cyrilzakka/clinical-trials huggingface dataset:
PECS Block vs. Multimodal Analgesia for Prevention of Persistent Postoperative Pain in Breast Surgery

In this double blinded randomized placebo-controlled trial, 160 subjects scheduled for breast surgery involving the axilla will be administered a multimodal pain regimen including acetaminophen, dexamethasone, celecoxib, and gabapentin. 80 subjects will also receive a Pectoral Nerve blocks I and II (PECS I and II block) preoperatively.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled to undergo elective breast cancer surgeries at Barnes-Jewish Hospital:

  * unilateral axillary dissection
  * unilateral modified radical mastectomy
  * mastectomy with same day unilateral reconstruction
  * unilateral sentinel lymph node biopsy (SLNB)
  * partial mastectomy with unilateral SLNB
  * simple mastectomy with unilateral SLNB
* At least 18 years of age.
* Able to understand and willing to sign an Institutional Review Board (IRB)-approved written informed consent document.
* Enrollment in the SATISFY-SOS study (WUSTL IRB# 201203088, NCT02032030).

Exclusion Criteria:

* Planned for bilateral axillary or bilateral reconstruction surgery.
* Previous surgery on the surgical breast and/or axilla with the exception of partial mastectomy or sentinel lymph node biopsy
* Pre-existing pain in the axilla affecting the ability to use extremity for activities of daily living or requiring medication for treatment.
* Current or past medical history of liver disease or cirrhosis with an elevated INR \>1.4 or currently elevated transaminase levels.
* Known contraindications to peripheral nerve block placement.
* Pregnant or breastfeeding.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition
* Planned additional surgery to the surgical breast or axilla in the next year (exception would be minor surgery to breast but not axilla such as simple tissue expander replacement or lumpectomy)
Ultrasound Cavitation Therapy for CLI

In this study, we will explore how ultrasound exposure of ultrasound contrast agents, which produces beneficial shear-mediated bioeffects, can be used to treat patients with severe non-healing ulcers secondary to peripheral arterial disease (PAD). The primary outcome measure is whether ultrasound exposure to microbubble contrast agents in the inflow artery and at the wound site can accelerate wound healing. A secondary outcome measure is whether cavitation-related changes occur in tissue perfusion in the treated limb and wound measured by ultrasound perfusion imaging and skin flow.


Eligibility Criteria:
Inclusion Criteria:

* Known history of unilateral or bilateral PAD diagnosed by reduced ankle-brachial index (\<0.9) or non-compressible vessels
* Diagnosis of CLI (Rutherford class IV-VI), and a non-healing ischemic ulcer defined as no change in the prior 3 months.

Exclusion Criteria:

* Major medical illness other than PAD affecting the limb (muscle disease, blood diseases that influence flow or rheology, severe heart failure \[NYHA class IV\]).
* Pregnant or lactating females
* Hypersensitivity to any ultrasound contrast agent or to polyethylene glycol (PEG, macrogol).
* Hemodynamic instability (hypotension with systolic BP \<90 mm Hg, need for vasopressors).
* Expected amputation or revascularization procedure within the ensuing 1 month.
Infusion Laboratory: Protocol 3 (Risperidone) - 4

The purpose of this study is to evaluate clinical safety issues pertaining to risperidone, to cocaine and to its interaction, and to determine how pretreatment with risperidone modifies the subjective as well as physiological effects of cocaine.


Eligibility Criteria:
Inclusion Criteria:

M/F ages 21-50. Meet DSM-IV criteria for cocaine dependence. Agree to conditions of the study and sign informed consent.

Exclusion Criteria:

Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nuring women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical condtions that deem participation to be unsafe.
Biomarkers of Cardiovascular Complications in Chronic Kidney Disease

Identification of new retention solutes associated with cardiovascular (CV) toxicity in Chronic Kidney Disease (CKD) patients will help to better understand the pathophysiological mechanisms at stake and to prevent CKD-associated mortality and morbidity. For a molecule to be defined as a toxic retention solute, plasma accumulation in the course of CKD has to be demonstrated but also proof needs to be made that plasma accumulation during CKD is indeed associated with an increased risk of CV complications. Moreover, precise determination of the plasma concentration has to be performed in order to later study in vitro and in vivo the toxic mechanisms involved. Based on previous results of plasma proteome analysis using mass spectrometry, a previous study has selected 10 promising protein candidates. These proteins accumulated in the plasma of patients during CKD progression and are known to be associated with CV events in non-CKD patients. The objective of the present study is now to 1) evaluate the association of the plasma accumulation of the 10 retention solutes with CV complications in CKD patients and 2) determine their plasma concentration using ELISA. One hundred and seventy six patients with advanced CKD will be included and divided in 2 groups: 44 patients with history of CV complications in the past 4 years and 132 patients free of any CV complications.


Eligibility Criteria:
Inclusion Criteria:

* patient with stage 4 or 5 CKD.

Exclusion Criteria:

* patient with stage 1, 2 or 3 CKD
* patient with solid tumor
* patient with malignant blood disease
* patient with acute kidney disease in the past 3 months
* patient with acute glomerulonephritis in the past 6 months.
Influence of Different Teaching Strategies on the Academic Performance and Caring of Nursing Students

The participants in this study are college students with studying long-term care. After different teaching strategies, the students are hypothesised to improve their caring ability in the future and apply rhythmic muscle training programmes.

Therefore, this study will explore the relationship amongst three different teaching strategies of nursing students through multimedia audio-visual, multimedia audio-visual and experiential learning programmes and teachers' personal demonstration and experiential learning, as well as identify their relationship with caring ability.


Eligibility Criteria:
Inclusion Criteria:

1. Students aged 20 or above who have taken long-term care/long-term care-related courses.
2. Participate in this Community elders of the research project, aged 50 or above.

Exclusion Criteria:

1. No willingness to participate in the research.
2. Exercise taboos or physical health factors, such as severe frailty cases, severe illnesses Emotional instability, injury and inability to walk, pregnancy, etc.
3. Elders or students who cannot communicate in Chinese/Taiwanese.
A Cohort Study on Biomarkers of Hypertension in Guangdong Province(GDP Study)

Hypertension is the most common chronic diseases and a most important risk factor for cardiovascular and cerebrovascular diseases, and also a substantial public health problem. The purpose of the study is to investigate the association between biomarkers and adverse outcomes in patients with hypertension.

Study population includes subjects who are hypertension, of any race or ethnicity, 18 or older years of age, and have provided written informed consent to provide whole blood specimens at one or more study visits.

Physical examination, questionnaire survey and biological sample collection will be conducted at baseline and the incidence of all-cause and cardiovascular mortality will be investigated during follow-up.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old
* In accordance with the diagnosis of hypertension (including Blood pressure ≥140/90mmHg and/or taking antihypertensive drugs and/or self-reported hypertension)

Exclusion Criteria:

* \<18 years old
* Unsigned informed consent
* Pregnant Women and Lactation
Augmenting rTMS With Cognitive Control Training in Major Depressive Disorder

Repetitive transcranial magnetic stimulation (rTMS) is an effective treatment for MDD, but the overall effect sized of the treatment is equivalent to antidepressant pharmacotherapy, and responses are highly variable. Given that rTMS is usually given to patients who have failed pharmacotherapy, a more effective alternative is needed.

Therefore, this study will combine computerized cognitive training (CCT) during standard rTMS treatments and assess its feasibility, tolerability, and changes in cognitive control performance and depression symptoms.

Participants that agree to the study and meet eligibility will receive standard rTMS (generally 25-36 daily treatments) along with CCT (starting on day 5 of treatment until the pre-taper treatment). In addition, to CCT participants will be asked to complete assessments before and after treatment

This project will also have a registry for participants that are approached to be in the clinical trial with the CCT but don't wish to be enrolled. Although the registry will be available for these participants, the information entered into this ClinicalTrials.gov registration will reflect the clinical trial portion of this project.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of major depressive disorder
* Eligible to receive and recommended for rTMS for depression
* Willingness to complete computerized cognitive training and undergo brain stimulation procedures
* Must be enrolled as a Michigan Medicine patient and currently receiving TMS treatment as part of your clinical care.

Exclusion Criteria:

* History of serious neurological illness or brain injury (e.g., stroke)
* Poor visual acuity impairing performance on the computerized tasks (eyeglasses must be removed for rTMS treatment, but contacts are permissible)
* Diagnosed intellectual disability
* Inability to manipulate a tablet device while seated in the rTMS chair
The Role of the Submucosal Conchoplasty Technique in Improving the Postoperative Middle Meatus Outcome After ESS

The study aimed to compare the applicability of the classic lateral lamellectomy versus the submucosal conchoplasty techniques in managing the concha bullosa during and after ESS.

The study included fifty-six patients with bilateral concha bullosa who were undergoing primary ESS for refractory chronic sinusitis. They were divided into two equal groups randomly. One group had the submucosal conchoplasty technique, and the other group had the lateral lamellectomy technique. The study compared the intraoperative findings including the time required for each technique and the amount of intraoperative bleeding. Furthermore, it compared the postoperative endoscopic outcome of the middle meatus and middle turbinate stability using the LKES and the POSE score. Also, the postoperative olfaction outcome was assessed.

Eligibility Criteria:
Inclusion Criteria:

* patients above 18 years
* patients diagnosed with chronic sinusitis based on the 2012 European Position Paper on Rhino-sinusitis and Nasal Polyps's criteria (EPOS 2012)
* patients presented by bilateral concha bullosa

Exclusion Criteria:

* patients below 18 years
* smokers
* patients with nasal polyps
* patients with primary ciliary dyskinesia
* patients with nasal masses
* revision cases
Tolerance for Using Virtual Reality With Subjects Living in Accommodation Establishment for the Elderly Dependent (EHPAD)

The main purpose of this study is to assess the tolerance of the virtual environment in the elderly living in a nursing home (EHPAD). It will be evaluated by the cybersickness collection after each session (1 session every other day for a total of 3 sessions).

The purpose of this muliticentric, interventional, uncontrolled study is to assess the tolerance of the virtual environment in the elderly living in a nursing home

subjects who fulfil the inclusion criteria and after signing the informed consent will benefit from three individual virtual reality (VR) sessions.

The sessions will be performed out with one day apart

An assessment of anxiety trait and well-being of each subject will be performed before the first session (D1) and after the third (D3).

An assessment of anxiety as a condition will be performed before and after each session.

Heart rate and blood pressure measurements will be made before, during and after each session.

At the end of each session, an evaluation of cybersickness will be performed. Feedback on the acceptability of the experience will be provided at the end of each session.

Each session will last 1 hour in total: the person will visualize a single scene of virtual reality presenting a natural environment of a duration of 7 minutes preceded by a time of introduction, evaluation and followed by a time dedicated to evaluations and maintenance.

Eligibility Criteria:
Inclusion Criteria:

* Mini Mental State Examination (M.M.S.E) scale ≥ 20.
* University of California, San Diego Brief Assessment of Capacity to Consent (UBACC) scale ≥ 12/20.
* Living in Retirment Homes (EHPAD).
* Good understanding of the French language.
* Benefiting from a social security scheme.
* Have read the newsletter and have consented to participate in the study by signing a written consent.

Exclusion Criteria:

* History of epileptic seizures.
* Taking antihypertensive, neuroleptic, tricyclic antidepressants or parkinsonian drugs
* Psychiatric disorders (Schizophrenia, dissociative disorders, borderline states, paranoia).
* Hypertension (unless it is stabilized due to the absence of a change in antihypertensive treatment in the last 3 months and without a notable episode of orthostatic hypotension reported).
* Vestibular or cerebellar syndromes.
* Subjects under legal protection (curatorship, tutorship and safeguard of justice).
* Refusal to participate.
Peripheral Perfusion Index in Weaning From Mechanical Ventilation

Peripheral perfusion index (PPI) is variable measured by Radical-7 (Masimo) device and reflects the ratio between pulsatile and non-pulsatile portions of peripheral circulation. PPI is characterized by being non-invasive, real time, and simple variable. Impairment of various perfusion indices (such as central venous oxygen saturation and serum lactate) during spontaneous breathing trial (SBT) were previously reported; however, these indices are characterized by being relatively invasive. We hypothesized that impairment of PPI during SBT might be predictive of weaning failure. The aim of this work was to evaluate the possible association between PPI and success of SBT

This prospective observational study will be carried out in surgical intensive care unit (SICU) unit of trauma and emergency hospital at Cairo University teaching hospital. Informed consent will be obtained from patients' next-of-kin prior to the enrolment in the study. All mechanically ventilated patients for more than 48 hours presented will be consecutively included.

The excluded patients are: patients \< 18 years, patients with peripheral vascular disease, patients on vasopressors, and those with hand injuries hindering which would preclude the application of the device probe will be excluded.

Assessment of readiness to wean from mechanical ventilation will be done by ICU physician according to the ICU protocol Spontaneous breathing trial (SBT) will be applied through pressure support (PS) mode with PS 5 cmH2O and positive end expiratory pressure (PEEP) 5 cmH2O for 30 minutes; then, weaning parameters will be assessed again. The decision of extubation will be taken by the intensivist in charge who is blinded to peripheral perfusion index (PPI) measurements. Weaning failure will be defined according to the guidelines of international conference on weaning from mechanical ventilation PPI will be continuously monitored using Radical-7 device pulse co-oximeter (Masimo corporation, Irvine, CA) via a pulse oximeter probe applied to the third or fourth digit of left hand. The probe will be covered with an opaque shield to avoid any error by external light sources. A baseline reading for PPI will be obtained followed by a reading each 5 minutes till the end of the SBT. We calculated a PPI ratio to evaluate the change in PPI during SBT. PPI ratio is defined as PPI by the end of SBT / baseline PPI).

Eligibility Criteria:
Inclusion Criteria:

* mechanically ventilated patients for more than 48 hours

Exclusion Criteria:

* patients \< 18 years
* patients with peripheral vascular disease
* patients on vasopressors
* patients with hand injuries hindering which would preclude the application of the device probe
Probiotic Treatment in Juvenile Idiopathic Arthritis (JIA)

This study investigates the efficacy of probiotic VSL#3 as an add on standard care on the activity of the disease in patients with Juvenile Idiopathic Arthritis.

Juvenile Idiopathic Arthritis (JIA) is the most frequent rheumatic disorder in children. Numerous studies suggest that alteration of the intestinal barrier may induce abnormal immune responses implicated in development or persistence of arthritis. This paves the way to new therapeutic options aiming to reestablish intestinal homeostasis to treat arthritis or to prevent disease flares. This study investigates the efficacy of probiotic VSL#3 as an add on standard care on the activity of the disease in patients with Juvenile Idiopathic Arthritis.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥1year and \<7years
* Patients with oligoarthritis and polyarthritis with rheumafactor negative and antinuclear antibodies (ANA) positive JIA with onset before the age of 6 years

Exclusion Criteria:

* Change of JIA forme
Effect of Cooking Oils on Whole Blood and Saliva Fatty Acids in Children in Bogota, Colombia

We conducted a randomized trial to determine the effect of providing families from Bogota, Colombia, with a one month supply of one of two cooking oils, sunflower oil vs. soybean oil, on whole blood and saliva fatty acid composition of children. The aims were: 1) assess the effect of the oils on whole blood fatty acid composition in children, 2) assess the correlation between whole blood and saliva to evaluate if fatty acids measured in saliva would be adequate biomarkers of intake. The study was conducted in the context of an ongoing cohort study of school children from Bogotá, Colombia (HUM00043252). We conducted an intervention trial of 4 week duration. Participant families were randomly assigned to either sunflower oil or soybean oil. Families were visited two times during the 4 week period. We collected dietary information from the person in the household in charge of food preparation, and from the child. At the end of the intervention we collected information on whether or not they liked the oil and whether they would be willing to use it, exclusively, for two years, to assess acceptability for a longer intervention. We also collected two finger prick blood samples and two saliva/cheek cells samples from the child, at the beginning and at the end of the study, to evaluate compliance and to assess the impact of the intervention.

We conducted a randomized trial to determine the effect of providing families from Bogota, Colombia, with a one month supply of one of two cooking oils, sunflower oil vs. soybean oil, on whole blood and saliva fatty acid composition of children. The aims were: 1) assess the effect of the oils on whole blood fatty acid composition in children, 2) assess the correlation between whole blood and saliva to evaluate if fatty acids measured in saliva would be adequate biomarkers of intake. The study was conducted in the context of an ongoing cohort study of school children from Bogotá, Colombia (HUM00043252). We conducted an intervention trial of 4 week duration. Participant families were randomly assigned to either sunflower oil or soybean oil. Families were visited two times during the 4 week period. We collected dietary information from the person in the household in charge of food preparation, and from the child. At the end of the intervention we collected information on whether or not they liked the oil and whether they would be willing to use it, exclusively, for two years, to assess acceptability for a longer intervention. We also collected two finger prick blood samples and two saliva/cheek cells samples from the child, at the beginning and at the end of the study, to evaluate compliance and to assess the impact of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Being a participant in the ongoing Bogota School Children cohort

Exclusion Criteria:

* None
Clinical Intervention on Cognitive Impairment of Schizophrenia With Metabolic Syndrome

This is a single-center, randomized, parallel-control study conducted in schizophrenic inpatients with metabolic syndrome who have been conducted with olanzapine. The purpose of this study is to evaluate the efficacy and safety of omega-3 polyunsaturated fatty acids, Xbox aerobic exercise and transcranial direct current stimulation( tDCS). Following a screening period, subjects who meet the entry criteria will be randomized to treated with omega-3 polyunsaturated fatty acids1.2mg per day, Xbox aerobic exercise 30min per day and tDCS at 2mA, 20 min(5 session/week) for 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Meets the Diagnostic and Statistical Manual of Mental Disorder,Fifth Edition(DSM-V) criteria for Schizophrenia.
2. Patients have got standard treatment of olanzapine monotherapy for more than 6 months, PANSS baseline ≤ 60.
3. Meets the ATP-III criteria for metabolic syndrome.
4. Male or female subjects aged 18-60 years, education level of junior high school for above.
5. The patient fully understand and signed the informed consent form.

Exclusion Criteria:

1. Serious and instable body disease such as cerebrovascular disease, liver and kidney disease, disease of internal secretion (abnormal thyroid function), blood disease; any history of seizures or other organic brain diseases.
2. Pregnant or lactating women and women of childbearing potential throughout the study period; patients who have plans to move to other places within the year.
3. History of diabetes, hyperlipidemia and other metabolic abnormalities.
4. Due to other reasons, the researchers considered it unsuitable to participate in this clinical trial.

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Effects of Bronch™ on Respiratory Health

This study was conducted to investigate the effects of daily supplementation of Bronch™(mixture of extraction of Korean mint and licorice) on respiratory health.

This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial. 60 subjects were randomly divided into Bronch™ group and a placebo group. It is to evaluate the changes in the displayed evaluation items when taking one pill twice a day, in comparison with taking a placebo.

Eligibility Criteria:
Inclusion Criteria:

* Age 19-80 years at screening
* nonsmoker
* After fully hearing and fully understanding this clinical trials, those who agree to voluntarily decide to participate and to comply with the notice

Exclusion Criteria:

* Participants with clinically significant severe cardiovascular, endocrine, immune, respiratory, liver, biliary, renal and urinary tract, neuropsychiatry, musculoskeletal, inflammatory and hematologic and gastrointestinal disorders
* Participants who have Body Mass Index(BMI) less than 18.5 kg/m\^2 or more than 35 kg/m\^2
* Participants who have taken medication or dietary supplements related to the respiratory disease within 1 months prior to screening
* Participants with a history of antipsychotic medication use within 3 months prior to the screening examination
* Participants who alcoholic or drug abuse suspected
* Participants who have participated in the other human trials within 3 months before the screening test
* Laboratory test by show the following results

  * AST, ALT \> Reference range 3 times upper limit
  * Serum Creatinine \> 2.0 mg/dL
* Pregnancy or breast feeding
* Patients who are judged ineligible to participate in the trial by the principal investigator for other reasons, including laboratory test outcomes