cyrilzakka/clinical-trials huggingface dataset:
Trial to Evaluate the Effects of Sound Modulation on Critically Ill Patients

The goal of the project is to determine the effects of noise masking and noise reduction on stress related physiological parameters in critically ill patients admitted to the intensive care unit.

Sleep deprivation is common in critically ill patients in the intensive care unit (ICU) and may impair recovery. While noise is widely cited as the most common cause of sleep disruption in the ICU setting, its contribution to sympathetic activity in critically ill patients is not known. This is an important knowledge gap, because noise initiates a sequence of physiological changes including vasoconstriction, raised diastolic blood pressure, pupil dilatation and muscle tension. Furthermore, noise is implicated in sympathetic arousals, resulting in a release of adrenaline which prevents relaxation and consequently prevents the patient from falling asleep.

The investigators plan to study the effect of noise masking and noise reduction on stress related physiological parameters in critically ill patients admitted to the ICU. Subjects will be randomized into 3 separate groups: control, noise reduction, and noise masking. The investigators will compare the heart rate and blood pressure variability between and within the groups to determine the effects of treatment assignment on these variables. Non-invasive measurements obtained from the bedside monitor will be collected using physiological data acquisition software.

Eligibility Criteria:
Inclusion Criteria:

* Subjects aged 18-99 years who are expected to receive care on an adult critical care unit for at least 24 hours

Exclusion Criteria:

* Admission for drug overdose or with a known substance abuse disorder
* Untreated sleep apnea disorder, narcolepsy, REM sleep behavior disorder, parasomnia, restless leg syndrome or other sleep disorder
* Use of hearing aids, or known significant conductive or sensory hearing loss
* Ventilator support via an endotracheal tube
* Use of vasopressors
* Unresponsive or delirious
* Subjects with known Dementia, Parkinson's disease, or other neurodegenerative disorder
* Subjects with a pacemaker or who have received cardiac transplant
The Study on Bacterial Load Following Open-to-air Management in Burn Patients.

Burns are one of the common forms of trauma and are a cause of unintentional death and injury. Management of burns becomes complex due to multiple associated complications, for instance, secondary infection of burn wounds is the most common complication associated with burn injuries. Treatment of bacterial infections with antibiotics is becoming more challenging due to the development of multidrug-resistance. Hence, there is a critical need to investigate and establish non-antibiotic approaches to prevent colonization, control growth, and eliminate bacteria from burn wounds. Recent studies have explored the beneficial effects of open-to-air strategies on wound healing. Based on the evidence, the investigators hypothesize that bacterial load in burn wounds will be lowered when treated with an open-to-air strategy compared to the traditional closed wound approach.

Burns are one of the common forms of trauma and are a cause of unintentional death and injury in the world as well as in the United States (US). Management of burns becomes complex due to multiple associated complications, which result in short-term and long-term disability. Secondary infection of burn wounds is the most common complication associated with burn injuries. Approximately 10,000 people die in the US due to burn-related infections. For instance, gram-negative Pseudomonas aeruginosa is an opportunistic organism commonly found in burn wounds. Bacterial infections cause prolonged hospital stay, increase morbidity, and mortality of burn patients. Treatment of bacterial infections with antibiotics is becoming more challenging due to the development of multidrug-resistance. Hence, current antibiotic regimens and wound care are not always successful in eliminating bacterial infections. As such, there is a critical need to investigate and establish non-antibiotic approaches to prevent colonization, control growth, and eliminate bacteria from burn wounds.

Recent studies have explored the beneficial effects of open-to-air strategies on wound healing, especially in the presence of necrotizing infections. In an open-to air strategy, the wound is left open to the external environment with a heat lamp placed at 6 feet to promote drying. However, the spritz of a topical solution will be applied to avoid excessive drying. Based on current evidence, the investigators hypothesize that bacterial load in burn wounds will be lowered when treated with an open-to-air strategy compared to the traditional closed wound approach.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 to 89
2. Burn patients with TBSA≥ 20%
3. Any suspicion of skin colonization or infection based on a positive result of microbiologic testing. Testing would only be performed if the attending surgeon treating the patient had a clinical suspicion of wound infection.

Exclusion Criteria:

1. Children
OrthoPulse Gen 2 Initial Device Evaluation and Assessment of Clinical Effectiveness (CA)

This is a prospective, interventional, non-randomized, control, split-mouth, open-label, single centre, private practice study aimed to evaluate the effect of tooth movement during orthodontic treatment using a removeable thermoplastic orthodontic appliance. Intrusion and extrusion will be conducted using bilaterally equivalent elastomeric forces of 50 grams.

A comparison of the rate of bilateral orthodontic tooth movement will be conducted using six (6) varied photobiomodulation interventions on the maxillary (upper) and mandibular (lower) arches. The OrthoPulse Gen 2 and OrthoPulse (commercially approved) devices are being used in this clinical investigation. Each subject enrolled will go through intrusion and extrusion.

All subjects will be allocated to an OrthoPulse split-mouth intervention by the investigator.


Eligibility Criteria:
Inclusion Criteria:

* Patient must be 19 years of age or older
* Likely to be compliant to OrthoPulse use, aligner wear, and Dental Monitoring scanning
* Have a compatible iOS or Android device and are willing to download the OrthoPulse and Dental Monitoring apps for frequent automatic syncing of data

Exclusion Criteria:

* Patient is currently enrolled in another clinical study
* Crowding or rotations of bilateral bicuspids that would prevent or interfere with intrusion
* Periodontally involved teeth, acute oral infection or periodontal disease
* Patient has active/untreated caries
* Use of bisphosphonates at any time
* Use of drugs that may cause photosensitivity
* History of photosensitivity
* Epilepsy
* Pregnant or planning pregnancy during the study.
* Patient plans to relocate over the treatment period
The Impact of Music on Nociceptive Processing

The investigators are studying the ways that different music may change pain perception

In this study, the investigators are comparing healthy individuals to HIV and Fibromyalgia patients. The investigators are measuring the differences in pain processing between subject groups in the presence and absence of different music and distraction conditions. The investigators will be using Quantitative Sensory Testing (QST) in order to induce varying pain conditions on the participants. The investigators will also have participants complete sets of psychosocial questionnaires. Patients with Fibromyalgia tend to have a higher pain sensitivity. Additionally, patients with an HIV diagnosis tend to be prescribed opioid medications. The investigators would like to find out if music can modulate pain, and in turn help reduce the amount of opioid medications those with a chronic pain diagnosis take.

Eligibility Criteria:
Healthy volunteers no longer needed for this study (9/9/2021).

Inclusion criteria for Healthy volunteers (N=70) without a diagnosis of neuropathy or chronic pain:

* aged \>18 years
* able to speak and understand English
* willingness to undergo psychophysical and psychosocial testing.

Exclusion criteria:

* diagnosed hearing loss
* diagnosis of chronic pain/neuropathy
* history of chronic opioid use (having an opioid prescription \>30 days).

Inclusion criteria for Fibromyalgia patients: N=70:

* aged \>18 years
* have a diagnosis of fibromyalgia with concurrent chronic pain for \> 6 months, and meet the Wolfe et al 2011 research criteria for fibromyalgia
* have an average self-reported pain score of 4/10 or greater
* willing to undergo psychophysical and psychosocial testing
* able to speak and understand English.

Exclusion criteria:

--diagnosed hearing loss.

HIV Patients with chronic pain: N=70

* aged \>18- years
* have a diagnosis of HIV infection
* have had chronic pain with onset \> 6 months
* have an average self-reported pain score of 4/10 or greater
* willing to undergo psychophysical and psychosocial testing
* able speak and understand English.

Exclusion criteria:

--diagnosed hearing loss.
Switching From Octreotide to Lanreotide - A Look Back at Patients With Neuroendocrine Tumors

The purpose of this study is to understand how people with neuroendocrine tumors respond to treatment with lanreotide after having received treatment with octreotide.


Eligibility Criteria:
Inclusion Criteria:

* Males and females age 18 years or older at time of locally advanced or metastatic diagnosis
* Patients with a confirmed diagnosis of locally advanced or metastatic Gastroenteropancreatic neuroendocrine tumour (GEP-NET)
* Patients who switched treatment from long acting octreotide LAR to lanreotide, where both treatments were received for the treatment of locally advanced or metastatic GEP-NET. i. Treatment with long acting octreotide LAR monotherapy for at least 90-days before treatment with lanreotide monotherapy (rescue SSA# use permitted). ii. Treatment with lanreotide monotherapy for at least 90-days after treatment with long acting octreotide monotherapy (rescue SSA# use permitted)

Exclusion Criteria:

* Patients with other malignant disease
* Patients who participated in a concomitant clinical trial related to treatment of GEP-NET
* Patients being treated with a Somatostatin analogue (SSA) in combination with other NET treatments excluding rescue SSA#
* Patients who received other primary treatment (e.g., targeted therapy, chemotherapy) for GEP-NET during the interval between octreotide and lanreotide
* Patients with NET familial genetic syndrome (i.e., MEN1)
Sharing History Through Active Reminiscence and Photo-imagery - With MCI

The SHARP-MCI study tests impact of walking and social reminiscence on cognitive function, blood pressure, and weight among healthy Black Americans and those experiencing mild cognitive impairment (MCI).

For 6 months (24 weeks), triads of healthy and MCI Black adults aged 55 and over walk 3x/week (1 mile) in Portland's historically Black neighborhoods. Triads follow GPS-mapped routes accessible via the SHARP walking application on a group tablet device. At three points along each route, GPS-triggered "Memory Markers" (historical images of local Black culture and life from1940-2010) appear on the tablet screen serving as a conversational reminisce prompt as the triad walks. At baseline and 24 weeks, cognitive function is measured via the Montreal Cognitive Assessment (MoCA), and weight and blood pressure are measured. Pre-post health surveys rate activity levels, days feeling downhearted/blue, energy level, and health status. Program evaluation surveys at month 1, 3, 6 assess mood, pace and dose of walking, prompt effectiveness, program readiness, and liklihood to recommend program to others. Focus groups at month 1, 3, 6 evaluate participants' program experience and needed changes.

Eligibility Criteria:
Inclusion Criteria:

* Self-identified African American
* \> 55 years old
* Reside or resided for \>10 years in Portland's historically Black neighborhoods (to be familiar with Memory Markers about this area)
* Able to ambulate independently. Participants (n=7) with MCI will meet criteria consistent with those defined by Jak et al. 2009 and with criteria outlined by the NIA-Alzheimer's Association workgroup (2011)
* Participants without cognitive impairment (n=14) will have an MMSE score \> 24 (and not meet MCI criteria).
* Participants' cognitive function should allow them to get to/ from walk locations independently or with minimal assistance

Exclusion Criteria:

* Serious or unstable medical condition (such as, but not limited to, cardiovascular disease, pulmonary disease, or severe arthritis) where participation in the trial would, in the opinion of the investigator, pose a significant health risk to the subject.
* Diagnosis of Alzheimer's disease, vascular dementia, Parkinson's disease, or other dementing illness.
Pectopexy Autologous Vs Mesh

prospective comparative study describing using autologous graft for uterine- vault - cervical suspension vs mesh in treatment of apical prolapse


Eligibility Criteria:
Inclusion Criteria:

uterine - vault prolapse

-

Exclusion Criteria:

* previous vaginal repair for uterine or vaginal prolapse previous suspension procedures for apical prolapse
Post Hysterectomy Pain Prevention: Pre-op Wound Infiltration With Anesthetic Protocol Versus Standard of Care

The study is a blinded randomized clinical trial, comparing policies of high volume preemptive wound infiltration with a specific anesthetic cocktail versus standard of care (no wound infiltration and routine anesthesia) for post operative pain management after hysterectomy. Morphine use and pain will be measured during index admission, and pain will also be measured six weeks postoperatively. The study will be conducted at a single site, Rockyview General Hospital.


Eligibility Criteria:
Inclusion Criteria:

* women may be included if they require total abdominal hysterectomies (+/- BSO) at Rockyview hospital.

Exclusion Criteria:

* have endometrial cancer,
* require a vertical midline incision,
* have any additional surgery planned
* have a contraindication to morphine, Magnesium Sulfate, Dexmethasone, Lidocaine or Marcaine
* have difficulty communicating in English
Evaluation of Effectiveness and Safety of Aortic Valve Replacement in Routine Clinical Practice

This study evaluated effectiveness and safety of aortic valve replacement in real-world clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Age 19 and more
* Patient with aortic valve replacement

Exclusion Criteria:

* Combined with mitral stenosis requiring surgery or aorta stenosis
* Acute bacterial endocarditis within 1 month of valve replacement
EFFECT OF BUFFERED LOCAL ANESTHESIA ON PAIN IN ARETERIOVENOUS FISTULA

Pain and satisfaction score will be assessed at the end of surgery and compared in either of two groups

All patients meeting inclusion criteria will be randomly enrolled in two groups. Intervention group will receive buffered lignocaine . at the end of procedure data will be recorded regarding pain VASscore and satisfaction score

Eligibility Criteria:
Inclusion Criteria:

* ASA I to III
* Brachiocephalic arteriovenous fistula
* Radiocephalic arteriovenous fistula

Exclusion Criteria:

* basiic vein transposition
* redo surgery emergency surgery
* failure to understand the questionnnare
Transcriptomic Profile of Endometrium in Different Histological Dating of Natural Cycle

At present, the evaluation criterion of endometrial receptivity is controversial. The development of a molecular diagnostic tool, the endometrial receptivity array (ERA) for diagnosis of endometrial receptivity . But use of this test in patients with RIF has shown that the window of implantation (WOI) is displaced in only a quarter of these patients and use of a personalized embryo transfer (pET) on the day designated by ERA improves reproductive performance with higher cost .what is known to the others'population? The morphological changes observed on histology for each specific day after ovulation were described by Noyes and his colleagues in 1950 . An endometrial biopsy that shows a difference of more than 2 days between the histologic dating and actual day after ovulation is considered to be ''out of phase''. But such pET studies according to the Noyes criterion are lacking . The aim of this study is to explore the transcriptomic profile of endometrial receptivity in different histological dating of natural cycle and its clinical application.


Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria for RIF group were: unexplained repeated implantation failure (RIF) is defined as the absence of a gestational sac on ultrasound at 5 or more weeks after embryo transfer (ET) after 3 embryo transfers with high quality embryos or after the transfer of ≥10 embryos in multiple transfers.

The inclusion criteria for control group were: (1) age \<35 years; (2) regular menstrual cycles of 24-35 days; (3) baseline follicle- stimulating hormone (FSH) \< 9.0 IU/L; (4) endometrial thickness ≥8.0 mm on the day of hCG administration.

Exclusion Criteria:

* (1) uterine abnormalities (double uterus, bicornuate uterus, unicornuate uterus); (2) intrauterine adhesions（moderate - severe）, endometriosis, adenomyosis, untreated hydrosalpinx, uterine fibroids (submucosal fibroids, nonmucosal fibroids \>4.0 cm and/or endometrial pressure) (3) history of adverse pregnancy (including spontaneous abortion, stillbirth, and fetal malformation).
Detecting and Addressing Preclinical Disability

The Physical Functioning Inventory (PFI) is a standardized patient reported outcome measure that assesses preclinical disability. Preclinical disability is a functional state in which people are still able to complete daily living tasks (e.g., walking, bathing) but are changing the frequency or modifying the way that they complete the tasks. The investigators have done some preliminary research using the PFI as an online monitoring tool (Richardson 2012), but further study is required to examine its psychometric properties and its suitability for use as a primary outcome measure. This measurement study has been designed to identify the optimal number of items on the PFI and to determine the reliability, validity, and responsiveness of the PFI when administered to a sample of adults and older adults both with and without chronic conditions. This project will also allow us to evaluate the use of self-monitoring of physical function and the added value of rehabilitation professionals to support self-monitoring. Using the results of the PFI, the investigators aim to develop a "tailored" population-based rehabilitation self-management intervention delivered through a secure messaging system in the patient's electronic personal health record (myOSCAR) that focuses on the early detection and prevention of preclinical disability.


Eligibility Criteria:
Inclusion Criteria:

* Greater than or equal to 44 years of age
* Able to communicate in English
* Have had at least 3 physician visits in the last year
* Are able to access an email address independently
* Have a chronic disease

Exclusion Criteria:

* Any evidence of cognitive impairment
* Unable to travel to the clinic
* Awaiting long-term care
* Planning to relocate
* Experiencing an acute illness
* Are receiving palliative care
Asthma Biomarkers for Predicting Response to Therapy

Novel asthma biomarkers to predict the response to inhaled corticosteroid Brief description: This will be a single center study of asthmatic subjects and healthy controls which will investigate mechanisms underlying different response to inhaled corticosteroid, the mainstay of asthma therapy. Only about half of the asthmatic patients have improved lung function after treatment of inhaled corticosteroid. The investigators hypothesize that there are biomarkers such as epithelial cytokines (IL-25, IL-33, TSLP) in airway tissues or plasma of asthmatic patients which could predict the response of asthmatic patients to inhaled corticosteroid. Finding novel asthma biomarker will help the clinicians to choose the optimal treatment for individual asthmatic patient.


Eligibility Criteria:
Group A:

Inclusion Criteria:

* Male and female subjects between the ages of 18 and 70 years
* No respiratory symptoms
* Normal spirometric value and methacholine PD20 \>2.5mg

Group B:

Inclusion Criteria:

* Male and female subjects between the ages of 18 and 70 years
* History of asthma
* No use of oral or inhaled corticosteroids for the treatment of asthma
* No use of leukotriene antagonist for the treatment of asthma
* Hyperreactivity to methacholine (PD20 FEV1 Methacholine \< 2.5 mg) and/or ≥12% increase in FEV1 following inhalation of 200μg salbutamol
* Asthma symptoms of episodic cough, wheeze and/or breathlessness

Exclusion Criteria:

* Current or former smokers
* Pregnant women
* Subjects with a history of lung disease other than asthma
* Subjects with a history of a medical disease, which in the opinion of the investigator may put the subject at extra risk from study-related procedures or because the disease may influence the results of the study
Reduction of Spontaneous Prematurity by Antibiotic Treatment (Josamycin)

The purpose of this study is to test the effectiveness of an antibiotic treatment (Josamycin) in the case of positive PCR for Ureaplasma spp. and/or Mycoplasma hominis in the second quarter on the risk of premature birth.

Infection would be the cause of 40 % of spontaneous premature deliveries. The physiopathological hypothesis accepted is a premature ascent of present bacteria in the low genital ways towards the decidual, the foetal membranes then the amniotic liquid. These bacteria are responsible for an inflammatory reaction to the interface feto-maternal characterized by the production of proinflammatory cytokines and pro-contractants agents (prostaglandins, oxytocin) by the decidual and the membranes.

These mediators cause uterine contractions, a maturation of the uterine collar, a rupture of the membranes then a premature birth.

Several recent publications show on the one hand that Mycoplasma hominis and Ureaplasma spp. are the bacteria most frequently found in the amniotic liquid in the second quarter of the pregnancy and that a positive PCR for these bacteria is associated with a premature birth.

A probable assumption would be that Mycoplasma hominis or Ureaplasma spp. cause a premature birth by infecting the fetal membranes and the decidual, then activating the immune system and the pro-inflammatory production of cytokines. These bacteria are sensitive to antibiotic treatment.

Nevertheless, no randomized controlled trials have been carried out to determine wether an antibiotic treatment would decrease spontaneous prematurity in the case of positive PCR in the amniotic liquid.

Eligibility Criteria:
Inclusion Criteria:

* Patient older ≥ 18 years
* French speaking
* Women who have an amniocentesis between 15 and 20 weeks of amenorrhoea for an antenatal diagnosis
* Affiliated to social security or an equivalent system
* Karyotype analysis and ultrasound morphological normal (apart from minor signs of trisomy 21)
* Clear amniotic fluid (not contaminated by the mother's blood)
* Gestational age is between 15 WA(day+0) and 20 WA(day+6)
* Patient have not allergy to macrolides
* Do not have cure underway by macrolide
* Patient followed during her pregnancy in an investigator site
* Informed consent and signed

Exclusion Criteria:

* No speaking french
* Having an allergy to macrolides
* Having a multiple pregnancy
* Morphological Anomaly
* Patient no consented
* Lactose Intolerance
* Not agreed to participate