cyrilzakka/clinical-trials huggingface dataset:
Descriptive Analysis of Near Infrared Spectroscopy in Critically Ill and Injured Pediatric and Neonatal Patients

This study involves looking at Cerebral oximetry measurements in pediatric and neonatal patients who are experiencing a critical illness. Such as Altered mental status, seizures, trauma, sepsis, etc.

At Arkansas Children's Hospital (ACH) Pediatric Emergency Department (PED), NIRS cerebral tissue oxygenation rSO2 monitoring has become an adjunct noninvasive monitoring assessment tool along with Pulse Oximetry and End-Tidal CO2 in the critically ill and injured neonatal and pediatric patients' resuscitation endeavors or management. This has become a standard monitoring tool for patients who require medical (possible strokes, diabetic ketoacidosis, increased intracranial pressure, altered mental status, sepsis, drowning, shock, rapid sequence intubations, seizures, altered mental status, strokes, possible shunt malfunctions) or trauma (non-accidental trauma, Level One or Two Trauma with altered mental status, traumatic brain injury, altered mental status with trauma history, vascular compromise) resuscitation efforts.

Data will be collected as a retrospective and prospective chart review from the electronic medical record of patients that were treated in the pediatric emergency department of Arkansas Children's Hospital from 10-1-13 who require medical (possible strokes, diabetic ketoacidosis, increased intracranial pressure, altered mental status, sepsis, drowning, shock, rapid sequence intubations, seizures, altered mental status, strokes, possible shunt malfunctions) or trauma (non-accidental trauma, Level One or Two Trauma with altered mental status, traumatic brain injury, altered mental status with trauma history, vascular compromise) resuscitation efforts. This study will be based on the patient information recorded in these records, such as age, medications delivered, vital signs, interventions and outcomes and compared to their PED NIRS cerebral tissue oxygenation rSO2 data. All study subject materials will be assigned a unique identifying code or number. The cerebral NIRS rSO2 data will be collected/graphed and de-identified.

Eligibility Criteria:
Inclusion Criteria:

* Trauma: non-accidental trauma, Level One or Two Trauma with altered mental status, traumatic brain injury, altered mental status with trauma history, vascular compromise
* Or medical: possible strokes, diabetic ketoacidosis, increased intracranial pressure, altered mental status, sepsis, drowning, shock, rapid sequence intubations, seizures, altered mental status, strokes, possible shunt malfunctions

Exclusion Criteria:

* none
Multinational Point Prevalence Study on the Management of Diabesity in Hospitals

Diabetes related to obesity ("diabesity") is becoming increasingly prevalent. Hospitalizations among people with diabetes are frequent and glycaemic control is often suboptimal during these stays.

However, the pharmacological treatment of diabesity has made significant progress in recent years.

The objective of this study is to assess the management of diabesity in the international hospital setting. Aims include:

1. to determine the prevalence of causes and duration of hospitalization
2. to investigate the treatments used
3. to determine individual metabolic control achived This is a cross-sectional multi-centre study in which researchers will conduct a one-day point prevalence assessment in internal medicine wards.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized at the time of the survey for any cause
* Diabetes diagnosis (Known / documented in medical history or newly diagnosed using ADA diagnostic criteria)
* Age ≥ 18 years
* Written informed consent

Exclusion Criteria:

* Patients in wards and units other than internal medicine wards (such as outpatient areas, emergency departments, skilled nursing and intensive care units, etc.)
* Paediatric patients (Age \< 18 years)
* Patients without a diabetes diagnosis
Doxycycline and Airway Inflammation in Chronic Obstructive Pulmonary Disease (COPD)

COPD is a progressive pulmonary disease that is characterized by an inflammatory process in the airways and the lungs which leads to progressive airway obstruction. The inflammation is associated with tissue loss and remodelling. The investigators hypothesized that doxycycline reduces neutrophilic airway inflammation in patients with COPD. Therefore the investigators will conduct a randomized trial of doxycycline in 30 patients.

Rationale:

COPD is a disease characterized by chronic inflammation and irreversible airway obstruction. Chronic inflammation lead to degradation of extracellular matrix and hereby destruction of lung parenchyma. Tetracyclines are known for their anti-inflammatory properties in diseases such as rheumatoid arthritis.

Objective:

To assess the effect of doxycycline on markers of neutrophilic inflammation and proteolytic activity in induced sputum of stable GOLD II and III COPD patients.

Study population:

Thirty patients with stable GOLD II COPD.

Intervention:

Placebo versus doxycycline in randomised design.

Eligibility Criteria:
Inclusion Criteria:

* GOLD II or III COPD (GOLD II: FEV1/FVC \< 70%; 50% \< FEV1 \< 80% predicted, GOLD III: FEV1/FVC \< 70%; 30% \< FEV1 \< 50% predicted ).
* Stable disease (no exacerbations in the last 3 months).
* Age \> 40 yrs.
* Written informed consent.

Exclusion Criteria:

* Infections and/or use of antibiotics in the last month.
* Bacterial colonization of the airways, proven by sputum cultures or broncho-alveolar lavage (BAL).
* Allergy for tetracyclines or a history of substantial side-effects.
* Active respiratory diseases other than COPD (e.g. sarcoidosis, tuberculosis, lung cancer, bronchiectasis).
* Acute exacerbation of COPD as defined by Anthonisen et al. \[10\].
* Signs and/or symptoms of a current respiratory or non-respiratory infection.
* Use of oral or intravenous corticosteroids or other immunosuppressive drugs within the last month.
Indomethacin for Refractory Chronic Cough

Chronic cough is a common complain of patients in respiratory clinic and its global prevalence was up to 9.6%. Persistent cough of unexplained origin is a significant health issue that occurs in up to 5% to 10% of patients seeking medical assistance for a chronic cough and from 0% to 46% of patients referred to specialty cough clinics. Previous studies showed that sputum prostaglandin D2( PGD2) and prostaglandin E2 (PGE2) concentrations were significantly higher in chronic cough. And some research showed that Inhaled PGE2 /PGF2α /PGD2 / PGI2/ 6-oxo-PGF1a could induced cough. And PGE2 /PGF2α/PGI2/thromboxane A2 (TXA2) also increased the sensitivity of the cough reflex. All these five primary prostaglandins were synthesized though the metabolism of arachidonic acid via the cyclooxygenase pathway. Indomethacin is a strong inhibitor of cyclooxygenase , which decrease the level of prostaglandins in airway. The investigator's preliminary study showed that indomethacin could relieve cough and improve cough sensitivity of some patients with refractory cough. Therefore this randomized, double-blind, placebo-controlled trial were designed to investigate whether indomethacin can relive cough in patients with refractory cough and to explore the possible mechanism of indomethacin in improving cough in patients with refractory cough.


Eligibility Criteria:
Inclusion Criteria:

1）18 years old ≤ age ≤ 60 years old, male or female; 2）Chronic cough lasting more than 8 weeks as the sole or predominant symptom, without abnormalities on chest radiograph; 3）Chronic cough remains after investigation and supervised therapeutic trial(s) conducted according to "Clinical Practice Guidelines for Diagnosis and Management of Cough (2015)" 4）Cough VAS (0-100mm) ≥ 30 mm

Exclusion Criteria:

1. Patients had any contraindications to indomethacin;
2. Patients had active respiratory disease (such as chronic obstructive pulmonary Disease or untreated asthma), or moderate or above obstructive or restrictive or mixed pulmonary ventilation dysfunction;
3. Patients had a respiratory tract infection in the month before randomization;
4. Patients were taking an angiotensin-converting enzyme inhibitor;
5. Patient were pregnant or breastfeeding, or had impaired kidney function;
6. Current and recent smokers (\<6 months' abstinence), or ex-smokers with more than 20 pack-years (20 cigarettes per pack).
Study on the Biomarkers of Anti-VEGF Treatment for Choroidal Neovascularization

Choroidal neovascularization (CNV), also known as subretinal neovascularization, is a proliferative change from choroidal capillaries that has become one of the most important causes of blindness worldwide. CNV can occur in a variety of fundus diseases, including pathologic myopia, polypoidal choroidal vasculopathy. At present, intravitreal injection of anti-vascular endothelial growth factor (VEGF) drugs is the first-line effective treatment for CNV. Although a number of clinical studies have shown that the treatment of CNV with anti-VEGF drugs has achieved good visual and anatomical effects, there are still some patients whose CNV has not decreased significantly or even progressed continuously after treatment. Rapid advances in imaging technology have made it possible to explore the quantitative and qualitative characteristics of choroid and CNV, especially swept source optical coherence tomography angiography (SS-OCTA).

The objectives are to improve the OCTA typing of CNV and analyze the vascular morphological characteristics of each type; to identify the changes in vascular characteristics of CNV after anti-VEGF treatment in vitreous cavity; and to elucidate the predictive effects of neovascularization and choroidal vascular characteristics on visual acuity and anatomic effects of vitreous anti-VEGF drug treatment for CNV.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years old
* Active choroidal neovascularization (activity criteria: blood vessel leakage confirmed by FFA, or subretinal fluid accumulation or bleeding seen by OCT)
* History of anti-VEGF drug therapy
* At least 3 months of follow-up data.

Exclusion Criteria:

* Unable to complete the examination due to severe cataract or vitreous hemorrhage
* Any retinal diseases except choroidal neovascularization, such as multifocal choroiditis, diabetic retinopathy
* History of intraocular surgery
Digitalis Investigation Group (DIG)

To determine if digitalis had a beneficial, harmful, or no effect on total mortality in patients with clinical heart failure and sinus rhythm.

BACKGROUND:

Despite widespread use of digitalis and its availability for nearly two centuries, uncertainty surrounded the appropriateness of its role and value in treating congestive heart failure patients in sinus rhythm. The study was a multicenter collaborative effort with the Department of Veteran Affairs Cooperative Studies Program which provided support for a data coordinating center and a pharmacy coordinating center.

DESIGN NARRATIVE:

Randomized, double-blind, simple, multicenter, international trial with 186 centers in the United States and 116 in Canada. In the main trial, patients with left ventricular ejection fractions of 0.45 or less were randomly assigned to digoxin (3397 patients) or placebo (3403 patients) in addition to diuretics and ACE inhibitors. In an ancillary trial of patients with ejection fractions greater than 0.45, 492 patients were randomly assigned to digoxin and 496 to placebo. Patients were recruited over a three-year period at the 302 centers and followed for a minimum of two years. Patient enrollment began in February 1991 and ended in September 1993. Follow-up ended in December 1995. The main results paper was published in 1997.

Three substudies were conducted. The quality of life/6-minute walk test substudy determined the effect of treatment on a patient's well-being, daily activities, and functional status. The Holter/signal averaging electrocardiogram substudy examined the pathophysiology of sudden cardiac death. The neurohormonal substudy determined whether long-term administration of digoxin attenuated the neuroendocrine response in patients with heart failure.

The study completion date listed in this record was obtained from the "Completed Date" entered in the Query View Report System (QVR).

Eligibility Criteria:
Men and women with clinical heart failure, sinus rhythm, and an ejection fraction less than or equal to 45 percent.
PROtocol for Coxsackievirus VaccinE in Healthy VoluNTteers

Phase 1, first-in-human, randomized, double-blind, placebo-controlled, multiple-dose-escalation study to evaluate the safety, tolerability and immunogenicity of PRV-101, a coxsackie virus B vaccine, in healthy volunteers.

Thirty two healthy adult subjects will be enrolled into 2 dose cohorts (low-dose and high-dose cohorts, 16 subjects per cohort) and will be randomized in a double-blind manner to PRV-101 or placebo in a 3:1 ratio. Each subject will receive up to 3 administrations of the study drug (PRV-101 or placebo) at 4-week intervals and will be followed for 24 weeks after the final dose. Each cohort will start with a sentinel dosing group (2 subjects). Cohort 2 will commence after safety data from the first 2 doses from all Cohort 1 participants are reviewed.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults, males and females, ages 18 to 45 yrs, with BMI 19 to 30 kg/m2
* Women of childbearing potential must have negative pregnancy test and agree to use an acceptable method of highly effective contraceptive
* Men must either have a vasectomy or agree to use highly effective contraception

Exclusion Criteria:

* Prior or current clinically significant medical illness or disorder
* Has celiac disease or type 1 diabetes or related autoantibodies
* Has active acute or chronic/latent infection, or history of recent serious infection
* Recent acute illness or recent major illness, hospitalization or surgery
* Recent history of alcohol or drug abuse
* Received an experimental antibody or biologic therapy in last 6 months
* Received live, inactivated or subunit virus vaccine or a bacterial vaccine within last 4 weeks
* Intolerance or hypersensitivity to vaccines or vaccine components or has a drug or food allergy or allergic disease requiring medication
Evaluation of Non-cultured Epidermal Cellular Grafting vs Hyaluronic Acid for Repigmenting Vitiligo and Piebaldism

The purpose of this study is to assess the efficacy of autologous epidermal cells suspension grafting using a newly developed device named VITICELL® compared to placebo.

The secondary objective is to evaluate safety of VITICELL® and global satisfaction of patient and investigator.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged over 18 years old with a diagnosis of non-scaring leukoderma that has been stable over the last 2 years (non-segmental, segmental vitiligo and piebaldism)
* For non-segmental vitiligo: symmetrical vitiligo lesions, or parts of a lesion. A part of at least 1 cm2 (1 x 1 cm), but preferable 4 cm2 (2x2 cm) and preferably in the center of each lesions (left/right) should be treated.

The minimum distance between the normal pigmented skin and the test area should preferably be at least 0.5 cm.

* For segmental vitiligo lesion and piebaldism: all lesions possible if two parts of at least 1 cm2 (1 x 1 cm), but preferably 4 cm2 (2 x 2 cm) in the lesion can be treated. The minimum distance between the 2 areas should be 2 cm and between test areas and to the normal pigmented skin preferably at least 0.5 cm.
* Medical treatments of vitiligo failed (in case of vitiligo: at least cream treatment for 6 months).
* Absence of infected lesion
* Negative serology (HIV-hepatitis B and C- Syphilis)
* Without treatment one month for cream and 3 months for phototherapy

Exclusion Criteria:

* Hypersensibility to local anaesthetics or one of the components of the device (trypsin, hyaluronic acid)
* Indication against biopsies
* Patient with a history of melanoma
* Positive serology (ongoing serious systemic disease, herpes, HIV, hepatitis B and C-Syphilis)
* Positive pregnancy test
* History of keloidal scars and presence of Koebner's phenomenon (type 1 and type 2b)
* Infected lesion
* Test areas not on fingers and toes vitiligo areas in case of non-segmental vitiligo
* Test areas not on facial non segmental vitiligo
* Pregnant women, or lactating
* Age \<18years
* Major deprived of their freedom by administrative or legal decision, or being the subject of a legal protection measure, or out of state to express their consent
Evaluation of the Effectiveness of PREVENIR (PREVention ENvIronnement Reproduction) Platforms

Unblinded randomized clinical superiority trial in two parallel groups (intervention vs. no intervention) national multicentre to evaluate the effectiveness of the platforms on the evolution of phenoxyacetic acid levels measured in the urine at inclusion and 3 months after the intervention for patients who received the intervention compared to patients who did not receive the intervention.

it is now recognized that there is a link between certain environmental exposures (occupational and extra-occupational) and reproductive pathologies. During pregnancy, environmental exposures are associated with an increased risk of spontaneous miscarriage, congenital malformations, certain adverse outcomes (fetal death in utero, intrauterine growth retardation, prematurity) and could also increase the risk of chronic disease in childhood and adulthood (hypothesis of developmental origins of health and disease), and have transgenerational effects. Intervention studies have shown efficacy in reducing exposures to certain chemicals, particularly by reducing exposure to cosmetics. In the scientific literature, a pre-conception visit is recommended to identify environmental exposures. In France, platforms are dedicated to the evaluation of environmental exposures in patients with fertility disorders and pregnancy-related pathologies and provide support for the implementation of targeted prevention actions.

The intervention is taken care of by the PREVENIR platforms. This care consists of a consultation carried out by an environmental health expert (midwife, environmental health engineer) from the PREVENIR platforms. This consultation is carried out through a protocolized interview already developed which allows the identification of exposure to risk factors on reproduction. During the interview, prevention messages targeted at the exposures identified during the interview are delivered.

Eligibility Criteria:
Inclusion Criteria:

* All pregnant women less than 24 SA of age referred to the PREVENIR platforms participating in the study for management.
* Only women less than 24 SA months pregnant will be included to limit the number of women who gave birth during the study.
* More than 18 years old

For qualitative study:

* Professionnal working within PREVENIR platforms
* Women included in the intervention group and who agreed with participating

Exclusion Criteria:

* Women under court protection, under guardianship or curatorship, severely altered physical and/or psychological health, which, in the opinion of the investigator, may affect the participant's compliance to the study.
* Women with an altered medical condition related to prgnancy that may required a therapeutic abortion according to the environmental expert
* Non-French speakers
Subharmonic Imaging and Pressure Estimation for Monitoring Neoadjuvant Chemotherapy

This is a diagnostic accuracy study to evaluate if two novel ultrasound (US) techniques, quantitative 3D subharmonic imaging (SHI) and Subharmonic Aided Pressure Estimation (SHAPE), used with an intravenous ultrasound contrast agent (Definity, Lantheus Medical Imaging, Billerica, MA), can track changes in locally advanced breast cancer (LABC) angiogenesis and interstitial fluid pressure (IFP), respectively, by studying women undergoing neoadjuvant chemotherapy before as well as with around 10% and 60% (in part 1) or 30% (in part 2) of the neoadjuvant chemotherapy treatment delivered and after completion of the neoadjuvant chemotherapy treatment. Results will be compared to MRI and pathology.


Eligibility Criteria:
Inclusion Criteria:

* Females
* Be diagnosed with T1 or greater LABC, any N and M0.
* Be scheduled for neoadjuvant chemotherapy
* Be at least 21 years of age.
* Be medically stable.
* If a female of child-bearing potential, must have a negative pregnancy test.
* Have signed Informed Consent to participate in the study.

Exclusion Criteria:

* Males
* Females who are pregnant or nursing.
* Patients with other primary cancers requiring systemic treatment.
* Patients with any metastatic disease.
* Patients undergoing neoadjuvant endocrine therapy.
* Patients with known hypersensitivity or allergy to any component of Definity.
* Patients with cardiac shunts or congenital heart defects.
* Patients with unstable cardiopulmonary conditions or respiratory distress syndrome.
* Patients with uncontrollable emphysema, pulmonary vasculitis, pulmonary hypertension or a history of pulmonary emboli.
* Patients who have received any contrast medium (X-ray, MRI, CT or US) in the 24 hours prior to the research US exam.
Singing for People With Aphasia

To undertake a pilot study that will evaluate the feasibility and acceptability of procedures to inform the design and delivery of a definitive RCT of SPA (which would assess the clinical and cost effectiveness of SPA for people with aphasia)

Beyond language function, people with aphasia (PWA) report a range of health problems which negatively affect wellbeing, including reduced confidence and social isolation. These psychosocial outcomes of aphasia are not sufficiently met by healthcare services: improvements in language function do not appear to lead to improvements in wellbeing. National clinical guidelines for stroke reflect this observation and highlight the need for community integration and participation of people with aphasia. This research is about singing groups for people with aphasia (SPA) and is intended to address this need by focusing on the wellbeing and social participation needs of people with aphasia after stroke.

The Investigators engagement activities and early development project provided strong impetus for the proposed study: people with aphasia repeatedly told the investigators that singing in groups may help the participants to reconnect with society, and that this will improve wellbeing.

The investigators have planned a pilot study that will allow an assessment of the extent to which the study processes and the singing groups themselves are feasible to run and are acceptable to participants. The information from this work will help the investigators to decide whether to conduct a larger randomised controlled trial (RCT) which would be a fair test of whether SPA can improve the lives of individuals with post stroke aphasia.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of aphasia after stroke
* Willingness to be randomised to either control or SPA (and able to attend the singing venue)
* Conversational English speaker pre-morbidly
* Capacity to consent (assessed by recruiting team using standard tools)

Exclusion Criteria:

* \<18 years old
* Currently engaged in a speech or language therapy programme
* Intention to relocate outside the geographical region during the study
* Current participation in another study involving a lifestyle intervention
* Currently attending a singing/music group