cyrilzakka/clinical-trials huggingface dataset:
Assessment of Compliance With Monitoring Conducted by a Physician in Person or by a Nurse in Remote Monitoring

This is a multicenter, interventional, randomized study among adult patients recently diagnosed with a rare tumor (\<12 months). The study will aim to compare compliance with the personalized post-treatment surveillance plan, established for each patient according to national guidelines, when the surveillance is conducted in person by a hospital-based physician (control arm) or remotely by a trained nurse (experimental arm).

The primary objective of this study is to compare 2-year compliance with the personalized post-treatment surveillance plan between the two arms.

The secondary objectives are to compare between the two arms :

* Long-term compliance (5-year follow-up)
* Use of care
* Oncological events and their management
* Supportive care needs

The exploratory objectives are to :

* Evaluate the costs in terms of medical transportation
* Evaluate and compare patients' satisfaction and psychological well-being (in terms of anxiety/depression)
* Evaluate the homogeneity of the impact of the intervention according to covariates (gender, tumor pathology, occupational status, and center)
* Evaluate the reasons for recruitment failures

Eligibility Criteria:
Inclusion Criteria:

* Positive diagnosis (anatomopathology) of tumor within 12 months
* Patient 18 years of age or older
* Patient with one of the following conditions:

  1. Desmoid fibromatosis of the abdominal wall operated on or under active surveillance
  2. Stage I testicular seminoma (whether or not treated with carboplatin AUC7)
  3. Stage I non-seminomatous germ cell tumor (with or without adjuvant BEP chemotherapy)
  4. Operated GIST with low risk of relapse
  5. Rare gynecological tumors (sex cord and stromal tumors; germ cell tumors of the ovary, clear cell adenocarcinoma, mucinous adenocarcinoma of the ovary, borderline tumors, small cell carcinoma, ovarian and uterine carcinosarcoma, low grade serous tumors), operated
  6. Low-grade glioma, operated
  7. Low-grade neuroendocrine tumor, treated by surgery alone
* Patient who has given consent to participate in the study

Exclusion Criteria:

* Contraindication to imaging tests required for the surveillance plan
* No telephone
* Patient under guardianship or curatorship
Long-term Safety and Effectiveness of Growth Hormone With GHD, TS, CRF, SGA , ISS and PWS in Children

The purpose of this study is to evaluate the long-term safety and effectiveness of growth hormone (Eutropin Inj./Eutropin plus Inj.) treatment with GHD (Growth Hormone Deficiency), TS (Turner Syndrome),CRF (Chronic Renal Failure), SGA (Small for Gestational Age), and ISS (Idiopathic Short Stature).


Eligibility Criteria:
Inclusion Criteria:

* short stature children aged 2 years or more
* children with GHD,TS, CRF, SGA or ISS
* written informed consent from the person, person's parent or legal guardian
Topical SB-275833 Ointment, 1% For The Treatment Of Impetigo

The goal of this study is to determine if topical SB-275833 ointment, 1% is as safe and effective as topical sodium fusidate ointment, 2% for the treatment of impetigo in adults and children as young as 9 months of age.

A Randomised, Observer-blind, Multicentre, Non-inferiority, Comparative, Phase III Study of the Safety and Efficacy of Topical 1% SB-275833 Ointment, Applied Twice Daily for 5 Days, versus Topical 2% Sodium Fusidate Ointment Applied Three Times Daily for 7 Days in the Treatment of Adult and Paediatric Subjects with Impetigo.

Eligibility Criteria:
Inclusion criteria:

* Must have primary impetigo with total lesion area being 100 square centimeters or less.
* Women who could bear children must have a negative urine pregnancy test and agree to either abstain from sexual intercourse or the use of specific effective contraceptive measures.

Exclusion Criteria:

* Any signs and symptoms of systemic infection.
* Any serious underlying disease that could be imminently life threatening.
Effect of Portal Vein Thrombosis on the Prognosis of Liver Cirrhosis

The prevalence of portal vein thrombosis (PVT) in patients with liver cirrhosis is 5-20%. Current evidence regarding the effect of portal vein thrombosis on the prognosis of cirrhotic patients remains under debate. Considering that PVT potentially elevates the portal pressure and thereby increase the risk of variceal bleeding, we focus on the patients with high-risk varices and variceal bleeding as the study population. Thus, the main goals are to analyze the effect of PVT on the incidence of first variceal bleeding in patients without any prior bleeding history but with high-risk varices, the incidence of recurrent variceal bleeding in patients with a history of variceal bleeding, and the treatment failure rate of variceal bleeding in patients with acute variceal bleeding. Certainly, the survival is also observed in all patients.


Eligibility Criteria:
Inclusion Criteria:

1. A diagnosis of liver cirrhosis.
2. Patients should be diagnosed with high-risk varices endoscopically, or a prior history of variceal bleeding, or an episode of acute variceal bleeding.
3. Patients agreed to undergo endoscopy to evaluate the presence and severity of varices.
4. Patients agreed to undergo contrast-enhanced CT scans to evaluate the portal vein patency. But if an abdominal contrast-enhanced CT scans was performed within 3 months after admission, it was not necessarily repeated.

Exclusion Criteria:

1. Non-cirrhotic patients.
2. Malignancy.
3. Contrast-enhanced CT scans were neither feasible nor available.
4. Severe cardiopulmonary diseases.
5. Severe infectious diseases.
6. Pregnant or breastfeeding.
7. Allergic to contrast agents.
8. Poor adherence.
Immediate Postoperative Adjuvant Hormonal Treatment in High Risk Localised or Locally Advanced Prostate Cancer Patients.

The primary objective is to assess the efficacy of immediate postoperative adjuvant hormonal treatment according to 2 year PSA recurrence rate in high risk localised or locally advanced Chinese prostate cancer patients.The secondary objective is to assess the quality of life（QoL）of the high risk localised or locally advanced Chinese prostate cancer patients with immediate postoperative adjuvant hormonal treatment and get the information of immediate postoperative adjuvant hormonal treatment (including the regimen, dosage and duration).


Eligibility Criteria:
Inclusion Criteria:

* Localised with one of any high recurrence risk factors(Gleason score≥8 or preoperative serum PSA≥20ng/ml), or locally advanced(T≥pT3、N0M0 and any T、N（+）M0 ) Chinese prostate cancer patients confirmed histologically through radical prostatectomy either with laparoscopy or laparotomy within 1 month after surgery. Before the patient recruitment, the investigator has decided to prescribe immediate postoperative adjuvant hormonal treatment to the patient according to the Chinese routine practice.
* Provision of written informed consent prior to any study specific procedures.

Exclusion Criteria:

* Patients must not enter the study if any of the following exclusion criteria are fulfilled
* Have used neoadjuvant hormonal treatment prior to the surgery.
Prospective Sensor Controlled Compliance Analysis of Shoulder Abduction Splint After Rotator Cuff Repair

The postoperative shoulder rehabilitation in an abduction brace after rotator cuff reconstruction of the shoulder is crucial for a successful healing of the reconstruction.

In this study the investigators want to analyse the abduction brace-wearing time using a electronic sensor, which is implanted in the abduction brace. The participants will be informed about the sensor after completion of the abduction brace rehabilitation 6 weeks postoperatively.

After arthroscopic reconstruction of a rotator cuff tear the healing depends on a tension free positioning of the reconstructed tendon. Therefore a abduction brace is administered routinely for 6 weeks. The re-rupture rate of rotator cuff reconstruction is about 30%. One of the reason may be mechanical overuse caused by non wearing of the abduction brace. From experience the investigators suggest that the abduction brace wearing behaviour differs among patients. The participant´s wearing compliance has been evaluated by Silverio et al. with a questionary but never with a sensor. In this study the investigators want to analyse the participant´s abduction brace wearing compliance by using an sensor, which is implanted in the abduction brace and monitors the wearing time, which reveals the objective wearing time.

The sensor is a certificated sensor, which measures temperature in °C every 15 min. If the abduction brace is worn by the participants the body temperature can be captured by the sensor. If the measured temperature is over 33°C the sensor capture the time period as a "worn" time. With this measurements the abduction brace wear time should be captured objectively. A similar kind of sensors were used to evaluate the wearing time of scoliosis-braces in patients with adolescent idiopathic scoliosis (Miller DJ eta al., Morton A et al., Takemitsu et al.) With a questionary the participants are asked of the wearing time before they will be informed about the implanted sensor. This answer represents the subjective wearing time.

The first endpoint of the study is the evaluation of the objective and subjective abduction wearing time. The second endpoint is the evaluation of the correlation between compliance and subjective outcome.

Eligibility Criteria:
Inclusion Criteria:

* Patients with rotator cuff repair and postoperative abduction for 6 weeks

Exclusion Criteria:

* Revision surgery
Benchmarking Outcomes in Pancreatic Surgery - WhippleBenchmarks.Org

The WhippleBenchmark 2 Collaborative study aims at defining benchmark criteria for best achievable outcomes after pancreaticoduodenectomy with portal vein resection.

Pancreatoduodenectomy (PD) with portal vein resection (PVR) is performed for the achievement of complete resection (R0) in patients with locally advanced pancreatic head lesions. Despite most commonly performed in high-volume pancreatic surgery centers by experienced surgeons, best achievable outcomes, such as morbidity and mortality, following such complex procedure remain unknown.

The aim is to conduct a retrospective multicenter cohort study to define benchmark values for best achievable outcomes following duodenopancreatectomy (DP) with portal vein resection (PVR).

Data collection and study design are based on to the well established standardized reporting for benchmarking (Sánchez-Velázquez et. al. Ann Surg, February 2019 ).

This multicenter cohort study will include all consecutive pancreaticoduodenectomies with portal vein resections from at least 20 high volume centers performing over 50 pancreatic operations per year or 150 cases within 3 years from at least 3 continents over a period of 10 years (2009-2019). Every center included in the study must have a prospective database from which data can be collected as well as previous publications critically reporting on their outcome.

Eligibility Criteria:
Center Eligibility Criteria

* High volume centers from ≥3 continents
* Minimum 50 cases of pancreatic surgery per year or 150 cases within 3 years
* Published in the area of pancreas surgery
* Prospective database available

Patient Eligibility Criteria

Inclusion Criteria:

* Adults ≥ 18 years
* Resectable malignant or benign diseases (i.e. all indications)
* Open pancreaticoduodenectomy (all techniques allowed) with concurrent portal vein resection

Exclusion Criteria:

* Patients \< 18 years
* Pancreatic resections other than pancreaticoduodenectomy and portal vein resection
* Pancreaticoduodenectomy with arterial reconstruction
* Laparoscopic or robotic pancreaticoduodenectomy
Lung Lavage With Dilute Poractant Alfa for Meconium Aspiration Syndrome

Meconium aspiration syndrome (MAS) is an important cause of severe respiratory failure in newborn infants. Treatment for MAS is mainly supportive but surfactant therapy might change the course of the disease. Aim of the study to evaluate whether lung lavage with dilute or bolus poractant alfa changes the duration of mechanical respiratory support or other outcomes in MAS.


Eligibility Criteria:
Inclusion Criteria:

* Infants with a gestational age ≥ 36 weeks, birth weight ≥ 2.0 kg, evidence of passage of meconium at or before delivery, typical chest radiology findings and mechanically ventilated infants with a mean airway pressure ≥ 12 cm H2O were enrolled.

Exclusion Criteria:

* Congenital cardiac anomalies
* Major congenital anomalies
* Hemodynamically unstable infants
The Effectiveness of AAD and IPV to Treat Hospitalized Infants (<2years) With Acute Viral Bronchiolitis.

The purpose of this study is to investigate the effectiveness of two airway clearance techniques; Intrapulmonary Percussive Ventilation and Assisted Autogenic Drainage in hospitalized infants under the age of 2 with acute viral bronchiolitis.


Eligibility Criteria:
Inclusion Criteria:

* first period of wheezing
* Wang score between 3 and 7
* age \< 24 months
* Sa02\> 90%

Exclusion Criteria:

* ICU patients
* mechanical ventilation
* use of antibiotics
* use of corticosteroids
* gestational age \< 34 weeks
* chronic cardiac or pulmonary disease
* no parental consent
COVID-19 Health Professional Impact Study

The COVID-19 (coronavirus) pandemic has had a huge impact on healthcare resources and staff in the UK. Understanding the key risk factors associated with infection amongst healthcare workers is essential for future pandemic response plans.

Currently there are scarce data relating to the infection rates and associated factors amongst healthcare workers in the United Kingdom (UK). Studies of infection rates in healthcare workers have largely relied on the real-time reverse transcriptase-polymerase chain reaction (RT-PCR) test to date and it appears that Healthcare workers are twice as likely to succumb to Coronavirus infection, when compared to the general population and those from Black and minority ethnic (BAME) backgrounds appear to be particularly at risk.

Currently there is no evidence that the presence of SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) antibodies provides seasonal or long term immunity to future infection.

Therefore, this study aims to understand the current level of SARS-CoV-2 antibody positivity and try to determine the likely risk to healthcare workers in the UK to COVID-19 infection. This study hopes to find out whether certain individual characteristics will have an impact on likelihood of infection susceptibility and antibody response and determine the impact of the presence of antibodies on the likelihood of future clinical infection over a 12 month period.

The study involves an initial online survey and linkage to the recent antibody test, then a further online survey in 6 and 12 months' time. The data obtained will be linked to data that the Human Resources Department (HR) holds.

Participants also have the option to partake in another antibody test at 6 and 12 months' time and linked to the data collected.

Participants will have access to the study via the link given in an SMS (Short Message Service - text message) which will direct then to the first online survey.

They will then be contacted again in 6 and 12 months' time to complete the online survey again.

The survey answers will be linked to the results of the antibody tests by their mobile and Employment Number and also to data held about them by the HR Department.

The survey will take approximately 15 minutes to complete and will include questions on the following: profession; work-line type; demographics and behavioural factors; ethnicity; and symptoms (if COVID 19 was manifested).

Participants can also attend for another blood test (SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) antibody test) to detect any presence of antibodies at 6 and 12 months (optional) which will again be linked to the survey and HR data.

Eligibility Criteria:
Inclusion Criteria:

* All Staff employed by Royal Wolverhampton Trust, having undergone the SARS-CoV-2antibody test at the Trust's testing facility

Exclusion Criteria:

* Royal Wolverhampton NHS Trust staff who have not participated in antibody testing • Staff who have opted out to receiving the text message invite and be part of the study
Use of MiniMed 780G System in Children and Adolescents

Hybrid closed-loop technology have shown that it improves glycemic control parameters, but the investigators do not have sufficient data at more than 6 months of follow-up, allowing us to describe the effectiveness of these systems in the long term.

All MiniMed 780G system users from November 2020 to March 2022 were included (n=32) For every time points, there was a significant difference in Time In Range between the pre-AHCL and post-AHCL. Noted difference were +14.5% and, +10.8% at respectively 3 months and 1 year. No more hypoglycemia were identified.

This "real-life" analysis shows that the algorithm is effective in improvement of metabolic control for T1 diabetic children and adolescents, at one year of follow-up.

However, an effect of breathlessness is observed which underlined the need for a solid therapeutic education program.


Eligibility Criteria:
Inclusion criteria:

All children with type 1 diabetes in whom a Medtronic G780 closed-loop pump was placed between November 2020 and March 2022 in our center were included.

Exclusion criteria:

Participant opposition
Multimodality Imaging and Functional Lesion Assessment in Intermediate Coronary Stenosis in Chronic Coronary Syndrome

The aim of this prospective, investigator-initiated study is to evaluate the diagnostic accuracy and correlations between functional indices (fractional flow reserve, FFR) and morphometric indices: luminal and qualitative parameters assessed by optical coherence tomography (OCT) including minimal lumen area, plaque type, presence of thin cap fibroatheroma among patients with chronic coronary syndrome identified with intermediate grade coronary stenosis.

This is a prospective, single center, non-randomized, single-arm, investigator-initiated study evaluating diagnostic accuracy and correlations between functional indices (fractional flow reserve, FFR) and morphometric indices: luminal and qualitative parameters evaluated by OCT including minimal lumen area, plaque stratification into fibrotic, calcific, lipidic plaque, or thin cap fibroatheroma) among patients with chronic coronary syndrome identified with intermediate grade coronary stenosis.

The additional objectives include: evaluation of the impact of age, sex, diabetes mellitus, renal dysfunction on the assocation between functional and morphometric indices of coronary stenosis.

We hypothesized that in patients with intermediate grade coronary stenosis in chronic coronary syndorme there is a positive correlation between the functional parameters and the morphometric parameters of cornary stenosis.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Chronic coronary syndrome defined as presence of chest pain ranked 2-3 in the Canadian Cardiovascular Society classification or positive ischemia test (exercise test, single photon emission tomography (SPECT)
* Intermediate grade coronary stenosis of 40-80% assessed visually in coronary angiography
* FFR and OCT examination of the same lesion
* The patient is willing to participate in the study and has provided a written informed consent

Exclusion Criteria:

* Acute coronary syndrome
* Proximal left main lesion
* Ostial right coronary artery lesion
* Bypass of the assessed vessel
* Contraindications for adenosine administration
* Hemodynamic instability
* Heart insufficiency in New York Heart Association (NYHA) class IV scale
* Acute renal insufficiency
* Pregnancy
Primary Care Implementation Study to Scale up EIBI and Reduce Alcohol Related Negative Outcomes

The aim of this implementation study is to compare the effect of tailored training and support (T\&S) for general practioners with T\&S and alcohol community actions and the impact it has on early identification of hazardous and harmful drinking and brief intervention.

A quasi-experimental three-arm implementation study will be undertaken in Flanders (Belgium) to assess the effects of tailored training and support to general practitioners (GPs) alone or in an area context of alcohol community actions and compared to 'support as usual' on GP's performance in terms of early identification of hazardous and harmful drinking and brief intervention.

The study will last 18 months and will take place in three cities of comparable size. In each area at least 28 GPs will be recruited.

The primary outcome will be the proportion of consulting adult patients screened for hazardous and harmful alcohol use at the end-point of an 18-month implementation period. The secondary outcomes will be the screening rate as assessed at 3, 6, 9, 12 and 15 months and the proportion of patients screening positive for hazardous and harmful alcohol use that receive a brief intervention at 3,6,9, 12, 15 and 18 months. Furthermore, the relation between GP's views and needs and practices' contexts, and EIBI performance will be explored.

Data regarding screening and brief intervention activities will be collected from the electronic health records (EHR).

Eligibility Criteria:
Inclusion Criteria:

* GP or GP trainee
* Dutch language use in practice
* Working in general practice in 3 cities of comparable size or their sub municipalities

Exclusion Criteria:

- No possibility of integration of e-form into the EHR-system.
Analgesic Effect of Breastmilk for Procedural Pain in Preterm Infants

Hypothesis: Breastmilk has a more powerful analgesic effect than oral sucrose to avoid procedural pain in preterm neonates.

The objective is to test this hypothesis in a randomized, controlled study using a standardized and validated pain scale (DAN). The sample size is 21 preterm infants in each two groups. The main end point is a reduction of the risk to have a DAN superior to 1 from 80% with oral sucrose to 40% with breastmilk.


Eligibility Criteria:
Inclusion Criteria:

* preterm neonates born before 27 and 29+6 weeks GA
* blood sampling procedure
* obtention of parental consent

Exclusion Criteria:

* congenital malformation
* intravenous continuous analgesia
* contraindications to feed
* high grade intracerebral hemorrhage