cyrilzakka/clinical-trials huggingface dataset:
Immunogenicity of COVID-19 Vaccination in PLWH

Various facts support the study of COVID-19 vaccine immunogenicity in People Living With HIV (PLWH) at this time: (1) Many PLWH in Canada will be eligible to receive COVID-19 vaccination as they are in a high priority risk group, such as residents or staff of shared living facilities for seniors, health care workers with direct patient contact, aged 70 years of age or older, or adults in Indigenous communities; (2) As vaccines against many other pathogens, it is plausible that the current standard vaccination strategy of COVID-19 is less effective in PLWH; (3) The potential burden of significant COVID-19 infection in PLWH is likely large given many PLWH are aging and have co-morbidities known to predispose to worse COVID-19 outcomes; (4) The vaccine clinical trials which include PLWH63, have stringent exclusion criteria, making results non-generalizable to many PLWH such as those with lower CD4 counts.

With the rapid roll-out of COVID-19 vaccination, many PLWH will be receiving the COVID-19 vaccine. Through vaccination, the provision of the same dosage of antigen stimulation to all individuals will result in a controlled method to measure immune response in PLWH. Therefore, we propose to develop a pan-Canadian cohort of PLWH receiving a COVID-19 vaccine(s) to assess a spectrum of immune responses. We also aim to assess the safety and tolerability of the COVID-19 vaccines in PLWH. These data may provide support for the use of one vaccine product over another and for exploring alternate vaccination strategies in PLWH (i.e., increased dose or double-dose vaccination and so forth).


Eligibility Criteria:
Inclusion Criteria:

* Age \>/=16 years (Sites may choose to only enrol adults based on their provincial age of majority)
* HIV positive for HIV group; For HIV negative group, individuals should be immunocompetent and generally in good health (i.e. participants should not have a condition associated with immunodeficiency nor be receiving immunosuppressant medication)
* Receiving at least 1 dose of COVID-19 vaccine, or have received 1 or 2 doses of a COVID-19 vaccine
* Able to provide signed, informed consent
* Able to attend study visits

Exclusion Criteria:

* Signs or symptoms of active COVID-19 infection
* For HIV-uninfected persons: immune-compromising conditions or on medication which suppresses the immune response
Preoperative Education With Image Illustrations Enhances Effect of Tetracaine Mucilage in Alleviating Postoperative CRBD

Catheter-related bladder discomfort (CRBD) is not uncommon in male patients under general anesthesia, and it may cause patient agitation and exacerbated postoperative pain. In this study, the investigators will enroll male patients undergoing elective colonal and rectal surgery with surgical duration of at least 2 h, requiring catheterization of the urinary bladder with urinary catheterization after anesthetic induction, and compare preoperative education with image illustrations combined with local tetracaine mucilage vs. local tetracaine mucilage alone in alleviating CRBD during the post-operative period.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18 years to 75 years.
2. American Society of Anesthesiologists (ASA) physical status I, II.
3. Undergoing elective noncardiac surgery with urinary catheterization after 4.anesthetic induction under general anesthesia.

5.Duration of surgery more than 2h 6.Glasgow Coma Scale (GCS) score of 15. Ability to communicate.

Exclusion Criteria:

1. History of bladder dysfunction, such as over active bladder (OAB, urinary frequency: more than three times in the night or more than eight times in 24 h).
2. History of bladder outflow obstruction.
3. Neurogenic bladder.
4. Impaired renal function.
5. Coagulopathy.
6. Known allergies to any anesthetic agent.
7. Family history of malignant hyperthermia.
8. Impairment of communication or cognition.
9. Psychopathy.
10. Active participation in another trial where the primary endpoint follow-up is ongoing.
11. Unwillingness or inability to comply with protocol procedures.

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Intravenous Colistin Versus Intravenous Colistin Plus Nebulized Colistin in VAP Due MDR Acinetobacter Baumannii

Compare the clinical efficiency evaluated by the treatment of the intravenous colistin plus inhaled colistin opposite to the treatment with colistin intravenous plus inhaled saline solution in patients with VAP due to baumannii carbapenems resistant.

Compare the clinical efficiency evaluated by the treatment of the intravenous colistin plus inhaled colistin opposite to the treatment with colistin intravenous plus inhaled saline solution in patients with VAP due to baumannii carbapenems resistant.

Eligibility Criteria:
Inclusion Criteria:

* Diagnose of VAP due A. baumannii or A. baumannii and another microorganism carbapenems resistant.
* Clinical Pulmonary Infection Score (CPIS) \> 6

Exclusion Criteria:

* Allergy to colistin.
* Asthma
* Shock status
* Diagnose of VAP due A. baumannii colistin resistant.
The Inflammatory Response to Stress and Angiogenesis in Liver Resection

Patients with resectable liver metastases of colorectal origin will be assigned to laparoscopic liver resection or conventional open liver surgery.

Blood samples will be drawn preoperatively and 24 hours after resection. Determination of Interleukin-6 (IL-6) and IL-8 will be done to assess the stress response between open and laparoscopic liver resection (Elisa test).

The Messenger Ribonucleic Acid (mRNA) of inflammation related factors (cyclooxygenase-2 (COX-2) and Matrix metalloproteinase (MMP-9)), angiogenesis related factor (vascular endothelial growth factor (VEGF) and hypoxia induced factor-1 (HIF-1)) in tumor tissue and normal liver parenchyma will be detected by real-time real time-Polymerase Chain Reaction (RT-PCR).

According to the null hypothesis, no difference in the IL6 postoperative value, between the two groups would be expected. To calculate sample size, a IL6 postoperative value of 100±40 pg/mL in the laparoscopic group and 60±40 mL/m pg/mL in the open group was hypothesized. Considering a two-sided α=0.05 and β=0.1, the minimal sample size required to achieve statistical significance was 17 subjects in both groups in a 1:1 randomization. Laparoscopic group was increased by 20% of patients considering a conversion rate of 20% accordingly. Randomization will be performed using computer-generated random numbers the day before operation and stopped when 20 patients per group will be reached.

Eligibility Criteria:
Inclusion Criteria:

1. 18-80 years old
2. Patients with colorectal liver metastases
3. Colorectal liver metastases ≤10 cm in size -

Exclusion Criteria:

1. Patients not fit for laparoscopic surgery due to comorbidities
2. Patients with tumors close or infiltrating the major vessels -
Electronic Skin Surface Brachytherapy for Cutaneous Basal Cell and Squamous Cell Carcinoma

The purpose of this study is to assess the effectiveness of electronic skin surface brachytherapy (ESSB) for early stage basal or squamous cell carcinoma of the skin using a new device. This new device is Nucletron's Esteya Electronic Skin Surface Brachytherapy System. The investigators want to understand what effects, good and/or bad this device for delivering brachytherapy has on your skin cancer. The investigators also want to assess the safety, cosmetic results, the effects that ESSB has on quality of life and to correlate skin imaging with clinical response to ESSB.


Eligibility Criteria:
Inclusion Criteria:

* Men or women ≥ 60 years old with estimated life expectancy of ≥ 5 years
* Histopathologic diagnosis of basal or squamous cell carcinoma
* Clinical stage T1N0M0 (by AJCC 2010 criteria)

  °Basal cell carcinoma with morpheaform, sclerosing, mixed, infiltrative or micronodular features must be ≤1 cm
* Low risk pathologic features (by AJCC 2010 criteria)
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-3 (Appendix C)
* Able and willing to complete the Skindex16 and Skin Cancer Index (must be able to speak English)
* Ability to provide informed consent

Exclusion Criteria:

* BCC/SCC that was previously treated (ie, recurrent BCC/SCC)
* BCC/SCC in region adjacent to or overlapping with region of prior radiotherapy
* BCC/SCC on irregular surface (ie, target area not flat)
* BCC/SCC adjacent to or overlapping with burn or scar
* BCC/SCC in area prone to trauma (including, but not limited to the skin overlying the tibia, dorsum of hands and elbow)
* BCC/SCC in area with compromised lymphatic drainage or vascular supply
* BCC/SCC within 3 cm of another treated or untreated BCC/SCC
* Inflammatory process in target area
* Collagen vascular disease (lupus, scleroderma, rheumatoid arthritis)
* Diabetes that is poorly controlled
* Genetic disorder predisposing patient to skin cancers or radiation sensitivity (basal cell nevus syndrome, xeroderma pigmentosum, ataxia telangiectasia mutans)
* Receipt of treatment with another investigational device or drug
* Receipt of drug that will affect biologic response to radiation (radiosensitizer or radioprotector)
* High likelihood of protocol non-compliance (in opinion of investigator)
Acceptance and Commitment Therapy Delivered by Automated Software Messaging

This study aims to 1) observe the course of pain, 2) mental status, and 3) possible effect of a behavioral intervention delivered via an automated mobile phone messaging robot in patients were indicated and/or scheduled to undergo joint replacement but have been cancelled or delayed due to the COVID-19 crisis.

Adult patients presenting to a University Hospital and found to have hip and knee osteoarthritis that had failed conservative management were subsequently indicated for primary hip or knee replacement (arthroplasty). Patients who subsequently had their surgery delayed or cancelled due to the COVID-19 pandemic were eligible for this study. Eligible patients consenting to the study will be assigned a unique study identification number (ID). A master database linking patient ID to patient name and medical record number will be housed on a password protected and encrypted departmental server location, which only research personnel can access.

Participants will complete a basic demographics survey and preoperative/ baseline patient reported outcome surveys at enrollment, including the Patient-reported outcomes measurement information system (PROMIS) Pain Intensity 1A short form, PROMIS Pain Intensity 3A short form, PROMIS Pain Interference 8A short form, and PROMIS 8A Emotional Distress-Anxiety 8A short forms. Following completion of these surveys, subjects will be randomized in a 1:1 ratio using a random number generator into one of two study groups. The intervention group will receive mobile messages communicating the behavior intervention. The control group will not receive the intervention. Subjects will not be blinded to their study group. Participants randomized to the intervention group were subsequently enrolled into the automated mobile messaging protocol and received a confirmation message welcoming them to the study, which was reviewed with them by the research assistant. Subjects were instructed that they were only required to read all messages, no responses were required.

A single instance of follow-up will take place on Day 14 of the study. This will occur over the phone with a research team member. Subjects will fill out a second set of the patient reported outcome surveys completed at enrollment. Collection of these followup items marks the end of the subject's participation in the study. No data collection is planned following the two week study period. The study hypothesis is that subjects receiving the behavior intervention delivered via an automated mobile messaging robot would demonstrate better patient reported outcome survey scores than controls at follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Any patient who had been indicated for primary joint replacement but subsequently experienced a delay or cancellation in their surgical date due to the COVID-19 pandemic.

Exclusion Criteria:

* Patients undergoing revision joint replacement
* Patients who do not own a mobile phone or do not utilize text messaging as a form of communication
The Effect of Helicobacter Pylori Eradication on Liver Fat Content in Non-alcoholic Fatty Liver Disease

The role of Helicobacter pylori(HP)in the pathogenesis of non-alcoholic fatty liver disease (NAFLD) is controversial.

This randomized double blind clinical trial was performed in dyspeptic patients with positive antibody to HP and the evidence of fatty liver in ultrasonography. After excluding other causes, participants with persistent elevated serum aminotransferase levels were presumed to have NAFLD. Those with NAFLD liver fat score greater than (-0.64) and positive urea breath test (UBT) were enrolled. They were randomly assigned to lifestyle modification alone or lifestyle modification plus HP eradication groups. Quadruple therapy (omeprazole, amoxicillin, bismuth subcitrate, and clarithromycin) for HP eradication was performed in two weeks. HP eradication was documented by UBT. Liver fat content, fasting serum glucose, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, triglyceride, cholesterol, high and low-density lipoprotein,homeostasis model assessment-insulin resistance(HOMA-IR), and anthropometric measurements (body mass index and waist circumference) were checked at baseline and six months later.

Eligibility Criteria:
Inclusion Criteria:

* dyspeptic patients with positive antibody to H.pylori and
* persistent elevated aminotransferase levels with the evidence of fatty liver in ultrasonography, who were referred to a gastroenterology clinic.

Exclusion Criteria:

* alcohol use (more than 20 gram per day in men and 10 gram per day in women per day),
* heart disease (ischemic or congestive),
* hepatic disease (viral hepatitis, autoimmune hepatitis, wilson disease, hemochromatosis, liver mass lesion),
* renal disease (serum creatinine concentration of \> 1.5 mg/dl),
* any severe systemic co-morbidities, neoplasm,
* using any hepatotoxic medication during the past 3 months,
* previous history of peptic ulcer,
* previous history of H.pylori eradication,
* existence of alarm signs (weight loss, dysphagia, anemia, vomiting, positive family history of gastrointestinal cancers), and
* pregnant or lactating women.
A Study of the Efficacy and Safety of Vibegron (MK-4618) in Participants With Overactive Bladder (OAB) (MK-4618-008)

This is a 2-part study to assess if vibegron (MK-4618) reduces the number of daily urinations more effectively than placebo in participants with overactive bladder (OAB). The primary hypothesis of the base study is that administration of vibegron demonstrates a dose-related reduction, compared with placebo, in average number of daily micturitions in participants with OAB after 8 weeks of treatment.

All participants received placebo (run-in) for 1 week prior to randomization to Parts 1 and 2. Participants who complete the base study may be screened for a year-long, multicenter extension for assessment of long-term safety and efficacy.

Eligibility Criteria:
Inclusion Criteria:

* If participant is of reproductive potential, must agree to remain abstinent or use (or have his/her partner use) 2 acceptable methods of birth control within the projected duration of the study
* Clinical history of OAB for at least 3 months and meets either the OAB wet or OAB dry criteria
* Is able to read, understand and complete questionnaires and voiding diaries without assistance
* Is ambulatory and in good general physical and mental health
* No clinically significant electrocardiogram or laboratory abnormality

Exclusion Criteria:

* If female, is currently pregnant or breast-feeding, or expecting to conceive within the projected duration of the study
* Evidence of diabetes insipidus, uncontrolled hyperglycemia or uncontrolled hypercalcemia
* Allergy, intolerance, or history of a significant clinical or laboratory adverse experience associated with any of the active or inactive components of tolterodine ER or vibegron (MK-4618) formulation; or has a history or active diagnosis of any condition contraindicated in the tolterodine ER prescribing label
* Has lower urinary tract pathology that could be responsible for urgency, frequency, or incontinence
* History of injury, surgery, or neurodegenerative diseases (e.g., multiple sclerosis) that could affect the lower urinary tract or its nerve supply
* History of continual urine leakage
* Surgery to correct stress urinary incontinence or pelvic organ prolapse within 6 months
* Known history of elevated postvoid residual
* Bladder training or electrostimulation within 2 weeks or is planning to initiate either procedure during the study
* Active or recurrent (\>6 episodes per year) urinary tract infections
* Current hematuria
* Required use of an indwelling catheter or requires intermittent catheterization
* History of fecal incontinence
Dispensing Evaluation of a Galyfilcon A Prototype Lens and a Marketed Contact Lens

The purpose of this study is to compare visual acuity and redness of eyes between a prototype contact lens and an already marketed contact lens.


Eligibility Criteria:
Inclusion Criteria:

* The subject is a current spherical soft contact lens wearer and willing to wear the study lenses on a daily wear basis for the duration of the study.
* The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and - 5.00D.
* Any cylinder power must be ≤ -0.75D.
* The subject must have visual acuity best correctable to 20/25+3 or better for each eye.
* The subject must read and sign the Statement of Informed Consent.
* The subject must appear able and willing to adhere to the instructions set forth in the clinical protocol.

Exclusion Criteria:

* Ocular or systemic allergies or disease which might interfere with contact lens wear.
* Systemic disease or use of medication which might interfere with contact lens wear.
* Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
* Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
* Any ocular infection.
* Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
* Pregnancy or lactation.
* Diabetes.
* Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).
* Habitual contact lens type is toric, multifocal, or is worn as extended wear.
rTMS for the Prevention Treatment of CM: a Single Arm Study

We design this pilot, single arm study to explore the safety and efficacy of repetitive transcranial magnetic stimulation (rTMS) for the treatment of chronic migraine. The hypothetical control group is pooled sham group in latest meta-analysis. We expect a significant improvement of the outcome measures during and after the treatment as compared to the hypothetical control group.

After a 28-day prospective baseline period using a headache diary to record headache symptoms and any abortive medications used, subjects who meet diagnostic criteria for chronic migraine and don't meet the exclusion criteria will receive rTMS for 4 weeks. The outcome measure will be evaluated at 4 weeks. During the whole trial period, any adverse events are requested to be recorded in the headache diary for analyses. The primary outcome is 50% reduction in the number of days with headache. 50% reduction as assessed by migraine days, moderate/severe headache days, the mean VRS, and conversion to episodic migraine, SGIC, the change from baseline HALT-28, HIT-6, and MSQ v2.1, are used as secondary outcome measures for exploring other benefits associated with treatment.

Eligibility Criteria:
Inclusion Criteria:

* Subjects meeting the diagnostic criteria for chronic migraine according to the International Classification of Headache Disorders, 3rd edition.
* The duration of chronic migraine ≥ 6 months.
* age range of 18 - 65 years old

Exclusion Criteria:

* Secondary headaches except MOH
* any change of the prophylaxis or the analgesic drug strategy during the baseline and follow-up period
* structural brain lesions
* seizures
* severe systemic disease
* TMS contraindications (such as metal implants)
* psychosis
* severe depression or anxiety
* drug or alcohol dependence
* pregnancy
* participating in other experiments at the same time
Training and Evaluation of Ultrasound-Guided Procedures

38 certified registered nurse anesthetist (CRNA) students will learn 5 different ultrasound-guided regional anesthesia blocks both with and without a novel device, the EDU which gives the student help finding the right needle path.

38 students enrolled in a course for ultrasound-guided nerve blocks will be participants in a study to evaluate the benefit of learning with ultrasound guidance. The EDU, a computer assisted guide for ultrasound interventions will be used for half the students for each of 5 nerve blocks/interventional procedures. Then the students will switch (crossover study) and perform the same interventions. Data will be recorded by dint of the tiny video cameras on the EDU and anonymized and evaluated.

Eligibility Criteria:
Inclusion Criteria: All CRNA students in Dr. Hauglum's class on ultrasound-guided nerve blocks -

Exclusion Criteria: Any CRNA students who drop Dr. Hauglum's class on ultrasound-guided nerve blocks

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