cyrilzakka/clinical-trials huggingface dataset:
GPS: Adaptation Trial of an HIV Prevention Counselling Program for HIV-positive and HIV-negative Gay and Bisexual Men

GPS is a sexual health promotion and HIV prevention peer-delivered counselling program. The GPS program has 4 parts: information provision about HIV and sexually transmitted infections, motivational interviewing counselling, sexual health behavioural skills building, and linkage to care. The adaptation grant has three goals: 1) to establish a multi-region and multi-sectoral team that can deliver the revised program across a variety of settings, 2) to learn how best to deliver this program as individual counselling program and also how to adapt this program for HIV-negative MSM, and 3) to pilot the individual program in 5 settings across Ontario and British Columbia. The research team will evaluate the pilot adaptation through mixed methods, employing a quantitative questionnaire and one-on-one semi-structured interviews.


Eligibility Criteria:
Inclusion Criteria:

* aged 18 years or older
* self-identify as a man
* self-identify as gay, bisexual, queer, same-gender-loving, or a man who has sex with men
* report having engaged in condomless anal sex in the last 3 months
* able to speak, read, and aurally comprehend English
* depending on the study site, report HIV-negative or HIV-positive status
577nm Micropulse Laser vs Half-dose Photodynamic Therapy on Acute Central Serous Chorioretinopathy

The purpose of this study is to determine whether micropulse laser (MPL) is different to half-dose photodynamic therapy on acute central serous chorioretinopathy.

Central serous chorioretinopathy(CSC) is characterized by serous detachment of neurosensory retina which can cause lose in visual acuity.Some studies have shown that Half-dose photodynamic therapy(PDT) is effective on CSC,although accompanied with side-effects,such as choroidal ischemia, retinal pigmental epithelium(RPE) atrophy,and RPE rip,and with exorbitant price.Recent retrospective studies suggest micropulse laser (MPL) therapy may also be effective without obvious complications in this disease. But to date, there is no study on effectiveness of CSC between PDT and MPL.

The study is the first prospective randomized controlled trial about 577nm micropulse laser versus half-dose photodynamic therapy on acute central serous chorioretinopathy.The null hypothesis of the study is that there is difference between MPL and half-dose photodynamic therapy on acute central serous chorioretinopathy at first month after treatment.The primary outcome measures is the proportion of eyes with complete absorption of subretinal fluid at 1 month after treatment.

Eligibility Criteria:
Inclusion Criteria:

1. onset for the first time, as an episode duration of less than 6 months
2. patient was between 18 and 55 years of age
3. the presence of subretinal fluid(SRF) involving the macula and detected by use of optical coherence tomography (OCT)
4. active fluorescein leakage during fluorescein angiography (FA)
5. best corrected visual acuity (BCVA) more than 0.1, and less than 1.0

Exclusion Criteria:

1. previous PDT, focal photocoagulation, intravitreal injections of anti-vascular endothelial growth factor, or ocular surgery
2. other macular abnormalities such as choroidal neovascularization(CNV) or polypoidal choroidal vasculopathy(PCV)
3. retinal atrophy
4. pregnancy
5. inability to obtain photographs or to perform FA
6. use of steroid systemically or topically in the last 6 months
Laser-excimer Versus High-pressure Dilation to Treat Under-expansion of the Stent

The laser-excimer technology could be an essential tool to correct the under-expansion of the stent once it has been implanted unless severe calcification. The laser-excimer technology achieves a greater minimum luminal area when treating an infra-expanded stent, when compared with the results obtained with the simple dilatation at high or very high pressure.

The laser-excimer technology could be an essential tool to correct the under-expansion of the stent once it has been implanted unless severe calcification.

The investigators propose a study that serves as proof of concept for this technology (laser Excimer) used according to its intended use in this specific substrate of coronary lesions. (stent under-expansion without severe underlying calcification).The laser-excimer technology achieves a greater minimum luminal area when treating an infra-expanded stent, when compared with the results obtained with the simple dilatation at high or very high pressure.

Eligibility Criteria:
Inclusion Criteria:

Patients with:

* Age ≥ 18 years.
* Consecutive real-world patients, referred for cardiac catheterization for any cause, who present in any main vessel, bypass or in the common trunk an under-expanded stent tributary of being treated (minimum luminal area \<4 mm2 or \<6 mm2 in the left main coronary artery measured by IVUs (Intravascular Ultrasound) / OCT(Optical Coherence Tomography)) and that it is not possible to dilate with a NC balloon to a maximum of 20 atm.

Exclusion Criteria:

* Refusal of the patient to participate in the study.
* Patients with life expectancy \<1 year.
* Patients with advanced kidney disease (grade IV) or liver failure (Child C)
Exercise in Patients With End Stage Kidney Disease

This study will be conducted over a 3 year time period. This is a trial of an exercise intervention vs. standard of care in patients receiving chronic dialysis. The specific aims will be to determine feasibility of patient recruitment, adherence to the exercise program, and efficacy of the intervention on patient important outcomes.

The exercise intervention will be delivered to randomized participants for 12 months, and consist of the prescribed use of Nordic Walking poles, online resources for exercise in the home, regular use of a pedometer to monitor progress, and regular verbal encouragement to exercise (monthly) by dialysis unit staff. Both groups will receive the same standard of care co-interventions including individualized dialysis prescriptions and health-care interactions according to practices at their centre.


Eligibility Criteria:
Inclusion Criteria:

1. All ambulatory adult patients with end stage kidney disease
2. Treatment with peritoneal dialysis or hemodialysis for greater than six months
3. Able to understand English or French
4. Abuse to use Nordic Walking poles
5. Able and willing to provide informed consent

Exclusion Criteria:

1. Any absolute contraindication to exercise \[unstable angina, uncontrolled hypertension (systolic or diastolic blood pressure greater than 180 mmHg (millimeters of mercury) or greater than 110 mmHg, respectively), deemed not suitable for exercise by the treating physician\]
2. Baseline step count greater than 8000 steps a day
3. Planned living donor kidney transplant
4. Potential for recovery of renal function
5. Patients who feel unsafe using Nordic walking poles in place of their mobility aid
6. Participation in another interventional trial that may affect the results of this study
Buprenorphine Naltrexone-P1 A-Cocaine

The purpose of this study is to determine if the opioid agonist effects of doses of 4/1 mg, 8/2 mg, and 16/4 mg of buprenorphine/naloxone can be completely blocked by 50 mg of oral naltrexone. This study will provide data to support the design of a similar study of the depot formulation of naltrexone and ultimately to study this combination for the treatment of cocaine dependence.


Eligibility Criteria:
Inclusion Criteria:

* Provide written informed consent
* Be male/female between the ages of 18-55
* Be in good physical and mental health as determined by interview and physical exam
* Have a body mass index between 18 and 30, inclusive
* Have no oral cavity pathology that would interfere with sublingual absorption of buprenorphine/naloxone or placebo
* Have negative qualitative urine toxicology screen for opioids, cocaine, benzodiazepines, and barbiturates prior to administration of the first dose of naltrexone
* Be able to comply with protocol requirements
* If female, have a negative pregnancy test and agree to use an acceptable method of birth control from date of consent and until two weeks after the last administration of study drug or placebo

Exclusion Criteria:

* please contact site for more information
Intestinal Microbiome After Gastrectomy

The gastric barrier plays a major role in the maintanance of the distal intestinal microbiome composition. It has been shown before that the use of gastric acid suppression medication, such as proton pump inhibitors, are associated with distinctive alterations of the intestinal microbiome. Foremost, the invasion of predominantly oral bacteria, like Veillonella and Streptococcus species, were a resurring finding in previous reports.

Gastric cancer treatment includes the total or subtotal resection of the stomach which can influence the gastric acid production. However, the influence by alterations in gastric milieu after this treatment on the composition of the intestinal microbiome is not well studied.

Therefore, the intestinal microbiome of patients after total or subtotal gastrectomy and its influence on intestinal inflammation and gut permeability will be studied.


Eligibility Criteria:
Inclusion Criteria:

* age 18 years and above
* history of radical removal of gastric cancer (Test group and Control group 1) or PPI (Control group 3)
* informed consent

Exclusion Criteria:

* chemotherapy or radiotherapy 12 months prior to inclusion
* gastric stump cancer
* usage of antibiotics, pro- pre or synbiotics, H2-blocker 1 month prior to inclusion
* PPI use (except for Control group 3) 1 month prior to inclusion
* history of radical removal of gastric cancer (Control group 2-3)
* history of gastrointestinal tract resections (other than gastric)
* recurrence of gastric cancer
* current non-gastric malignancies
Effects of Topical Sesame Oil in the Prevention of Peripheral Venous Catheter Phlebitis: Clinical Trial.

Cancer is a disease that, despite having a higher cure rate, is currently on the rise, with an increase in the number of diagnoses.

For the treatment of these patients a venous access is required, which in the first treatments is of peripheral insertion. These peripheral venous catheter in combination with the highly aggressive treatments for the veins are the cause of the appearance of chemical phlebitis.

Phlebitis is an inflammation caused by a combination of factors, whether chemical, perfusion of irritating medication; mechanical, due to the puncture site, type and fixation of the catheter and infectious, caused by the colonization of pathogenic agents whose origin is the skin and that migrate inward.

Phlebitis involves an injury to the wall of the vein, and consequently, the patient will also be at risk of thrombus formation, which in turn leads to thrombophlebitis, deep vein thrombosis or pulmonary embolism.

The existence of phlebitis involves intense and constant pain, with increased sensitivity and a sensation of heat and swelling.

With the use of topical sesame oil, and thanks to its anti-inflammatory properties, the investigators intend to study whether it is effective in preventing the appearance of phlebitis.


Eligibility Criteria:
Inclusion Criteria:

* Be over 18 years of age.
* To be conscious and have a cognitive state that allows him/her to give consent to participate in the study.
* Be diagnosed with a neoplasm that requires chemotherapy treatment.
* To be a carrier of a CVP in the upper extremity as vascular access for chemotherapy administration.

Exclusion Criteria:

* Being allergic to sesame oil.
* Be allergic to nuts.
* Not being able to speak, read and write in Spanish.
* Last days or palliative situation.
Preliminary Study of Early, Primary HIV Infection in a High Risk Cohort

The study of early, acute HIV infection is critical to understanding subtype-specific pathophysiologic differences, since up to 50% of acute HIV infections may be incapacitating. This study will establish whether the patient population of the Thai Red Cross Anonymous Clinic is suitable for the study of early, acute infection.

This study will utilize existing (collected after 1 January 2006) and prospectively collected HIV seronegative clinical specimens not used as part of any research protocol. The specimens in this study are discarded anonymous samples from the Voluntary Counseling and Testing (VCT) facilities at the Thai Red Cross Anonymous Clinic in Bangkok, Thailand. The specimens cannot be linked to the tested subjects. The samples will be labeled using the anonymous clinic identification number which is a 7 digit number with the first 2 digits representing the year and the following 5 digits representing the sequence of which the client sought care in that calendar year. Preliminary Study of Early, Primary HIV Infection in a High Risk Cohort.

Eligibility Criteria:
Inclusion Criteria:

* All clients who access services included in the "Health Check Up Packages by Age Groups" at the Thai Red Cross AIDS Research Centre.

Exclusion Criteria:

* None
Impact of Tear Substitute Use on Dry Eye in Gamers.

Clinical, prospective, comparative, controlled, single-blind study, on the signs and symptoms of dry eye before and after 3 days of playing video games with the use of artificial tears (Hyabak) versus no intervention.

Adult attendees to a Gamers convention will complete questionnairs and undergo an opthalmological evaluation before and after playing for 3 days in a row. Participants will be randomized into 2 groups of equal size:

1. Study group.
2. Control group. The Study group will instill hyaluronic acid 0.15% artificial tears in both eyes 4 times a day during the 3 days of the video game session, while the control group will not instill artificial tears.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Participants in videogame convention planning to play video games for a minimum of 6 hours daily for the next 3 days.
* Voluntarily accept to participate and sign informed consent form

Exclusion Criteria:

* Ocular, nasolagrimal or palpebral active condition different from dry eye disease.
* History of ocular trauma or infecction in the last 3 months previous to inclusion.
* History of refractive surgery.
* Visual acuity 0.5 or less in at least 1 eye.
* Ocular medication use in the 3 days prior to inclusion.
* History of systemic condition asociated to dry eye.
* Use of systemic medication known to induce dry eye in the last 30 days.
* Known allergy to hyaluronic acid.
* Pregnant or lactating women.
Impact of an Increased Restrictive Factor of One Anastomosis Gastric Bypass on Metabolic Outcomes Type 2 Diabetes.

The purpose of the study is to evaluate the effect of an increased restrictive factor of one gastric anastomosis (OAGB) using a "FundoRing" fundoplication on metabolic outcomes in type 2 diabetes mellitus. The randomized controlled trial compared two interventional procedures: one group - using the original fundoplication procedure to enhance the restrictive effect and another group without fundoplication in the standard version of the OAGB.

The randomized controlled trial compared two interventional procedures: one group - using the original fundoplication procedure to enhance the restrictive effect and another group without fundoplication in the standard version of the OAGB.

The purpose of the study is to evaluate the effect of an increased restrictive factor of one gastric anastomosis (OAGB) using a "FundoRing" fundoplication on metabolic outcomes in type 2 diabetes mellitus.

The main hypothesis is that an increase in the restrictive effect will lead to an increase in the metabolic effect and an increase in its persistence over time.

Eligibility Criteria:
Inclusion Criteria:

* BMI 25-55 kg/m2
* Patients with Diabetes Mellitus, Type 2

Exclusion Criteria:

* BMI \<25 and \>55 kg/m2
* Patients without Diabetes Mellitus, Type 2
* History of surgery on the stomach
* Less than 18 or more than 60 years of age
* Psychiatric illness
* Patients unwilling or unable to provide informed consent
A Post Market Study on DRG Stimulation in FBSS (SYMPATHY)

The purpose of this Post Market Observational Study is to monitor the effect of the Axium® SCS System in the management of chronic pain following surgical lumbar discectomy in subjects whom are routinely scheduled for treatment with the Axium® SCS System.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is at least 18 years old
2. Subject is able and willing to comply with the follow-up schedule and protocol
3. Chronic pain following surgical lumbar discectomy for at least 6 months
4. Failed conservative treatments for chronic pain including but not limited to pharmacological therapy, physical therapy and interventional pain procedures for chronic pain
5. Minimum baseline pain rating of 60 mm on the VAS in the subjects' primary area of pain
6. Subject is able to provide written informed consent

Exclusion Criteria:

1. Female subject of childbearing potential is pregnant/nursing or plans to become pregnant during the course of the study
2. Escalating or changing pain condition within the past month as evidenced by investigator examination
3. Subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days
4. Subject has had radiofrequency treatment of an intended target DRG within the past 3 months
5. Subject currently has an active implantable device including ICD, pacemaker, spinal cord stimulator or intrathecal drug pump
6. Subject is unable to operate the device
7. Subjects with indwelling devices that may pose an increased risk of infection
8. Subjects currently has an active infection
9. Subject has participated in another clinical investigation within 30 days
10. Subject has a coagulation disorder or uses anticoagulants that, in the opinion of the investigator, precludes participation
11. Subject has been diagnosed with cancer in the past 2 years.
12. Subject has an anatomical spinal abnormality which is anticipated to require further surgery
Multi-modality Imaging of Ischemia With 18F-FDG PET and CTA

Coronary artery disease results in narrowing of the blood vessels supplying oxygenated blood to the heart muscle. Diagnosis in patients with symptoms of chest pain is now quickly done with CT coronary angiography. This x-ray test can show narrowed blood vessels but has limited ability to predict the severity of the narrowings in some cases. We have described a new approach using PET exercise 18F-FDG imaging as a method to image areas of heart muscle not getting enough blood during exercise stress. The 18F-FDG images are co-registered with the CT anatomy from the CTA to provide direct evidence of the consequences of the narrowing.

The Investigators and others have demonstrated direct imaging of myocardial ischemia using 18F-Fluorodeoxyglucose (18FDG) with exercise or dipyridamole stress and positron emission tomography (PET) or single photon emission computed tomography (SPECT). This approach with "hot-spot" imaging may have greater diagnostic accuracy for ischemia than conventional "cold-spot" myocardial perfusion imaging.

Recent advances in multi-modality imaging permit fusion of CTA images with PET or SPECT perfusion images and functional assessment of anatomical CAD. Registration of the 2 data sets can be optimized using the CT acquired with the PET or SPECT15. 18FDG uptake as a marker for ischemia can be directly related to the coronary anatomy and guide revascularization.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with suspected CAD referred for CTA and found to have moderate CAD stenoses and 20 normal volunteers with less than 5% probability of CAD.
2. Age ≥ 18 years

Exclusion Criteria:

1. Inability to undergo stress protocol due to co-morbidities
2. Pregnancy
Using Visual Arrays to Support Understanding of Genetic Risk

The goal of this study is to understand how people understand risk from genetic testing. The investigators want to understand what visual aid best helps people accurately assess risk. The investigators also want to understand how people relate risk to their health. The main questions the study aims to answer are:

1. Which visual aid most accurately show genetic risk?
2. How do people perceive risk related to genetic test results?
3. What factors are associated with people discussing their results with family?

Participants will:

1. receive of of two visual aids showing risk
2. state their estimation of risk
3. answer questions about how they feel about risk and sharing information with family

This study aims to determine how visual aids help people most accurately interpret risk from genetic test results. The study also examines how people perceive risk by drawing on the Tripartite Risk Model. Last, the study examines factors that are associated with intention to share genetic test results with family members.

Participants will provide brief sociodemographic information, complete brief health literacy and numeracy assessments, and questions about how they perceive risk. Participants will be informed of a genetic testing scenario and will receive one of two visual aids. After reviewing the visual aid, participants will state the risk shown in the visual aid and will answer questions about their perceived risk and sharing results with family members (blood relatives).

Eligibility Criteria:
Inclusion Criteria:

* ability to read and understand English
* opt-in consent

Exclusion Criteria:

* incorrect responses to validation questions
Teens Taking Charge: Managing Cancer Online

Cancer is the most common potentially fatal disease of adolescence and the Internet represents an ideal means to deliver education, self-monitoring capabilities, and social support to enhance disease self-management by adolescents with cancer. While two interactive coping websites exist for young people with cancer, they are: (1) not interactive, (2) do not focus on helping youth gain skills for transition and independence, and (3) do not provide opportunities for meaningful social support. In summary, there is a crucial need to develop a comprehensive interactive Internet-based self-management program targeting AWC that is comprised of cancer education, self-management skills, and opportunities for social support, and that is cost-effective.

Overall aim of this program of research is to develop and evaluate the "Teens Taking Charge: Managing Cancer Online" Internet intervention that will help AWC to better cope with their disease, improve their HRQL, and enhance readiness to transition to adult health care using a sequential phased approach. The first phase of this project has determined the self-management and transitional care needs of adolescents with cancer. The second phase consisted of website development and usability testing to ensure the website is easy to use and understand, and is efficient and satisfying to complete. Subsequently, we will assess the feasibility of the program and the outcomes from the use of the site in a randomized controlled trial (RCT) pilot study (Phase 3). This will inform the design and methods of the main trial, and will permit us to obtain estimates of treatment effects on AWC health outcomes to inform the calculation of an appropriate sample size for the future definitive RCT (Phase 4). The focus of this study is Phase 3. Phase 4 will be a multicentre randomized controlled trial to assess outcomes for teens that complete the intervention as compared to those of an attention control group.

Eligibility Criteria:
Inclusion Criteria:

* Parents and adolescents will be eligible to participate if the adolescents are:

  1. between 12-18 years of age
  2. diagnosed with cancer (at least 3 months from diagnosis)
  3. on active treatment
  4. able to speak and read English and/or French at a Grade 6 level

Exclusion Criteria:

* Adolescents will be excluded if they:

  1. have major cognitive impairments
  2. have reduced executive function that may impact their ability to understand and use the online program
  3. are terminal/palliative as determined by their oncologist Parents/caregivers are not eligible to participate in the study alone (without an adolescent)