cyrilzakka/clinical-trials huggingface dataset:
Effects of Memory Boot Camp on Brain Function in Adults With Symptoms of Mild Cognitive Impairment (MCI)

This is a prospective controlled clinical trial to determine the effects of a 12-week Memory Boot Camp (MBC) program on cognitive function in older adults with symptoms of Mild Cognitive Impairment.

This prospective trial evaluates the 12-week, multi-domain Memory Boot Camp program for adults ages 55 to 85 with symptoms of mild cognitive impairment. The Memory Boot Camp program incorporates neurofeedback, heart rate variability biofeedback, memory and cognitive training, and one-on-one coaching to encourage behavior change in diet, sleep, physical fitness, and stress reduction. Participants are evaluated via neurocognitive assessments, questionnaires, quantitative electroencephalography parameters, and heart rate variability parameters at four time points: baseline, pre-program, post-program, and follow-up. The trial included a 12-week waiting period between baseline and pre-program, such that each participant acts as their own control, and follow-up takes place six months after completion of the program.

Eligibility Criteria:
Inclusion Criteria:

* Subjective memory concerns
* At least a high school education
* Having a current primary care doctor (or agreement to get a primary care doctor)
* Ability to read and write English
* Time availability of 4-5 hours/week
* Be in good general health

Exclusion Criteria:

* Major depression
* Known neurological illness (e.g. Alzheimer's or other dementia, Parkinson's, epilepsy, multiple sclerosis)
* Serious psychiatric diagnosis
* Substance abuse
* Complete blindness or deafness
* Plans to be out of town for more than 10 days during the active phase of the trial
* Current or past client of the Sponsor
* Complete blindness or deafness
* Employee or family member of Sponsor employee
Next Science Wound Gel Efficacy in Chronic Wound Versus Standard of Care

This is a 3 to 4 months, multi-site, prospective randomized clinical study of patients diagnosed with a chronic wound. The primary objective is to assess changes in healing rate, by measuring differences in wound area when treating chronic wounds with the Next Science Wound Gel compared to the Triple Antibiotic Ointment Neosporin (Standard of Care, SOC). At the end of the study period, patients may continue receiving their assigned study treatment provided they have signed the "Continuation of Treatment Informed Consent" and the rational for continuation is documented by the investigator.


Eligibility Criteria:
Inclusion Criteria:

* Male or female 18 years or older
* Presence of full-thickness wound for more than one month (i.e. chronic)
* Ulcer must be greater than 1 centimeter in area to enable biofilm sampling
* NOT a candidate for vascular reconstructive surgery to restore blood flow to the wound
* Willing to comply with all study procedures and be available for the duration of the study
* Provide signed and dated informed consent

Exclusion Criteria:

* Subjects unable to provide signed and dated informed consent
* Male or female less than 18 years old
* Presence of a full-thickness wound for less than one month
* A candidate for vascular reconstructive surgery to restore blood flow to the wound
* Subjects with bleeding dyscrasia or with medical conditions that would make a bleeding complication likely
* Subjects who's wound is less than 1 cm precluding adequate wound biofilm sampling
* Subject with known allergic reaction to the study products
Travoprost APS Versus Xalatan® in Patient Reported Outcomes and Ocular Surface Health

The purpose of this study is to understand differences in visual function-related patient-reported outcomes between a non-BAK medication (Travoprost APS) and a BAK-preserved medication (XALATAN®) in patients with open-angle glaucoma or ocular hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Must have a clinical diagnosis of open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component), or ocular hypertension in at least 1 eye.
* Must be willing and able to discontinue use of any topical ocular medication other than the study medication for the duration of the study.
* Must have had Intraocular Pressure (IOP) controlled with mono-therapy using XALATAN® for at least 1 continuous month prior to Visit 1.
* Women of childbearing potential must meet all of the following conditions at Visit 1:

  * They are not breast-feeding.
  * They have a negative urine pregnancy test at Visit 1.
  * They agree to undertake a urine pregnancy test upon entering and exiting the study.
  * They are not planning to become pregnant during the course of the study.
  * They are currently using, and agree to use adequate birth control methods for the duration of the study.
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Any abnormality preventing reliable applanation tonometry in the study eye(s).
* Presence of any ocular pathology in either eye seen during the slit lamp or fundus exams, that in the opinion of the Investigator may preclude the safe administration of test article or safe participation in this study.
* Dry eye or keratoconjunctivitis sicca (KCS) which has been, or is currently being, treated with the use of punctal plugs, punctal cautery, Restasis®, or topical ocular corticosteroids.
* Patients who have undergone keratorefractive ocular laser procedures, corneal surgery or surgery to the corneal surface, including but not limited to LASIK and PRK, within 6 months prior to Visit 1.
* Patients who have undergone intraocular or extra-ocular surgery, in either eye, within 6 months prior to Visit 1.
* Any history of ocular infections or inflammatory ocular conditions within the past 3 months in either eye.
* Use of any systemic medications on a chronic basis that have not been on a stable dosing regimen for at least 30 days prior to Visit 1.
* Use of ocular medications other than XALATAN® within 7 days of Visit 1.
* Use of corticosteroids within 30 days of Visit 1.
* Use of contact lenses within 30 days of Visit 1. Concomitant use of contact lenses is also excluded for the duration of the study.
* History of intolerance or hypersensitivity to any component of the test articles.
* Participation in an investigational drug or device study within 30 days of entering this study.
* History or evidence of corneal transplant or transplant variant procedures.
* Other protocol-specified exclusion criteria may apply.
Clinical Significance of Occult Central Nervous System Disease In Adult Acute Lymphoblastic Leukemia

Central nervous system involvement at diagnosis remains an obstacle to a long-term cure of patients affected by acute lymphoblastic leukemia. The investigators have previously reported that flow cytometry (FCM) is better than conventional cytology (CC) in demonstrating the presence of leukemic cells in the patients'(pts) cerebrospinal fluid (CSF), especially in samples with low cell counts. In the framework of the national Campus ALL program aimed at improving the management of adult ALL patients in the context of the GIMEMA protocols, in the present study the investigators retrospectively evaluated the incidence of occult CNS positivity and its impact on outcome in 241 adult pts with newly diagnosed ALL from 13 centers.

Demographic and of laboratory data of 241 adult patients with ALL were retrospectively recorded. All patients underwent diagnostic lumbar puncture and each cerebrospinal fluid sample was examined by CC and FCM. The investigators identified patients with the only FCM positivity and the investigators correlated this condition with clinical and of laboratory data and with clinical outcome.

Eligibility Criteria:
Inclusion Criteria:

* ALL at onset
* Age \>18 years

Exclusion Criteria:

* ALL relapsed or refractory
* Age \<18 years
Comparative Effectiveness of Peripheral Nerve Blocks for Outpatient Shoulder Surgery

This retrospective, population-based cohort study will evaluate the comparative effectiveness of peripheral nerve blocks on patient outcomes after ambulatory shoulder surgery in adults patients undergoing surgery in Ottawa, Ontario.

The investigators will use a coarsened exact matching algorithm prior to the analysis to minimize bias in this observational study. A multivariate logistic regression model will be used to compare the effect of anesthesia interventions on the primary outcome within matched cohorts. Sensitivity analyses will be used to evaluate the robustness of the primary analysis.

Eligibility Criteria:
Inclusion Criteria:

* Ontario residents
* Aged 18 years and older
* Elective ambulatory shoulder surgery

Exclusion Criteria:

* Emergency Surgery
GA-68 DOTA-TOC of Somatostatin Positive Malignancies

This phase I/II trial studies how well gallium Ga 68-DOTA-TOC positron emission tomography (PET)/computed tomography (CT) or PET/magnetic resonance imaging (MRI) works in imaging patients with somatostatin receptor positive tumors. Gallium Ga 68-DOTA-TOC binds to somatostatin receptor positive tumors and can be seen using a PET scan. A PET scan uses a special camera to detect energy given off from gallium Ga 68-DOTA-TOC, to make detailed pictures of areas where material accumulates in the body. Diagnostic procedures, such as gallium Ga 68-DOTA-TOC PET/CT or PET/MRI, may help find and diagnose somatostatin receptor positive tumors and help plan the best treatment.

PRIMARY OBJECTIVES:

I. To determine if gallium Ga 68-DOTA-TOC (gallium-68 labeled DOTA-TOC) results in the delineation of more lesions than with conventional imaging.

SECONDARY OBJECTIVES:

I. To determine if the incorporation of gallium (Ga)-68 DOTA-TOC PET/CT into the management decision making process results in a change in stage of the patient.

OUTLINE:

Patients receive gallium Ga 68-DOTA-TOC intravenously (IV) over 1-2 minutes. Within 55-70 minutes, patients then undergo a PET/CT scan over 30-40 minutes or a PET/MRI scan over 50 minutes.

After completion of study, patients are followed up for 2 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Known or suspected somatostatin receptor positive tumor such as carcinoid; neuroendocrine tumor; neuroblastoma; pheochromocytoma. Supporting evidence may include MRI, CT, biochemical markers, and or pathology report.
* Age \> 1.
* Karnofsky performance status of \> 50 (or Eastern Cooperative Oncology Group (ECOG) / World Health Organization (WHO) equivalent).
* Not pregnant. A negative serum pregnancy test is required for all female subjects with childbearing potential.
* Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion Criteria:

* Hepatic enzymes 5 times greater than the upper limits of normal, serum creatinine \> 3.0 mg/dL (270 Micromole per liter (uM/L).
* Patients exceeding the weight limitations of the scanner or are not able to enter the bore of the PET /CT scanner due to BMI
* Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.); although at Mission Bay Hospital pediatric patients may be sedated per clinical protocol.
* Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.).
* Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance.
* Recognized concurrent active infection Previous systemic or radiation treatment for another cancer of any type within the last 2 months.
* Use of any other investigational product or device within 30 days prior to dosing, or known requirement for any other investigational agent prior to completion of all scheduled study assessments
A Dose Escalation Study of STA-9090 and Docetaxel in Patients With Solid Tumors

This is an open-label, Phase 1, dose-escalation study to determine the recommended doses of STA-9090 (ganetespib) and docetaxel for the treatment of subjects with solid tumor malignancies. The safety and tolerability of the treatment will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Must have histologically confirmed metastatic or unresectable malignancy with evidence of progression
* If subject has been treated with docetaxel, must have evidence of persistent or progressive disease
* Measurable disease per RECIST
* CNS metastases are permitted if treated and radiographically and clinically stable for 4 weeks prior to first dose
* ECOG status less than or equal to 2
* Life expectancy greater than 3 months
* Adequate hematological, hepatic and renal function as defined by protocol
* Willingness and ability to comply with study requirements
* Female subjects of childbearing age must have a negative pregnancy test at study entry
* Female subjects of child bearing age and males must agree to use adequate contraception as defined in the protocol

Exclusion Criteria:

* Prior chemotherapy or investigational agents within 3 weeks or 5 times the agent's half life, whichever is shorter prior to first dose
* Radiotherapy within 2 weeks of first dose
* Surgery, radiotherapy or ablative procedure to the only area of measurable disease
* Major surgery within 4 weeks of first dose
* Poor venous access that would require an indwelling catheter for study drug administration
* History of severe allergic or hypersensitivity reactions to STA-9090 or docetaxel or their diluents or excipients
* Baseline QTc \>470 msec or previous history of QT prolongation while taking other medications
* Peripheral neuropathy \> Grade 1
* Ventricular ejection fraction less than or equal to 55% at baseline
* Treatment with chronic immunosuppressants. However subjects may receive steroids for stable CNS metastases
* Women who are pregnant or lactating
* Uncontrolled intercurrent illness
Evaluation of the 755nm Alexandrite Laser for the Treatment of Scars

Evaluate the safety and efficacy of removing unwanted scars using a 755nm Alexandrite laser.


Eligibility Criteria:
Inclusion Criteria:

1. Is a healthy male or female between 18 and 85 years old.
2. Has unwanted scars (including atrophic, hypertrophic, hyper or hypo pigmented, erythematous )and wishes to undergo laser treatments to remove or improve them.
3. Is willing to consent to participate in the study.
4. Is willing to comply with all requirements of the study including being photographed, following post treatment care and attending all treatment and follow up visits

Exclusion Criteria:

1. Is hypersensitive to light exposure.
2. Has active localized or systemic infection.
3. Is taking medication(s) for which sunlight is a contraindication.
4. Has a history of squamous cell carcinoma or melanoma.
5. Has a history of keloid scarring.
6. Has used oral isotretinoin (Accutane®) within 12 months of initial treatment or plans on using during the course of the study. Note: Skin must regain its normal degree of moisture prior to treatment.
7. Has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications.
8. Is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
9. Is allergic to lidocaine, tetracaine or Xylocaine with epinephrine.
10. Has any other reason determined by the physician to be ineligible to participate in the study.
High Water Intake in Polycystic Kidney Disease

DRINK is an open-label randomised controlled feasibility trial of high versus ad libitum water intake in ADPKD.

Autosomal Dominant Polycystic Kidney Disease (PKD) affects 12.5 million people worldwide, and accounts for 7% of those requiring renal replacement therapy. The hormone vasopressin drives cyst growth until ultimately most of the normal functioning kidney tissue is replaced and compressed by cysts over the life course. Half of those affected will require dialysis by the age of 55 years.

Vasopressin blockade has emerged as a viable strategy for altering disease course. High water intake suppresses vasopressin, and may therefore slow cyst growth and consequent disease progression. However, evidence to support high water intake in PKD is lacking, and it is not clear whether patients can adhere sufficiently to a high water intake.

DRINK is a single-centre prospective, open label, parallel group randomised controlled feasibility trial. The primary objective is to establish whether a definitive large randomised trial comparing high versus ad libitum water intake on long-term disease progression is deliverable. Fifty patients will be recruited from the Renal Genetics service at Addenbrooke's Hospital. Participants will be randomly allocated to the high water intake (high) or the ad libitum (standard) water intake group. For the high intake group the aim is to drink large enough volumes of water to achieve and maintain dilute urine (urine osmolality \< 270 mOsmo/kg or urine specific gravity ≤ 1.010 ). Multiple methods will be employed to promote adherence these include instruction and education as well as self-monitoring of urine specific gravity twice weekly by participants and the recording of results via a trial specific smartphone application.

Eligibility Criteria:
Inclusion Criteria:

* Have given written informed consent to participate
* Aged 16 years or older
* Have a diagnosis of ADPKD (fulfilling radiological diagnostic criteria ± genetic evidence)
* eGFR ≥ 20ml/min/1.73m2
* Able to self-monitor urine SG

Exclusion Criteria:

* Inability to provide informed consent
* eGFR \< 20ml/min/1.73m2
* Fluid overload states e.g. heart failure, cirrhosis, or requirement for fluid restriction
* Confounding illness impacting on renal disease e.g. concomitant diabetes or glomerulonephritis
* Treatment with diuretics for fluid overload (those on diuretics for hypertension may participate in the trial after a run-in period of 2 weeks)
* Treatment with Tolvaptan in the last 4 weeks
* Pregnancy or breastfeeding
Bowel Preparation by Face-to-face Re-education on the Day of Colonoscopy for Outpatient: a RCT

The study compares the efficacy of bowel preparation between the face-to-face re-education(FFRE group) and normal education (no-FFRE group) in patients.

Despite advances in bowel preparation methods,bowel preparation is inadequate in up to one-third of all colonoscopies in reported series.Inadequate bowel cleansing results in negative consequences for the examination, including incomplete visualisation of the colon, missed lesions, procedural difficulties, prolonged procedure time and reduced time interval until follow-up, and an estimated 12-22% increase in overall colonoscopy cost.

The adequacy of a bowel preparation is closely linked to patient compliance with both dietary and purge instructions.One study performed in Asia showed that non-compliance with bowel preparation instructions, lower education level, and a long wait for the colonoscopy appointment were independent risk factors for poor bowel preparation. Another study performed in China showed that telephone re-education（TRE) about the details of bowel preparation on the day before colonoscopy significantly improved the quality of bowel preparation and PDR. So,it is reasonable to hypothesise that efforts to improve education and maximise patient compliance during the preparatory period will enhance the efficacy of bowel preparation.

The study compares the efficacy of bowel preparation between the face-to-face re-education (FFRE group) and telephone re-education (TRE group) in patients.

Eligibility Criteria:
Inclusion Criteria:

* Outpatients aged 18-80 years undergoing colonoscopy who had provided written informed consent

Exclusion Criteria:

* history of colorectal surgery
* severe colonic stricture or obstructing tumour
* dysphagia
* compromised swallowing reflex or mental status
* significant gastroparesis or gastric outlet obstruction or ileus
* known or suspected bowel obstruction or perforation
* severe chronic renal failure (creatinine clearance\<30 ml/min)
* severe congestive heart failure (New York Heart Association class III or IV)
* uncontrolled hypertension (systolic blood pressure\>170 mm Hg, diastolic blood pressure\>100 mm Hg)
* toxic colitis or megacolon
* dehydration
* disturbance of electrolytes
* pregnancy or lactation
* unable to give informed consent
* haemodynamically unstable
Validation of a Novel Diagnostic Tool for the Evaluation of Post Renal Transplant Immunosuppression: The ImmuKnow Assay

Patients undergoing renal transplantation at London Health Sciences Centre, University Hospital and who are participating in the study "A Comparison of Effects of Standard Dose vs Low Dose Advagraf with IL-2 Receptor Antibody Induction, MMF and Steroids, With or Without ACEi/ARB-based Antihypertensive Therapy on Renal Allograft Histology, Function, and Immune Response" will be evaluated with the ImmuKnow Assay to assess the ability of this assay to predict underimmunosuppression (rejection) or overimmunosuppression determined by this test and to determine retrospectively whether decision making utilizing this novel assay would have improved outcomes over standard techniques.

This study is designed to evaluate an in vitro assay (Cylex®ImmuKnow Assay) for the measurement of cell-mediated immune response in renal transplant patients receiving immunosuppressive therapy. This assay measures ATP as an activation response of CD4+ cells to stimulation with phytohemagglutinin (PHA) in whole blood samples as a reflection of the immune system of the patient at any point in therapy. The natural history of the immune status of the renal transplant recipient as reflected by the ImmuKnow assay will be determined at specific time points of interest including: pre and post transplant, as an adjunct to therapeutic drug monitoring, and pre and post infectious or rejection episode. Analysis of the results of the assay at these time points will allow us to retrospectively study the effects of routine immunosuppressive agent modulation on immune function, and its subsequent effects in times of renal allograft insult.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing implantation surgery for renal transplantation at London Health Sciences Centre, University Hospital
* Patients who have consented to the study entitled, "A Comparison of Effects of Standard Dose vs Low Dose Advagraf with IL-2 Receptor Antibody Induction, MMF and Steroids, With or Without ACEi/ARB-based Antihypertensive Therapy on Renal Allograft Histology, Function, and Immune Response" Exclusion Criteria:

Exclusion Criteria:

* None