cyrilzakka/clinical-trials huggingface dataset:
Trauma Routing Algorithm for Pediatrics

Traumatic injury is the leading cause of pediatric death in the United States for those forty-four years of age and younger. Pediatric trauma patients generally have reduced mortality when treated at pediatric trauma centers rather than at adult centers or non-tertiary care facilities. However, nearly half the US pediatric population lives over fifty miles from a Level I or II Trauma Center. While air ambulances are readily available in many jurisdictions, few guidelines and little evidence dictate their appropriate use, especially with regard to pediatric trauma. Previous research is mixed regarding mortality benefit from helicopter Emergency Medical Services (EMS) in injured children. Previous attempts to develop appropriate field triage criteria have failed due to poor sensitivity and specificity for identifying the critically injured child. The current high rate of overtriage is particularly concerning in today's cost-conscious medical community. This research study aims to categorize pre-hospital pediatric trauma in North Carolina, to determine what benefits helicopter EMS provides in the North Carolina trauma system, and to formulate an enhanced screening tool for pre-hospital use to help determine which patients are suitable candidates for helicopter EMS transport.

The North Carolina Trauma Registry will identify pediatric trauma patients between 0 and 18 years of age who presented directly to North Carolina Level 1 Trauma Centers from the field after sustaining injury from January 1st, 2013 and October 2017.

The analysis will be a retrospective cohort study by nature of the data set. Final methodology will be determined after Institutional Review Board approval and enlistment of statistical support through the Clinical and Translational Science Institute. Clinical and non-clinical factors will first be summarized with univariate analysis to provide a descriptive overview of the study population. These factors will include number of case-patients, demographics, scene address/location, time of injury, EMS agency involved, EMS call times, transport mechanism, time of transport, distance of transport, geographic area of injury, mechanism of injury, severity scores, Glasgow Coma Score, vital signs, receiving hospital name, and other variables. Similarly, interventions and outcomes will be compared between study groups through such factors such as length of emergency department stay, emergency department disposition, time to operating room, intubation status on arrival, administration of blood products, days of hospital stay, days of intensive care unit stay, days on ventilator, if viable organs were procured post-mortem, and mortality at given time points. Outcomes will be compared through regression analysis or related means.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric trauma victims 0-16 years old who are reported in the North Carolina Trauma Registry after presenting to a North Carolina Trauma Center between January 1st, 2013 and October, 2017.

Exclusion Criteria:

* Interfacility transport patients are excluded
Effect on Early Somatic Growth of a Daily Kinesthetic Stimulation on Preterm Infants

Kangaroo position (KP), the essential component of the Kangaroo Mother Care (KMC) method, has been increasingly implemented, given the benefits of early skin-to-skin contact on the cerebral maturation of preterm infants. In addition it allows for parents to bond with their infants and humanize the care of fragile infants in neonatal units. Evidence on kinesthetic stimulation (KS) is scarce and currently there is no available evidence on KS during the KP. KS is associated with massage in this paper

The objective is to study the impact of standardized KS delivered either in KP (KSKP) or in an incubator (KSI) on the early growth of very preterm infants.

Patients and methods: Sixty six newborns ≤32 weeks of gestational age at birth received KS delivered 3 times/day during KP or in an incubator. They were randomized when the infants were considered eligibleto initiate KMC which was part of the routine care for all newborns in the Neonatal Care Unit (NCU). The primary outcome were the weight gain (g/kg/day) between randomization, 5, and 15 days after the start of the intervention and weight at 40 weeks of gestational age (term). The secondary outcomes were the same measures according to the chronological age (days of life) of the infant at randomization.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants (GA ≤33 weeks of gestation)
* Deemed clinically stable and eligible for the KMC intervention by the neonatologist were included.

Exclusion Criteria:

* Infants with congenital anomalies
* Unstable during the first 15 days of life
Periodontal Osseous Wall Piezosplitting and EDTA Root Surface Etching

This study was designed to investigate the use of minimally invasive Piezo knife to harvest vascularized interceptal bone pedicle in treating intrabony defects.

Sixteen non-smoking patients with severe chronic periodontitis participated in this prospective, randomized clinical study. Patients were randomly assigned into one of a 2 groups (8 patients each): bone substitute grafting of the intrabony defect, control group (Gr1), intrabony defect osseous wall swaging (OWS) combined xenograft (Gr2). In both groups root surfaces where treated with a neutral 24% EDTA gel and saline irrigation. Clinical and radiographic measurements were reassessed at 6 months after surgery.

Eligibility Criteria:
Inclusion Criteria:

1. good compliance with plaque control instructions following initial therapy
2. teeth involved were all vital with no mobility ;
3. each subject contributed a single predominately 2 or 3-wall intrabony interproximal defect around premolar or molar teeth without furcation involvement;

Exclusion Criteria:

1. no systemic diseases which could influence the outcome of therapy;
2. absence of periodontal treatment during the previous year.
Blood Glucose Homeostasis in Type 2 Diabetes: the Effects of Saccharose

Hyperglycemia forms a direct and independent risk factor for the development of cardiovascular co-morbidities in type 2 diabetes. Consumption of sucrose-sweetened soft drinks might further increase the prevalence of hyperglycemic episodes.

The objective of the study was to assess glycemic control in type 2 diabetes patients and healthy lean and obese controls under strict dietary standardization but otherwise free living conditions, with and without the consumption of soft drinks.


Eligibility Criteria:
Inclusion Criteria:

Lean NGT Group

* Normoglycemic (according to 2006 ADA guidelines)
* BMI \< 27 kg/m2

Obese NGT Group

* Normoglycemic
* BMI 30- 35 kg/m2

Obese type 2 diabetes Group

* BMI 30- 35 kg/m2
* Oral blood glucose lowering medication

Exclusion Criteria:

* Exogenous insulin use
* Cardiac disease (any cardiac event in the last 5 years)
* HbA1c \>10%
* Microalbuminuria: albumin:creatinine ratio \>2,5
Gabapentin for Alcohol Relapse Prevention

This treatment study is a 16-weeks outpatient clinical trial where subjects with alcohol dependence will get medication, which might help them to reduce or stop their drinking, or a placebo ( placebo is a capsule that looks the same as the investigational drug, but has no real medication. It is a "sugar pill").

This treatment study is a 16-weeks outpatient clinical trial where subjects will get medication, which might help them to reduce or stop their drinking or a placebo ( placebo is a capsule that looks the same as the investigational drug, but has no real medication. It is a "sugar pill"). This study will recruit and randomize subjects who have expressed an interest in receiving treatment for alcohol dependence. Upon enrollment into this study there will be 11 outpatient visits. Each visit will last about 1-1.5 hours.

Eligibility Criteria:
Inclusion Criteria:

1. Meets criteria for alcohol use disorder based on DSM-5 criteria
2. Meets criteria for history of alcohol withdrawal based on DSM-5 criteria
3. Able to maintain abstinence for a minimum of 3 days prior to randomization as verified by self report, urine ETG, and breathalyzer.

Exclusion Criteria:

1. Significant psychiatric or medical illness
2. No other substance abuse
3. Taking other medications known to treat alcohol use disorder
4. Unstable living arrangements
5. Significant legal problems pending
Project ICARE: Intervening for Community Awareness, Respect, & Empowerment

This project will test the efficacy of a behavioral intervention to reduce sexual risk for HIV infection among African American Men who Have Sex with Men (MSM).


Eligibility Criteria:
Inclusion Criteria:

* Be 18 years of age or older;
* Self-identify as African American
* Understand and read English;
* Live within the Chicago area;
* Report at least two (male or female) sex partners in the past three months, and unprotected anal sex with at least one male sex partner in the past three months.

Exclusion Criteria:

* Have been diagnosed with HIV within the past three months (to allow for psychological and behavioral adjustment following an initial HIV diagnosis);
* Have a specific plan to move from the Chicago area within the next nine months;
* Report active injection drug use other than hormones or steroids.
* Participated in the intervention video or the pilot phase of this study.
Intervention to Improve Inhalative Adherence

Despite progress in pharmacological and non-pharmacological treatment in recent years, the burden of disease among asthma and COPD patients is high and patients may be frequently hospitalized due to exacerbations. Reasons for uncontrolled disease are manifold, but are frequently associated with poor inhalation technique and non-adherence to the prescribed treatment plan which may cause substantial mortality, morbidity, and cost to the healthcare system. In this respect, the study of causes for non-adherence and the development of measures to increase respectively maintain treatment adherence, particularly in chronic diseases, is of major clinical importance.

The aim of this study was to investigate the impact of an acoustic reminder and a close supervision on adherence to inhaled medication and on course of disease and quality of life (Qol) in asthma and COPD patients.

In this single-blinded trial, asthma and/or COPD patients were randomly assigned either to the intervention or the control group. Adherence to inhaled medication was monitored using electronic data capture devices, recording date and time of each inhalation device actuation. Follow-up was six months. Primary outcome was defined as "time to next exacerbation". Secondary outcomes included number of exacerbations, number of exacerbations with hospitalization, taking/timing adherence, and Qol during follow-up. Adherence was measured using electronic data capture devices which saved date and time of each inhalative device actuation. Patients are randomly assigned to an intervention, respectively control group. Patients assigned to the intervention group will receive audio reminder and support calls in case medication is not been taken as prescribed or if rescue medication is used more frequently than prespecified in the study protocol. During the study, participants are assessed every two months.


Eligibility Criteria:
Inclusion:

* Aged 18 years or older
* Have an established asthma-diagnosis according to the Global Initiative for Asthma (GINA) guidelines and/or
* Have an established COPD diagnosis according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines (severity GOLD I-IV based on the international GOLD-Criteria) \[46\] and
* Are prescribed daily inhaled medication (controller medication for a daily maintenance treatment)
* Had at least one exacerbation in the previous 12 months before study start
* With a metered dose Inhaler (e.g. Ventolin®), Diskus (e.g.Seretide®), Turbohaler (e.g.Symbicort®), Aerolizer/Breezhaler (e.g.Onbrez®), HandiHaler (e.g. Spiriva®) or Ellipta (e.g Relvar®)

Exclusion:

* Suffering from malignancies and/or other severe diseases
* Insufficient in the German language
* Pregnant or lactating
Revascularization Strategies for STEMI; The CMR Endpoint Study

Revascularization strategies for ST elevation myocardial infarction (STEMI) study (ASSIST-CMR) will compare the effects of two revascularization strategies \[same sitting multivessel primary PCI (SS-PCI) and culprit vessel only primary PCI (IRA-PCI)\] on myocardial infarct size (MIS) as determined by cardiac magnetic resonance (CMR) imaging in patients presenting with STEMI and multivessel disease (MVD).


Eligibility Criteria:
Inclusion Criteria:

* High risk ST elevation myocardial infarction evidenced by: ≥2 mm ST elevation in 2 anterior or lateral leads; or ≥2 mm ST elevation in 2 inferior coupled with ST depression in 2 contiguous anterior leads for a total ST deviation of ≥8 mm; or New left bundle branch block with at least 1 mm concordant ST elevation.
* Multivessel CAD as evidenced by ≥1 significant (≥70% by visual assessment or FFR\<0.80 for 50-70% stenosis) stenosis in non-IRA.
* Successful IRA-PCI with \<10% residual angiographic stenosis and TIMI III flow.
* Written informed consent.

Exclusion Criteria:

* Age ≤ 18 years.
* Prior coronary artery bypass graft (CABG) surgery.
* Administration of thrombolytic therapy.
* Non-IRA stenosis is a chronic total occlusion or located in left main artery.
* Hemodynamic instability evidenced by BP\<90 mmHg, Killip class ≥2, need for inotropes/vasopressors.
* Known renal insufficiency (estimated GFR \< 50ml/min).
* Contraindication to CMR.
Exploration of High Frequency Otoacoustic Emissions and Developmental Language Disorders

Among the objective non-invasive audiological explorations the distorsion products of otoacoustic emissions (DPOAE) allow to quickly assess the function of the cochlear outer hair cells (without the active participation of the subject). This technique is used in newborn screening. While humans are able to perceive sounds in a frequency range of 20Hz to 20kHz, routine clinical audiological assessment is only concerned with frequencies between 1-4kHz.

This obscures the importance of high frequencies (HF) which can be easily assessed by DPOAEs. In young children, the perception of these high frequencies could also play an important role in language acquisition.

The main objective of this study is to evaluate the relationship between subtle high-frequency hearing impairment, as assessed by the DPOAE (non-invasive, rapid and simple audiological test), and language delay or difficulties in a pre-, peri- and school-age pediatric population.


Eligibility Criteria:
Inclusion Criteria for case (children with language disorder):

* Normal hearing (after an audiometry test, even if an ENT consultation has been carried out beforehand and if the doctor has not found any hearing problem, as defined in the NF EN ISO 70292017-04 standard, and according to an average hearing loss calculated according to the BIAP \<20dB HL)
* Free and informed consent of the parental authority and the patient
* Affiliated to the social security system
* Presenting a developmental language acquisition disorder (score according to the EVALO / EVALEO test)
* For children between 15 and 17 years of age, completion of the EVALEO test before their 16th birthday

Inclusion Criteria for control (children without language disorder) :

* Normal hearing (after an audiometry test, even if an ENT consultation has been performed beforehand and if the doctor has not found any hearing problem, as defined in the NF EN ISO 70292017-04 standard, and according to an average hearing loss calculated according to the BIAP \<20dB HL)
* Free and informed consent of the parental authority and the patient
* Enrolled in the social security system

Exclusion Criteria:

* Hearing disorder identified during the inclusion visit (presence of cerumen or foreign body in the earwax plug or foreign body in the external auditory canal, tympanometry suggesting a middle ear disorder, audiometry with thresholds outside the normal thresholds outside the normal range (0-20dB HL), absence of responses in (0-20dB HL), absence of responses in acoustic otoemissions or acoustic distortion products) on conversational frequencies between 500Hz and 4kHz.
* Declaration by the parents of an ENT follow-up for a hearing disorder and/or a speech therapy for a language disorder
* Refusal of participation evoked by the subject
Comparison of Conventional Versus 3-D Printed Complete Denture Regarding Retention, Accuracy, Elctromyographic Activity and Patient Satisfaction.

Analyzing and comparing the retention, accuracy, EMG and patient satisfaction of maxillary complete denture base fabricated by conventional and rapid prototyping techniques.


Eligibility Criteria:
Elligibility Criteria:

Inclusion Criteria:

* Completely edentulous patients were selected to have their ridges covered with firm, thick and compressible mucosa
* All patients accepting prosthodontic treatment by an removable denture.

Exclusion Criteria:

* TMJ disorder.
* Limited mouth opening or mandibular movement
* Muscle spasm or tenderness
* Mandibular deviation
The Effect of the ALDH2 Gene Polymorphism on the Propofol Potency for Inducing Loss of Consciousness

The aim of this study is to determine whether ALDH2 gene polymorphisms (G/G, G/A A/A) have effect on the potency of propofol.


Eligibility Criteria:
Inclusion Criteria:

* ASA II

Exclusion Criteria:

* ASA III-IV
* OSAS
* hepatic and renal insufficiency
Regulatory Post-Marketing Surveillance Study for Brolucizumab

This study is an open-label, multicenter, single-arm, observational post-marketing surveillance.

The investigators will collect safety information and evaluate effectiveness in patients who are prescribed Beovu ® Injection, Beovu ®Prefilled Syringe (brolucizumab) in the approved indication after receiving informed consent over a period of 12 weeks. In addition, longer-term data (24 weeks, optionally 36 weeks) will be collected.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged ≥18 years with nAMD that are prescribed with Brolucizumab as per approved local product information
2. Patients who consent to participate in the study after the purpose and nature of the study have clearly explained to them (written informed consent)

Exclusion Criteria:

1. Contraindications as per local prescribing information 1) Hypersensitivity to the active substance or to any of the excipients. 2) Active or suspected ocular or periocular infection. 3) Active intraocular inflammation.
2. Patients participating in other investigational drug trial
Allogeneic Umbilical Cord Mesenchymal Stem Cell Transplantation for Type 1 Diabetes With Diabetic Ketoacidosis

This is a phase II trial in individuals who have been diagnosed with type 1 diabetes within the previous 12 months and suffered from diabetic ketoacidosis at onset of disease. The purpose of this study is to determine whether allogeneic umbilical cord mesenchymal stem cell transplantation is effective in the treatment of patients with severe type 1 diabetes.

To assess the clinical efficacy of allogeneic umbilical cord mesenchymal stem cell transplantation in the treatment of patients with severe type 1 diabetes, defined as with the history of diabetic ketoacidosis from diagnosis. All the patients are intravenously administrated with single-dose or double-dose umbilical cord mesenchymal stem cell and followed up for 36 months. Clinical and laboratory manifestations are compared before and after transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes
* Duration of disease less than 12 months from diagnosis
* With the history of diabetic ketoacidosis

Exclusion Criteria:

* Pregnancy
* Severe psychiatric disorder
* Severe organic impairment(renal,hepatic,cardiac,pulmonary)
* Active infectious disease
* Previous or present neoplastic disease
Protocol to Examine Methylation of Tumor Suppression Genes in Women at High Risk of Developing Breast Cancer

A study to examine the correlations between methylation of various genes associated with breast cancer and proliferation and cytomorphology in breast epithelial cells acquired by random periareolar fine needle aspiration of women at high risk for development of breast cancer.

A study to examine the correlation between gene promotor methylation and benign breast tissue proliferation and cytomorphology collected via random periareolar fine needle aspiration in postmenopausal women at increased risk for breast cancer.

Eligibility Criteria:
Inclusion criteria:

* women at high risk of developing breast cancer determined by family or personal history
* willing to participate in companion protocol (KUMC HSC#4601) for random periareolar fine needle aspiration (RPFNA) for correlational studies

Exclusion criteria:

* exclude women who have been on raloxifene, tamoxifen, letrozole, anastrozole or exemestane within the six months prior to RPFNA
Impact of MultiPoint Pacing Technology in CRT Patients With Reduced RV-to-LV Delay

Observational, retrospective and perspective study with acute and chronic endpoints

Study to assess the benefit from Multipoint Pacing (MPP) in presence of RV-to-LV delay\<80ms in terms of rate of CRT responder patients at 6 Months from CRT-D system implantation

Eligibility Criteria:
Inclusion Criteria:

* Indication to CRT-D system implantation according to current guidelines or CRT-D system already implanted in patient scheduled to CRT-D system implantation according to current guidelines

Exclusion Criteria:

* Right Bundle Branch Block
* Severe Irreversible Renal Failure (eGFR\<30)
* NYHA IV
* Atrio-Ventricular Block above the 1st grade
* Prosthetic Valves
* Atrial Fibrillation at implantation
Evaluation of Optimal Time of Methimazole Discontinuation Before Radio-iodine Therapy in Hyperthyroid Grave's Patients

Iodine therapy is the best treatment for graves disease.Most patients receive methimozale prior to radio-iodine treatment. This may decrease treatment response to iodine therapy.

Some physicians advice to discontinue methimazole 3 days before radioiodine therapy and others prefer longer off - methimazole period which bothers most patients. This study aimed to evaluate optimum time for methimazole discontinuation in graves disease.


Eligibility Criteria:
Inclusion Criteria:

* age 18-65
* graves disease(TSH\<0.1 \&increased FT4 \& positive TSI
* one or more bartlena criteria for radio-iodine therapy
* 24 hour RAIU\>25%
* euthyroidism after methimazole treatment

Exclusion Criteria:

* pregnancy or lactation
* moderate or severe graves ophthalmopathy
* CHF or coronary heart disease
* palpable thyroid nodule
* lithium or amiodarone or lugol or ipodate treatment
* recent imaging with contrast agent
* very large goiter(more than 150 gram)
Neuromuscular Electrical Stimulation Cycling

A new electromyography (EMG)-driven neuromuscular electrical stimulation (NMES)-cycling system is introduced to stroke survivors for lower-limb rehabilitation. The system will generate NMES to targeted muscle according to the user's voluntary intention, represented by the EMG signal during cycling.


Eligibility Criteria:
Inclusion Criteria:

1. diagnosis of ischemic brain injury or intracerebral hemorrhage shown by magnetic resonance imaging or computed tomography after the onset of stroke;
2. sufficient cognition to follow simple instructions as well as understand the content and purpose of the study;
3. significant gait deficit (Functional Ambulatory Category, FAC, scale \<4 \[person cannot walk independently\]).

Exclusion Criteria:

1. any additional medical or psychological condition that would affect their ability to comply with the study protocol, e.g., a significant orthopedic or chronic pain condition, major post-stroke depression;
2. severe hip, knee or ankle contracture that would preclude passive range of motion of the leg;
3. implanted cardiac device (e.g. pacemaker and internal defibrillator).