cyrilzakka/clinical-trials huggingface dataset:
Examining the Incidence of Oral Human Papillomavirus (HPV) Shedding and Oral Warts After Beginning HAART in HIV-Infected Adults

Oral human papillomavirus (HPV) and oral warts are common health concerns for HIV-infected people. This study will examine the frequency of oral HPV DNA shedding and oral warts in HIV-infected people who are enrolled in ACTG A5257 and who are beginning treatment with highly active antiretroviral therapy (HAART).

Oral HPV infection occurs at a higher rate among HIV-infected people than among the general population. Recent research in the United States and Europe has also found that HIV-infected people have a higher risk of oral and oropharyngeal squamous cell cancer than HIV-uninfected people. In one study, it was found that HPV seropositivity was associated with an increased risk of squamous cell carcinoma of the oropharynx (SCCOP). In addition to SCCOP, another HPV-related health concern is oral warts, a condition for which there is no effective treatment. Even after beginning treatment with highly active antiretroviral therapy (HAART), active HPV replication in the mouth and oropharynx may persist in HIV-infected people, leading to an increased risk of SCCOP and oral warts. The purpose of this study is to evaluate the frequency of oral HPV DNA shedding and oral warts in HIV-infected people prior to HAART initiation and at regular time points after HAART initiation.

ACTG A5257 is a study that is comparing the effectiveness of three non-nucleoside reverse transcriptase inhibitor (NNRTI)-sparing HAART regimens in treatment-naïve participants. This study will enroll participants from the ACTG A5257 study. Participants will attend a baseline study visit at the same time as their ACTG A5257 baseline study visit. At baseline and at Week 4, 16, 24, and 48 study visits, participants will undergo an examination of their mouth, throat wash and saliva collection, and behavioral questionnaires. A blood collection will also occur at Week 24.

Eligibility Criteria:
Inclusion Criteria:

* Meet inclusion criteria for and be enrolled in ACTG A5257
* Ability and willingness of participant or legal guardian/representative to provide informed consent

Exclusion Criteria:

* Co-enrollment in A5260s
* Has begun receiving HAART as part of the A5257 study
* Has ever received an HPV vaccine or plans to receive an HPV vaccine in the 6 months after study entry
Comparison of the Fixed Combinations of Brimonidine/Timolol and Dorzolamide/Timolol in Subjects With Open-Angle Glaucoma or Ocular Hypertension

This study compares the efficacy and tolerability/comfort of brimonidine/timolol and dorzolamide/timolol in patients with open-angle glaucoma or ocular hypertension. In an investigator masked randomisation process, each subject is allocated to received either brimonidine/timolol or dorzolamide/timolol as fixed-combination monotherapy or as an adjunctive to a prostaglandin analogue for a period of 12 weeks. After screening, patient returns at baseline, Month 1 and Month 3 for ophthalmic evaluations.


Eligibility Criteria:
Inclusion Criteria:

* Male or female over 18 years
* Female subjects of childbearing potential must have negative pregnancy test and practice contraception
* Subjects must have confirmed diagnosis of primary open-angle glaucoma or ocular hypertension in both eyes
* Subjects who are or have been insufficiently responsive to IOP reducing monotherapy and use of either study medication is deemed appropriate
* Subjects able to complete questionnaires and provide informed consent

Exclusion Criteria:

* Female subjects who are pregnant, planning to become pregnant during study period, breast feeding or not practicing a reliable method of birth control
* Subjects wherein the study drugs are contraindicated
* Subjects who have had intraocular surgery with 6 months (3 months for laser)
* Subjects with known side effects/allergy or sensitivity to any component of study treatments
* Subjects with any uncontrolled systemic disease
Study of TRM-1(TRAIL-R1 Monoclonal Antibody) in Subjects With Relapsed or Refractory Non-Small Cell Lung Cancer (NSCLC)

The purpose of this study is to evaluate the efficacy and safety of TRM-1 in subjects with relapsed or refractory non-small cell lung cancer.


Eligibility Criteria:
Primary Inclusion Criteria:

* Relapsed or refractory histologically or cytologically confirmed Stage IIIB, IV, or recurrent NSCLC
* Previously treated and failed to respond to standard therapy or progressed after standard therapy
* 18 years of age or older

Primary Exclusion Criteria:

* Received a non-FDA approved investigational agent within the last 4 weeks.
* Previous cancer therapies (chemotherapy, hormonal therapy, monoclonal antibodies or radiation therapy) within the last 3 weeks, 8 weeks for fully human or humanized monoclonal antibodies
* Infection requiring antibiotics or hospitalization within the last 2 weeks
* HIV, Hepatitis-B, Hepatitis-C
* Pregnant or breast-feeding women
* Major surgery within the last 4 weeks
* History of other cancers within the past 5 years
Diagnostic Accuracy of the DPP II Assay

Burkholderia pseudomallei is responsible for melioidosis, a disease that can present a range of signs and symptoms and can be treated by a specific drug regimen. Diagnosis of melioidosis is made by isolation of the bacteria from body fluids or tissues such as blood, skin or sputum. Although this is considered the gold standard, bacterial isolation has low diagnostic sensitivity, requires specific infrastructures (biosafety level 3 laboratories) and skilled staff that are not always available in LMICs. This may lead to inappropriate patient management and care.

Chembio, in partnership with FIND, has developed a multiplex lateral flow immunoassay (DPP® Fever Panel II Assay) that is able to detect antigens from common causes of febrile illnesses, included Burkholderia. FIND will conduct a laboratory study in Menzies Health School of Research to estimate the diagnostic accuracy of the DPP II Assay using retrospective samples that are positive for B. pseudomallei. Results will help in estimating the diagnostic accuracy of the assay for this pathogen.


Eligibility Criteria:
Inclusion Criteria:

- Samples that can be included in the trial must have been collected exclusively during the "Assessment of a New Rapid Diagnostic Test for Melioidosis" study (HREC 04/09) conducted by the Menzies School of Health Research. They must be well-characterized with confirmation of presence or absence of B. pseudomallei by bacterial culture.

Exclusion Criteria:

* Samples with volume \<120 µL
* Samples collected during projects other than the HREC 04/09 project
Expanded Access Study for Renal Transplant Patients With Envarsus XR ™

Open label, multi-center, expanded access study for renal transplant patients with once daily Envarsus XR (Tacrolimus).

The study is designed to facilitate expanded access of Envarsus XR treatment to renal transplant patients. Patients are identified by the site investigator as a patient who has experienced favorable outcomes while in an Envarsus XR (LCP-Tacro) clinical study and/or the site investigator has identified a renal transplant patient with a medical need for an alternative tacrolimus treatment versus the patient's current tacrolimus treatment.

Eligibility Criteria:
Inclusion Criteria:

* Eligible patients will fulfill all of the following criteria:

  1. Patient age ≥18years old
  2. Willing to give written informed consent and is able to speak, write and understand English
  3. Patient understands potential risks or benefits with treatment of Envarsus XR
  4. Patients who have received a primary or secondary kidney transplant
  5. Patient who have received prior treatment with Envarsus XR (LCP-Tacro) and who are not currently participating in an Envarsus/LCP-Tacro study OR
  6. The treating Investigator has identified the patient as having a medical necessity for switching from their current tacrolimus treatment to Envarsus XR: Investigator is aware the medical necessity for switching is not related to the inability to purchase available tacrolimus.

Exclusion Criteria:

* Patients fulfilling any of the following criteria are NOT eligible for study inclusion:

  1. Recipients of organ transplants other than kidney
  2. Pregnant or nursing (lactating) women, or planning to become pregnant, where pregnancy is defined as a state of female after conception and until the termination of gestation, confirmed by a positive hCG serum or urine laboratory test.
  3. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant who are unwilling to use a defined SOC method of contraception, UNLESS they are
* Women whose career, lifestyle, or sexual orientation preclude intercourse with a male partner
* Women whose partners have been sterilized by vasectomy or other medically approved means
Contrast Enhancement on Coronary Computed Tomographic Angiography

Computed tomographic angiography (CTA) is an important prognostic tool with regard to the detection of coronary artery stenoses. Both iodine delivery rate (IDR; the amount of iodine delivered to the patient per second) and iodine concentration are decisive factors in the opacification of arterial vessels.

There remains to be some debate in the literature about whether the use of high iodine concentration contrast media is beneficial compared to lower iodine concentrations.

To date, there have not been any studies comparing intracoronary attenuation using concentrated contrast media lower than 300 mg I/ml at coronary CTA. For a reliable comparison of CM with different iodine concentrations, adapted injection protocols insuring an identical IDR (in g iodine per second) are mandatory. The investigators hypothesize that usage of lower iodine concentrations, while maintaining identical IDR and total iodine load, will result in comparable diagnostical intra-vascular attenuation in CTA.

To evaluate intravascular contrast enhancement and image quality in coronary CTA using different iodine concentrations ranging from 240 to 370 mg iodine per ml, administered with an identical IDR and total iodine load.

To describe the effect of iodine concentration and flow rates on contrast bolus characteristics, eg time to peak, bolus homogeneity, injection pressure and patient comfort.

Eligibility Criteria:
Inclusion Criteria:

* Atypical or typical chest pain

Exclusion Criteria:

* Unstable angina
* Hemodynamic instability
* History of CAD
* Pregnancy
* Renal insufficiency (defined as glomerular filtration rate (GFR) \<45ml/min or \<60ml +diabetes
* HR \> 90 bpm and the inability to receive beta-blockers and iodine allergy
Dairy Lipids and Cardiometabolic Risk

It is a randomized parallel arm intervention study in adults with severe obesity. The objective is to demonstrate that within a dietary handling for weight loss, the daily ingestion during 3 months of whole dairy products enriched with milk polar lipids or whole dairy products decreases to a greater extent fasting plasma apolipoprotein B concentrations than the daily ingestion of low-fat dairy products (control group).

Metabolic parameters will be assessed before and after the 3-month intervention, both at fasting and in postprandial period after the consumption of standardized meals.


Eligibility Criteria:
Inclusion Criteria:

* Men and women between 18-70 years
* Body Mass Index (BMI) between 35 and 60 kg/m2 inclusive
* Stable body weight (weight change +/- 5 % for 3 months prior to screening)
* Consumption of at least 1 serving/day of dairy products made from cow's milk
* Informed consent

Exclusion Criteria:

* History of bariatric or digestive surgery or disease interfering with main outcomes
* Drinking more than 3 glasses of alcohol per day (\>30g/day)
* Pregnancy, parturiency or breastfeeding
* Food allergies or intolerance to dairy products
* Dietary restriction (vegetarian or lactovegetarian) or high protein diet
* Use of dietary supplements
* Treated with lipid lowering drugs (fibrates, statins, anti-PCSK9, ezetimibe, cholestyramine) within the last 6 weeks before study entry
* Treated with insulin, GLP-1 analogs, acarbose, corticoids, beta-blockers.
* Medications interfering with intestinal microbiota (beta-lactamines within 3 months before the study or laxatives)
* Smoking ≥ 5 cigarettes/day during the past 6 months.
Study Evaluating MAC-321 in Non-small Cell Lung Cancer Refractory to Platinum-based Therapy

This non-randomized, open-label clinical trial is designed to determine safety and clinical activity of a new chemotherapeutic agent, MAC-321, when given intravenously to patients with non-small cell lung cancer. Clinical activity will be evaluated by determining the percentage of patients with an objective tumor response after treatment with MAC-321. Patients must have been previously treated with a platinum-containing chemotherapy regimen.

A total of 96 patients will be enrolled in this trial. Eligible patients will receive MAC-321 intravenously every 3 weeks for up to a total of 6 courses of treatment. All patients will receive MAC-321 at the same dose. MAC-321 is an experimental drug, and is not offered outside of this research trial.


Eligibility Criteria:
Inclusion Criteria:

* Recurrence of non-small cell lung cancer after at least 1 prior chemotherapy regimen containing a platinum agent
* Recovery from all acute side effects of prior therapies (with the exception of hair loss)
* Adequate bone marrow, liver, and kidney function

Exclusion Criteria:

* More than 2 prior chemotherapy regimens for treatment of advanced or metastatic non-small cell lung cancer. (Treatment given in conjunction with surgery will not be included in the maximum of 2 prior regimens)
* Radiation therapy, chemotherapy or any other anticancer therapy within 28 days of beginning study
* Symptomatic brain metastases
Using SPOZ Technology to Support and Enhance the Vitality Acupunch (VA) Exercise Program for Older Adults With Dementia

This project aims to examine the effects of a six-month VA exercise program incorporate the SPOZ technology in improving the cognitive behavioral impairment and sensory perceptual impairment of older adults with dementia in adult daycare centers.

A cluster-randomized controlled trial will be conducted to examine the effects of a six-month VA exercise program incorporate the SPOZ technology in improving the cognitive behavioral impairment (using Montreal Cognitive Assessment and Neuropsychiatric Inventory Questionnaire) and sensory perceptual impairment (using Pain Assessment in Advanced Dementia) of older adults with dementia in adult daycare centers. Using convenience sampling, 10 adult daycare centers with 122 older adults will be recruited, and then cluster-randomized by the daycare centers to an experimental or a control group. The experimental group will receive a 40-minute program 3 times a week for 6 months; the control group will maintain their routine activities. The two groups will be measured at three time points: before the intervention, and at three months and six months of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed as dementia by a physician, or
* screened by the SPMSQ as dementia
* age 65 and older

Exclusion Criteria:

* have severe cardiopulmonary disease
* have physical mobility impairment
* have spinal cord injury
Long-term Safety, Tolerability and Efficacy of Aclidinium Bromide in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-35)

The purpose of this study is to evaluate the safety, tolerability and efficacy of inhaled aclidinium bromide at two dose levels in patients with moderate to severe, stable chronic obstructive pulmonary disease. The study will be 56 weeks in duration; a 2-week rin-in period, a 52-week treatment period and a 2-week follow up phone call. All patients will be randomized to one of two doses of aclidinium bromide.


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of stable moderate to severe COPD as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines, 2010; postbronchodilator FEV1/FVC \< 70%, and postbronchodilator FEV1 ≥ 30% and \< 80% predicted
* Current or former cigarette smokers

Exclusion Criteria:

* Patients who have been hospitalized for an acute COPD exacerbation within 3 months before the first visit
* Respiratory tract infection or COPD exacerbation in the 6 weeks before Visit 1
* Patient with any clinically significant respiratory conditions other than COPD, cardiovascular conditions or mental illness
* History or presence of asthma verified from medical records
* Chronic use of oxygen therapy greater than or equal to 15 hours per day
* Patient with uncontrolled infection due to HIV and/or active hepatitis
* Patients with a history of hypersensitivity reaction to inhaled anticholinergics
* Patients with clinically significant cardiovascular conditions, including myocardial infarction during the previous 6 months, newly diagnosed arrhythmia within the previous 3 months, unstable angina, unstable arrhythmia that had required changes in pharmacological therapy or other intervention.
Virtual Reality for Urological Procedures

It is standard practice for most cystoscopies and vasectomies in an office or outpatient setting to be performed under local anesthesia while the patient is awake and conscious. However, given the conscious nature of these procedures, patients may experience anxiety-inducing stressors that they otherwise would not under general anesthesia. Stressors such as hearing surgical terminology, technical discussion, and injection of local anesthetic have been previously documented as sources of perioperative anxiety and pain in awake surgeries.

The current study will examine the feasibility and pilot outcomes of Virtual Reality (VR) guided meditation therapy during cystoscopies and vasectomies. Feasibility will be examined through: (1) recruitment capability and resulting sample characteristics, (2) data collection procedures (including randomization) and outcome measures, and (3) participant acceptability and suitability of the VR intervention during the procedures. The investigators will also evaluate pilot outcomes of the VR intervention on pain, anxiety, and overall satisfaction with the procedure. Results of this study will inform the development of a large-scale randomized clinical trial (RCT) to evaluate the efficacy of this intervention.

Participants will be asked to complete questionnaires before and after their procedure and will be asked for a verbal measure of their pain and anxiety during the procedure.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* can speak and read English
* have an indication for a cystoscopy or elected for a vasectomy
* are scheduled to undergo their respective procedure under local anesthesia at the Men's Health Clinic between the dates of May-November 2024.

Exclusion Criteria:

* those who are not competent to provide informed consent (e.g., due to cognitive impairment)
* those who are unable to participate in a VR intervention (e.g., due to visual or auditory impairment)
The Impact of RPh201 on CVS Patients: Clinical and fMRI Measurements

The investigators are studying the impact of RPh201 on chronic vegetative patients. RPh201 has been reported to induce neuronal regeneration in animal models. Evaluation will be done by combining clinical /behavioral assessment with fMRI studies.


Eligibility Criteria:
Inclusion Criteria:

* Chronic vegetative patients

Exclusion Criteria:

* Inability to go through an MRI scans (i.e. metal implants, neurotransmitters)and pregnancy
Graded Exposure Therapy for Fear Avoidance Behaviour After Concussion

Concussions are very common. Although many people recover well from concussion, some will have persistent symptoms and difficulties with daily activities. How people cope with their symptoms following concussion powerfully influences their recovery. Fear avoidance behaviour is a particularly unhelpful approach to coping, in which people perceive their pre-injury activities as unnecessarily dangerous and take great care to avoid overexertion and overstimulation. The investigators developed and pilot tested a behavioural therapy, called graded exposure therapy, to reduce fear avoidance behaviour. Our preliminary work suggested that graded exposure therapy was acceptable to patients with concussion and possibly beneficial for their recovery. The GET FAB after concussion study will assess the effectiveness of graded exposure therapy.

GET FAB is a multisite randomized controlled trial designed to evaluate a behavioural treatment (graded exposure therapy) for adults with persistent symptoms after concussion. Participants in this study will be recruited from a network of concussion clinics in Canada. This study follows from the investigators' prior work establishing that (1) fear avoidance behaviour is a risk factor for poor concussion outcome, (2) graded exposure therapy reduces fear avoidance behaviour, and (3) graded exposure therapy is perceived as credible and is well-tolerated by patients with persistent post-concussion symptoms.

Participants will be assigned at random (in a 1:2:2 ratio) to receive enhanced usual care, graded exposure therapy group, or another therapy that might have similar benefits (prescribed aerobic exercise). The investigators hypothesize that patients who participate in graded exposure therapy will have reduced fear avoidance behaviour and improved daily functioning compared to other treatment conditions and this difference will be greatest for patients who enter the study with high fear avoidance behaviour.

Eligibility Criteria:
Inclusion Criteria:

1. aged 18-70 years;
2. sustained a concussion according to the ACRM mTBI Task Force definition between 1 and 24 months ago
3. fluent in English, because validated translations are not available for most questionnaires and recruiting multilingual therapists is not feasible;
4. access to a computer, tablet, or smartphone with internet capability;
5. 3 or more moderate-severe symptoms on the Rivermead Postconcussion Symptom Questionnaire.

Exclusion Criteria:

1. medical contraindication to aerobic exercise (cardiac disease, chest pain with exertion, acute bone/joint/soft tissue injury aggravated by exercise)
2. change in cardiac medication within the last month, such as beta blockers, calcium channel blockers, or ivabradine
3. involved in personal injury litigation for index mTBI
4. currently pregnant or plan to become pregnant within the next three months
5. severe/unstable medical or psychiatric condition that could worsen over the next year")