cyrilzakka/clinical-trials huggingface dataset:
Symphony IL-6 Reference Range Study

Symphony IL-6 is a device that quantitates human IL-6 by fluorescence enzyme immunoassay (FEIA) from whole-blood specimens. Use of Symphony IL- 6 removes the need for plasma separation before testing. Symphony IL-6 comprises two components, the Symphony Fluorescence Immunoanalyzer and the Symphony IL-6 Cartridge. Whole blood is added to the cartridge and then up to six cartridges can be inserted into the immunoanalyzer. After 20 minutes a readout and printout are given with a quantitative IL-6 concentration. The used cartridges are fully enclosed and can be easily disposed of in general hospital bio-waste. Given the nature of this device and its portability, there is potential for future deployment as a point-of-care (POC) device.

The objective of this study is to establish a reference range for Symphony IL-6 in a cohort of apparently healthy individuals.


Eligibility Criteria:
Inclusion Criteria:

* Subject is willing and able to provide informed consent
* \> 18 years of age
* Whole blood specimen collected in EDTA anticoagulant tubes
* Minimum volume of 100µL for Symphony IL-6 testing
* Specimen is available for testing within 12 hours from collection
* C-Reactive Protein (CRP) \< 10 mg/L

Exclusion Criteria:

* Subjects presenting with a fever
* Subjects with a diagnosis of COVID-19 or other respiratory illness at the time of collection
* Subjects otherwise self-reported as unhealthy
* Hemolyzed specimens
Predicting Pediatric Pulmonary Vein Stenosis Outcomes Using Data Acquired During a Cardiac Catheterization

This is a prospective, single center study which applies a standardized, comprehensive catheterization assessment to patients with a known or suspected diagnosis of pulmonary vein stenosis (PVS) who are undergoing a cardiac catheterization at Boston Children's Hospital. As part of the assessment, each pulmonary vein will undergo angiography (pictures using moving x-rays and contrast dye), intravascular ultrasound (IVUS; pictures of the vein wall using a catheter inside the vein), pressure assessment and compliance testing. The status of each pulmonary vein will then be assessed 12 months after the catheterization (i.e. no disease, severe disease, etc.). Using statistics, the investigators will determine which patient and vein characteristics (obtained at the of catheterization) can predict whether or not a pulmonary vein will have disease. The investigators hypothesize that this comprehensive, standardized, invasive assessment of pediatric intraluminal PVS can predict vein outcome.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients undergoing cardiac catheterization for the indication of known or suspicion for intraluminal pulmonary vein stenosis.

Exclusion Criteria:

* Hemodynamically unstable patients as determined by the patient care team.
Telemedicine Wounds

This study aims to explore the effectiveness of the flipped education model applied to distance digital learning in enhancing the pressure injury staging interpretation skills of long-term care nursing staff. A quasi-experimental design was employed, dividing participants into a flipped education group and a conventional digital learning group. Pre- and post-intervention assessments were conducted to evaluate knowledge and skills, and differences in satisfaction and cognitive load were compared.


Eligibility Criteria:
Inclusion Criteria:

* Home care worker
* Those who have access to a smartphone and the Internet
* After the purpose of the study was explained, they agreed to participate in the study and signed the consent form.

Exclusion Criteria:

* Business managers or administrative managers who do not actually provide frontline care at the patient's home.
Passive Tactile Stimulation for Stroke Rehabilitation

Stroke can lead to weakness and spasticity in the arm or hand. The purpose of this study is to optimize the design of gentle vibratory stimulation delivered to the hands of individuals with chronic stroke, and explore the effect on range of movement and spasticity.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 and older.
* diagnosis of stroke with upper extremity spasticity or other movement deficits that affect strength and range of movement.
* willing to participate in the vibrotactile stimulation sessions for consecutive days and willing to return for follow up visits as needed for the PHASE in progress.
* able to provide informed consent.

Exclusion Criteria:

* Patients with severe contracture that precludes Modified Ashworth Score (MAS) testing.
Efficacy and Tolerability of Escitalopram and Duloxetine in Outpatients With Major Depressive Disorder

The primary objective of this study was to compare the efficacy of escitalopram with that of duloxetine in outpatients with Major Depressive Disorder (MDD) after 24 weeks of treatment. The study hypothesis was that there were clinically important differences between the two drugs in terms of efficacy and adverse event profiles.

Depression is a common mental disorder that presents with depressed mood, loss of interest or pleasure, disturbed sleep or appetite, low energy, feelings of guilt or low self-worth, and poor concentration. The lifetime prevalence of Major Depressive Disorder (MDD) in community samples is 10-25% for women and 5-12% for men. Depression may become chronic or recurrent and lead to substantial impairments in an individual's ability to take care of his or her everyday responsibilities. At its worst, depression may lead to suicide. Depression is recurrent in 75-80% of patients and becomes chronic in 15-20% of depressed patients.

The selective serotonin reuptake inhibitors (SSRIs) have become the leading class of antidepressants throughout the world. The efficacy and safety of SSRIs in the treatment of depression has been demonstrated in several clinical trials. With respect to safety, the studies show an advantage for the SSRIs over the older antidepressants. If the prescribing physicians are to make a well-founded judgement in their choice of drug factors like efficacy, safety, quality of life, and health economics must be taken into consideration. The primary aim of this study is to compare the efficacy of escitalopram with that of the serotonin norepinephrine reuptake inhibitors (SNRIs) duloxetine in the treatment of MDD.

Eligibility Criteria:
Inclusion Criteria:

* The patient suffers from a primary diagnosis of MDD according to DSM-IV-TR criteria (classification code 296.xx; current episode assessed using the MINI)
* The patient has a MADRS total score \>=26 and a CGI-S score \>=4 at the Baseline Visit

Exclusion Criteria:

* Any current psychiatric disorder other than MDD as defined in the DSM-IV TR
* Female patients of childbearing potential who are not using effective contraception
* Use of any psychoactive medication 2 weeks prior to screening and during the study

Other protocol-defined inclusion and exclusion criteria may apply.
Fluoride Intake From Toothbrushig With Children's or Regular Toothpastes

There are controversial data about fluoride intake by children when tooth brushing with children's or regular toothpastes. However, a study have showed that children were exposed to a dose of 0.051 mg F/Kg/day and 0.046 mg F/kg/day by tooth brushing with children's and and regular toothpaste, respectively. Fluorides doses were too close and is questioned if there is a real clinical relevance in terms of risk of dental fluorosis. It is important to evaluate if children's toothpastes does really represent a risk of fluoride intake when compared to the regular toothpastes in terms of risk of dental fluorosis. The hypothesis is that both children's and regular toothpastes can represente risks of development of dental fluorosis and can represent similar fluoride exposure by children.

Subjects: Children at age of development of dental fluorosis (up to 4 years) enrolled at day care centres from the city of Montes Claros (0.7 ppm F), Brazil.

The study design has two phases:

1. In the first phase, children are required to bring at the day care centres the tooth brush and the toothpaste used at home. There is no randomization, since the inclusion in either children's or regular toothpaste groups will be done based on each child's preference. The children are requested to tooth brush as the usual manner that the parent and the child do at home. Saliva expectorates are collected as the protocol described by Guha-Chowdhury et al. (1996). No instructions are provided in this phase or interventions by the researcher. Saliva expectorates are collected for further laboratory analysis. Toothpastes are collected for laboratory analysis.
2. In the second phase, children are required to toothbrush with other type of toothbrush following the same tooth brushing protocol. For example, children that previously used children's toothpaste will be provided a regular toothpaste, and vice-versa.

Parents are requested to answer a questionnaire regarding their children's tooth brushing habits and socioeconomic factors.

Laboratory analysis provides estimation of fluoride intake from tooth brushing with both toothpastes.

Analysis will base on dose of fluoride intake (mg F/Kg body weight/day) considering children's and regular toothpastes.

Eligibility Criteria:
Inclusion Criteria:

1. Consent demonstrates understanding of the study and willingness to participate as evidenced by voluntary written of informed consent and has received a signed and dated copy of the informed consent form.
2. Age up to 48 months.
3. Compliance understands of the study and ability to comply with the study procedures.
4. Good oral health as considered by the investigator.
5. Good general health as considered by the investigator, with no clinically significant and/or relevant abnormalities of medical history.

Exclusion Criteria:

1. Children aging older than 48 months or younger of 6 months.
2. Parents who do not allow the child's participation.
3. Children that refuse to follow the study procedure.
4. Volunteers that do not complete the whole study protocol.
Effect of Passive Leg Raise for Pediatric Peripheral IV Placement

The investigators wish to determine whether passive leg raise allows for easier peripheral vascular access in the pediatric population. The investigators hypothesize that pediatric anesthesiologists will have higher rates of successful intravenous catheterization in children where a passive leg raise is employed.


Eligibility Criteria:
Inclusion Criteria:

* pediatric participants undergoing dental procedures under general anesthesia

Exclusion Criteria:

* Children who already have adequate IV access
Coagulation Monitoring in Patients on Extracorporeal Membrane Oxygenation (Observational Study)

Coagulation disorders are on top of the list of extracorporeal-membrane oxygenation (ECMO) complications. They contribute significantly to morbidity and mortality of ECMO patients. This observational study aims to evaluate coagulation profiles of ECMO patients treated on the intensive care units of the Department of Anaesthesiology of LMU Munich.

Coagulation disorders are on top of the list of extracorporeal-membrane oxygenation (ECMO) complications. They contribute significantly to morbidity and mortality of ECMO patients. This observational study aims to evaluate coagulation profiles of ECMO patients treated on the intensive care units of the Department of Anaesthesiology of LMU Munich. Adult ECMO patients are included in the study after informed consent.

Bleeding and thromboembolic complications as well as treatment details are recorded. Additional coagulation laboratory markers (such as von-Willebrand-factor, ADAMTS13-protease, platelet function tests and thromboelastometric tests) are correlated with clinical signs of bleeding. Regular ultrasound examination of the large vessels are performed to Screen for thrombosis.

Eligibility Criteria:
Inclusion Criteria:

* patient treated on ICU of Department of Anesthesiology of LMU Munich
* treated with ECMO
* age \>/= 18 years (adult patients only)
* informed consent

Exclusion Criteria:

* underage patients
* pregnant patients
* hemoglobin level \< 8mg/dl
Stability and Balance in Locomotion Through Exercise

Persons with Morbus Parkinson commonly develop gait and balance disorders leading to dependence, loss of mobility and a high risk of falling.

This study investigates the effectiveness of a sensorimotor treadmill intervention to improve walking and balance abilities in persons with early stages of Parkinson's disease. The sensorimotor treadmill training is conducted on a special treadmill device which is challenging the participants by small oscillations. This intervention, which is supposed to simulate walking on natural, uneven surfaces, is compared to a conventional treadmill training.

Hypothesis: Sensorimotor treadmill training leads to larger improvements in walking and balance abilities as compared to conventional treadmill exercise.


Eligibility Criteria:
Inclusion Criteria:

* Parkinson's disease stage 1-3 Hoehn and Yahr
* United Parkinson Disease Rating Scale (UPDRS) 'gait' or 'postural stability' subscore of 1 or more
* Ability to stand unaided and walk without an assistive device
* Stable medication during the study period

Exclusion Criteria:

* On-off and wearing-off phenomena
* Unstable medical or psychiatric illness
* Clinically relevant cardiovascular or orthopaedic disease
* Severe polyneuropathy
* Cognitive impairment
A Phase 2 Study to Evaluate Early Bactericidal Activity, Safety, Tolerability, and Pharmacokinetics of Multiple Oral Doses of Telacebec (Q203)

This is a Phase IIa, open-label, randomized study in treatment-naïve, sputum smear-positive patients with drug-sensitive pulmonary TB to assess the early bactericidal activity of telacebec (Q203).


Eligibility Criteria:
Inclusion Criteria:

1. A new episode of pulmonary TB determined by testing at the study appointed laboratory: Mycobacterium tuberculosis positive and rifampicin and isoniazid sensitive on a rapid molecular test
2. A chest X-ray taken no more than 14 days before Screening which in the opinion of the Investigator is consistent with TB
3. Sputum smear positive on direct microscopy for acid-fast bacilli on at least 1 pre-treatment sputum sample
4. Ability to produce an adequate volume of sputum as determined by an approximately 16-hour overnight sample collection
5. Be of non-childbearing potential or using effective methods of birth control, as defined in the protocol

Exclusion Criteria:

1. The patient is mentally or legally incapacitated at Screening
2. Any condition or circumstance, in the opinion of the Investigator, which may make the patient unlikely to complete the study or comply with study procedures and requirements, or may pose a risk to the patient's safety
3. Clinically significant evidence of extra-thoracic TB (miliary TB, abdominal TB, urogenital TB, osteoarthritic TB, TB meningitis), as judged by the Investigator
4. The patient has been infected with hepatitis B or C virus as confirmed by tests for hepatitis B core antibodies, hepatitis B surface antigens, and the hepatitis C virus antibodies
5. The patient with history of allergic reaction to isoniazid, rifampicin, pyrazinamide, ethambutol or related substances (eg, tosylate), as confirmed by the clinical judgement of the Investigator
Mechanism(s)of Airflow Limitation in Moderate-severe Persistent Asthma

The purpose of this study is to evaluate the site and mechanisms responsible for expiratory airflow limitation in chronic, treated, non-smoking, stable asthmatics with moderate to severe persistent expiratory airflow obstruction. Treatment will include inhaled corticosteroids and long acting beta2agonists and long acting muscarinic antagonists. We are interested in determining whether the large and/or small airways are the predominant site of airflow limitation. We are also interested in determining whether intrinsic small airways obstruction and/or loss of lung elastic recoil is responsible for expiratory airflow limitation and to what extent may be attributed to loss of lung elastic recoil vs decreased airway conductance in peripheral airways. We are also interested to evaluate the role of varying doses of inhaled corticosteroids to suppress large and small airway inflammation using exhaled nitric oxide as surrogate markers of inflammation. For comparison purposes, spirometry and measurements of exhaled nitric oxide will also be obtained if possible during a naturally occurring exacerbation of asthma. High resolution thin section CT of the lung will also be obtained. Analysis will evaluate integrity of the lung parenchyma as to absence and or presence of emphysema and extent of emphysema using voxel quantification. We will also investigate optical coherence tomography to detect clinically unsuspected emphysema. We will also obtain autopsy material when available in asthmatics who expire. Will also measure serum periostin as a marker of inflammation by collaborating with Genetech in San Francisco.

Results will be evaluated during exacerbation and when stable following treatment.

Eligibility Criteria:
Inclusion Criteria:

* Current non-smoking (\<10 pack yr smoking history)
* Stable, treated asthmatics
* Age 12-95 yr
* post 180ug albuterol by MDI: FEV 1/FVC \< 70% and FEV 1 \<80% predicted

Exclusion Criteria:

* Pregnancy
The Effect of the Usage of Squeezable vs Standard Bottles After Cleft Palate Surgery on the Feeding Process of Infants

This study aims to examine the effect of the usage of squeezable bottles and standard bottles on the feeding process of infants with CLP after cleft palate surgery.

Infants with cleft palate commonly have feeding difficulties due to incomplete development of orofacial structures. It has been reported that 67% of infants with cleft palate have feeding difficulties and 86% cannot be breastfed. Feeding difficulties in an infants with a cleft palate can lead to poor weight gain and growth retardation. Therefore, it is essential to provide nutritional interventions for these infants.

This study was designed as a randomized controlled prospective study and was planned to be carried out in the surgical inpatient wards of a private hospital in Istanbul.

Following the diagnosis of cleft lip and palate given to their infants, the families of infants with CLP apply to Aesthetic, Plastic and Reconstructive Surgery Department. In conclusion of the consultations performed in polyclinics, surgery dates are scheduled by the specialist and hospitalization is performed on Surgery Service Ward. Operations of the patients take approximately 3 to 4 hours. Following the operation, for follow-up purposes the patients are taken to Recovery Unit and are observed for 30 to 45 minutes before infants get transferred to Surgical Service. Following the completion of patients' observations in Surgical Service and their transition to full oral feeding, the patients are planned for discharge. The infants continue to be provided with hydration by intravenous infusion until their complete transition to full oral feeding. İnfants with CLP are provided with different nutrition methods before and after surgery. Since the literature also lacks a single or appropriate method that can remove nutrition issues of the babies with CLP, the same nutrition protocol is maintained with an approach in context of resuming the on-going nutrition method after surgery, just like the method previously used before the surgery.

In this study, the patients who use standard bottle before surgery will be included to control group, those who use squeezable bottle will be included to experimental group and participants both will be fed with same methods after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Infants between ≥ 6 to 12 ≤ months,
* Infants with lip, cleft palate and isolated cleft palate anomaly,
* Infants who are being fed using squeezable bottle or standard bottle,
* Infants not having any congenital anomalies or chronic diseases other than CLP,
* Infants with CLP who will undergo CLP surgery,
* Infants who will undergo Cleft Palate surgery

Exclusion Criteria:

* Infants having congenital anomalies or chronic diseases apart from CLP
* Infants who are being fed with a different method rather than using squeezable nipple bottle or standard bottle.
Effectiveness of Transverse Friction Massage in Latent Myofascial Trigger Points in Anterior Deltoid Muscle

The purpose of this study is to determine whether Transverse Friction Massage (TFM) in Latent Myofascial Trigger points (MTrP) is more effective making this technique in two different ways.

The investigators divide in two groups. The investigators apply the TFM in similar way in both, but the investigators cause local twitch response (isolated contraction of muscle fibers containing the latent trigger points)just in one group. So the investigators want to know whether the effectiveness of this technique is due to those local twitch responses, comparing both groups. The investigators asses Strength, range of motion, and overall, pressure pain thresholds to evaluate the pain sensitivity progress.

Eligibility Criteria:
Inclusion Criteria:

* Having latent myofascial trigger points in anterior deltoid
* Visual local twitch response

Exclusion Criteria:

* Having active Myofascial trigger points in anterior deltoid
* Having suffered injuries or surgery in upper limb.
* Pain in the first evaluation session.
* Not obtaining local twitch response
Using Smart Phone Technology in Detecting the Presence of Atrial Fibrillation

The purpose of this study is to examine whether patients can use the AliveCor case to record their heart rhythm and to assess the accuracy of the software in detecting AF vs sinus rhythm

AliveCor is a new monitoring technology used with a smart phone which allows patients to record their rhythm. The study will compare AliveCor recordings and automated interpretation of the rhythm with the interpretation by an Electrophysiologist.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female between \> 18 and \< 80 years of age
2. Paroxysmal or persistent atrial fibrillation
3. Admitted for antiarrhythmic drug loading (Dofetilide or Sotalol)
4. Already has iPhone 4, 4S or 5 with data plan that accommodates the AliveCor case
5. Willing to use the Alive Cor case
6. Written informed consent

Exclusion Criteria:

1. Unable or unwilling to use the Alive Cor case for their smart phone
2. Presence of a permanent pacemaker