cyrilzakka/clinical-trials huggingface dataset:
Improvement of Tolerance of Bowel Cleansing Before Colonoscopy in Diabetic Patients

This trial will compare the tolerance to 2 different methods for colon cleansing before colonoscopy in diabetic patients.

Consecutive diabetic patients undergoing an ambulatory colonoscopy at the participating sites will be randomized to 2 different methods of colon cleansing before the procedure.

Both will be based on the oral ingestion of a fluid solution (half of it on the evening before the procedure is planned and the rest on the morning of the same day), and the main difference between them will be the volume of fluid that will be ingested in each case.

Analogic visual scales and standardized questionnaires on various aspects that may influence the degree of satisfaction about the preparation will be answered by the participants and collected before the colonoscopy. The endoscopist, blinded to the preparation method, will grade the adequacy of the preparation. Adverse events will be recorded up to 1 month after the procedure

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for a diagnostic, screening or follow-up outpatient colonoscopy
* Diabetes mellitus (being treated with insulin or any oral agent).

Exclusion Criteria:

* Unwillingness to participate.
* Hospital admission at the time of colonoscopy.
* Inability to follow instructions
* Active inflammatory bowel disease
* Previous colectomy.
* Incomplete colonoscopies due to technical reasons or contraindication for the procedure as evaluated by the endoscopist
Reducing Oxygen Consumption in Critical Care

In normal practice oxygen supply can be easily met with existing hospital infrastructure. COVID - 19 however results in lung damage which greatly increases the amount of oxygen patients require - as a consequence some hospitals in the UK and other countries had situations where there was not enough oxygen for their inpatients.

COVID - 19 has caused many more patients to requiring assistance with their breathing using a ventilator. Due to the limited supply of sophisticated ventilators that 're-use' oxygen patients breathe out, some hospitals have used ventilators normally used by patients at home (domiciliary ventilators). Whilst these are inexpensive and commonly available, any oxygen the patient breathes out is simply released into the atmosphere.

The address this problem, and in turn reduce the oxygen demand on hospital infrastructure the biomedical engineering team (BME) at the Royal Brompton Hospital, London devised a simple 3-D printed modification which captures and reuses oxygen on commonly used domiciliary ventilators. Laboratory testing found this modification can increase the oxygen given by the ventilator without increasing the oxygen consumption of the ventilator - effectively reducing oxygen demand on hospital infrastructure.

This study will evaluate this modification in patients admitted to intensive care requiring assistance with their breathing. This will involve measuring oxygen levels on domiciliary ventilators (Breas Nippy 4+, ResMed Lumis 150 or Vivo 1, 2 or 3) with and without the modification and with small increases in oxygen supplied to the patient for a total study period of 2 hours.


Eligibility Criteria:
Inclusion Criteria:

* Patient in critical care using a ResMed LumisTM 150, Breas® Nippy 4+ or Vivo 1, 2 or 3 ventilator or deemed safe by treating consultant safe to switch to one.
* 28% or more of entrained oxygen (FiO2)
* Judged to be safe to tolerate increased fraction of inspired oxygen for periods of 10 minutes
* Arterial line insitu for clinical reasons

Exclusion Criteria:

* Thought to be clinically unstable during study protocol (2 hours)
Prevalence Of COVID-19 Among Health-workers in a French General Hospital

The aim of this study is to evaluate the prevalence of COVID-19 among the workers of our hospital and the factors that are likely to influence this prevalence. It must be underlined that our hospital is settled in two towns and both hospital sites had different missions regarding the admissions of COVID-19-infected patients.

Since December 2019, the COVID-19 pandemic has widespread from China and put under strong tension the health organizations throughout the world, especially since march 2020 in France.

As a consequence, the French hospitals had to cope with a massive amount of COVID-19 infected patients and, thus, their organisations had to evolve in order to be able to admit more patients in their critical care units.

First studies reported an important level of inter-human contagiousness of the SARS-CoV-2 virus with an "R0" (basic reproduction number) superior to 3, which could lead to a massive contamination of healthcare workers since they are directly in charge of infected patients.

Other studies suggested that the healthcare workers are more likely to be contaminated by the COVID-19 than the rest of the population, which pushed governments and hospital managers to put in place individual and collective measures of protection in order to avoid nosocomial transmissions and also to preserve the health of the hospital staffs in a context of high tension on the hospital work force.

There are today few data about the contamination level among the healthcare workers of general hospitals in France and about the severity of these contaminations. A national study is being conducted but on a macroscopic regional scale. In addition to that, the proportion of asymptomatic SARS-CoV-2 contaminated healthcare workers is not known as well as the origin (hospital or community) of the contaminations.

In June 2020, the French Health Ministry decided to launch a collection of epidemiological data in the French hospitals based on serologic tests. Thanks to this action and with the results of all the RT PCR tests systematically conducted since the beginning of the pandemic when a healthcare worker had COVID-19-like symptoms, the Centre Hospitalier Sud Essonne has decided to conduct an observational study.

The aim of this study is to evaluate the prevalence of COVID-19 among the workers of our hospital and the factors that are likely to influence this prevalence. It must be underlined that our hospital is settled in two towns and both hospital sites had different missions regarding the admissions of COVID-19-infected patients.

Eligibility Criteria:
Inclusion criteria:

* hospital staff working at the Centre Hospitalier Sud Essonne,
* employed by the Centre Hospitalier Sud Essonne between March, 5th, 2020, and August, 31rst, 2020,
* with the result of an RT PCR test or a serologic test,
* this (these) result(s) must have been/be communicated to the occupational health service of the hospital.

Exclusion criteria:

* interim workers,
* workers in holidays during the entire period of inclusion above,
* opposition to participate in this study.
Insulin Glargine in Type 2 Diabetes

The aim of this project is to confirm the efficacy and safety profile of Insulin glargine in daily practice and to improve the physicians' knowledge and experience concerning Insulin glargine


Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes Mellitus patients,
* Diabetic patients receiving insulin or patients who are insulin-naive and whose glycemic control cannot be sufficiently maintained with single or combined oral antidiabetic agents,
* Patients with HbA1C\>8
* Patients able to self-measure its blood glucose levels.

Exclusion Criteria:

* According to package insert information (Summary of Product Characteristics)
Evaluation of ESMO Guidelines Applicability and Adherence in Cancer Pain Management in the Palliative Care Setting

Palliative care (PC) is focused on improving the Quality of Life (QoL) of patients living with a life-threatening illness. Each year, an estimated 40 million people need PC management in the world. In the European Union, it is estimated that about 4,5 million of people are in the need of PC every year, with about 40% affected by malignant neoplasia.

Data from a recent systematic review of the literature report that the prevalence of pain is 66% (95% confidence interval 58-75) in cancer patients with advanced stages of the disease. In 52% of cases, pain was moderate or severe in intensity (NRS, Numeric Rating Scale ≥4). Furthermore, in addition to the basic pain, having characteristics of continuity over time even in the presence of fluctuations in intensity, the presence of acute painful episodes must also be considered, which are defined with the term of Breakthrough Cancer Pain, (BTcP), whose prevalence is estimated between 21 and 59%.

The positive impact on the quality of life of cancer patients of adhering to current guidelines has been amply demonstrated. Recently, new guidelines or recommendations produced by scientific societies have published, including the European Association of Palliative Care, the National Comprehensive Cancer Network and the European Society for Medical Oncology (ESMO).

In clinical facilities directly involved in the treatment of pain in cancer patients, implementing the directives set out in the guidelines appears to be a correct objective for the appropriateness of treatments. Nevertheless, there are no studies in Europe that have evaluated the applicability and adherence to guidelines in the treatment of cancer pain in advanced cancer patients. The present study intends to collect detailed information on the characteristics of pain and the treatment in a population of cancer patients cared by a network of specialized palliative care centers in order to assess the applicability and adherence of the latest European guidelines published by ESMO in 2018 for the treatment of pain in the specific area.


Eligibility Criteria:
Inclusion Criteria:

* age \>18 years;
* cancer diagnosis;
* patient enrolled within 48h from admission in PC;
* presence of pain with or without analgesic therapy or absence of pain being already on ATC analgesic therapy;
* life expectancy longer than two weeks;
* written patient informed consent.

Exclusion Criteria:

* diagnosis of primary brain tumor or leukemia (acute or chronic);
* clinical conditions that, at Investigator evaluation, prevent the follow up visits;
* absence of pain without analgesic therapy.
The Safety Evaluation of Silver Alginate (Algidex™) Dressing in Very Low Birth Weight (VLBW) Infants

The purpose of this study is to test the safety of silver alginate (Algidex™) dressing in VLBW infants in preparation for a large efficacy trial.

We are conducting a pilot randomized controlled trial in VLBW infants to evaluate the safety of silver alginate (Algidex™) dressing compared to standard catheter care. Following parental consent, infants are randomized to receive silver alginate or standard of care dressing. Infants with birth weights less than 1,500 grams admitted to Baylor University Medical Center (BUMC) NICU with any of the following lines are eligible for inclusion into this study up to 72 hours after birth: umbilical arterial line (UAL), umbilical venous line (UVL), peripheral arterial line (PAL), peripheral long line (PLL), and central venous line (CVL). Safety is assessed by measuring silver levels and monitoring for cutaneous reactions. Dressings are changed every seven days. Silver levels are drawn on study days 1, 7, and 28. Blood culture results are used to compare infection rates between the two groups. Patient demographics and clinical conditions are recorded. Results will be analyzed based on intention to treat.

Eligibility Criteria:
Inclusion Criteria:

* Infants with birth weights less than 1,500 grams admitted to Baylor University Medical Center (BUMC) NICU with any of the following lines are eligible for inclusion into this study up to 72 hours after birth: umbilical arterial line (UAL), umbilical venous line (UVL), peripheral arterial line (PAL), peripheral long line (PLL), and central venous line (CVL).

Exclusion Criteria:

* N/A
Focus on Experienced Anxiety Related to an Emergency Department Visit

The aim of the present study is to determine the prevalence of anxiety in adult patients attending the ED of the Medical Centre Leeuwarden.

Determination of the prevalence of anxiety in adult patients attending the ED of the Medical Centre Leeuwarden. Secondarily, the common causes of anxiety and the effect of anxiety on the time of presentation to the ED and perceived pain will be investigated. In addition to gaining more insight into the relationship between the ED and anxiety, the study aims to raise awareness of anxiety among patients in the ED.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and older
* Competent to decide on study participation
* Written informed consent obtained

Exclusion Criteria:

* Patients from who a Dutch questionnaire cannot be obtained (e.g. delirious, comatose, confused and non-Dutch speaking patients)
* If the reason for ED presentation is: suicide, intoxication or reporting from a sexual violence center
* Patients with an active eating disorder
* Patient already included in this study
* Objection to the use of patient data registered in the EPD
Study of BMS-936558 (Nivolumab) Compared to Docetaxel in Previously Treated Advanced or Metastatic Squamous Cell Non-small Cell Lung Cancer (NSCLC) (CheckMate 017)

The purpose of the study is to compare the overall survival of BMS-936558 as compared with Docetaxel in subjects with squamous cell non-small cell lung cancer (NSCLC), after failure of prior platinum-based chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Men and women ≥18 years of age
* Subjects with histologically or cytologically-documented squamous cell NSCLC who present with Stage IIIB/IV disease or with recurrent or progressive disease following multimodal therapy (radiation therapy, surgical resection or definitive chemoradiation therapy for locally advanced disease)
* Disease recurrence or progression during/after one prior platinum doublet-based chemotherapy regimen for advanced or metastatic disease
* Measurable disease by computed tomography (CT)/Magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
* Eastern Cooperative Oncology Group (ECOG) performance status ≤1
* A formalin fixed, paraffin-embedded (FFPE) tumor tissue block or unstained slides of tumor sample (archival or recent) must be available for biomarker evaluation. Specimens must be received by the central lab prior to randomization. Biopsy should be excisional, incisional or core needle. Fine needle aspiration is insufficient

Exclusion Criteria:

* Subjects with untreated central nervous system (CNS) metastases are excluded. Subjects are eligible if CNS metastases are treated and subjects are neurologically returned to baseline for at least 2 weeks prior to enrollment. In addition, subjects must be either off corticosteroids, or on a stable or decreasing dose of ≤10 mg daily prednisone (or equivalent)
* Subjects with carcinomatous meningitis
* Subjects with active, known or suspected autoimmune disease. Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll
* Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of randomization
* Prior therapy with anti-Programmed death-1 (PD-1), anti-Programmed cell death ligand 1 (PD-L1), anti-Programmed cell death ligand 2 (PD-L2), anti-CD137, or anti-Cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
* Prior treatment on the first line study CA184104 first line NSCLC study
* Prior treatment with Docetaxel
* Subjects with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity
* Treatment with any investigational agent within 14 days of first administration of study treatment
Safety, Tolerability and Efficacy of Immunomodulation With AT-1501 in Islet Cell Transplantation

This study will evaluate the safety, tolerability and efficacy of AT-1501 in an immunomodulation regimen in adult patients with T1D undergoing an islet cell transplant.

This study will evaluate the safety, tolerability and efficacy of AT-1501 in an immunomodulation regimen in adult patients with T1D undergoing an islet cell transplant. This study will also provide valuable data with respect to its potential additional uses in autoimmunity and solid organ transplant. This is a single arm open-label study and up to 6 participants will be recruited at a single center in Canada.

The objectives include:

* To assess the safety and tolerability of immunomodulation with AT-1501, in combination (AT+) with rabbit anti-thymoglobulin (ATG), etanercept and mycophenolate mofetil (MMF/EC-MPS) in adults with T1D undergoing islet cell transplant.
* To assess the efficacy of immunomodulation with AT-1501 in adults with T1D undergoing islet cell transplant.

The duration of treatment may vary from participant to participant and could be up to 20 months. Participants may receive up to 2 islet cell transplants.

Eligibility Criteria:
Inclusion Criteria:

1. Men and women 18-65 years of age
2. A diagnosis of T1D ≥5 years with onset of disease at \<40 years of age
3. Involvement in intensive diabetes management as directed by an endocrinologist or diabetologist with at least 3 clinical evaluations within the 12 months prior to Screening; using an insulin pump or multiple daily injection (MDI) insulin therapy; and, unable to achieve acceptable metabolic control because of the occurrence of severe hypoglycemia
4. At least 2 unexplained SHEs not secondary to a missed meal or dosing error, etc., in the 12 months prior to Screening
5. Glycosylated hemoglobin (HbA1c) level greater than 7% (53 mmol/mol) and less than 9.5% (80 mmol/mol) inclusive
6. Absence of stimulated C peptide (\< 0.3 ng/mL) in response to a mixed meal tolerance test (MMTT) measured at 60 and 90 minutes after the start of consumption
7. Reduced awareness of hypoglycemia as defined by a Clarke Score \[Clarke 1995\] of 4 or more at the time of Screening, during the Screening period and within the last 6 months prior to the transplant

Exclusion Criteria:

1. Any previous transplant
2. HbA1c level less than 7% (53 mmol/mol)
Induction and Maintenance Study of BMS-936557 Patients With Moderate to Severe Ulcerative Colitis

The purpose of this study is to determine whether BMS-936557 is effective in the treatment of moderate to severely active ulcerative colitis in patients who have had insufficient response and/or intolerance to other medical therapy for ulcerative colitis


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of moderate to severe UC confirmed by endoscopic and histologic evidence
* Mayo score ≥6 with an endoscopic subscore of ≥2
* Inadequate response and/or intolerance to one or more conventional therapy (i.e. oral aminosalicylates, immunosuppressants, corticosteroids, and/or TNF antagonist)

Exclusion Criteria:

* Diagnosis of Crohn's Disease or Indeterminate Colitis
* Diagnosis of UC that is limited to the rectum
* Evidence of fulminant colitis, toxic megacolon, or bowel perforation
* Current need for a colostomy or ileostomy
* Previous total or subtotal colectomy
Noninvasive Ventilatory Support After Lung Surgery in COPD Patients

Rationale: respiratory complications are the most frequent complications following lung resection and represent a noticeable cause of mortality. Benefits from non-invasive ventilation (NIV) in acute respiratory failure are now clearly demonstrated. The use of preventive NIV after lung resection, in the absence of acute respiratory failure and/or hypercarbia, could be justified by the physiological benefits expected. The goal of this study is to assess the efficacy of post-operative NIV in moderate-to-severe COPD, for prevention of respiratory complications.

Material and Methods: This is a prospective randomised multicenter trial with an open parallel design in moderate-t-o-severe COPD patients hospitalised in thoracic surgery for lung resection.

Expected results: This study will determine whether post-operative NIV decreases the incidence of acute respiratory events (acute respiratory failure) and whether some subgroups of patients benefit more from this strategy.

Conclusion: This study should help evaluating the utility of post-operative NIV after lung resection.


Eligibility Criteria:
Inclusion Criteria:

* Patients with COPD (FEV1 pre-operative \<80% and FEV1/CV\<70%)
* Patients undergoig pulmonary resection
* Informed consent

Exclusion Criteria:

* Apnea syndrom and chronic noninvasive support
* Post-operative extrarespiratory organ failure
* Inhability to follow study protocole
* Absence of medical coverage
Retrospective Evaluation of Effect of Anterior Iliac Block

In this study, the investigators aimed to evaluate the effect of ultrasound-guided anterior iliac block which was performed preoperatively. Anterior iliac bone harvesting is associated with severe postoperative pain. As several fascial plane blocks were defined to provide analgesia, their effects are debatable and requires high volumes of local anesthetic considering the regional anesthesia technique used for the main surgical procedure.

Autologous bone grafting is the method called the gold standard in the reconstruction of bone defects and nonunions. Anterior iliac crest is most frequently preferred as the source of autologous bone graft. However, severe pain after anterior iliac crest graft harvesting increases morbidity. Various regional anesthesia techniques have been defined for the purpose of postoperative analgesia. The mechanism of fascial plane blocks, one of these techniques, has not been fully elucidated and drug distribution varies from person to person. Postoperative analgesia of the iliac crest donor site can be achieved by i infiltration of local anesthetics or morphine. Single injection or continuous infusions of local anesthetic have proven effective in adults.

In this study; the investigators aimed to retrospectively scan the records of patients who received anterior iliac bone graft in our clinic and determine the postoperative analgesia effectiveness of anterior iliac block. The data obtained after the research will make a significant contribution to the literature in the postoperative analgesia management of patients who are planned to receive anterior iliac bone graft.

Eligibility Criteria:
Inclusion Criteria:

* ASA-1, ASA-2 and ASA-3 patients
* Female/male

Exclusion Criteria:

* Anticoagulant drug use
* Known allergy to the medications to be used
* Infection in the area where the needle will be inserted
* Missing data