed Resistance to Prior Therapy

The purpose of this study is to determine the feasibility of administering the combination of nilotinib and LDE225 to patients with chronic or accelerated phase of chronic myeloid leukemia and to establish the maximum tolerated dose (MTD) and/or recommended Phase II dose level (RP2D) of LDE225 in combination with nilotinib.


Eligibility Criteria:
Inclusion Criteria:

1. Philadelphia chromosome positive (Ph+) CML in chronic phase (CP) or accelerated phase (AP)with resistance to at least one prior BCR-ABL targeting TKI
2. Documented chronic phase CML
3. Adequate end organ function
4. Female patients of childbearing potential must have a negative serum pregnancy test and must be using highly effective methods of contraception. Male patients with female partners of child-bearing potential must use condoms.

Exclusion Criteria:

1. Impaired cardiac function
2. Severe and/or uncontrolled concurrent disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol
3. History of acute pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis
4. Patients actively receiving therapy with strong CYP3A4 inhibitors and/or inducers, and the treatment cannot be either discontinued or switched to a different medication prior to entering the study
5. Patients who are currently receiving treatment with any medications that have the potential to prolong the QT interval and the treatment cannot be either safely discontinued or switched to a different medication prior to starting study drug.
6. Previously documented BCR-ABL Y253H, E255K/V, T315I or F359C/V mutation

Other protocol-defined inclusion/exclusion criteria may apply.
Pressure Injury Prevention in the ICU With Multi-Layer Foam Dressings

A Multi-Centre, Open, Non-controlled, Clinical Investigation to Evaluate the User Friendliness and Wear Time of Multi-layer Foam Dressings With Safetac® for Pressure Injury Prevention in the Intensive Care Unit

This was a multi-centre, open, non-comparative, prospective, clinical investigation involving 50 enrolled subjects using competitive enrolment at two sites in the United States of America (USA). The study was conducted on subjects at risk of developing PIs according to investigators' judgment and facility protocol being treated in ICUs. The target subjects were male and female, 18 years and above, with an expected hospital stay of 4-6 days. An evaluable subject was defined as a subject that was enrolled and had data for at least one visit after the baseline visit. There were two parts to the study: Part A: Mepilex Border/Protect Sacrum; Part B: Mepilex Border/Protect Heel (on both left and right heels), used within intended use and according to IFU.

Eligibility Criteria:
Inclusion Criteria:

* Patient is at risk for developing a pressure injury to the heels and/or sacrum
* Aged ≥ 18 years
* Patient or his/her legal representative is able to understand and voluntarily sign the informed consent
* Estimated treatment period in ICU for patient at least 4-6 days

Exclusion Criteria:

* Patient has a pressure injury or blistering on sacrum and/or heels
* Patient with known or suspected sensitivity to any of the components of the products being evaluated
* Patient included in other clinical investigations at present or within the last 30 days
High Protein and High Energy Intakes and Physical Activity on Growth of Extremely Low Birth Weight Infants

The aim of this study is to evaluate the effect of increasing amino acid and energy intake during parenteral and enteral nutrition with and without the stimulation of the infant's physical activity, on growth of extremely low birth weight infants .

Increasing protein and energy intake above the anabolic capacity of a given individual may result in increased lipogenesis and excessive fat deposition. Adults with reduced mobility or with neuromuscular conditions will develop excessive fat deposition if they receive normal to high protein and energy intakes. Excessive fat deposition have been demonstrated in preterm infants receiving high energy intakes. Given that physical activity in preterms is often reduced for the prematurity itself, the associated sickness and the numerous medications, the investigators speculate that physical stimulation may have a beneficial effect on protein accretion and on lean mass accretion. The investigators further hypothesize that today's recommended daily intakes of proteins and energy cannot be fully incorporated into lean body mass without a concomitant physical activity. In spite of the fact that this notion is well accepted in adult physiology and in the elderly, it has never been tested in preterm infants.

This factorial randomised controlled trial will evaluate the effect of increasing amino acid intake (by 1 g/kg/d) and energy intake (by 20 kcal/kg/d) during parenteral nutrition and also of increasing protein intake and energy intake by an extra 1 g/kg/d during enteral nutrition, with and without the stimulation of the infant's physical activity, on growth of extremely low birth weight infants. The investigators aim at demonstrating that increasing energy and protein intake above the standard of care intakes will result in better growth only in association with adequate physical activity, in particular in relation to body composition and lean mass accretion.

Eligibility Criteria:
Inclusion Criteria:

* 24 weeks \< gestational age \< 32 weeks
* inborn or outborn admitted before 24 hours of age
* parenteral or enteral nutrition start before 48 hours of age
* parental consent

Exclusion Criteria:

* difficulty in starting physical activity stimulation before 10 days of life
* death before 36 W PMA
* diagnosis of necrotising enterocolitis (before 36 W PMA)
* any major surgery (before 36 W PMA)
* congenital syndrome, severe malformations
* inborn errors of metabolism
* parental consent withdrawn
Mood Alterations in the Patients With Non-Muscle Invasive Bladder Cancer Treated With BCG

The purpose of this study is to evaluate mood changes in patients with Non-Muscle Invasive Bladder Cancer who are receiving intravesical Bacillus Calmete-Guerin (BCG). Patients with Non-Muscle Invasive Bladder Cancer receiving intravesical treatments are eligible to participate in this study. Participation involves providing research blood and urine samples prior to the start of treatment and throughout the treatment course. The study team will also collect participant's medical history and clinical information. Participants will be asked to complete questionnaires and daily mood diaries.

Patients with Non-Muscle Invasive Bladder Cancer who are receiving intravesical treatments are eligible to participate in this study. Participants will be asked to complete the Zung Self-Rating Anxiety Scale and Zung Self-Rating Depression Scale prior to each induction intravesical treatment. During the 6-week induction intravesical treatment, participants will also be given a daily mood dairy to complete. Urine Specimens will be collected prior to each induction intravesical treatment and at each 3-month cystoscopy appointment during the treatment course. An at home urine collection may occur 6 hours post intravesical treatment. Research Blood Samples will be collected prior to the first induction intravesical treatment, prior to the fourth intravesical treatment, and prior to each 3-month follow-up cystoscopy as indicated by the participant's treatment course. Participants will be asked to complete the Zung Self-Rating Anxiety Scale and Zung Self-Rating Depression Scale prior to each 3-month follow-up cystoscopy during the treatment course. A 3-week daily mood diary will be completed by participants during the 3-week intravesical maintenance treatment. Participants will be given a daily mood diary to complete between the 3-month follow-up cystoscopy appointments.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with a pathologically confirmed non-muscle invasive bladder cancer
* Age ≥ 18 years old
* Ability to understand and willingness to sign a written informed consent document

Exclusion Criteria:

* Patients that are not candidates for intravesical treatment due to the nature of their disease, such as variant histology or progressive disease after a prior course of intravesical treatment.
* Patients who are pregnant
Role of Lung Ultrasound and Pulsed-wave Doppler in Lung Consolidations in Mechanically Ventilated Patients

In infectious lung consolidations, the inhibition of hypoxic pulmonary vasoconstriction (HPV) results in a higher regional acceleration time (RAcT) compared to the RAcT measured in atelectatic consolidations.

Ventilator-associated pneumonia has a considerable impact on morbidity and mortality in intensive-care patients. Chest radiography, which is the most frequently used imagery test for bedside lung evaluation in mechanically ventilated patients, is recognized to be poorly sensitive and non-specific for the diagnosis of ventilator-associated pneumonia. Bronchoalveolar lavage using a bronchoscope remains the most reliable tool for the diagnosis of this nosocomial infection. However, a bronchoscopy may not be feasible in all patients and waiting time before final results become available may cause a delay in the initiation of the treatment, thus increasing the risk of mortality. Lung ultrasound is a promising non-invasive, non-radiant, portable and easy to use tool especially in critically-ill patients.

Dependent atelectasis is a frequent phenomenon in mechanically ventilated patients. The presence of clinical infection signs raises the question of the nature of the infiltrate. A consolidation of infectious nature differs from atelectasis by its local hypoxic pulmonary vasoconstriction inhibition. In patients breathing spontaneously, it is possible to detect this difference using the RAcT, measured by pulsed-wave Doppler in an arterial blood vessel located in a pulmonary consolidation visible by ultrasound examination. The use of pulsed-wave Doppler to measure the RAcT in a consolidation added to the value of general lung ultrasound could help determine the infectious or atelectatic nature of a consolidation in mechanically ventilated patients. However, the RAcT has never been studied in patients under positive pressure ventilation. In this observational study, the investigators will explore the role of measuring the RAcT and of general lung ultrasound as a diagnostic tool to detect pneumonia in mechanically ventilated patients.

Eligibility Criteria:
Inclusion Criteria:

* Under mechanical ventilation and presenting one or more consolidations on chest radiography or CT scan

Exclusion Criteria:

* Participation to another study
* Poor echogenicity (morbid obesity, multiple thoracic dressings)
* Contra-indications to superior limbs or torso mobilization
* Contra-indications to bronchoscopy
* Antibiotics initiated more than 24 hours but less than 72 hours before inclusion or changes in the antibiotic regimen in the last 72 hours.
Diaphragm Dysfunction During Prolonged Mechanical Ventilation

The transition to unassisted breathing after invasive ventilation often proves challenging. Persistent ventilator dependence predisposes patients to nosocomial complications and death and increases the economic burden of critical illness. Ventilator-dependence results from an imbalance between the load and capacity of the respiratory muscle pump. Patients who fail a trial of spontaneous breathing commonly exhibit excess respiratory loads secondary to weaning-induced pulmonary edema, atelectasis or dynamic hyperinflation. At the same time, many ventilator-dependent patients exhibit striking loss of respiratory pump capacity due to diaphragm dysfunction which predisposes to prolonged ventilator dependence. Diaphragm dysfunction is common in ventilated patients. By prolonging ventilator dependence it may be an important contributor to the poor long-term clinical and functional outcomes of survivors of critical illness. While some main risk factors for diaphragm dysfunction have been already described (diaphragm disuse induced by mechanical ventilation, sepsis, initial severity upon admission), the determinants of recovery of diaphragm dysfunction are unknown, as well it has not been elucidated whether diaphragm function can simply improve after the acute phase of ICU admission. Therefore, the goal of this study is to investigate the time course evolution of diaphragm function in patients exposed to prolonged duration of mechanical ventilation (i.e. in a weaning center) and to determine which factors are associated with an improvement of the diaphragm function leading to a safe mechanical ventilation discontinuation.

In this prospective study, all patients admitted to the weaning center of Pitié-Salpêtrière Hospital to undertake a weaning program will be closely followed up to assess twice a week their diaphragm function. Only one experimental group will be constituted. Diaphragm function will be assessed with both 1) the phrenic nerves stimulation technique and 2) diaphragm ultrasound (thickness, thickening fraction). The time course evolution of the diaphragm function over the stay will be investigated and all potential factors involved in the change in diaphragm function will be determined.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old;
* Admission in weaning center;
* Tracheostomy;
* Ventilator dependence as defined by clinical intolerance criteria under spontaneous - breathing (Boles et al. ERJ 2017);
* Oral consent

Exclusion Criteria:

* Contre indication to the phrenic nerves stimulation technique (pace maker);
* Impossible liberation from the ventilator (degenerative neuromuscular diseases; high level spinal injury);
* Pregnancy;
* No insurance coverage
Expanding Patient Applicability With Polymer Sealing Ovation Alto Stent Graft Investigational Device Exemption (IDE) Study

A prospective clinical evaluation of the effectiveness of the Ovation Alto Abdominal Stent Graft System when used in the treatment of subjects with abdominal aortic aneurysm (AAA).

A prospective clinical evaluation of the effectiveness of the Ovation Alto Abdominal Stent Graft System when used in the treatment of subjects with abdominal aortic aneurysm (AAA). The primary objective is to evaluate treatment success at 12 months with the Ovation Alto Abdominal Stent Graft system. The study will have up to 16 sites, and up to 75 patients based on attrition rates. The follow-up intervals will be at 1, 6, and 12 months following initial implant procedure.

Eligibility Criteria:
Inclusion Criteria include:

1. Patient has adequate iliac/femoral access compatible with the required delivery systems.
2. Patient has non-aneurysmal proximal aortic neck.
3. Patient has non-aneurysmal distal iliac landing zone.

Exclusion Criteria include:

1. Patient has dissecting aneurysm.
2. Patient has acutely ruptured aneurysm.
3. Patient has need for emergent surgery.
Comparing the Effects of Smoked and Oral Marijuana in Individuals With HIV/AIDS

Smoked marijuana (MJ) and dronabinol (also known as THC or by the trade name Marinol) are used to increase appetite, food intake, and weight in patients with HIV who experience unintended weight loss. This study will compare the effects of MJ and Marinol use in marijuana smokers who are HIV infected.

Little is known about the efficacy and tolerability of oral THC versus smoked MJ in a clinically relevant population. Additionally, it is not clear how THC's effects vary as a function of the duration of treatment or the patient's current patterns of smoked MJ use. This study directly compares 3 doses of smoked marijuana and 3 doses of Marinol across a range of behavioral measures in HIV infected marijuana smokers.

Outcome measures will include analysis of food intake, body composition, mood, physical symptoms (e.g., nausea, stomach pain), psychomotor task performance, and sleep.

Eligibility Criteria:
Inclusion Criteria

* HIV infected
* Smoke marijuana
* Taking HIV medications

Exclusion criteria

* Naive marijuana smokers
* People with history of respiratory/pulmonary disease
The Establishment of a Survival Prediction Model for ER Positive / HER-2 Negative Advanced Breast Cancer

This project is a prospective, clinical cohort study initiated by researchers to study the high-risk factors affecting the overall survival of newly diagnosed ER + / HER2 - advanced breast cancer patients and to establish a prediction model of ER + / HER2 - advanced breast cancer patients affecting overall survival. This project is the first prospective prediction model for the survival of patients with advanced breast cancer, and it is also the first time to establish a survival prediction model for ER-positive / HER2 negative advanced breast cancer suitable for China's national conditions. According to the survival outcome predicted by the model, the newly diagnosed ER positive / HER2 negative advanced breast cancer was divided into three groups: low, medium, and high risk, which provided an important theoretical basis for further design of randomized controlled clinical research and guidance of individualized precise treatment scheme for different groups in the future.


Eligibility Criteria:
Inclusion Criteria:

1. At the time of signing the informed consent form, 18 years old ≤ 70 years old, female
2. ER positive breast cancer confirmed by pathology: ER positive (≥ 1%) by immunohistochemistry
3. Newly diagnosed advanced patients, including patients with early breast cancer who have evidence of recurrence and metastasis after adjuvant therapy and patients with stage IV breast cancer at the first visit
4. Patients who are willing to receive follow-up treatment in the research center.

Exclusion Criteria:

1. ErbB-2 gene amplification was recorded by fish (defined as HER2 / CEP17 ratio ≥ 2) or chromogenic in situ hybridization (CISH) or IHC (defined as ihc3 +, or ihc2 + confirmed by fish or CISH) was used to record HER2 positive tumors.
2. Any form of anti-cancer treatment has been carried out for recurrent or metastatic lesions
3. Combined with other malignant tumors or had other malignant tumors in recent 5 years
4. Patients with nervous system disorders caused by diseases or obvious mental disorders will affect patients' right to know, compliance or make them in a dangerous state
5. Patients with life expectancy less than 3 months
Predictors of the Metabolic Effect of Sleep Loss

To test whether baseline levels of slow wave activity (SWA) during sleep are lower in obese adults, and even lower in persons with sleep disordered breathing (SDB) compared to lean adults.

To compare levels of SWA in individuals in relation to their sleep time, blood pressure, heart rate, and markers of glucose metabolism.


Eligibility Criteria:
Inclusion Criteria:

* healthy,
* normal sleepers,
* lean, overweight,
* obese,
* pre menopausal

Exclusion Criteria:

* no shift workers or night-shift workers,
* no mental health disorders,
* no acute or chronic health conditions (stable, well controlled hypertension are accepted),
* no hormonal treatments,
* no substances that may interfere with sleep,
* problems with sleep