cyrilzakka/clinical-trials huggingface dataset:
Longterm Observational Study in Subjects Treated With AA4500 in AUX-CC-854, 856, 857, 858 & 859

The purpose of study AUX-CC-860 is to assess the durability of response of the AA4500 treatment regimen. This study will also evaluate long-term safety and progression of disease in joints.

Phase 3 non-treatment study in which Year 2 to Year 5 year follow-up of subjects who received AA4500 in the 9-month open-label studies (AUX-CC-854 and AUX-CC-856) or the 12-month double-blind with open-label extension studies (AUX-CC-857/AUX-CC-858 and AUX-CC-859). After completion of one of the above mentioned studies, subjects are enrolled and followed once a calendar year for 4 consecutive years with at least 6 months between consecutive visits.

Eligibility Criteria:
Inclusion Criteria:

To be eligible for this study a subject had to:

* Have received at least one injection of AA4500 in one of the Auxilium sponsored studies (AUX-CC-854, AUX-CC-856, Studies AUX-CC-857/AUX-CC-858, or AUX-CC-859) and have at least one fixed-flexion contracture measurement after treatment with AA4500
* Be able and willing to comply with the yearly assessments outlined in the protocol, as determined by the investigator
* Voluntarily sign and date an informed consent agreement approved by the Institutional Review Board/Independent Ethics Committee (IRB/IEC)

Exclusion Criteria:

* None
Surgiphor vs Saline Joints

This study will be an open-label superiority, multicenter, single-blind, controlled randomized clinical trial investing the role of a PVP-I irrigation solution (Surgiphor) in reducing the risk of acute PJI in the 90 days following total hip and knee revision arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

1. Patient ≥18 years old
2. Male or non-pregnant, non-lactating, postmenopausal or surgically sterilized females
3. Subjects scheduled to undergo total knee or total hip revision for aseptic reasons (per 2018 ICM criteria 5)
4. Subjects provide informed consent, which will consist of reading, signing, and dating the informed consent document after the Investigator, sub-Investigator or other designated study staff member has explained the study procedures, risks, and contact information. Subjects not willing to sign consent form to be randomized must be willing to sign alternate consent form to allow prospective data collection in the non-randomized arm of the study

Exclusion Criteria:

1. Subjects with known allergies to iodine or any other ingredients in Surgiphor
2. Subjects unwilling to sign informed consent
3. Subjects, for health reasons or other, in the opinion of the Investigator, with a life expectancy less than one year, which is the follow-up period of the study
Sensitivity of Targeted Biopsy Within Sydney Protocol for GIM

Sensitivity of Targeted Biopsy Within Sydney Protocol by Using Narrow Band Imaging for Extensive Gastric Intestinal Metaplasia Diagnosis

Objective:

The aim of this study is to evaluate the sensitivity of targeted biopsy within Sydney protocol by using narrow band imaging for Extensive Gastric Intestinal Metaplasia diagnosis

Research design: Diagnosis study

Sample size: 105 cases

Data analysis:

The outcomes will be presented using 2 by 2 tables and if the data are normal distribution the categorical data will be analysed using McNemar's test

Background and Rationale:

Gastric cancer has been in the top-5 of cancer-related death worldwide. Early detection by screening program in high risk patients is very important. If we can detect pre-malignant lesion eg. gastric intestinal metaplasia, we can provide the appropriate surveillance program to those patients. However, the screening protocol for gastric intestinal metaplasia remained unclear. Recently in July 2019, British Society of Gastroenterology published the guideline on the diagnosis and management of patients at risk of gastric adenocarcinoma. The image-enhanced endoscopy (IEE) is recommended as the best modality for assessing gastric intestinal metaplasia. Additionally, they recommended taking biopsy by using Sydney protocol which means taking biopsy at two areas for antrum, two areas for body and one for incisura although they look normal. We aimed to evaluate the sensitivity of this protocol for extensive gastric intestinal metaplasia (GIM) diagnosis in this study.

Methodology:

* All patients with history of GIM will be enrolled and undergone standard with white light esophagogastroduodenoscopy (EGD).
* Those with suspected lesions of GIM will proceed to narrow band imaging (NBI)-mode endoscopy.
* Targeted biopsy will be done at the suspected GIM lesions. Random biopsy will be while will be done if no suspicious GIM lesion seen.

Data collection:

All data will be processed and recorded by one physician.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 year of age
* Suspected GIM by previous tissue pathology
* Able to provide informed consent for participation

Exclusion Criteria:

* Previous gastric surgery including gastrectomy and bypass surgery
* Coagulopathy
* Pregnancy
* Active upper GI bleeding
Endoscopic Ultrasound-guided Fine-needle Aspiration of Solid Pancreatic Lesions With Rapid Staining of Cytological Smears Followed by Whole Slide Scanning and Artificial Intelligence Diagnosis: A Prospective, Multicenter Study.

The objective of this observational study is to investigate whether the self-developed whole slide scanning and artificial intelligence diagnostic system for pancreatic solid lesion puncture cytopathology (hereinafter referred to as the "Zhiying Shunxi" ROSE-AI diagnostic system) can promptly and accurately diagnose solid pancreatic lesions (SPLs). The main question it aims to answer is:

By utilizing optical imaging technology to capture RGB images of Diff-Quik stained smears from pancreatic punctures, can the development of artificial intelligence algorithms assist in differentiating solid pancreatic space-occupying diseases (such as pancreatic ductal adenocarcinoma, pancreatic neuroendocrine tumors, and non-neoplastic benign lesions)?

Researchers will compare the diagnoses of SPLs made by the ROSE-AI system with the actual pathological diagnoses of the SPLs themselves to determine whether the ROSE-AI system can effectively diagnose SPLs.


Eligibility Criteria:
Inclusion Criteria:

* A dated and signed informed consent form A commitment to abide by the research procedures and cooperate throughout the entire study Subjects aged 18 and above, regardless of gender Diagnosis or suspicion of a solid pancreatic space-occupying lesion based on imaging studies (B-mode ultrasound, CT, or MRI)

Exclusion Criteria:

* Unable or refusing to sign the informed consent form Unable to suspend anticoagulation/antiplatelet therapy Pregnant or lactating Having a mental illness or other medical conditions that are unsuitable for undergoing FNA/B biopsy Presence of coagulation disorders (PLT \< 50 × 10\^3/μl, INR \> 1.5) Pancreatic cystic lesions Non-diagnostic EUS-FNA/B specimens Having less than 8 microscopic fields of interest (ROI) in the digital pathology images of the entire Diff-Quik smear slide
Reason Evaluation of Initial Treatment Failure in Patients With CAP

This research is to evaluate the effect of different antibiotics (Moxifloxacin Hydrochloride and Sodium Chloride Injection vs. β-lactam antibiotics for injection +/- Azithromycin for Injection) on the early deterioration or progression (\<72 h of treatment) of community acquired pneumonia and to study the effect of the early deterioration or progression on the prognosis of community acquired pneumonia.


Eligibility Criteria:
Inclusion Criteria:

1. Age\>=18y.
2. Diagnosed with CAP.
3. Need hospitalization.
4. Receive Moxifloxacin Hydrochloride and Sodium Chloride Injection or β-lactam antibiotics for injection +/- Azithromycin for Injection as initial treatment.
5. Signed informed consent form.

Exclusion Criteria:

Patients who meet any of the following criteria will not be included in the study:

1. Pneumonia is aquired more than 48h after admission or the patient was admitted to hospital within 30 days prior to admission.
2. Start antibiotic treatment before admission.
3. Gestational period or suckling period.
4. Admitted to ICU.
5. Immunocompromised patients.
6. Pneumonia is the terminal event of a serious disease.
7. Tuberculosis, lung cancer, non-infectious interstitial lung disease, pulmonary edema, atelectasis, pulmonary embolism, pulmanory eosinophilia, pulmonary vasculitis.
8. Allergic to the antibiotics of the study.
The Effect of Catheter-Associated Infection Control Training

The goal of this type of study: clinical trial is to determine the effectiveness of educational practices on catheter-associated infection control measures on surgical nurses. The main question it aims to answer are:

* Is there a difference between the knowledge and attitude levels of surgical nurses receiving and not receiving catheter-related infection control training on preventing peripheral and central catheter-related bloodstream infections?
* Is there a difference between the knowledge and attitude levels of surgical nurses receiving and not receiving catheter-related infection control training to prevent catheter-related urinary tract infections?

The main tasks that the participants will be asked to do will be explained and their consent will be obtained. The two research groups will be compared.

This study will be conducted with a total of 70 nurses working in the surgical clinics of a city hospital in Istanbul and meeting the inclusion criteria. Nurses who meet the inclusion criteria of the study will be divided into two groups: intervention (n=35) and control group (n=35) according to the randomization method created with computer-based random numbers. Nurses in the intervention group will be given face-to-face training on evidence-based catheter-related infection control measures. The content of the training program will also be given to the participants as written material (brochure). The training will take an average of 30 minutes. Routine in-service training practices will be given to the control group. Descriptive Characteristics Form, the Peripheral and Central Venous Catheter-Related Bloodstream Infection Prevention Knowledge and Attitudes Scale, and Catheter-Associated Urinary Tract Infections Control Precautions will be used in data collection. Data will be collected from all participants before, immediately after, and three months after the training practices.

Eligibility Criteria:
Inclusion Criteria:

* Being a nurse
* Working in the surgical unit
* Agreeing to participate in the research

Exclusion Criteria:

* Being on leave/reported (maternity leave, unpaid leave, medical report, etc.)
* Not filling out the questionnaire
Effectiveness of Laying-on-of-hands for Sickle Cell Disease

The objective of this study is to evaluate the effectiveness of 1-year administration of laying-on-of-hands on the morbidity and mortality of patients with sickle cell disease in Africa.

Patients with sickle cell disease (SCD) have a high risk of premature death in Africa, mainly due to insufficient medical services. SCD patients often visit emergency department and need hospitalization when they suffer from severe pain; however, they manage most of painful episodes at home. Appropriate pain management at home is, therefore, crucial to improve their clinical course and quality of life. Laying-on-of-hands may be a good candidate for home care management, because family member(s) can become a practitioner of laying-on-of-hands without difficulty and administer it to their loved one as an initial treatment whenever necessary. There are no reports concerning the effectiveness of laying-on-of-hands for the outcomes of SCD patients, as far as we have investigated.

Eligibility Criteria:
Inclusion Criteria:

* patients with symptoms associated with sickle cell disease
* those able to receive laying-on-of-hands every weekday for 1 year
* those able to receive conventional medical treatment whenever necessary
* those able to receive blood test at the beginning, after 6 month and after 1 year

Exclusion Criteria:

* those who wish to use other complementary and alternative therapies along with laying-on-of-hands
An Oral Intake Screening Tool for Patients Receiving Non-Invasive Ventilation

This study aims to explore how the introduction of an oral intake screening tool can benefit patients requiring noninvasive ventilation. The Quality Care Commission has identified nutritional problems in hospital and there is much literature on the importance of nutrition when critically ill. Literature is short however concerning the specialized population of those requiring noninvasive ventilation and they are a high risk group of suffering from malnutrition.

This study will potentially benefit patients by improving their nutritional care through guided assessment and nurse training.

The study will use mixed methodology, a prospective cohort study and qualitative interviews. The prospective cohort study will collect data from patients prior to the tool introduction, the control group, and post the tool introduction, the exposure group. This will enable comparisons to be made between the exposure and the control groups.

Nurses will be interviewed in semi structured focus groups prior to tool introduction and post to identify themes and sub themes to give a deeper understanding of nutrition in hospital and to examine the use of the tool in practice.

Patients will be eligible if they are over 18 and requiring noninvasive ventilation and nurses will be eligible if they work on the high dependency unit. Patients will be visited daily and have four mid arm circumference measurements at day 1, day 3, day 7 and day 14. The other daily visits will involve collecting data, which is recorded as part of routine care.

Nurses will undergo 2 focus group interviews and a teaching session. The study will take place at St Mary's hospital funded by Imperial College London. The study will be split into two periods with a two week gap in between. Each period will last until 22 patient participants have been recruited.

No patients were recruited to the study due to decreased levels of patients requiring non-invasive ventilation during the study period and time constraints owing to an academic award submission date. Six nurse participants were recruited to the study and underwent two focus group interviews, one prior to tool implementation and one post.

Eligibility Criteria:
Patients

Inclusion Criteria:

* over 18 years old
* require non-invasive ventilation as defined by the protocol

Exclusion Criteria:

* Patients on the Liverpool Care Pathway
* Patients requiring nocturnal non-invasive ventilation only
* Patients with a tracheostomy
* Patients with a nasogastric feeding tube insitu on admission
* Patients with a PEG/RIG tube insitu on admission

Staff

Inclusion Criteria:

* full time employees
* work in the medical high dependency unit

Exclusion Criteria:

* staff only working bank or agency shifts on the medical high dependency unit
* staff who have not had formal high dependency/critical care training
* staff who do not work more than 5 shifts per month in the medical high dependency unit
* staff who have not held a full time post on Douglas Acute Admissions Unit for more than six months
RAOLA Observational: Local Anesthesia During Cardiac Catheterization

An open label observational clinical study to compare the efficacy of EMLA cream (lidocaine 2.5% and prilocaine 2.5% in a ratio of 1:1 by weight) in comparison to the established local anesthesia (LA) protocol of lidocaine subcutaneous injection, in providing adequate peri-operative local anesthesia during transradial coronary angiography

A total of 800 consecutive patients, who are referred for elective coronary angiography to 1st Cardiology Department cathlab, with the suspicion of coronary artery disease (CAD) will be enrolled in this study. Exclusion criteria are acute coronary syndrome, previous ipsilateral transradial approach, Raynaud's syndrome, abnormal renal function with or without need for hemodialysis, known history of sensitivity to local anesthetics, non-palpable radial pulse, abnormal Barbeau's test and patient's refusal. Baseline clinical, demographic and procedural data of the study population will be recorded.

The study will not involve any intervention but it will observe patients assigned to other EMLA cream or lidocaine injection for local anesthesia as part of their clinical routine treatment during transradial catherization.

Primary end-point: the perception of radial pain assessed during artery puncture and 30 minutes after sheath removal. Secondary end-point: The number of puncture attempts, the total time required before successful sheath insertion, and the occurrence of radial artery spasm will be also documented in each group Participants will be observed for 4 hours post angiography for development of local complications or side effects.

Eligibility Criteria:
Inclusion Criteria:

- patients, referred for elective diagnostic coronary angiography

Exclusion Criteria:

* acute coronary syndrome
* previous ipsilateral transradial approach
* Raynaud's syndrome
* abnormal renal function with or without need for hemodialysis
* known history of sensitivity to local anesthetics
* non-palpable radial pulse, abnormal Barbeau's test
* patient's refusal
Patient's and Caregiver's Expectations and Preferences Concerning Art Therapy Activities for Cancer Support

Cancer patients and their caregivers often experience difficulties in coping with the cancer diagnosis and the treatment that follows. Creative art therapy could support cancer patients and their caregivers in coping with these issues by using their creativity and self-expression. The aim of this study for the investigator's research team is to create a clear image of what cancer patients and their caregivers expect of supportive care to help them coping with cancer diagnosis, cancer therapy and life after cancer. This is a prospective, interventional study. Cancer patients and their caregivers will be approached to participate in this study. They will be asked to complete a questionnaire about their satisfaction with the current support they get to help them coping with cancer diagnosis, cancer therapy and life after cancer and whether they would like to participate in an art therapy program, which art therapy forms they would like to participate in, how they would like them to be organized, etc.


Eligibility Criteria:
Inclusion Criteria:

* Dutch speaking patients and caregivers
* Patients and caregivers presenting at the outpatient clinic, including the day-care clinic and follow up visits
Using Iron With Procrit in Advanced Lung Cancer Patients With Chemotherapy-Induced Anemia

The purpose of this study is to find a better, more convenient way to improve anemia results by increasing the amount of medication given at 3 week intervals. Researchers want to know if giving a higher dose of Procrit® and intravenous (IV) iron once every 3 weeks would give better results in treating anemia without the need for more office visits.

There are more than 170,000 patients diagnosed with lung cancer in the United States each year and many will develop anemia (iron deficiency) during the course of treatment. Anemia is associated with poor quality of life and treatment delays for advanced lung cancer. The treatment of iron deficiency anemia is with iron. Iron is an essential mineral used in red blood cells to carry oxygen throughout the body. Iron is necessary to make hemoglobin, a key element in red blood cells.

The FDA has approved Procrit® (epoetin alfa) to treat anemia in people with non-myeloid (bone marrow) malignancies. Procrit® is a man-made, injectable drug for treating anemia and it encourages red cell production. While the administration of intravenous iron therapy, injected into veins through an IV, did increase the response rate of Procrit® in a previous study, researchers want to find out the best amount of drug to use and the best time to administer Procrit®, along with ferric gluconate, (Ferrlecit®), added for lack of iron.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed small cell or non small cell lung cancer
* Stage III or Stage IV lung cancer
* Platinum containing chemotherapy induced anemia (\< 10 g/dl Hb)
* Cancer related anemia (\<10 g/dl Hb) at time of initiation of chemotherapy
* ECOG performance status of 0,1, or 2
* Informed consent
* Age\>18
* Expected to receive platinum based outpatient chemotherapy for at least nine weeks

Exclusion Criteria:

* Pregnant women
* Intolerance to epoetin alfa or parenteral iron
* More than 2 cycles of the planned platinum chemotherapy at time of enrollment
* Chronic GI bleed (\> than 4 weeks positive hemoccult or gastroccult)
* Ferritin \> 500 mg/dl
* Anemia due to other causes than cancer or chemotherapy
* Previous parenteral iron therapy
* Uncontrolled hypertension (systolic BP \> 160, diastolic \> 100 mmHg)
Multiple Dose Trial Examining Dose Range, Escalation and Efficacy of Oral Semaglutide in Subjects With Type 2 Diabetes

This trial is conducted globally. The aim of the trial is to examine the dose range, escalation and efficacy of oral semaglutide in subjects with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* BMI above or equal to 25 and below or equal to 40 kg/m\^2
* Subjects diagnosed with T2D (Type 2 diabetes) treated with diet and exercise and/or who have been on a stable dose of metformin for at least 30 days prior to screening
* HbA1c 7.0-9.5% (53-80 mmol/mol) (both inclusive)

Exclusion Criteria:

* Subjects on selected oral medication with a narrow therapeutic window, such as warfarin, digoxin, tricyclic antidepressants, lithium, aminophylline, theophylline and anticonvulsants
* History of chronic pancreatitis or idiopathic acute pancreatitis
* Chronic malabsorption, regardless of aetiology
* History of Crohn's disease, ulcerative colitis, or other inflammatory bowel disease
* Treatment with glucose lowering agent(s) other than metformin as stated in the inclusion criteria in a period of 90 days before the screening visit
An Observational Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis And Inadequate Response Or Intolerance to a First Anti-TNF Alpha Therapy

This prospective, multi-center, observational study will evaluate the efficacy and the safety of MabThera (rituximab) in participants with rheumatoid arthritis who have not responded or have been intolerant to a first anti-TNF alpha therapy. Participants have commenced MabThera or an alternative anti-TNF alpha treatment as a second biological therapy. Data will be collected for 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Adult participants, \>/=20 years of age
* Participants with rheumatoid arthritis, who have not responded or have been intolerant to a single anti-TNF alpha therapy and who have initiated MabThera or an alternative anti-TNF alpha therapy

Exclusion Criteria:

* Participants whose first anti-TNF alpha treatment was, or second biological therapy is given as part of a clinical trial studying rheumatoid arthritis
* Participants who have not signed the informed consent form