cyrilzakka/clinical-trials huggingface dataset:
FORMAT Clinical Study

The FORMAT Clinical Study is a clinical trial to evaluate the safety and effectiveness of the Formula™ 535 Iliac Balloon-Expandable Stent in treatment of symptomatic vascular disease of the iliac arteries.


Eligibility Criteria:
Inclusion Criteria:

* Up to two documented common or external iliac artery lesions (one on each side), with \>50% diameter stenosis, suitable for stenting
* iliac artery reference vessel diameter of 5-10 mm
* Rutherford Category 1, 2, 3, or 4.

Exclusion Criteria:

* Less than 18 years of age
* lesion site \<10 or \>100 mm in length
* external iliac artery lesion visually estimated to be 100% occluded
* presence of infrarenal aortic aneurysm \>4 cm (treated or untreated)
* presence of any aneurysm (treated or untreated) within target vessel
* significant stenosis (\>50%) or occlusion of inflow tract (infrarenal aortic lesions) not successfully treated before this procedure (success is measured as \< 30% residual stenosis)
* absence of at least one patent runoff vessel with ≤ 50% stenosis throughout its course (i.e., confirmed in-line patency to the level of the foot)
* angiographically evident thrombus within the target vessel (treated or untreated)
* lesion is in an iliac artery that has been previously stented
Impact of Microbial Exposure of the Habitat at the Time of Birth on the Development of Allergic Diseases.

In 2001-2002, a longitudinal study on the risk of atopic sensitization in children was conducted by the Pneumo-Allergology and Pediatrics departments of the CHU Saint-Pierre Hospital and at the Neonatology Department of the Queen Fabiola Children's University Hospital (HUDERF). The aim of the study was to study bacteria and endotoxins in airborne dust in Brussels homes in order to evaluate their impact on the development of allergic diseases in newborns.

Between December 2000 and August 2002, 114 children (67 from HUDERF and 47 from CHU St-Pierre) were included in the study. These were eutrophic children without acquired pathology or known genetics.

Simultaneously a microbial habitat assessment was performed based on a detailed description and on endotoxin assays in the airborne and deposited dust (mainly mattress).These data can be used to define habitats with high or low contamination.Samples for microbial analyzes (Gram positive and negative and mold) were also carried out.

Preliminary results suggested:

1. A protective effect of airborne dust endotoxins on the risk of developing atopic dermatitis in children at 6 and 12 months of life,
2. An effect of endotoxins promoting the occurrence of wheezing in children after 6 months.

In this current, new study, the investigators will recontact the children who were included in the 2003 study. The goal is to evaluate them clinically and allergically and associate the risk of sensitization / allergic diseases with the microbial exposure of the habitat, measured during the neonatal period.

Siblings and parents who were exposed during the same period will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

Children who participated in the study conducted in 2001-2002, their parents and the siblings who were exposed to the same environment at this period.

Exclusion Criteria:

None
Home Blood Pressure Study for Recent Stroke Survivors With High Blood Pressure *On Hold Due to Global Pandemic*

The purpose of this pilot study is to assess the feasibility of implementing a home blood pressure self-management program in a population of recent stroke survivors in the Washington, D.C. area. The investigators hypothesize that hypertensive stroke survivors in the Washington, DC area who participate in the Home Blood Pressure Monitoring program will have a greater reduction in mean systolic blood pressure (SBP) from baseline to 3 months, as measured by automated office blood pressure (AOBP), as compared to usual care.

The purpose of this trial is to determine if a home blood pressure self-management (HBPS) program, including home monitoring and medication adjustments, is practical to use in recent stroke survivors and whether or not it is associated with lowering blood pressure after 3 months. Data from this trial may be used to do more research and may be used by doctors when seeing patients.This research is being done because high blood pressure, also called hypertension, is the leading risk factor for stroke. Lowering blood pressure (BP) has been shown to lower the risk of future strokes. The majority of stroke survivors continue to have uncontrolled BP. Currently, blood pressure (BP) is most often measured in the doctor's office. However, those single BP measurements are not the best picture of blood pressure over time and can be influenced by the stress of being in a doctor's office, known as the "white coat effect". This is why measuring BP at home may paint a more accurate picture of a patient's true long-term BP. Home blood pressure monitoring (HBPM) is recommended in the recently updated national hypertension guidelines. Home BP monitoring plus guided BP medication self-adjustments is associated with lower BP in patients with high blood pressure. The investigators believe that a HBPS program, including medication self-adjustment and home monitoring, may help to reduce blood pressure in patients with hypertension within 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Acute ischemic stroke in the past 180 days of screening
* Age \>/= 18 years old
* Automated Office Blood Pressure ≥135 systolic or ≥85 diastolic at time of screening
* Stage 2 hypertension (as defined by \>140 mmHg SBP and or \>90 mmHg DBP on 2 occasions or history of hypertension prior to stroke or currently taking antihypertensive medications)
* Able to live independently (as defined by modified Rankin scale score of 0-2)

Exclusion Criteria:

* CKD stage IV or greater (GFR \< 30)
* Inability to check BP in either arm (e.g. amputation, lymphedema)
* Pregnancy
* High-grade intracranial or extracranial stenosis requiring a higher BP goal
* Unable to provide informed consent for themselves in English or Spanish
* Life expectancy less than 12 months
Mechanism-based Choice of Therapy for Neuropathic Pain

Mechanism-based choice of therapy for neuropathic pain:

Can treatments success in neuropathic post-operative pain be coupled to psychophysical pain modulation profile?

Neuropathic or idiopathic pain patients will be assessed with the variety of pain tests including the conditioned pain modulation (CPM) and temporal summation (TS). Then, they will be offered on the double-blind design a several weeks treatment with either pregabalin or duloxetine. Patients will be followed-up weekly by phone for their pain relief and will be re-assessed in the lab toward the end of the treatment. The investigators suggest that patients with less-efficient CPM (deficient pain inhibition) will "earn" more pain relief from the treatment with duloxetine, while the patients with the enhanced pain summation will response better to pregabalin.

Eligibility Criteria:
Inclusion Criteria:

* patients planned for thoracotomy

Exclusion Criteria:

* age below 18 and above 75 years
* patients with psychiatric or cognitive dysfunction precluding use of psychophysics
* those who cannot communicate in Hebrew
* patients with existing thoracic or other current chronic pain
Cognitive Rehabilitation for Opioid Abuse-related Cognitive Impairment

Research has consistently found that cognitive impairment is common in persons with a history of substance abuse. The most commonly identified impairments across all substances are in attentional and working memory functioning and executive functioning; opioid-specific research finds that memory is an additional area of common impairment. Initial research in applying cognitive rehabilitation methods to substance abuse have shown it to be helpful overall.

To develop a cognitive rehabilitation intervention that is effective for opioid abuse, this study will adapt a cognitive training program that has been shown to be effective in other patient groups. Patients in a residential opioid-abuse treatment program will undergo a cognitive evaluation and then be assigned to receive the 4-week cognitive intervention or the 4-week placebo control arm. It is expected that the intervention group will show greater gains on the cognitive post test and will have higher rated treatment adherence and opioid treatment program completion rates.


Eligibility Criteria:
Inclusion Criteria:

* Has completed the detoxification process
* Has completed at least 8 years of formal education
* Speaks and reads English fluently
* Is beginning residential inpatient treatment for opioid abuse (note: may be receiving treatment for polysubstance abuse but opioid must be one of their regular drugs of abuse)

Exclusion Criteria:

* Unable to self-consent (has a proxy for medical decision-making, legal guardian, or been otherwise determined unable to give consent)
* Past diagnosis or suspected current diagnosis of a neurodevelopmental disorder (e.g., autism, learning disability), attention-deficit disorder, or neurocognitive disorder (e.g., dementia)
* History of major head trauma (defined as loss of consciousness for 30 minutes or longer) or brain surgery. (Note: History of concussion, including brief loss of consciousness, is okay)
Managing Insulin With a Voice AI

This study randomizes participants to have their basal insulin titrated either through standard of care or by receiving prompts through interactions with an AI-enabled smart speaker device. The primary objective of this study is to investigate the feasibility of an AI-enabled smart speaker device and whether such a device facilitates insulin titration management, increases insulin adherence and decreases time to optimal insulin dose. The secondary objective of the study is to explore whether the device improves glycemic control as defined by improvements in fasting blood sugar.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Type 2 Diabetes
* Patients clinically indicated to be taking daily long-acting insulin
* Patients currently taking long-acting insulin but necessitating active dose adjustments

Exclusion Criteria:

* Patients who do not speak English
* Patients who do not own a smart phone
* Patients who do not have stable wireless internet connection at home
Immediate and Delayed Effects of Kinesio Taping on the Neuromuscular Performance

The purpose of this study is analyze the immediate and late effects of the application of KT in neuromuscular performance of the quadriceps in postural balance and function of the lower limb of healthy subjects.

Sixty volunteers, females will be recruited and randomly divided into 3 groups with 20 members each: control group (CG) - 10 minutes at rest; placebo group (PG) - Kinesio Taping (KT) without application of tension in the vastus lateralis (VL), vastus (VM) and rectus femoris (RF); and Kinesio Taping group (KTG) - application of KT with tension in VL, VM and RF. All volunteers will be evaluated for their distance from the single and triple hop test, postural balance (baropodometry), the joint position sense (JPS), the knee extensor torque (concentric and eccentric assessment at 60 °/s) and electromyographic activity of the VL muscle in five distinct stages: the first before the intervention (AV1), the second immediately after (AV2) and the following three 24h (AV3), 48 (AV4) after the intervention protocol. Soon after the AV4, KT will be removed after 24 hours and take place the last review (AV5).

Eligibility Criteria:
Inclusion Criteria:

* Be recreationally active, with no history of osteomyoarticular lesion or surgery in the lower limbs in the previous six months, non-corrected neurological, vestibular, visual and/or hearing impairments, in addition to displaying no allergy to adhesive material.

Exclusion Criteria:

* Individuals experiencing pain during collection procedures or who do not perform exercises as instructed by the researchers would be excluded.
Antecedents of Hypertension: Role of Race and Stress

To determine the role of environmental stressors in the development of hypertension in Black and white school-age children from hypertensive families.

BACKGROUND:

The theoretical rationale for the role of environmental stress factors in the development of essential hypertension has been outlined in several studies. Briefly, individuals at increased risk for essential hypertension are more likely than non-risk cohorts to exhibit exaggerated cardiovascular reactivity to environmental stressors. This may be especially true for Blacks compared to whites. Furthermore, individuals at risk for developing essential hypertension who are subjected to more frequent physical and/or sociopsychological stressors may experience frequent feelings of anger and hostility with concomitant exaggerated cardiovascular reactivity. Blacks may experience many of these stressors more frequently than whites. The exaggerated cardiovascular reactivity, in turn, is associated with complex neuroendocrine changes which result in pathophysiological alterations, eventually causing chronic elevated blood pressure. Although this rationale has received some empirical support in animal and human studies, definitive evidence to support an etiologic role of environmental stress factors is still lacking and needs to be tested in a prospective manner.

DESIGN NARRATIVE:

The study was cross-sectional and longitudinal. An estimated 1,523 children, 7 to 14 years old at baseline, whose families reported essential hypertension, participated in a blood pressure screening following medical verification of their family history of hypertension. Children whose systolic blood pressures were in the 5th to 25th percentiles or 75th to 95th percentiles were recruited. A sample of children was obtained with relatively equal distributions by race, age, gender, and blood pressure grouping. Environmental stress factors evaluated include: psychophysiological responses to physical and psychological stressors including physical exercise testing, video game, and mental arithmetic tests; sociopsychological variables including anger and hostility coping styles; and sociostructural variables including socioeconomic status and family stability. The environmental risk factors were assessed within the context of other hypertension risk factors such as cholesterol level, sodium and alcohol intake, tobacco usage, resting blood pressure, and body weight. Each child and his parents were followed annually.

The study was renewed in 1994 and again in 1998 to continue follow-up for an additional four years. Follow-up continued of these adolescents and young adults who were 13 to 20 years old in 1998. The purpose was to index early markers of preclinical disease including resting blood pressure, left ventricular mass, and several new measures including plasma endothelin-1 (ET-1) and endothelium dependent arterial dilation (EDAD).

Eligibility Criteria:
No eligibility criteria
Fructose and Lactose Intolerance and Malabsorption in Functional Gastrointestinal Disorders

Background: The association of fructose and lactose intolerance and malabsorption with the symptoms of different functional gastrointestinal disorders (FGID) is unclear. The mechanisms behind the multi-organ symptoms remain unclear. Both FGID and saccharide intolerances are common (\>10% of any given population). Dietary modification based on intolerance diagnostics could provide an effective treatment for FGID, which are otherwise difficult to treat.

Aim: To investigate the prevalence and interrelationships of fructose and lactose intolerance (symptom induction) and malabsorption (breath test gas production) and their association with clinical GI as well as non-GI symptoms in FGID and the outcome of standard dietary intervention. Mechanisms related to symptom genesis will be investigated using metabolomic analysis of plasma and urine by gas chromatography/time-of-flight mass spectrometry (GC/TOFMS).

Methods: Fructose and lactose intolerance (defined by positive symptom index) and malabsorption (defined by increased hydrogen/methane) will be determined in successive male and female FGID patients in a single center using breath-testing. Symptoms will be recorded using standardised questionnaires and the Rome III criteria. The prevalence of the intolerances in the different FGID subgroups and the associations between breath testing results, clinical symptoms and the outcome of dietary modification will be assessed. Factors predictive of the outcome of dietary modulation will be screened for. GC/TOFMS will be used to assess the human and microbial metabolome in urine and plasma.


Eligibility Criteria:
Inclusion criteria:

* Patients with functional GI disorders according to ROME 3 criteria
* Without evidence of organic disease by standardised testing in GI practice.

Exclusion criteria:

* Current or relevant history of organic disease.
Platelet Rich Fibrin Versus Melatonin Around Dental Implants

Dental implant is a dental treatment that allow oral rehabilitation for partial and fully edentulous patients. Osteointegration is the factor that control success s or failure of dental implant that can be improved by addition of different adjunctive biological materials. Platelets Rich fibrin plays a significant role in tissue regeneration and wound healing. Melatonin is biological hormone that secreted from pineal gland and played an important role in human growth.


Eligibility Criteria:
Inclusion Criteria:

1. good oral hygiene participants,
2. free of any systemic diseases,
3. Patients' age ranged from 20 to 40 years old.
4. Patients who can complete surgery and the study protocol.
5. Partially edentulous patients in the posterior mandibular region (at least a single-mandibular edentulous area) with periodontal health.

Exclusion Criteria:

1. patients who had parafunctional habits,
2. current and former smokers, pregnant
3. lactating women
4. unmotivated patients
5. patients with psychological problems
6. patients who were not able to follow the treatment protocol -
Epidemiology of Community - Associated Extended-spectrum Beta-lactamases (ESBL) Producing Escherichia Coli

The purpose of this study is to review patients with E. coli infections at the University of Pittsburgh Medical Center (UPMC) from July 1, 2007 to June 30, 2010 to determine if these infections have arisen in the community rather than in hospitals or nursing homes.

This is chart review at UPMC. There is no human interaction.

Eligibility Criteria:
Inclusion Criteria:

* All patients with E. coli, Klebsiella species and Proteus species infections during the time period of the study will be reviewed.
Validating an ELISpot for Early Detection of an Active Immune Response Against COVID-19

The RT-PCR on rhino-pharynge sampling highlights the genetic material of the virus and indicates that a subject is infected with SARS-CoV-2. This test can be in about 30% of false negative cases, it does not allow to date the infection, nor to predict the asymptomatic, mild, moderate or severe evolution of the disease. In terms of public health, we need 1/ to better understand the chronology of the immune response to the virus in the general population and in contacts of index cases; 2/ To know which characteristics of the immune response are protective of future reinfections. Finally, in symptomatic subjects, we need biomarkers that predict the evolutionary mode of the disease (moderate vs. severe form).


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years,
* patients with confirmed SARS-Cov2 infection (RT PCR positive)
* or patients suspected (evocative chest scanner)
* OR patients exposure to SARS-CoV2 but no symptoms (patient's family, caregivers)
* OR patients Non exposure to SARS-Cov2 volunteer subjects (general population)

Exclusion Criteria:

* pregnant or breastfeeding female
Validation of a Simple and Cost-Effective Nucleic Acid Test for HIV Detection

Validate a simple and cost-effective Nucleic Acid Test for HIV Detection in order to develop a rapid, highly sensitive and specific, one-stage test for the diagnosis of HIV infection. Blood samples collected will be assayed using the BioHelix Corporation helicase-dependent amplification or the Cepheid Xpert HIV-1 Quant Assay. A false negative or false positive rate of \>1.0% would make this test unacceptable as a screening test for HIV viremia.


Eligibility Criteria:
Inclusion Criteria:

* Current patient in the Medical Faculty Associates Infectious Diseases (ID) clinic with known HIV infection
* Suspected to be viremic at the time of their clinic visit based on history and/or current symptoms
* Able to provide informed consent
* 18 Years or older

Exclusion Criteria:

* Patient unable to provide informed consent.
* Pregnancy
Kineesiotaping for Patients With LCPD

Kinesiotaping is increasingly being used as a complement to musculoskeletal pain management. This study aimed to evaluate the immediate clinical efficacy of kinesiotaping on pain and pain-related symptoms of Legg-Calvé-Perthes Disease (LCPD).

Kinesio taping is increasingly being used as a complement to musculoskeletal pain management. A randomized, double-blind, placebo-controlled clinical trial was conducted. Activity-related hip pain, passive and pain limited hip range of motion, gluteus medius muscle strength, function and balance were assessed.

Eligibility Criteria:
Inclusion Criteria:

* Having received unilateral LCPD diagnosis,
* Anterior hip pain minimum three points on 10-cm Visual Analog Scale (VAS) over the previous week,
* Having the following symptoms; weakness of gluteus medius muscle and patient-reported complaints on function or balance

Exclusion Criteria:

* Having a history of any other hip pathologies,
* Having allergy to polyacrylate adhesive,
* Having used analgesic medication within the previous three days.
Ketamine Versus Midazolam for Prehospital Agitation

This research study is being done to figure out the best approach to treatment of pre-hospital agitation. It will compare two tiered dosing treatment protocols, one ketamine-based and one midazolam-based. Agitation is a state of extreme emotional disturbance where patients can become physically aggressive or violent, endangering themselves and those who are caring for them. Often chemical substances or severe mental illness are involved in this level of agitation. Specifically, the investigators are interested in studying agitation that is treated in the prehospital setting by paramedics. This study's hypothesis is a ketamine-based protocol will achieve a faster time to adequate sedation than a midazolam-based protocol for treatment of agitation in the prehospital environment. This study will observe the natural history of an emergency medical services standard operating procedure change from a ketamine-based protocol to a midazolam-based protocol.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Severe agitation (AMSS +2 or +3) or profound agitation (AMSS +4) requiring chemical sedation
* Transport to Hennepin County Medical Center

Exclusion Criteria:

* Obviously gravid women
* Patients known or suspected to be less than 18 years of age
* Patients in which stopwatch activation, for safety reasons, is unable to occur