cyrilzakka/clinical-trials huggingface dataset:
Liposomal Bupivacaine With Dexamethasone for Foot Surgery

This study aims to understand the ideal formulation to utilize in saphenous nerve and popliteal nerve blocks for foot and ankle procedures. It will examine the use of liposomal bupivacaine alone or liposomal bupivacaine with dexamethasone prior to foot and ankle procedures in peripheral nerve blocks. We will compare liposomal bupivacaine (Exparel) and liposomal bupivacaine (Exparel) combined with dexamethasone to determine if the addition of dexamethasone significantly decreases postoperative narcotic use and prolongs analgesic effects when administered in a popliteal and saphenous block prior to foot and ankle orthopedic procedures.


Eligibility Criteria:
Inclusion Criteria:

* Participants with foot and ankle procedures at Jefferson Surgery Center, Navy Yard
* Participants with foot and ankle orthopedic procedures requiring a preoperative nerve block
* Age 18 and older
* English speaking
* Ability to complete surveys by phone or in person
* Ability to provide informed consent

Exclusion Criteria:

* Revision foot and ankle cases
* Allergies to study medications
* Non-English speakers
* Known alcohol or narcotic abuse history
* Existing contract with a pain specialist due to underlying preoperative pain syndrome
* Preoperative opioid use within the 3 months prior to surgery
* Participants who are pregnant, plan to become pregnant, or are breastfeeding.
Epidemiologic Data of Patients in a Teaching Hospital

This small cross-sectional epidemiological study is designed to evaluate the prevalence of the following parameters in hospitalized patients in a tertiary teaching hospital (medical department only):

* kidney insufficiency
* obesity
* use of unfractionated heparins / low molecular weight heparins
* other drugs effecting the hemostatic system

This small cross-sectional epidemiological study is designed to evaluate the prevalence of the following parameters in hospitalized patients in a tertiary teaching hospital (medical department only):

* kidney insufficiency
* obesity
* use of unfractionated heparins / low molecular weight heparins
* other drugs effecting the hemostatic system

Eligibility Criteria:
Inclusion Criteria:

* All patients hospitalized at the defined days (two days) at Kantonsspital Luzern, Department of Medicine
Paired Vagus Nerve Stimulation (VNS) With Rehabilitation for Upper Limb Function Improvement After Stroke

Patients (UK only) at least 6 months post stroke, with upper limb deficits, may enroll. Patients will be randomized to one of two groups - a group implanted with a device that allows pairing VNS with rehabilitation and a group that only receives rehabilitation (no implant). Patients have two baseline evaluations, one evaluation after implant but before initiation of treatment, and then six weeks of rehabilitation or rehabilitation + VNS, followed by post acute therapy evaluations at 1, 7, and 30 days after the 6-weeks of treatment. The intent is to assess safety and provide preliminary effectiveness information for VNS for upper limb functional improvement after stroke. Implanted patients may receive longer-term treatment and follow-up after the acute study.


Eligibility Criteria:
Major Inclusion Criteria:

1. History of unilateral supratentorial ischemic stroke that occurred at least 6 months prior
2. Age \> 18 years and \< 80 years
3. Right or left sided weakness of upper extremity

Major Exclusion Criteria:

1. Hemorrhagic stroke
2. Any deficits in language or attention that interferes with reasonable study participation
3. Presence of significant apraxia
4. Profound Sensory loss
5. Active major neurological or psychiatric diagnosis that would likely interfere with study protocol including alcohol or drug abuse
Baby Detect : Genomic Newborn Screening

Newborn screening (NBS) is a global initiative of systematic testing at birth to identify babies with pre-defined severe but treatable conditions. With a simple blood test, rare genetic conditions can be easily detected, and the early start of transformative treatment will help avoid severe disabilities and increase the quality of life.

Baby Detect Project is an innovative NBS program using a panel of target sequencing that aims to identify 126 treatable severe early onset genetic diseases at birth caused by 361 genes. The list of diseases has been established in close collaboration with the Paediatricians of the University Hospital in Liege. The investigators use dedicated dried blood spots collected between the first day and 28 days of life of babies, after a consent sign by parents.

Every year, thousands of children around the world are born with rare genetic diseases leading to death or lifelong disability. With technological advancements in the field of genetics and medicine, the rate of introduction of treatments for these rare conditions has grown remarkably.

However, timing is of great importance for medication administration. The benefit that can be measured in a patient who has already suffered from a long irreversible degenerative disorder is small and, sometimes, it hardly justifies the cost and the burden of the treatment. Early diagnosis is, thus, of primary importance both to obtain the best effect of the innovative medications and to accelerate their development.

The investigators are pioneered in the field of genetic newborn screening (NBS) in rare diseases by funding, designing, and leading an innovative genetic NBS program initiated in March 2018 in Southern Belgium for Spinal Muscular Atrophy (SMA) that allowed, so far, for 11 children to be detected and treated early and avoid the terrible fate of the disease. The program was disseminated in 17 countries and included public dissemination and health-economic analysis since the very beginning \[1\]. (www.facebook.com/sunmayariseonsma).

Drawing upon our experience with SMA screening, the investigators have designed a project to screen up to 40,000 newborns/year progressively in 3 years for virtually all the rare diseases that can benefit from treatment or a pre-symptomatic clinical trial.

The methodology of Baby Detect includes sequencing of target genes on dried blood spots collected from the NBS cards in a timely and cost-efficient manner, and its high dynamicity allows for any newly treatable rare disease to be included in its scheme in no longer than 6 months.

Baby Detect, as a multidisciplinary newborn screening program, involves expertise in areas from genetics and medicine to laboratory studies, computer science, Data Protection, Ethics, and health economy. It will constitute the proof of concept that is needed before moving to a whole region-scale population.

Eligibility Criteria:
Inclusion Criteria:

* newborn between birth and 28 days of life
* consent of parent

Exclusion Criteria:

* + 28 days
* Non consent of parent
Safety, Tolerability and Drug- Drug Interaction Study of Ubrogepant With Erenumab or Galcanezumab in Participants With Migraine

This study will evaluate the potential for a pharmacokinetic (PK) interaction and provide safety and tolerability information when ubrogepant and erenumab or ubrogepant and galcanezumab are co-administered.


Eligibility Criteria:
Inclusion Criteria:

* At least a 1-year history of migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd edition, (ICHD-3, 2018)
* By history, the participant's migraines typically last between 4 and 72 hours if untreated or treated unsuccessfully and migraine episodes are separated by at least 48 hours of headache pain freedom
* History of at least 2 migraine attacks per month in the 2 months prior to Screening
* Have a sitting pulse rate ≥ 45 beats per minute (bpm) and ≤ 100 bpm during the vital sign assessment at the Screening Visit. Clinical site may perform a maximum of 2 repeats of vital sign measurements if the initial measurement is out of range.
* Negative test results for benzoylecgonine (cocaine), methadone, barbiturates, amphetamines, benzodiazepines, cannabinoids, opiates, and phencyclidine at the Screening Visit and Day -1; unless explained by concomitant medication use (eg, opioids prescribed for migraine pain)
* Participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period

Exclusion Criteria:

* Difficulty distinguishing migraine headache from tension-type or other headaches
* Has a history of migraine aura with diplopia or impairment of level of consciousness, hemiplegic migraine, or retinal migraine as defined by ICHD-3
* Has a current diagnosis of new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy as defined by ICHD-3
* Required hospital treatment of a migraine attack 3 or more times in the 6 months prior to Screening
* Has a chronic non-headache pain condition requiring daily pain medication (with the exception of pregabalin)
* Has clinically significant cardiovascular or cerebrovascular disease per the investigator's opinion
* Previously participated in an investigational study of ubrogepant
* Participation in any other clinical investigation using an experimental drug within 30 days prior to study intervention administration
* Participation in a blood or plasma donation program within 60 or 30 days, respectively, prior to study intervention administration
Abbott i-STAT High Sensitivity Troponin I Study

The goal of this observational multi-center study is to evaluate the clinical performance of the i-STAT hs-TnI test (i-STAT High Sensitivity Troponin I) using the investigational i-STAT hs-TnI cartridge for the proposed intended use as an aid in the diagnosis and treatment of myocardial infarction (MI). The cartridge measures cardiac troponin I (cTnI) in whole blood or plasma samples using the i-STAT 1 Analyzer or i-STAT Alinity Instrument. Subjects presenting to the emergency department (ED) with chest discomfort or equivalent ischemic symptoms suggestive of Acute Coronary Syndrome (ACS) who are enrolled in this study will be asked to provide blood samples for testing.

The i-STAT High Sensitivity Troponin I (i-STAT hs-TnI) test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I (cTnI) in whole blood or plasma samples using the i-STAT 1 Analyzer or i-STAT Alinity Instrument in point of care or clinical laboratory settings. The hs-TnI test is intended to be used as an aid in the diagnosis of myocardial infarction (MI).

The objective of this study is to evaluate the clinical performance of the i-STAT hs-TnI test using the investigational i-STAT hs-TnI Cartridge with the i-STAT 1 Analyzer and i-STAT Alinity Instrument for subjects presenting to the emergency department (ED) with chest discomfort or equivalent ischemic symptoms suggestive of acute coronary syndrome (ACS).

The clinical evaluation will use prospectively collected whole blood specimens from subjects presenting to the ED with chest discomfort or equivalent ischemic symptoms suggestive of ACS.

Eligibility Criteria:
Inclusion Criteria:

* Subject is 18 years of age or older
* Presenting to the Emergency Department (ED) with signs and symptoms suggestive of Acute Coronary Syndrome (ACS): Acute chest, epigastric, neck, jaw or arm pain or discomfort or pressure without apparent non-cardiac source; Shortness of breath, nausea, vomiting, fatigue/malaise; Other equivalent discomfort suggestive of a myocardial infarction (MI) in accordance with the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines.
* Electrocardiogram (ECG) ordered as part of the standard of care

Exclusion Criteria:

* Previously enrolled in the study
* Enrolled in any interventional clinical trial (within the last 30 days)
Comparing Rater Reliability of Familiar Practitioners to Blinded Coders

The purpose of this study is to determine how coders who have seen multiple time points of the same dyad, and are therefore familiar with the case, rate emotional connection using the WECS compared to coders who are blinded to the case's previous time points.

The investigator hypothesizes that the WECS will show external validity: that all coders will have high reliability on their WECS scores, despite exposure to the dyads' past videos by the clinical coders.

The purpose of this study is to determine the external validity of a scale for emotional connection between children and their parents through a retrospective longitudinal study. The Welch Emotional Connection Scale (WECS) is a screen that allows healthcare providers to rate the emotional connection of a mother-child relationship in just a few minutes of observed interaction, and shows preliminary predictive properties when performed in the first year of the child's life. Administration of the WECS involves watching interactions of a child sitting face-to-face on a parent's lap, and scores the interaction on sliding scales in 4 domains. During the WECS development, the Nurture Science Program of Columbia University Medical Center created and coded hours of parent-child interaction videos. This video data set will be used to determine how clinical WECS scores, where raters are familiar with mother-child dyads over time, compare to research WECS scores, where rate-rs are blinded to each case. The WECS scores of clinical coders, who are exposed to the same case at different time points, will be compared to blinded coders who see cases at just one time point. To simulate implementation of the WECS in a clinical setting, two primary care nurse practitioner (PNP) students who are trained in rating emotional connection will view videos to rate the emotional connection of mother-child dyads collected at different time points. To recreate WECS used in a research setting, blinded coders trained in rating emotional connection will rate the emotional connection of the same video data set. Each blinded coder will only view a dyad once, to not be influenced by previous time points of the same subject. The inter-rater reliability of the blinded and clinical coders will be determined. The comparison of inter-rater reliability scores between clinical and blinded coders is the main outcome of this study.

Eligibility Criteria:
Inclusion Criteria:

* Children and their parents who participated in previously conducted studies (AAAD0389)

Exclusion Criteria:

* Children and their parents who had not participated in previously conducted studies (AAAD0389)
Treatment Using 448 kHz CRMRF in Subacromial Syndrome.

The purpose of this study is to assess the effectiveness of 448 kHz capacitive resistive monopolar radiofrequency in the treatment of subacromial syndrome.

Shoulder pain has a high prevalence in our society, several studies estimate an annual prevalence between 5% and 47%. It is one of the main causes of musculoskeletal pain, particularly in third place, after the low back pain and neck pain.

Symptoms of pathologies of subacromial syndrome, where, regardless of origin, pain is the number one symptom for the patient, which emanates functional impairment and the impact on quality of life.

Among the non-pharmacological treatments of subacromial syndrome, a systematic review concludes that the first line of intervention should be a therapeutic exercise program. In many cases, this is usually accompanied by the application of electrophysical agents (short wave, laser, etc.). A recent study has shown that the application of Short Wave Radio Frequency improved pain in people with subacromial syndrome. The current frequency that is applied in the short wave is 27.12 MHz, however, there are other relatively new forms of radiofrequency in which a frequency less than 1 MHz is used. These are beginning to be used in clinical practice and recently have shown positive results related to pain and functionality of musculoskeletal pathologies such as knee osteoarthritis. In these two clinical trials, what is called Resistive Capacitive Monopolar Radio Frequency (RFCR) was used, the frequency of which was 448 KHz and 485KHz respectively, much lower than the frequency used in Shortwave. The RFCR has a potential advantage since it is applied with electrodes directly on the skin and is not transmitted in the air unlike the Short Wave.

Based on the few clinical trials in people with pathology and the physiological effects evidenced in healthy people and in vitro preclinical studies, it is considered pertinent to carry out the present investigation.

Eligibility Criteria:
Inclusion Criteria:

* Patients between 18 and 70 years years old with diagnosis of subacromial syndrome
* Visual Analogue Scale (VAS) less than or equal to 7.
* Positive Neer and Hawkins test.

Exclusion Criteria:

* Clinical examination compatible with complete rotator cuff tear (Drop-arm positive test)
* Fibromyalgia
* Adhesive capsulitis
* Be receiving physiotherapeutic treatment or have received it previously for this pathology one month before the start of treatment.
* Patients with alterations of thermal sensitivity.
* Derived from the absolute and relative contraindications of CRMRF:
* Pacemaker
* Thrombophlebitis
* Pregnancy
* Skin disorders (recent wounds or burns)
Radiological Dating of Child Fractures Before One Year

The aim of this study was to use, in a precise manner, defined radiographic semiological criteria to determine an analytical methodology to facilitate the dating of long bone fractures of infants under one year of age. A total of 99 radiographs of infants under one year of age with long bone fractures of known date were studied. Four dating groups were established on the basis of data in the literature, with the aim of developing predictive models based on well-defined semiological criteria, in order to construct a simplified dating decision tree.


Eligibility Criteria:
Inclusion Criteria:

* had X-rays taken at the University Paediatric Hospital for the diagnosis and/or follow-up of a fracture of the long bones of the limbs (tibia, femur, fibula, radius, humerus and/or ulna)

Exclusion Criteria:

* child maltreatment,
* chronic illnesses
Ischemic Injury and Ischemic Preconditioning in Diabetes

In this proof-of-concept study, forearm vulnerability to ischemic exercise is studied in patients with type 1 diabetes mellitus with and without prior ischemic preconditioning (short period of ischemia that protects against subsequent ischemic exercise). Annexin A5 scintigraphy is used to quantify subtle signs of mild and reversible forearm injury that results from ischemic exercise.

The following hypotheses are tested:

1. Patients with type 1 diabetes are not more vulnerable to ischemic injury as compared with previously studied healthy volunteers.
2. Ischemic preconidtioning is still present in patients with type 1 diabetes. Depending on the validity of hypothesis 2, the effect of short pharmacological interventions are studied on vulnerability to forearm ischemia/reperfusion injury in the absence or presence of local forearm ischemic preconditioning.

All patients will be studied in supine position after an overnight fast, while plasma glucose levels are monitored. In the first 8 patients intravenous insulin is administered as needed, to reach target glucose levels between 5-7 mmol/l. Patients will be subjected to 10 minutes of forearm ischemia (non-dominant arm), combined with handgripping at 50% of maximal force until exhaustion. Upon reperfusion, Tc-99m-HYNIC-Annexin A5 will be injected intravenously. Targeting of annexin A5 to thenar muscle and forearm flexor muscle will be quantified as the percentage difference in radioactivity between experimental and control side. This procedure will be performed twice (randomized cross-over design), with at least 2 week interval, either with or without 10 minutes ischemia followed by 10 minutes of reperfusion prior to ischemic exercise.

Depending on the results of this study, substudies will be performed to study the effect of diazoxide (K-ATP channel opener, may mimic ischemic preconditioning), glibenclamide (K-ATP channel blocker, may inhibit ischemic preconditioning) or adenosine (infusion into brachial artery of non-dominant arm as a substitute for ischemic preconditioning).

Eligibility Criteria:
Inclusion Criteria:

* type 1 diabetes mellitus
* age 18-50 years

Exclusion Criteria:

* hypertension (systolic blood pressure \> 140 mmHg and/or diastolic blood pressure \> 90 mmHg
* cardiovascular disease (coronary artery insufficiency,CVA/TIA, peripheral artery disease
* HbA1c \> 9%
* Body Mass Index \< 25 kg/m2
* Unable to stop co-medication (other than insulin) for 1 week
* Previous exposure to radiation (diagnostic or therapeutic) in the past year
Chagas Disease as an Undiagnosed Type of Cardiomyopathy in the United States

A detailed review was made of data pertinent to the occurrence of chronic Chagas disease in the United States.

BACKGROUND:

In Latin America, 16 to 18 million individuals are thought to have Chagas' disease and 90 million are considered to be at risk of infection. In the United States, the occurrence of Chagas' disease is virtually limited to individuals who have resided in Latin America where they acquired the infection, and then migrated to this country.

DESIGN NARRATIVE:

Data on the prevalence of positive serologic reactions for Trypanosoma cruzi (a protozoan causing Chagas cardiomyopathy) serve for calculating that a total of up to 74,000 Latin Americans residing in the United States have the chronic form of chagasic cardiomyopathy. The vast majority of these individuals are either undiagnosed, or misdiagnosed as having idiopathic dilated cardiomyopathy or coronary artery disease. Vector transmission of T. cruzi infection is very unlikely to occur in the United States because of variations in biological behavior of local species of insect vectors and because of changes in human living conditions. Transfusion of blood from infected but asymptomatic individuals is considered the most important mechanism of transmission of this disorder in the United States.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
The Interaction of Flavor With Nicotine Form in Adult Smokers

This study seeks to elucidate the impact of e-cigarette flavor on subjective effects and nicotine exposure from e-cigarettes containing different forms of nicotine.


Eligibility Criteria:
Inclusion Criteria:

* At least 21 years old, able to read and write, use of combustible

Exclusion Criteria:

-
LIMBO : Breast Reconstruction by Lipomodeling Alone or With Flap: Evaluation in Franche-Comté

The Limbo study is a retrospective descriptive study which aims to establish the current state of breast reconstruction surgery at the Besançon University Hospital and Hôpital Nord Franche-Comté, between October 2017 and December 2021.


Eligibility Criteria:
Inclusion Criteria:

* Patient who has undergone breast reconstruction using lipomodelling alone or in association with a flap (greater dorsal, DIEP Deep Inferior Epigastric Perforator flap or TRAM Tranverse Rectus Abdominis Myocutaneous Flap), since October 2017.

Patient whose follow-up in plastic surgery is considered completed (final result obtained, patient lost to follow-up or not wishing to continue) at the time of data collection.

Exclusion Criteria:

* Patient under 18 at first consultation
* Opposition of the patient to the collection of her data