cyrilzakka/clinical-trials huggingface dataset:
Comparing Approaches to Assess Nitric Oxide-dependent Cutaneous Vasodilation

The increase in skin blood flow in response to rapid local heating of the skin (i.e., cutaneous vasodilation) is commonly used to assess nitric oxide (NO)-dependent dilation and overall microvascular function. Historically, rapid local heating to 42°C was considered the standard approach for these assessments. More recently, many investigators have adopted rapid local to 39°C instead, based on its larger dependency on NO and therefore improved ability to quantify NO-dependent dilation without the use of pharmacological techniques. However, to date, only one direct methodological comparison between these protocols has been performed.

In this study, the investigators use the blood vessels in the skin as a representative vascular bed for examining mechanisms of microvascular dysfunction in humans. Using a minimally invasive technique (intradermal microdialysis for the local delivery of pharmaceutical agents) they examine the blood vessels in a nickel-sized area of the skin in young adults ages 18 - 30 years old. Local heating of the skin at the microdialysis sites is used to explore differences in mechanisms governing microvascular control. As a compliment to these measurements, the investigators also have participants fill out a variety of surveys to assess things such as sleep quality, physical activity, daily stressors, etc.


Eligibility Criteria:
Inclusion Criteria:

* men and women
* 18-30 years of age

Exclusion Criteria:

* Current or recent (within 8 wks) use of medication that could conceivably alter microvascular function \[including (but not limited to) stimulants, antihypertensives, HMG-CoA reductase inhibitors\]
* Changes or alterations in medication status (starting a new, additional, or different medication or changing the dose of a current medication)
* Unstable or diagnosed chronic clinical disease, including cardiovascular, metabolic, renal, hepatic, autonomic, autoimmune, or dermatological disease (e.g., hypertension, heart disease, diabetes, hyperlipidemia, psoriasis)
* Body mass index \<18.5 or \>35 kg/m2
* Pregnancy (including a positive urine pregnancy test) or breast-feeding
* Known allergies to pharmacological agents or study drugs
* Non-English-speaking. Participants need to understand English to follow instructions and comply with procedures conducted during the screening and experimental visits.
Fungal Prophylaxis With Isavuconazole for Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant (HCT)

The purpose of this study is to study the effects of isavuconazole in preventing fungal infections in patients who have had a hematopoietic stem cell transplant (HCT).


Eligibility Criteria:
Inclusion Criteria:

* Subjects of greater than or equal to 18 years of age of either sex and of any race.
* Have received first peripheral blood, marrow or cord blood transplant from a family or unrelated donor for hematologic malignancy or myeloproliferative disorder.

Exclusion Criteria:

* Proven or probable aspergillosis or other mold infection or deep mycoses including hepatosplenic candidiasis less than 60 days from first dose of ISA.
* History of allergy or intolerance to ISA.
* Clinically significant elevation of liver function tests prior to the first day of dosing (FDD) that at the discretion of the treating physician would preclude the administration of an azole antifungal.
* Familial short QT syndrome.
What Amount of Stress is Enough for a Successful Conception?

The aim of the study is to determine whether premedication with midazolam before oocyte aspiration in IVF procedures affects the amount of (oxidative) stress in women undergoing IVF and whether stress is also transmitted to the follicular fluid of aspirated follicles. The primary endpoint is the impact of stress during aspiration on the success of medically assisted fertilization (IVF / ICSI in the stimulated cycle).

The procedure of in vitro fertilisation (IVF) is used to treat the infertility problems. The procedure includes ovary aspiration, to isolate oocytes. During the aspiration the patient is sedated with short-term intravenous aesthetic. Premedication is often used in anaesthesiology, and includes drugs application 30 minutes prior to procedure to sedate and treat the anxieties of the patient. One of the most often used drugs in premedication is midazolam. As the procedure is quite stressful for the patients, our aim is to investigate the influence of midazolam premedication on the stress release during the oocyte aspiration procedure, as well as its influence on the whole IVF procedure. Therefore, patients will be divided into two groups, control and midazolam. Blood samples will be taken before and during the procedure. Stress, antioxidant parameters (with glutathione and catalase) and oxidative status will be monitored in serum and follicular fluid.

The results will be correlated with subjective stress levels in the two groups in an effort to establish ties with IVF results.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent, healthy women undergoing IVF procedures for the first time

Exclusion Criteria:

* Refusal to enroll, chronic endocrine and psychiatric illnesses that might affect baseline stress levels
Retention and Retrieval for Three Different Training Methods

The hypotheses that will be studied are:

H0: Providers trained by a web based application for skill competency in basic life support (BLS) and automated external defibrillation (AED) are as competent as those who were trained by certified instructors using the European Resuscitation Council (ERC) curriculum

H00-1: Providers who trained themselves with the used of web based training are more competent when they had a personal manikin for home exercise compared to providers who trained themselves with only a web based training

H0-2: Providers who did not receive any training will score lower than those who did.

Research questions for this study are:

1. What are the results in skill competency for non trained people?
2. What are the results in skill competency for trained people immediately after training?
3. What is the retention of skills for trained and non trained people after six months?


Eligibility Criteria:
Inclusion Criteria:

* willing to follow a BLS/AED course

Exclusion Criteria:

* CPR training within the last five years
* professional health care provider
Arterial Elasticity: A Substudy of Strategic Timing of AntiRetroviral Treatment (START)

The purpose of this study is to find out if starting anti-retroviral therapy (ART) above 500 cluster-of-differentiation-4 (CD4)+ cells/milliliter (mL) ('early ART group') is better at reducing the stiffness of arteries than waiting to start ART until the CD4+ drops below 350 cells/mL ('deferred ART group'). Artery stiffness has been associated with an increased risk of cardiovascular (heart) disease, and could be useful as an earlier indicator of heart disease. In this study, the stiffness of arteries will be measured at study entry, months 4, 8, 12, and annually thereafter, using a tonometer on the participant's forearm.


Eligibility Criteria:
Inclusion Criteria:

* Simultaneous co-enrollment in the START study
* Signed informed consent

Exclusion Criteria:

* Inability to ascertain waveform measurements that can be analyzed, i.e. atrial fibrillation
Analysis of Patterns of Recurrence in Head and Neck Cancer Using Clinicopathomic Markers

Here, the investigators will develop a clinicopathomic assay from biomarkers obtained from digital pathologies of resected whole-mount oral cavity and oropharyngeal squamous cell carcinoma (OCSCC and OPSCC) specimens with the goal of administering personalized novel image-guided therapies immediately after primary surgical management in OCSCC and OPSCC patients. The primary aim is to determine the association between clinicopathomic biomarkers and LRR. The secondary aim is to develop a clinicopathomic risk score (assay) such that a decision-support tool can be used by physicians for measuring the benefit of additional therapies (i.e. conventional chemotherapy +/- radiation or administering dose-escalated chemoradiation) in the adjuvant setting to reduce LRR rates.

The proposed study is significant for developing personalized treatments. The proposed research will yield high rewards to patients by providing additional information to clinicians for better prognostication and potentially adapting adjuvant treatments to improve the survival of patients with OCSCC or OPSCC.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be men and women age 18+
* Confirmed diagnosis of oral cavity or oropharyngeal squamous cell carcinoma
* Participants must have received or will undergo surgery to excise the primary oropharyngeal tumor.

Exclusion Criteria:

* Participants who had other primary cancers prior to oral cavity or oropharyngeal cancer
AbsorbaTack Evaluation of Postoperative Pain Following Laparoscopic Hernia Repair

The objective of this study is to assess pain that occurs following hernia repair that is related to mesh fixation. The study is designed to see if there is any difference in pain after surgery between absorbable and permanent methods of mesh fixation in inguinal and ventral hernia repair.


Eligibility Criteria:
Inclusion Criteria:

* Ability and willingness to provide written informed consent and comply with the schedule of protocol assessments
* Age \> 18 years
* Subjects undergoing laparoscopic hernia repair with Parietex or Parietex Composite reinforcements depending on indication and fixation of reinforcements with helical tackers (ProTack, Covidien) or absorbable tacks (AbsorbaTack, Covidien) in accordance with recommendations for use

Exclusion Criteria:

* Pregnancy
* Patients considered to have greater than reasonable surgical risk associated with general anesthesia and laparoscopic hernia repair
* Known active infection or any major episode of infection requiring hospitalization or treatment with IV antibiotics or oral antibiotics within 30 days prior to screening
* History of alcohol or drug abuse within 6 months prior to screening
* History of chronic pain condition requiring more than 30 days of medical management
* Use of an additional nonresorbable means of fixation (inguinal)
* Patients considered not able to comply with the protocol and follow up schedule
* ASA grade of 4 or above
A Single-Center,Evaluation of the Onset and Duration of Action of AC-170 0.24% Compared to Vehicle

The purpose of this study is to evaluate the onset and duration of action of AC-170 0.24% compared to vehicle in the prevention of the signs and symptoms of allergic conjunctivitis in the conjunctival allergen challenge (CAC) model.


Eligibility Criteria:
Inclusion Criteria:

* positive bilateral conjunctival allergen challenge (CAC)reaction

Exclusion Criteria:

* known contraindications or sensitivities to the study medication or its components
* any ocular condition that, in the opinion of the investigator, could affect the subjects safety trial parameters
* use of disallowed medication during the period indicated prior to the enrollment or during the study
Can Quantitative MRI After cTACE Help Predict Survival ?

Transcatheter arterial chemoembolization (TACE) is a widely accepted palliative therapy for the treatment of HCC. Palliative means that it does not cure the disease prolongs your life and improves quality of life. During TACE, a mixture of chemotherapy drugs is combined with an oil called lipiodol. Lipiodol has a role as both drug carrier and embolic agent (a material that blocks blood flow to tumors). The lipiodol/chemotherapy mixture is injected into an artery (blood vessel) directly supplying blood to a HCC tumor.

Lipiodol is made up of fat and water which can be seen on MRI. Therefore, MRI can be used to quantify the amount of lipiodol delivered to the HCC tumors.

In this study, the investigators want to see if patient survival is related to the amount of lipiodol delivered to HCC tumors.


Eligibility Criteria:
Inclusion Criteria:

* Prospective studies will be performed in 20 patients with Hepatocellular Carcinoma (HCC) independently scheduled to undergo TACE; tumors in each of these candidates will already have been deemed un-resectable.
* Reasons may include

  * concurrent co-morbidities including cardiac or respiratory compromise
  * recurrent or multi-lobar disease
  * cirrhosis or portal hypertension
  * vascular invasion
  * high tumor burden
  * contraindications to general anesthesia.
* Diagnosis of HCC will have been established by a) biopsy or b) non-invasively, based upon \> 2cm diameter tumor with characteristic imaging findings in the setting of cirrhosis.
* Male or female aged 18 to 89 years, all ethnicities

Exclusion Criteria:

* Infiltrative or diffuse HCC.
* Does not meet inclusion criteria.
* Pregnant women.
* Individuals with pacemakers or other non-MRI compatible metallic implants.
* Hemodialysis patients or patients with severely impaired renal function.
* Individuals with severe claustrophobia or unwilling to get a MRI.
Observational Study to Evaluate Safety of Idarucizumab in Pediatric Patients

Idarucizumab is a humanized monoclonal antibody fragment (Fab) that binds to dabigatran with very high affinity. Idarucizumab potently and specifically binds to dabigatran and its metabolites and neutralises its anticoagulant effect. A clinical development program is ongoing to support marketing authorisation submissions for idarucizumab indicated in patients treated with dabigatran who require emergency surgery/urgent procedures or who have a life-threatening or uncontrolledbleeding when rapid reversal of the anticoagulant effects of dabigatran is required.

Purpose:

Study Design:

Eligibility Criteria:
Inclusion criteria:

* Male or female, \<18 years of age
* Were administered idarucizumab at sites and usage identified by various methods (eg.through the Idarucizumab drug administration surveillance program, spontaneous reporting)

Exclusion criteria:

Participation in a dabigatran or idarucizumab clinical trial
A Long-Term Prospective Randomized Controlled Study Using Repetitive Education at Six-Month Intervals and Monitoring for Adherence in Heart Failure Outpatients - The REMADHE Study

Recent meta-analysis reported reduction in mortality and hospitalization of HF patients.However, important issues in DMP for HF remain to be resolved. DMP are not homogeneous concerning methodology and in general included only elderly patients; most were tested in high-risk HF patients discharged from hospital; quality of life results are controversial; few reports included long-term results; some protocols had limited enrollment of screened patients, and it was suggested that could be less effective when patients are already followed by HF specialist.Improved survival was associated with cardiologist care as well with multidisciplinary teams providing specialized follow-up.Whether both together could benefits HF is not well defined. Also, no studies reported the long-term effects of a cyclic repetitive reeducation program.We tested whether a DMP that consisted of a long-term repetitive education program associated with a telephone monitoring could benefit HF outpatients in usual ambulatory care already under care of cardiologist with experience in HF


Eligibility Criteria:
Inclusion Criteria:

* Eligible patients on ambulatory care were aged 18 years or older with irreversible chronic heart .failure with at least 6 months duration, and non planned surgical procedure or other procedure that could influence the follow-up in the next 6 months

Exclusion Criteria:

* impossibility for attendance of education sessions and monitoring based on non corrected limitations of transport, or unfavorable distance, or social, or of communication; myocardial infarction or unstable angina within 6 months before randomization; cardiac surgery or angioplasty within 6 months randomization; hospitalized patients or recent discharged patients; severe renal/hepatic/neurological/pulmonary or any systemic disease that could confuse the interpretation of results and impair expected survival; and pregnant women or women of childbearing potential.
Visual Feedback Goggle for Positional Vertigo Treatment

Benign Paroxysmal Positional Vertigo (BPPV) is one of the most common causes of vertigo and the most common vestibular disorder of the inner ear. BPPV is the result of small free-floating particles (canaliths) in the posterior semicircular canals where they aggravate the sensory apparatus and induce sudden and severe attacks of vertigo when the head is turned into certain positions.

The treatment of BPPV was revolutionized by the introduction of the Epley maneuver, a sequence of head movements that use gravity to reposition the canaliths within the inner ear. The Epley maneuver provides prompt relief from vertigo in approximately 80% of patients.

The innovation, the Vertigone goggle, provides both physician and patient with visual feedback to guide them through an accurate Epley maneuver. This changes the current treatment paradigm for BPPV, greatly increasing the availability of the maneuver to non-specialist physicians, nurse practitioners, physician's assistants and physical therapists. The device is designed so that the patient with recurrent vertigo can use the goggle to treat BPPV at home. The goggle is currently a pre-market prototype.

The hypothesis for the study is that accuracy in the performance of the Epley maneuver correlates with improved clinical resolution of vertigo in BPPV patients. If the hypothesis is true, then there is a clear case for the utility of the visual feedback provided by the VertiGONE goggle in performing the maneuver.


Eligibility Criteria:
Inclusion Criteria:

* Age: 30-80
* Old patients (more than one year since first symptom)or new patients(more than 3 months duration of symptoms) diagnosed by physicians with Benign Paroxysmal Positional Vertigo (BPPV)
* Must have good neck flexibility to perform the movements of the Epley maneuver
* Subject is willing and able to provide written informed consent
* Subject is willing to remain in the clinic for the treatment and follow-up visits

Exclusion Criteria:

* Age \< 30 or Age \> 80
* Can not perform the movements of the Epley maneuver
* No informed consent form
* Not willing to remain in the clinic for the treatment and follow-up visits
Comparing NGENUITY vs Conventional Microscope in a New Hydrus User

To compare the potential efficiency and educational value of using NGENUITY (3D camera system, FDA approved for this indication) vs the conventional microscope for Hydrus microstent placement by new users.


Eligibility Criteria:
Inclusion Criteria:

* Patients with mild to moderate primary open angle glaucoma as defined by AGS with visually significant age-related cataract undergoing uncomplicated cataract surgery and Hydrus microstent
* Either eye or both eyes may participate

Exclusion Criteria:

* Lack of patient cooperation severely affecting ability to place stent with any visualization technique
* Angle abnormalities including PAS in nasal quadrant
* Unable to properly visualize the angle due to complicated cataract surgery
DAPHNE Scale Validation in Frontotemporal Lobar Degeneration

Psycho-behavioral disorders assessment is crucial for the diagnosis and follow-up of patients with frontotemporal degeneration (FTD). DAPHNE scientific staff have therefore developed a quantification and follow-up scale specifically dedicated to patients with FTD in current clinical practice. This scale is called DAPHNE to Disinhibition, Apathy, Perseveration, Hyper orality, Negligence and loss of Empathy.

Psycho-behavioral disorders assessment is crucial for the diagnosis and follow-up of patients with frontotemporal degeneration (FTD). DAPHNE scientific staff have therefore developed a quantification and follow-up scale specifically dedicated to patients with FTD in current clinical practice. This scale is called DAPHNE to Disinhibition, Apathy, Perseveration, Hyperorality, Negligence and loss of Empathy. This study aims to validate this scale. This validation will include methodological steps required to develop a new clinical tool, by studying internal consistency, loyalty, and concurrent validity in comparison with validated existing tools. Complementarily, sensitivity and specificity will be assessed via a control population including patients with Alzheimer's disease, , progressive supranuclear palsy and bipolar disorder with cognitive disorders.

Eligibility Criteria:
Inclusion Criteria:

Group 1:

1. Patients with FTD according Neary (1998) and Raskowsky (2011) diagnostic criteria.
2. Mini-Mental State Examination ≥ 18
3. Consent

Group 2 Control:

1. Patients with Alzheimer's disease (MacKahn, 2011), patients with supranuclear palsy (Litvan, 1996) and patients with bipolar disorder with cognitive disorders.

   criteria.
2. Mini-Mental State Examination ≥ 18
3. Consent

Exclusion Criteria:

* Minor patient
Experimental Control Investigation of the Impact of Assistive Technology on the User-caregiver Dyad: a Multi-site Trial

The purpose of this study is to determine the effectiveness of an assistive technology updating and tune up intervention on users and their caregivers. This intervention includes 4 components:

* an in-residence assessment of the mobility preferences of the older person and his/her caregiver
* a detailed review of forms of assistance, technological and human, that are currently being used
* recommendations by an occupational therapist for possible changes in the older person's mobility assistive technology or assistance strategy
* therapist negotiation of an mobility assistive technology updating and tune-up intervention plan with the individual and his or her caregiver. The intervention is provided to the immediate treatment following the administration of baseline measures and the delayed intervention group six weeks later, after an additional baseline measurement. The treatment is six weeks long and the follow-up is 26 weeks.

Hypothesis 1: For community-dwelling older people, an intervention that increases the appropriateness of existing or new assistive technology(AT) for mobility or self-care will alter established patterns of human assistance, such that caregiver burden is reduced or eliminated.

Hypothesis 2: At the same time, AT users will report less difficulty in mobility or self-care, as well as enhanced subjective well-being, and satisfaction with their modified personal assistance strategy.

Hypothesis 3: Following the AT intervention, caregivers will report reduced physical and/or psychological demands and increased satisfaction with their caregiving-related activities compared with

* the pre-intervention period
* caregivers in a delayed intervention control group. Hypothesis 4: Decreased physical and/or psychological demands on helpers will be associated with increases in device users' satisfaction with their personal assistance strategies.


Eligibility Criteria:
Inclusion Criteria:

* Users: Aged 65 years and over
* Have moderate to severe disability that limits their ability to move from place to place independently and/or to perform self-care activities.
* Living at home
* Receiving 2 or more hour per week of assistance with mobility and/or self-care activities from a non-professional, caregiver who is also willing to take part in the study.
* Those caregivers will be adults aged 18 years and over.

Exclusion Criteria:

* Assistive technology users will be excluded if they have severe aphasia, are currently on a community occupational therapist caseload, or are unable to communicate in English or French.