cyrilzakka/clinical-trials huggingface dataset:
Triple Therapy Prevention of Recurrent Intracerebral Disease EveNts Trial (TRIDENT) Cognitive Sub-Study

A Sub-Study of an investigator initiated and conducted, multicentre, international, double-blinded, placebo-controlled, parallel-group, randomised controlled trial (TRIDENT) to determine the effect of more intensive long-term blood pressure control, provided by a fixed low-dose combination blood pressure lowering pill ("Triple Pill") strategy on top of standard of care, for slowing memory decline as measured by Cambridge Neuropsychological Test Automated Battery (CANTAB), in patients with a history of acute stroke due to intracerebral haemorrhage (ICH).

Cognitive decline and dementia in ICH is high due to the common underlying vasculopathy of cerebral small vessel disease (CSVD). However, in general, detailed cognitive outcomes in ICH have been neglected, possibly due to the high mortality rate of ICH (up to 60% within the first year).

Blood pressure (BP) management in those with ICH has been suboptimal. Most hypertensive patients need more than two medications. Combination therapy may improve adherence and BP reduction and reduce cardiovascular (CV) event rates. In the main TRIDENT study, it is hypothesised that a fixed low-dose triple combination BP-lowering agent, termed the 'Triple Pill' will prevent recurrent stroke. The Triple Pill is composed of a single capsule containing either a combination of telmisartan 20 mg, amlodipine 2.5 mg and indapamide 1.25 mg, or placebo.

In addition to achieving optimal BP control, the Triple Pill also has the capacity to slow cognitive decline and dementia in ICH survivors. Research shows that elevated BP is associated with Alzheimer's disease and vascular dementia, even after accounting for prior stroke or transient ischaemic attack, and large scale prospective studies have shown a 50% reduction in dementia when BP is managed appropriately

Eligibility Criteria:
Inclusion Criteria:

1. Eligible for, randomised and continuing in the TRIDENT Main Study
2. Must be able to attend the site conducting the cognitive assessments. In Sydney, this will either be at the same site as where TRIDENT study is conducted or at the BMC, University of Sydney, Camperdown.
3. Ability and willingness to undergo neuropsychological testing (i.e. have no major visual, auditory or motor impairments)
4. Language spoken compatible with CANTAB administration (i.e. CANTAB will be administered in the local language(s) of the country in question. E.g. in Australia, the CANTAB will only be administered in English).
5. Provision of written informed consent

Exclusion Criteria:

1. Study medication has been permanently stopped prior to or at the 6-month visit of the TRIDENT main study
2. Informant Questionnaire for Cognitive Decline in the Elderly (IQCODE) score of 3.313 or higher
3. Cognitive performance indicative of dementia at 6-month TRIDENT main study visit defined by Montreal Cognitive Assessment (MoCA) score less than 2414.
4. Evidence of rapid deterioration suggestive of dementia by decline of 3 points in MoCA assessments between randomisation and the 6-month study visit in the TRIDENT main study
Single Dose Monurol for Treatment of Acute Cystitis

Urinary tract infecton (UTI) is a very common problem in young healthy women, afflicting approximately one-half of women by their late 20's. One of the most common antibiotics used to treat UTIs is Trimethoprim-Sulfamethoxazole (TMP-SMX), usually for total of three days. However, concerns about increased antibiotic resistance have led to increased interest in studying other antibiotics for UTI.

An alternative antibiotic which is also FDA approved for the treatment of UTIs is fosfomycin (Monurol). The effectiveness of fosfomycin in curing UTIs when given as a single dose is not well studied. The purpose of this research study is to determine what the cure rates are with a single dose of fosfomycin versus the more standard 3-day course of TMP-SMX.

Procedures subjects will undergo once they have read and signed the consent are:

Questions about their medical and sexual history and current symptoms of UTI. They will be asked to provide a urine and peri-urethral sample and then are randomly assigned to one of the two treatment groups.They will be given a sheet to record symptoms at home. They will be asked to return to the clinic in 5-8 and 28-30 days after completing antibiotic therapy.Follow-up questions will be asked and urine and peri-urethral will be self collected at each visit.

Eligibility Criteria:
Inclusion Criteria:

* Non pregnant women in good health with symptoms of acute cystitis for less than 7 days

Exclusion Criteria:

* Pregnant, lactating, or not regularly contracepting
* History of chronic conditions such as diabetes
* Known anatomic abnormalities of the urinary tract
* Use of prophylactic antibiotics
* History of allergy or intolerance to any of the study drugs
* Recent (\> 2 weeks)exposure to oral or parenteral antimicrobial
* History of UTI in previous 1 month
Detraining in People Living With HIV/AIDS

The goal of this study was to evaluate the effect of detraining in the components of physical aptitude of people living with HIV/Aids (PVHA).

The study was experimental with a sample composed by an Experimental Group (EG) with 11 PVHA, under antiretroviral therapy and a Control Group (CG) with 10 individuals without the infection; all which were under medical release and insufficiently active. The body composition was evaluated through the DXA, as well as the cardiorespiratory aptitude through the ergometer and the strength of the upper and lower limbs through dynamometry. Both groups conducted interventions with concurrent training for 15 weeks and the interruption of exercise was evaluated after a period of 5 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Group experience to have a diagnosis of at least 2 years living with HIV / AIDS being in clinical follow-up in the Specialized Attention Services in HIV / AIDS (SAE), using ART, TCD4 lymphocyte count equal to or greater than 500 copies / mm³, viral load Undetectable (≤ 50 copies / mm³)
* Group control without any diagnosis of HIV / AIDS or any other pathology. Both groups completed the exercise program with a minimum frequency of 75%.

Exclusion Criteria:

* Both groups taking part in any physical exercise in time of detraining
Efficacy of IORT With CT-Guided HDR Brachytherapy for Treatment of Breast Cancer

The purpose of this study is to evaluate an investigational way to provide radiation therapy to treat early-stage breast cancer at the time of surgery.

This is a prospective single-arm phase II study designed to study the efficacy of high dose rate (HDR) brachytherapy with CT-imaging, single-fraction intraoperative radiation therapy (IORT). The study will accrue patients with early-stage breast cancer who will be treated with breast-conserving surgery (BCS). The main clinical eligibility criterion is based on suitability for accelerated partial breast irradiation. Patients may be eligible prior to receiving BCS or within 30 days of receiving BCS. Eligible patients that will undergo BCS will receive surgery according to the standard clinical practice in the Brachytherapy Suite in the Emily Couric Clinical Cancer Center. Patients that have already undergone BCS must meet all other eligibility criteria and are able to be treated with IORT within 30 days of their breast surgery. Eligible subjects will undergo a lumpectomy or re-excision lumpectomy according the standard clinical practice. Immediately following lumpectomy, the breast HDR brachytherapy applicator will be placed and CT imaging will be performed for treatment planning. After HDR brachytherapy is delivered, the applicator will be removed, and the breast surgeon will complete the skin closure. Although the ultimate goal of the study is to determine 5-year ipsilateral breast tumor recurrence (IBTR), all efforts will be made to follow the patients until death.

Eligibility Criteria:
Inclusion Criteria:

1. Patient has elected breast conserving surgery or whole breast irradiation treatment for early-stage breast cancer.
2. Tumor size must be less than or equal to 3 cm.
3. Patient is 45 years of age or older.

Exclusion Criteria:

1. Male patients.
2. Pregnant patients.
3. Breast cancer that involves the skin or chest wall.
4. History of ipsilateral breast cancer.
5. Multicentric breast cancer in the ipsilateral breast.
6. Known BRCA gene mutation.
7. Patient with nodal disease.
8. Patient is undergoing initial medical treatment (hormone or chemotherapy) to reduce tumor size.
9. Patient with breast implants (does not include patients having implants AFTER intra-operative radiotherapy).
Zoster Vaccine Response in the Frail Elderly

This study is being done to evaluate the zoster vaccine response in the nursing home elderly (80 years or older). As the immune system ages, the response to vaccines is not always as strong as in younger people. Previous zoster vaccine studies have excluded nursing home residents so the vaccine effect in this population is not known. Furthermore, the immune and genetic reasons as to why the vaccine works well in some people but not in others are also unknown. The goal of this study is to evaluate why some immune systems respond well to the vaccine and why others do not.

Deleterious changes in immunity that occur with aging are known as immunosenescence. Such changes, particularly in adaptive immunity, may lead to an impaired vaccine response in the elderly. Characterizing the immune determinants and the genetic basis for vaccine response in the frail elderly is a practical approach to better our understanding of immunosenescence. Data on genetic determinants to immunization are sparse, furthermore, to the best of our knowledge, none exist in the elderly. In this pilot study, we propose studying the immune response to the herpes zoster vaccine and the underlying genetic determinants of the immune response in elderly residents of nursing homes.

The three specific aims of this study are to generate data in order to 1) assess the T-cell response to the varicella-zoster virus (VZV) vaccine in the frail elderly; 2) assess whether immune (T-cell) phenotypes are associated with a response; 3) test the association between immune response genotype sets and T-cell response. We hypothesize that response to the VZV vaccine in elderly nonambulatory nursing home residents is a function of characteristic T-cell immune phenotypes prior to vaccination and that there are immune genetic polymorphisms associated with the response. This study will allow us to generate preliminary data and establish feasibility in order to address these questions fully in a larger population in a subsequent grant application.

Eligibility Criteria:
Inclusion Criteria:

* nursing home resident
* greater than or equal to 80 years old
* non-ambulatory

Exclusion Criteria:

* less than 80 years old
* ambulatory
* taking immunosuppressive medication
* history of primary or acquired immuno-deficiency states including leukemia, other malignant neoplasms affecting the bone marrow or lymphatic system, and AIDS
* active untreated tuberculosis
* previous receipt of varicella vaccine
* residents expected to expire within 30 days, in the opinion of the most responsible physician
* residents planning to move nursing homes within the year
* temporary residents
Improving Asthma Care for Very Low Birth Weight Infants

Children born less than 1500 grams are being enrolled into a study to test the effectiveness of a parental educational intervention in reducing the risk of future breathing problems. The intervention teaches parents of these children how to reduce the risk of / and recognize breathing problems.


Eligibility Criteria:
Inclusion Criteria:

* Premature babies weighing less than 1500 grams at birth receiving care at Strong Memorial Hospital Neonatal Intensive Care Unit

Exclusion Criteria:

* Non-English speaking parents
Headache Analysis and Intervention

Diagnosing and treating posture-related headache (PRH), such as tension-type and cervicogenic headache, is seriously hampered because of common features and complex interaction of the neurological and musculoskeletal system. Current therapies are therefore not as effective and the population of patients with PRH keeps on increasing. The diagnostic as well as the therapeutic process need more structure in order to select the most effective treatment; thereby contributing to preventive measures. This goal can be achieved through fundamental research with a clinically oriented background. Our study starts from a clinical problem, with a growing incidence, and is therefore highly relevant. Because sitting-posture seems to play an important role in PRH, the first step in the diagnostic process is to analyse postural differences between a PRH- and a control-group. In addition, the role of the dura mater in the headache-process will be examined. Patients with PRH will be classified in homogeneous groups based on these results. In a second phase individual-specific treatment programs will be composed. The general treatment-approach of postural abnormalities in the past failed because of the heterogeneous patient-populations. Sub-classifying musculoskeletal problems has been proven to be successful in the past (O'Sullivan \& Dankaerts, non-specific low back pain).

Our study is divided in 2 phases:

* phase 1: profile analysis (no intervention, experimental headache-group vs. asymptomatic controls)
* phase 2: interventional phase (clustered headache-groups, based on the results of phase 1


Eligibility Criteria:
Inclusion Criteria Headache-group:

1. Males and females between 20 and 50 years
2. Confirmed medical diagnosis of tension-type headache, cervicogenic headache or a mixture
3. Headache can be provoked by awkward cervical and/or head postures

Exclusion Criteria Headache-group:

1. Pregnancy
2. History of pericranial surgery
3. Serious pathology (neurological/cardiovascular/endocrine/musculoskeletal)
4. Red flags
5. Physical or manual therapy treatment for headache \< 4 weeks prior the study
6. Excessive (\> 10 days/month for \> 3 months) use of: ergotamine, NSAID's, opioids, triptans, acetylsalicylic acid and simple analgesics
7. Psychiatric comorbidity
8. Visual or temporo-mandibular dysfunction

Inclusion Criteria Control-group:

1. Males and females between 20 and 50 years
2. Asymptomatic, no headache-history

Exclusion Criteria Control-group:

1. Pregnancy
2. History of pericranial surgery
3. Excessive (\> 10 days/month for \> 3 months) use of: ergotamine, NSAID's, opioids, triptans, acetylsalicylic acid and simple analgesics
4. Visual or temporo-mandibular dysfunction
Temsirolimus in Recurrent Primary Central Nervous System (CNS) Lymphoma

This is an open-label trial investigating the efficacy of temsirolimus in recurrent or refractory primary CNS lymphoma (PCNSL) after initial chemotherapy with a high-dose methotrexate containing regimen. 37 patients are planned to be treated with weekly infusions of 25mg Temsirolimus (first 3 patients) or 75mg Temsirolimus (all other patients) up to a maximum of 12 months. The trial is designed in two stages, if less than one of the first 12 patients responds to treatment, the trial is stopped. In addition to efficacy, safety and penetration of temsirolimus into the cerebrospinal fluid will be investigated.


Eligibility Criteria:
Inclusion Criteria:

* Primary CNS lymphoma diagnosed histologically or by cerebrospinal fluid cytology; absence of systemic lymphoma manifestations
* Relapse or lymphoma progression after/during high-dose methotrexate containing first-line chemotherapy or alternative therapy in the case of contraindications against high-dose methotrexate
* ECOG performance score ≤ 2
* Age ≥18 years and ≤ 75 years
* Life expectancy of at least 3 months
* Absence of active infection
* Negative HIV serology
* Adequate renal function (GFR \>30ml/h)
* Adequate bone marrow reserve (neutrophils \> 1500/µl, platelets \> 80,000/µl)
* Bilirubin \<1.5x upper limit of normal (ULN), ALT and AST \<3x ULN
* At least 3 weeks interval from prior cytostatic treatment
* Negative pregnancy test
* Patient accessible for treatment and follow-up
* Patient compliance
* Signed informed consent

Exclusion Criteria:

* Secondary CNS lymphoma
* Primary intraocular lymphoma
* Patient eligible for high-dose chemotherapy and autologous stem-cell transplantation
* Concurrent treatment within another clinical trial
* Concurrent other malignant disease
* Symptomatic congestive heart failure (≥NYHA II)
* Active or uncontrolled chronic infection
* Severe concomitant disease incompatible with study conduct
* History of cerebral bleeding
* Concomitant treatment with strong CYP3A4/5-inductors or -inhibitors
* Premenopausal women without highly effective contraception (defined as Pearl index \<1)
* Pregnant or lactating women
* Refusal to record and pass on pseudonymized disease and treatment related data as part of the treatment protocol
* Concurrent admission to a psychiatric institution by public order
Impact of a Course on Stress Reduction

This project seeks to measure the effectiveness of a course in self-management strategies (including yoga, mindfulness, and breathing exercises). The course will be provided by a certified yoga instructor to patients being followed at the Pain Management Centre, Hamilton Health Sciences (HHS).

The Pain Management Centre at Hamilton Health Sciences is organizing a course in stress reduction techniques for patients with chronic pain. The Pain Centre has arranged for a local certified yoga instructor to lead a 6-week course that she has developed for our specific patient population. The course will include self-management strategies for pain control, such as breathing exercises, yoga poses, and mindfulness meditation. Standardized questionnaires and a semi-structured interview to record baseline and post-course outcomes. The study will involve the following questionnaires/surveys/interviews: 1) Canadian Occupational Performance Measure, 2) Perceived Stress Scale, 3) Burckhardt Quality of Life Scale, 4) Visual Analog Score, and 5) written questions concerning patient demographics, the patient's chronic pain condition, and their satisfaction with the course. The participants would be asked to fill out questionnaires at three different times: 1) baseline data collected within two weeks of starting course, 2) short-term outcome data within two weeks of completing course, and 3) long-term outcome data four to six months after the course.

Eligibility Criteria:
Inclusion Criteria:

* patients have a history of moderate to severe chronic pain

Exclusion Criteria:

* non-English speaking patients
A Phase 1, First-in-human Study of VX-634

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of VX-634 at various doses.

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Eligibility Criteria:
Key Inclusion Criteria:

* Participants of age between 18 to 55 years (inclusive)
* Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (kg/m\^2)
* A total body weight of more than (\>)50 kg
* Participants of non childbearing potential
* Non smoker or ex-smoker for at least 3 months before screening

Key Exclusion Criteria:

* Any condition possibly affecting drug absorption

Other protocol defined Inclusion/Exclusion criteria may apply.
The Effect of Vertical Versus Horizontal Vaginal Cuff Closure on Vaginal Length After Laparoscopic Hysterectomy

This study has been designed as a prospective randomized trial to be performed at Bridgeport Hospital. Patients planning to undergo a laparoscopic or robotically assisted total laparoscopic hysterectomy with or without removal of adnexal structures will be recruited by the Bridgeport Hospital Minimally Invasive Gynecologic Surgery fellows during their preoperative office visit at the Bridgeport Hospital Gynecologic Oncology office. If enrolled, they will be assigned a sequential study identification number. During their preoperative exam, a baseline POP-Q will be performed. Demographic information will be recorded from the electronic medical record.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing laparoscopic or robotic-assisted laparoscopic hysterectomy
* Under the care of Dr. Dan-Arin Silasi or Dr. Masoud Azodi at Bridgeport Hospital
* Planning to follow up at the Gynecologic Oncology office at Bridgeport Hospital
* Age 18 or older
* Able to give informed consent to participate in the research study

Exclusion Criteria:

* Age less than 18
* Unable to give informed consent
* Patients undergoing radical hysterectomy
* Patients receiving vaginal cuff radiation within the study period
* Patients undergoing concomitant pelvic floor or vaginal suspension procedure
FreeStyle Libre Flash Glucose Monitoring System Post Approval Study for Pediatric Patients

This is a prospective, multi-center, non-randomized, single-arm, post-approval study of the FreeStyle Libre Flash Glucose Monitoring System intended to characterize the safety of the Libre Flash Glucose Monitoring System when used in pediatric patients with diabetes.

Up to 400 pediatric subjects aged 4-17 years with type 1 or type 2 diabetes, who require daily blood glucose monitoring to manage their diabetes, will be enrolled to obtain at least 314 subjects who complete the final visit. Subjects and/or their caregivers will utilize capillary SMBG for managing diabetes for 6 months (control phase) followed by diabetes management using FreeStyle Libre for 6 months (intervention phase). Subjects and/or their caregivers will maintain a diary/log book of Adverse Events during each phase. Assessment of Adverse Events will occur via self reporting at each monthly visit and/or phone call.

Eligibility Criteria:
Inclusion Criteria:

* Subject must be 4 - 17 years of age.
* Subject must have a diagnosis of type 1 or type 2 diabetes mellitus for at least 3 months prior to enrollment.
* Subject is currently using SMBG for managing their diabetes.
* Subject and/or caregiver must be able to read and understand English .
* In the investigator's opinion, the subject and/or caregiver must be able to follow the instructions provided to him/her by the study site and perform all study tasks as specified by the protocol.
* Subject and/or caregiver must have access to an internet connected computer for uploading data from the blood glucose meter and FreeStyle Libre system.
* Subject must have an overnight companion (caregiver 18 years or older) present in the same home during participation of the study.
* Subject and/or parent or guardian must be willing and able to provide written signed and dated informed consent and assent when appropriate.

Exclusion Criteria:

* Subject and/or caregiver is a member of the Site Staff.
* Subject is currently using or has previously used a continuous glucose monitoring system for managing their diabetes
* Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
* Subject is known to be pregnant or is attempting to become pregnant at the time of enrollment.
* Subject is on dialysis at the time of enrollment.
* Subject has concomitant medical condition which, in the opinion of the investigator, could interfere with the study or present a risk to the safety or welfare of the subject or study staff.
* Subject currently is participating in another clinical trial.
* Subject is unsuitable for participation due to any other cause as determined by the Investigator.