cyrilzakka/clinical-trials huggingface dataset:
Emilia-Romagna Surgical Colorectal Cancer Audit- ESCA

Focus of this project is to evaluate the possible financial benefit resulting from an optimization of surgical outcomes throughout a collaborative and systematic auditing activity.The primary objective of this analysis is to assess the employed resources by National Health System related to surgical activities for primary colorectal cancer during a collaborative and systematic auditing activity in 8 Surgical Units of Emilia-Romagna

Focus of this project is to evaluate the possible financial benefit resulting from an optimization of surgical outcomes throughout a collaborative and systematic auditing activity.

The primary objective of this analysis is to assess the employed resources by National Health System related to surgical activities for primary colorectal cancer during a collaborative and systematic auditing activity in 8 Surgical Units of Emilia-Romagna. A project team composed by experts in colorectal cancer care will be created with the task of identifying the needed resources to allocate to the project and the set of administrative, economic and performance indicators to be measured during the project. A friendly, time-preserving dataset that includes all the items to be collected to measure established indicators will be developed. An analysis on costs and performance indicators will be conducted on colorectal procedures performed between 1 January 2019 and 31 December 2019 within the participating centers. From the second year auditing activity will be implemented among institutions of Emilia-Romagna. Analysis results obtained from the first year of collecting data will be used as a starting feedback report to implement the auditing activity dedicated to colorectal cancer. During the whole second year monthly feedback reports will be drafted and used for monitoring costs and performances outcomes of colorectal surgery procedures between 1 January 2020 and 31 December 2020.

At the end of the second year a final analysis will be performed to compare resources employed for colorectal cancer surgery between the first and second year. Economical and performance data will be collected.

Focusing on costs, the main sources to be used are administrative databases. Full in-hospital costs will be collected for each patient for the time interval between the day of admission for surgery and the following post-operative 90-days. The Diagnosis Related Groups (DRG) standardized payments will be used to calculate inpatient costs.

Another source for cost and performance information is the clinical chart (paper or electronic) in all its parts. The investigators will focus primarily on set of data, that potentially could contribute to define the cost of care on basis of post-operative pathway. Key performance indicators common to both colon and rectal surgery or specific for one of the two surgical procedure will be considered.

Eligibility Criteria:
Inclusion Criteria:

* Histological diagnosis of malignant colorectal cancer;
* Underwent colorectal cancer surgery;

Exclusion Criteria:

• multiple synchronous primary tumours;
Ethanol Lock for Prevention of Central Line-Associated Blood Stream Infections

Vascular access via central venous lines (CVL) is essential to the care of many patients in the intensive care setting. While the value of these lines for the management of critically ill patients is generally accepted, the potential for line-associated blood stream infection is a known complication of the use of this intervention.

Ethanol is an effective antimicrobial agent with activity against a broad spectrum of human pathogens.

The purpose of this study is to evaluate the effectiveness of daily treatment of the catheter lumen with ethanol to prevent central line associated blood stream infections (CLABSI). The hypothesis is that this treatment will reduce the incidence of CLABSI compared to maintenance of the lines with normal saline alone.

Blood stream infections are an important complication of the use of central venous lines (CVLs) and result in increased morbidity, mortality, and cost. Blood stream infections related to CVLs may be the result of migration of skin organisms along the catheter tract or introduction of organisms into the lumen of the catheter. The extraluminal route of infection appears to be most common early after catheter insertion while the frequency of infection acquired by the intraluminal route appears to increase the longer the catheter is in place. Meticulous attention to best practices for insertion and the subsequent care of the insertion site reduces infection by the extraluminal route. Adherence to good technique for entering the line may similarly reduce infection by the intraluminal route.

Ethanol is an effective antimicrobial agent with activity against a broad spectrum of human pathogens; including the bacteria and fungi which most commonly infect CVLs. The mechanism of the antimicrobial activity of ethanol is attributed to the ability to denature proteins and induced resistance to the effect of ethanol has not been reported. These features suggest that ethanol-lock is a promising approach to the prevention of acquisition of central line associated blood stream infections by the intraluminal route.

Eligibility Criteria:
Although this study is done in the patient-care setting, patients are not the subject of the study. The outcome of interest involves the development of CLABSI in patients but the intervention is directed at the patient's central lines rather than the patient. There are no inclusion or exclusion criteria; the determination of the line care regimen will be determined by the bed assignment rather than any characteristics of the patient occupying the bed.

All central line will be included in this study. Use of ethanol will be suspended whenever the usage of the line precludes instillation of ethanol with a dwell time of al least one hour.
Genetics Education: Preparing Physicians for the Future

This study examines the best way to teach genetics to family medicine residents. First year family medicine residents at the University of Toronto will be taught basic clinical genetics as well as a specific disease in genetics via 3 different educational methods. All participants will undergo an oral examination and written knowledge test 3 months after this education. Results between groups will be compared, and the best way to teach genetics to residents determined.

An educational module will be prepared by the investigators outlining important genetic fundamentals and hereditary colorectal cancer. Sixty four family medicine resident participants will take part in this study. Participants will be divided into 4 groups. Group 1 will be the control and receive no education. Group 2 will be given access to the self-study web-based educational module to do on their own time. Group 3 will be given a lecture on the material using the educational module, followed by a discussion. Group 4 will also be given this lecture and discussion, followed by an interactive standardized patient role-play experience.

Three months later, all participants will complete an simulated oral examination, an written knowledge test and an attitude survey. By comparing the results between the 4 groups, the best way to teach genetics will be determined. This template can then be used to develop a curriculum for teaching clinical genetics to family medicine residents.

Eligibility Criteria:
Inclusion Criteria:

* all first year family medicine residents in the Department of Family and Community Medicine at the University of Toronto

Exclusion Criteria:

-
To Investigate the Effects of AZD1981 on the QT Interval

The purpose of this research study is to evaluate the effect of AZD1981 on the electrical activity of the heart, in particular when the heart muscle is relaxed during a heart beat cycle. The effect of AZD1981 will be compared to a licensed antibiotic (moxifloxacin) which is well known to affect the electrical activity of the heart, but this effect is known to be at levels that are safe at the dose used in this study. The investigators will also compare the effects of AZD1981 with a "dummy drug" (placebo). The investigators will also be evaluating how safe and well tolerated AZD1981 is and how much AZD1981 enters the blood circulation by collecting blood during the study.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers aged 18 to 55 years (inclusive)
* Subjects must be willing to use barrier methods of contraception during study and for 3 months after last dosing.
* Be a non-smoker or ex-smoker who has stopped smoking for \>6 months

Exclusion Criteria:

* Any clinically significant disease or disorder (eg, cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment)
* History of additional risk factors for Torsade de Pointes (eg, heart failure, hypokalemia, personal or family history of arrhythmia or long QT syndrome)
Cervical Sensorimotor Control Training in Chronic Neck Pain

Impaired cervical joint position sense is associated with neck pain. This study will determine the effects of sensorimotor control training exercises on cervical joint position, pain, ROM and function in nonspecific chronic neck pain. There will be two groups ; experimental and control. Half of study group will receive cervical sensorimotor control training exercises and half of study group will receive conventional physiotherapy protocol.

The study is Randomized Control Trail , which is being conducted in physical therapy Out patient department of Pakistan Railway hospital (April 2019-July 2019) . Sample size of 18 individual was calculated using Epitool with 95% confidence interval (CI), and power 80%. Individual will be screened out according to inclusion criteria. Individuals will be allocated randomly into two groups , 9 in cervical Sensori-motor training group and 9 in conventional physiotherapy protocol group by sealed envelope method.

Both groups will receive conventional physiotherapy protocol (hot pack, stretching exercises and strengthening exercises) for neck pain in common and the experimental group will receive cervical sensorimotor control training in addition to conventional protocol.

Assessment will be done on baseline and 6th week.

Data will be analysed on SPSS version 21.

Eligibility Criteria:
Inclusion Criteria:

* Age between 20 to 50 years
* Non specific neck pain
* Insidious neck pain for at least 3 month
* Average pain intensity over the past week \>4 on Numeric Pain Rating Scale(NPRS)

Exclusion Criteria:

* Previous history of neck and head trauma or surgery
* Inflammatory joint disease
* Systemic conditions
* Cognitive impairment
* Taking four or more medications
Human Immunodeficiency Virus (HIV) Postexposure Prophylaxis (PEP) With Darunavir/Ritonavir (DRV/r)

The primary purpose of this study is to assess the rate of early discontinuation from randomized Human Immunodeficiency Virus (HIV) Postexposure Prophylaxis (PEP) for any reason other than confirmation of the negative HIV infection status of the index person in patients receiving HIV PEP for at least 28 and a maximum of 30 days.

This is a randomized (study medication assigned by chance), open-label (all people involved know the identity of the intervention), active-controlled (patients are assigned to either a recognized effective treatment or the study medication), parallel-group (each treatment group will be treated at the same time), multicenter study comparing DRV/r PEP (DRV/r administered with 2 NRTIs selected at the discretion of the investigator) to standard of care PEP (as per German-Austrian guidelines) in patients at risk of HIV infection due to HIV exposure through occupational injury and non-occupational exposure. This study consists of screening period, treatment period and a follow up period. HIV PEP will be administered for a total of at least 28 days and maximum of 30 days during treatment period, including any prestudy HIV PEP initiated before screening. Approximately 318 patients will be screened and enrolled to ensure that at least 131 patients are randomly assigned to receive DRV/r PEP or standard of care PEP. Safety will be evaluated during the entire study period. Data relating to a patient's functional impairment in conjunction with HIV PEP will be collected on Day 1 as baseline data, and further on Days 14 and 28 as well as at Month 3.

Eligibility Criteria:
Inclusion Criteria:

* Occupational injury and non-occupational exposure with documented human immunodeficiency virus (HIV) exposure, or potential for HIV exposure
* Indication for HIV postexposure prophylaxis (PEP), as determined by the treating physician and/or the investigator
* Women must be: postmenopausal (for at least 2 years), surgically sterile, using oral contraceptives
* Willing to continue HIV PEP for 28 days

Exclusion Criteria:

* Positive HIV rapid test
* History of liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastro intestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
* Pregnant or breast-feeding
* Any condition that, in the opinion of the investigator, would compromise the well-being of the participant or the study or prevent the participant from meeting or performing study requirements
Maitake for Integrative Cancer Care

Maitake is an edible mushroom that is used for both its nutritional and medicinal properties. Human and animal studies have shown Maitake may help improve immune function; however, its effectiveness in people with cancer is not clear. The investigators aim to measure if Maitake has any immunomodulatory effects when given alongside conventional systemic cancer therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Adults (≥18 years of age)
2. Confirmed cancer diagnosis through biopsy or radiologic imaging
3. Undergoing systemic treatment with either chemotherapy or CD4/6 inhibitors
4. Currently receiving cancer treatment in Ontario, Canada

Exclusion Criteria:

1. Hematologic cancers
2. Previously received any mushroom supplement within 6 months prior to enrolment
3. Allergy to mushrooms or mushroom products
4. Diagnosis of diabetes
5. Currently taking hypoglycemic or anticoagulant medications
6. Currently receiving immune checkpoint inhibitors
7. Unable to attend in in-person visits in either Ottawa or Toronto
8. Any reason which, under the discretion of the Qualified Investigator or delegate, would preclude the patient from participating
Liquid Biopsy Using Methylation Sequencing for Lung Cancer

This study aims to investigate the utility of circulating tumor DNA (ctDNA) methylation sequencing in the diagnosis of primary lung cancer.

Plasma sample of patients with and without lung cancer will be collected and analyzed using methylation-sensitive enzyme sequencing method. Diagnostic performance of ctDNA methylation sequencing will be compared with that of tumor markers (CEA, Cyfra 21-1, and NSE) combined.

Eligibility Criteria:
Inclusion Criteria:

* Lung cancer group

  1. Pathologically proven lung cancer
  2. Clinically suspected lung cancer on chest CT scan
* Benign pulmonary disease group

  * Chronic obstructive pulmonary disease, interstitial lung disease, pneumonia, bronchiectasis, non-tuberculous mycobacterial lung disease, pulmonary vascular disease

Exclusion Criteria:

* Patients with previous history of lung cancer
* Patients who have been diagnosed with other malignancy within 5 years
* Unstable vital status
* Active pulmonary tuberculosis
* Infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
Treatment of Oral Lichen Planus With Paeoniflorin and Photodynamic Therapy

Oral lichen planus (OLP) is a common chronic inflammatory disease of the oral mucosa and is considered a precancerous condition. It is characterized by white reticular changes in the oral mucosa, which can progress to erosions and cause pain in severe cases. The pathogenesis of OLP is still unclear, but it is believed to be a T-lymphocyte-mediated autoimmune disease. Currently, only symptomatic treatments are available, and there is no definitive cure.

In this project, we plan to use TCM differentiation to categorize OLP patients and conduct a randomized controlled clinical trial to demonstrate the enhanced therapeutic effect of paeoniflorin combined with photodynamic therapy for OLP. The implementation of this project will provide new insights into the clinical management of OLP, improve our understanding of the treatment mechanisms, and have important theoretical and clinical implications.

Paeoniflorin, a compound extracted from the traditional Chinese medicine, has anti-inflammatory and immunomodulatory effects. Photodynamic therapy is a novel local treatment approach, where photosensitizers selectively target and destroy diseased cells. Both treatments have shown efficacy in treating OLP when used individually.

Eligibility Criteria:
Inclusion Criteria:

* patients with oral lichen planus
* male or female patients older than 18 years of age
* patients willing to participate with signed informed consent.

Exclusion Criteria:

* pregnant or lactating
* had serious systemic diseases of the heart, lung, liver, and kidney, or had tumors
* were unwilling to participate in the experiment.
Laughter Yoga Effect on Cancer Patients' Physiopsychological Symptoms

The universe of this study will consist of cancer patients and their relatives who are hospitalized in the medical oncology clinic of Atatürk University Research and Practice Hospital between Oct 2024 and Feb 2024. The researcher will stratify the patients in the control and intervention groups according to age and the type of treatment they receive in order to ensure homogeneity. Accordingly, the patient in each stratum will be selected from one of the labels prepared in a bag with the words "experimental" and "control" written on it and the patient will be included in the group written on the label. The patients in the control and intervention groups will not know which group they are in, but only the researcher will know who is in which group. In this way, blinding will be ensured and the study will be completed as single-blind.

Sample Size Calculation:

The minimum number of people to be included in the sample was calculated by performing a power analysis. Using the "G.Power-3.1.7" program, the sample size was calculated with a test power of 0.80. As a result of the power analysis, it was determined that a total of 60 patients should be included in the control and intervention groups at α=0.05 level and 80% power. The patients to be included in the study will be randomized and assigned to the intervention (n=30) and control (n=30) groups. Volunteer acceptance for the study will begin after the acceptance of the study within the created work packages.

Data collection tools:

The data of the study will be collected in the experimental and control groups using the "Personal Information Form", "Edmonton Symptom Assesment Scale", "Herth Hope Scale" and "Life Engagement Scale".

Criteria for volunteers to be included in the study:

1. Being 18 years of age or older
2. Being diagnosed with cancer and having knowledge about the disease
3. Not having a physical illness or cognitive disability that would prevent understanding the scales used for data collection and the education provided, and not having a psychiatric illness diagnosis
4. Being literate
5. Being open to communication and collaboration

Eligibility Criteria:
Inclusion Criteria:

1. Being 18 years of age or older
2. Being diagnosed with cancer and having knowledge about the disease
3. Not having a physical illness or cognitive disability that would prevent understanding the scales used for data collection and the education provided, and not having a psychiatric illness diagnosis
4. Being literate
5. Being open to communication and collaboration

Exclusion Criteria:

1. Being under 18 years of age
2. Not having information about the disease
3. Having a physical illness or cognitive disability that prevents understanding the scales used for data collection and the education given, and being diagnosed with a psychiatric disease
4. Being illiterate
5. Not being open to communication and cooperation
Efficacy and Safety of Adding Azarga to Prostaglandin Monotherapy

The purpose of this study is to assess the safety and efficacy of adding AZARGA in glaucoma patients with uncontrolled intraocular pressure (IOP), currently on prostaglandin monotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Sign Informed Consent.
* 21 years of age or older.
* Able to follow instructions and willing to attend required study visits.
* Clinical diagnosis of ocular hypertension, primary open-angle, or pigment dispersion glaucoma in at least one eye (qualifying eye).
* Intra-ocular pressure (IOP) considered to be safe in both eyes in such a way that should assure clinical stability of vision and the optic nerve throughout the trial.
* Must have best corrected visual acuity of 6/60 (6/60 Snellen, 1.0 LogMAR) or better in each eye.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Presence of other primary or secondary glaucomas not listed in inclusion criterion.
* Presence of corneal dystrophies.
* Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye.
* Intraocular conventional surgery or laser surgery in qualifying eye(s) less than three months prior to Visit 1.
* Risk of visual field or visual acuity worsening as a consequence of participation in the trial, in the investigator's best judgment.
* Women of childbearing potential not using reliable means of birth control.
* Women who are pregnant or lactating.
* Participation in any other investigational study within 30 days prior to Visit 1.
* Current or anticipated use of systemic corticosteroids, by any route except inhaled, for greater than two weeks during the trial.
* Severe allergic rhinitis
* History of ocular herpes simplex.
* Other protocol-defined exclusion criteria may apply.