cyrilzakka/clinical-trials huggingface dataset:
Impact of an Automatic Alert Device on the Occurrence of Nocturnal Falls in Nursing Home Residents

Impact of an automatic alert device on the occurrence of nocturnal falls in nursing home residents Measurement of the number of nocturnal falls between 8 p.m. and 8 a.m. per registered resident in the 6 months preceding use of the device compared with the number of nocturnal falls in the 6 months after installation of the device.


Eligibility Criteria:
Inclusion Criteria:

* Resident of the elderly nursing home (EHPAD LES ORCHIDEES).
* Repeated nocturnal falls (more than 2 falls at night between 8 p.m. and 8 a.m.) during the last 12 months.
* Consent of the resident or his legal representative.
* Signature of informed consent
* French-speaking resident.

Exclusion Criteria:

* Refusal to participate in the study.
* Resident exclusive day faller.
Translational Research to Inform Interventions for Challenging Behavior

This project is meant to identify relations between the reinforcement histories of 80 adults with intellectual and developmental disabilities (IDD) and the prevalence of extinction bursts. Extinction bursts, or temporary increases in rates and intensities of behavior during extinction, often preclude the inclusion of extinction in intervention packages meant to suppress severe challenging behavior, despite the fact that extinction is often necessary to generate therapeutic outcomes. Study results will provide insight into how researchers can enhance interventions for the severe challenging behavior of individuals with IDD while mitigating the undesirable collateral effects (i.e., extinction bursts) of therapeutic action (i.e., extinction). Expanded access to study results will be made available to those who inquire after all data have been obtained and analyzed.

The Goal of this project is to identify mechanisms responsible for bursts, and to facilitate strategic extensions toward discovery for treatments of challenging behavior. AIM 1: In the service of this goal, the investigators aim to evaluate the accuracy of an efficient alternative to demand-curve analysis (i.e., progressive ratio reinforcer analysis) in quantifying reinforcer value (i.e., Pmax). AIM 2: Investigators also aim to evaluate the utility of manipulating baseline reinforcement parameters for controlling bursts when those manipulations are informed by the results of demand-curve analysis.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be older than 18.
* Participants must have a developmental disability (unconstrained to specific diagnoses).
* Participants must be able to correctly manipulate all items used in the study.
* Participants must consent (or assent, when relevant) to procedures prior to and throughout the study.

Exclusion Criteria:

* Participants younger than 18.
* Participants without disabilities.
* Participants who cannot correctly manipulate items used in the study.
* Participants who do not consent (or assent, when relevant) to participation.
Absolute Bioavailability Of Bosutinib

This is an open-label, randomized, single-dose, one-cohort, two-sequence, two-period crossover study in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects (of non-childbearing potential).
* Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
* Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, accept placement of indwelling catheter for infusion and other study procedures.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies).
* A positive urine drug screen for cocaine, tetrahydrocannabinol (THC), opiates/opioids, benzodiazepines and amphetamines.
Isotonic Versus Hypotonic Fluid for Maintenance IV Therapy

Hyponatremia associated with administration of hypotonic intravenous (IV) fluids may have serious complications. It has recently been suggested that isotonic saline may be a more appropriate choice of maintenance IV fluid. This pilot and feasibility study aims to compare isotonic saline to 0.45% saline in hospitalized children requiring parenteral fluid support in order to:

Aim 1: To determine the feasibility of conducting a double-blind, randomized controlled trial comparing these solutions.

Aim 2a: To compare the rate of change in serum Na (mmol/L/hr) and the incidence of hyponatremia (Na \<136 mmol/L) between patients receiving isotonic and hypotonic intravenous fluids at at least 50% of the traditional maintenance rate for an interval of at least 8 hours.

Aim 2b: To compare the incidence of adverse events between the two IV fluid treatment groups.


Eligibility Criteria:
Inclusion Criteria:

* 1 month to 18 years of age
* Require IV fluids for at least 8 hr.
* Baseline serum sodium \>=136 mmol/L \& \<=145 mmol/L

Exclusion Criteria:

* Baseline serum sodium concentration less than 136 mmol/L or greater than 145 mmol/L
* Renal disease, a history of cardiac dysfunction or evidence of cardiac dysfunction, pre-existing hypertension, diuretic use, edema, or known adrenal dysfunction
* Acute neurological illness such as meningitis or encephalitis
* Severe chronic neurological illnesses (uncontrolled seizure disorders, severe developmental delay)
The Effect of Exercise Training Intensity in Patients With Type 2 Diabetes

The purpose of this randomized clinical trial is to compare the effect of moderate versus high intensity exercise training on physical fitness and physical function in patients with type 2 diabetes. The research hypothesis is that high intensity exercise training will be superior to moderate intensity on such outcomes in individuals with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* All participants meet the American Diabetes Association diagnostic criteria for type 2 diabetes.
* A physician must consider each participant to be medically stable to participate in this investigation.

Exclusion Criteria:

* Any individual with a history of a medical condition identified by the American Heart Association as an absolute contraindication to exercise testing is excluded from this study.
* Any individual with angina (stable or unstable), uncontrolled hypertension, proliferative retinopathy, severe peripheral neuropathy, nephropathy, autonomic neuropathy, history of coronary artery disease, history of myocardial infarction, or unable to participate in this study due to a physical impairment is excluded from this investigation.
* Any individual involved in resistance training or aerobic training within 3 months of the beginning of this investigation is excluded.
ArcadiusXP L Post Market Clinical Follow-Up

The purpose of this study is to collect clinical and radiological mid-term (2 years) data on the ArcadiusXP L® lumbar stand-alone cage in a post-market clinical follow-up study (PMCF) limited to 32 patients.


Eligibility Criteria:
Inclusion Criteria:

* all indications as given by the instructions for use
* Patients with persisting lumbosacral and pseudo-radicular pain scheduled for monosegmental lumbar interbody fusion from L4 to S1
* Age 18 - 60
* at least 6 months of unsuccessful treatment including conservative measures
* Non-sequestrated and subligamentous prolapse

Exclusion Criteria:

* all contraindications, which are listed in the instructions for use.
* existing pregnancy, planned or occurring during study period
* patients with a higher degree of segmental degeneration in other than the segment to be operated
* body- mass-index (BMI) \> 30
* Systemic or local infection
* Increased risk of osteoporosis according to assessment by the SCORE evaluation
* Bone metabolism disorders
* Chemotherapy or radiotherapy (ongoing or planned)
* Participation in another clinical trial
* Scheduled for spinal litigation
* Other serious conditions that hinder the participation in the study
* Nanogel® filling of the cage, prior to implantation was not done
Bacterial Genomic Sequencing in Overactive Bladder

No one really knows what causes overactive bladder syndrome (OAB). Urinary tract infection (UTI)causes similar symptoms to OAB with the difference being the presence of bacteria, as evidenced by routine microbiology cultures. Recent work by the group on the genitourinary microbiome (GUM) has shown that female urine, even in the absence of culture evidence of bacteria does have evidence of bacterial DNA. Bacterial 16S rRNA can be isolated from urine and sequenced to identify bacterial species present in urine. From this the investigators can hypothesize that urinary bacteria contribute to urinary symptoms and that there is a difference in the bacterial communities in the urine of women who respond to Solifenacin, a drug used to treat OAB, versus those that do not.

This is a prospective study with two groups: Women who have accepted a clinical recommendation for OAB treatment with solifenacin and a comparator (control) group of women unaffected by OAB. All women will have a baseline urine assessment with bacterial genome sequencing. Solifenacin treated patients will also have urine assessments with bacterial genomic sequencing at 4 and 12 weeks on treatment.

Eligibility Criteria:
Inclusion Criteria:

Controls: Women without bother from urinary symptoms will be screened for potential study participation using the pelvic floor distress inventory (PFDI). Women with negative urinary responses will be further screened for participation using the following eligibility criteria:

* no anticholinergic medications for bladder conditions,
* no antibiotic exposure in the past 4 weeks for any reason,
* no immunologic deficiency,
* no pelvic malignancy or pelvic radiation, and
* Untreated symptomatic POP \> POP-Q Stage II.

OAB cohort: Women with bother from overactive bladder symptoms will be screened for potential study participation using the pelvic floor distress inventory (PFDI). Women with positive urinary responses for urge predominant symptoms will be further screened for participation using the following eligibility criteria:

* willing to take Solifenacin as treatment for OAB,
* no neurological disease known to affect the lower urinary tract,
* no current UTI (based on urine dipstick) or recurrent UTI,
* no antibiotic exposure in the past 4 weeks for any reason,
* no immunologic deficiency,
* no pelvic malignancy or pelvic radiation,
* untreated symptomatic POP \> POP-Q Stage II,
* no contraindications to receiving Solifenacin.

Exclusion Criteria:

* Women who are of child-bearing potential who are pregnant, nursing, intending to become pregnant during the study or not practicing a reliable form of contraception are also excluded.
Bronchial Dilation Test in Wheezy Infants

The purpose of the study is to establish the methodology of bronchial dilation test by salbutamol MDI with Spacer in wheezy infants with asthma and to evaluate the effects of atopy on the exacerbation of wheeze in wheezy infants.

After screening,each participant undergo baseline pulmonary function test(Jaeger Master Screen Baby Body, Germany)and post-bronchodilator measurements that performed 10min after 200ug of salbutamol administered using a metered-dose inhaler and a spacer.

The participants undergo baseline lung function test and bronchial dilation tests on the second and third visits with one-month interval,and whenever there is an exacerbation.

Eligibility Criteria:
Inclusion Criteria:

* normal term infants.Recurrent wheezing with or without atopy,none of the subjects had a history of respiratory illness, congenital heart disease,dysphagia,oxygen saturation≤90% on room air,an active seizure disorder,or upper airway obstruction,or requirement for assisted ventilation in the neonatal periods,all infants were asymptomatic for at least 2 weeks preceding the test.

Exclusion Criteria:

* subjects had a history of respiratory illness, congenital heart disease,dysphagia,oxygen saturation≤90% on room air,an active seizure disorder,or upper airway obstruction,;all infants were asymptomatic for at least 2 weeks preceding the test.
Pro-rEsolving and pRo-inflammatory reSPonses to Acute exhaustIve exeRcisE in Healthy Individuals

This is a study of the effects of acute, exhaustive exercise on pro-resolving and pro-inflammatory responses in healthy, trained and untrained adults.

The study requires one visit (a second, optional visit may occur). At the visit, participants will have blood drawn at several time points and also perform an exhaustive bout of treadmill exercise. Differences in specialized pro-resolving lipid mediators (SPMs) and other measures of inflammation and resolution over time will be characterized.

Eligibility Criteria:
Inclusion Criteria:

* Willingness and ability to provide informed consent and participate in PRESPIRE
* Able to read and speak English adequately to provide informed consent and understand verbal and written instructions. (the diet and sleep questionnaires are not validated in languages other than English)
* BMI \< 27kg/m2
* Untrained: self-reporting no more than 1 day per week of regular exercise (inclusive of walking \>5,000 steps daily and commuting via bicycle).
* Trained: self-reporting at least 4 hours of aerobic exercise / moderate or greater intensity physical activity weekly for the past year.

Exclusion Criteria:

* Anti-platelet medication use
* Chronic inflammatory or connective tissue disease
* History of bleeding or clotting disorder
* Immunological deficiency
* Diabetes mellitus
* Stage 2 or greater hypertension on screening
* Cardiovascular disease
* Chronic obstructive lung disease
* Anemia (hemoglobin \<13g/dL in males or \< 12 g/dL in females)
* Active smoking
* \>5% body weight change over the past 6 months or plan to gain/lose weight during the study
* Platelet count \<100,000
* Use of omega-3 fatty acid supplementation within 3 weeks of study participation
* Use of drugs or supplements known to inhibit COX-1/COX-2/lipoxygenases
* Corticosteroid use
* Use of beta-blocker medications
* Use of alpha-blocker medications
* Use of NSAIDs or aspirin within 2 weeks of study participation
* Vaccination within 2 weeks of study participation
* Pregnancy (a state of relative immunological deficiency)
* Any other cardiovascular, pulmonary, orthopedic, neurologic, psychiatric or other conditions that, in the opinion of the local clinician, would preclude participation and successful completion of the protocol.
* Any other illnesses that, in the opinion of the local clinician, would negatively impact or mitigate participation in and completion of the protocol
Decongestion Guided By VExUS Score Or Lung Ultrasound For Renal Recovery In Patients With Cardiorenal Syndrome Type -1

the goal of this observational study is to evaluate the role of VEXUS score and lung ultrasound to guide decongestive therapy in patients with cardiorenal syndrome type -1. the main question it aims to answer is: Can the VEXUS score and lung ultrasound guide the efffect of decongestive therapy on KFR and decongestion metrics in patients with CRS-1 compared to standard assesment ?


Eligibility Criteria:
Inclusion Criteria:

* • Patients of both genders aged 18-65 years old.

  * Patients with CRS1 criteria (worsening of renal function due to acute heart failure manifested by : ( Dyspnea , orthopnea ,hypoxia , congested neck veins , oliguria and congestion in imaging.)
  * Patients with Modified lung ultrasound score(LUSS) more than 15.

Exclusion Criteria:

* • Refusal to participate.

  * Patients with renal transplantation.
  * Unknowing baseline creatinine.
  * Patients with a life-threatening indication of RRT (defined as intractable hyperkalemia, acidosis, uremic symptoms) at enrollment,
  * RRT before recruitment,
  * known prehospitalization advanced chronic kidney disease (defined by an estimated GFR \<30 mL/min/1.73 m2 or chronic RRT),
  * use of extracorporeal membrane oxygenation (ECMO),
  * diagnosis of hepatic cirrhosis or other condition with portal hypertension
  * Or postrenal causes of AKI
PRESERVE & CONNECT: Impact Study of the BPC

The PRESERVE \& CONNECT project is a multi-site randomized control trial of the Breakthrough Parenting Curriculum: Navigating Trauma Across Generations (BPC) in rural and racially and ethnically diverse communities in Vermont and Connecticut.

The proposed study will determine the efficacy of the BPC at improving the lives of families with a significant history of trauma and establish the evidence base to allow the BPC to be listed on the Title IV-E Clearing House. The specific research questions that will be answered as are as follows:

Question 1: Does the BPC improve Child Safety? Hypothesis 1a: Parents who complete the BPC will have fewer substantiated of child maltreatment as per administrative records.

Hypothesis 1b: Parents who complete the BPC will report less psychologically aggressive and abusive parenting behaviors (Parenting Scale).

Question 2: Does the BPC improve Child Permanency? Hypothesis 2a: Parents who complete the BPC will have fewer out of family placements and placement disruptions as per administrative records.

Hypothesis 2b: Parents who complete the BPC will have stability or permanency with their family of origin as per administrative records.

Question 3: Does the BPC improve Child Well-Being? Hypothesis 3: Parents who complete the BPC will report improved behavioral and emotional functioning of their children (Strength and Difficulties Questionnaire).

Question 4: Does the BPC improve Adult Well-Being? Hypothesis 4a: Parents who complete the BPC will report improved use of parenting practices to improve the functional relationship with their children (Parenting Self-Efficacy Scale; Parent Stress Index, Parent-Child Relationship Scales).

Hypothesis 4b: Parents who complete the BPC will report improved understanding of the influence of trauma on their parenting behaviors and wellness (Trauma-Informed Knowledge and Parenting Skills Survey).

Question 5: Are the improvements of the BPC associated with demographic factors? Exploratory Analysis 5a: Examine the association between measures of child safety, child well-being, child permanency, and adult well-being and measures of acculturation.

Exploratory Analysis 5a: Examine the association between measures of child safety, child well-being, child permanency, and adult well-being and measures of acculturation

Eligibility Criteria:
Inclusion Criteria:

- Parents involved in, or at risk of involvement in, the child welfare system.

Exclusion Criteria:

* active psychosis without medication stabilization
* ongoing major depressive episodes
* active suicidal ideation
* active homicidal ideation
Maximal Use Systemic Exposure (MUSE) Study of Levulan Kerastick

The purpose of this study is to evaluate the potential for systemic exposure of aminolevulinic acid (ALA) when applied topically under occlusion, in a maximal use setting in patients with multiple actinic keratoses (AK) involving the upper extremities.


Eligibility Criteria:
Inclusion Criteria:

* At least 6 Grade 1/2 AKs on one upper extremity AND
* At least 12 Grade 1/2 AKs on the OTHER upper extremity

Exclusion Criteria:

* Pregnancy
* history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis
* lesions suspicious for skin cancer (skin cancer not ruled out by biopsy) or untreated skin cancers within the Treatment Area
* Body Mass Index (BMI) \> 32.0 kg/m2
* skin pathology or condition which could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy
* significant blood loss within 60 days or donated blood/plasma within 72 hours prior to Visit 2 (Baseline)
* tested positive at screening for human immunodeficiency virus (HIV) or was known to be seropositive for HIV
* a history of lead poisoning or a history of a significant exposure to lead or a screening lead level above 6μg/dl
* tested positive at screening for hepatitis B surface antigen, hepatitis C antibody or had a history of a positive result
* positive drug screen at Screening
* Screening safety labs are clinically significant in the opinion of the investigator
* major surgery within 30 days prior to Visit 2 (Baseline) or plans to have surgery during the study
* Subject is immunosuppressed
* currently enrolled in an investigational drug or device study
* has received an investigational drug or been treated with an investigational device within 30 days prior to Visit 2 (Baseline)
* known sensitivity to one or more of the vehicle components (ethyl alcohol, isopropyl alcohol, laureth 4, polyethylene glycol)
* use of the following topical preparations on the extremities to be treated:

  * Keratolytics including urea (greater than 5%), alpha hydroxyacids \[e.g.glycolic acid, lactic acid, etc. greater than 5%\], salicylic acid (greater than 2%) within 2 days of initiation of treatment
  * Cryotherapy within 2 weeks of initiation of treatment
  * Retinoids, including tazarotene, adapalene, tretinoin, retinol, within 4 weeks of initiation of treatment
  * Microdermabrasion, laser ablative treatments, ALA-PDT, chemical peels, 5-FU, diclofenac, imiquimod or other topical treatments for AK within 8 weeks of initiation of treatment
* use of systemic retinoid therapy within 6 months of initiation of treatment