cyrilzakka/clinical-trials huggingface dataset:
Corticosteroid Treatment for Community-Acquired Pneumonia - The STEP Trial

Background: An intact hypothalami-pituitary-adrenal (HPA) axis with an effective intracellular anti-inflammatory activity of glucocorticoids is indispensable for host survival during stress upon exposure to an infectious agent. Community-acquired pneumonia (CAP) is characterized by significant mortality and increased circulating inflammatory cytokines. Despite adequate antimicrobial therapy mortality rates for CAP have not changed over several decades. The use of corticosteroids in patients with CAP is inconclusive.

Study aim: To compare a 7 days treatment with prednisone and placebo in patients with community-acquired pneumonia with respect to time to clinical stability.

Study hypothesis: The investigators hypothesize that use of corticosteroids will lead to a 25% relative risk reduction for death and clinical instability.

Study type: randomized double blind intervention study

Patients: 800 patients with community-acquired pneumonia


Eligibility Criteria:
Inclusion Criteria:

1. Patients 18 years of age or older admitted for hospitalization from the community or a nursing home with CAP.
2. CAP will be defined by a new infiltrate on chest radiograph and the presence of one or several of the following acute respiratory signs or symptoms:

   * cough
   * sputum production
   * dyspnea
   * core body temperature \>38.0° C
   * auscultatory findings of abnormal breath sounds and rales
   * leukocyte count \>10 or \<4 x 109 cells L-1 (1)

Exclusion Criteria:

1. Patients or family members unable to give written informed consent, e.g. with severe dementia.
2. Patients with active intravenous drug use.
3. Severe immunosuppression (e.g. patients infected with human immunodeficiency virus infection and a CD4 count below 350 x 109/L, patients on immunosuppressive therapy after solid organ transplantation and neutropenic patients with neutrophil count \< 500 x 109/L and patients under chemotherapy with neutrophils 500-1000 x 109/L with an expected decrease to values \< 500 x 109/L); patients with cystic fibrosis as well as patients with active tuberculosis.
4. Patients with acute burn injury
5. Patients with acute gastrointestinal bleeding within 3 months of the current hospitalization
6. Patients with an acute concomitant condition requiring more than 0.5mg/kg/d prednisone equivalent
7. Pregnancy or breast feeding
8. Patients with known adrenal insufficiency
Weigh Easy: Simplifying Home Weight Monitoring for Infants

This single-site, experimental, pilot study in infants identified from 0 - 3 months of age who present to the Cleft and Craniofacial Clinic with a cleft lip and/or palate will compare weight outcomes of infants who used the Weigh Easy system to monitor weight and historical infants whose weights were monitored without the Weigh Easy system.

Patients will be recruited at the earliest possible visit to the Cleft and Craniofacial Clinic. At this visit, families will complete the consent process. After consent is obtained, the study team will ensure that the family is signed up for the Patient Portal and will provide a demonstration of how to safely obtain a weight using the Weigh Easy scale and the infant's car seat. In addition to the luggage scale, a handout will also be sent home with the family, including instructions and safety tips for weighing their infant and instructions for submitting a weight via the Patient Portal.

Families will be asked to submit a weight, obtained with the Weigh Easy scale, via the Weigh Easy eClipboard message on a weekly basis for 3 months.

Three months after the family is enrolled onto the study, the family will be provided the Parental Satisfaction Survey to complete. This will occur at a clinic visit, in the event that a standard of care visit occurs within the window for the visit. If a clinic visit is unavailable, the surveys will be emailed to the family and three reminders will be sent if the survey is not completed in a timely manner.

Eligibility Criteria:
Prospective Group:

Inclusion Criteria:

* Newborn patient ≤ 12 weeks old
* Referred to Children's Mercy Hospital Multidisciplinary Cleft Team from December 1, 2019 - November 30, 2020
* With a diagnosis of cleft lip and/or cleft palate
* Male or female infant of any ethnic background

Exclusion Criteria:

* Infant with secondary major birth defect such as heart or abdominal wall defect in addition to cleft condition
* Infant who is placed in foster care prior to or during the applicable study period
* Patient parents unable to complete an electronic survey.
* Patient parents unable to speak and read Spanish or English.

Retrospective Group:

Inclusion Criteria:

* Newborn patient ≤ 12 weeks old
* Referred to Children's Mercy Hospital Multidisciplinary Cleft Team from January 1, 2016 to June 30, 2019
* With a diagnosis of cleft lip and/or cleft palate
* Male or female infant of any ethnic background

Exclusion Criteria:

* Infant with secondary major birth defect such as heart or abdominal wall defect in addition to cleft condition
Study of Tarceva and Targretin in Stage I-II Lung Cancer

The purpose of this study is to learn the effects on lung cancer of 2 new drugs, Tarceva and Targretin, given in combination before surgical removal of the tumor. Tarceva is approved by the Food and Drug Administration (FDA) for lung cancer. Targretin is approved for the treatment of cutaneous T-cell lymphoma. This combination of drugs is experimental.

Erlotinib 150mg and bexarotene 400mg/m2 will be administered orally for 7-9 days prior to thoracotomy. Plasma samples will be collected on the day before surgery and along with tissue samples on the day of the thoracotomy. Analyses will be done on the resected specimen and it will be compared to the pre-study diagnostic specimen.

Eligibility Criteria:
Inclusion Criteria:

* Resectable stage I or II non-small-cell lung cancer
* Prior tissue biopsy (not cytology) available for research analysis
* Adequate hepatic and renal function

Exclusion Criteria:

* Prior chemotherapy or radiotherapy
An Observational Study to Collect Data on How Aflibercept (Eylea) Given Using a Paediatric Dosing Device is Used in Preterm Babies With Retinopathy of Prematurity in the United Kingdom (UK)

This is an observational study in which only data from babies with retinopathy of prematurity (ROP) who are being treated with aflibercept (Eylea) in prefilled syringe (PFS) using a paediatric dosing device (PDD) are collected and studied.

ROP is a condition that affects the eyes of preterm babies. It occurs when the baby's retina, the part of the eye that senses light, does not develop normally. This may result in vision problems, including blindness, if left untreated. Preterm babies are born before 37 weeks of pregnancy. ROP is more likely to develop in babies who are born before 32 weeks of pregnancy or weigh less than 1.5 kilograms at birth.

Aflibercept is a drug that is injected into the eye. It works by blocking a protein called vascular endothelial growth factor (VEGF) which causes abnormal growth of blood vessels in the retina.

Aflibercept in PFS given using a PDD is approved for the treatment of babies with ROP. The prefilled syringe will be fitted with an injection needle to give aflibercept. And a PDD is a tool used to give the right amount of aflibercept to children in a safe manner.

Since there are other treatments which are commonly used for babies with ROP, the extent of use of aflibercept given using a PDD is unknown.

The main purpose of this study is to:

* find the number of preterm babies who are treated with aflibercept using a PDD in the UK
* inform whether this number is enough to perform a study to learn about the long-term safety of aflibercept given using a PDD in babies with ROP

An additional purpose of this study is to describe characteristics including age, sex, and race, and signs and symptoms of ROP observed in babies being treated with aflibercept using a PDD.

The data will come from a database called the National Neonatal Research Database. The study will cover the period from March 2024 to March 2025, if the number of babies found is enough to perform the safety study. If not, data will be collected till April 2027.

In this study only available data from preterm babies born during the study period are collected. No visits or tests are required as part of this study.


Eligibility Criteria:
Inclusion Criteria:

* Eligible infants within the NNRD include those who were:

  * 1. Born during the study period, i.e. from Q4/2023 following market introduction of Eylea PFS+PDD and 31st December 2026, and
  * 2. Received care in a neonatal unit that contributes data to the NNRD and the unit has agreed to participate in the study, and
  * 3. Diagnosed with ROP in any stage in at least one eye.

Exclusion Criteria:

* Infants with missing data for gestational age at birth will be excluded.
Effect of Treatment Modality on Psychosocial Functioning of Survivors of Unilateral Retinoblastoma

The purpose of this study is to find out about the quality of life and health in patients who had retinoblastoma in one eye (unilateral retinoblastoma), who either received treatment with chemotherapy injected directly into an artery leading to the eye (intra-arterial chemotherapy) or removal of the eye (enucleation). By quality of life, the investigators mean how the participants are feeling about being satisfied with things in their life, including, physical health, emotional health, and their ability to carry out daily activities. The investigators want to see if either treatment option would affect quality of life differently. The investigators hope that this information will help us provide better care to future children with retinoblastoma and better follow-up care for survivors of retinoblastoma.


Eligibility Criteria:
Inclusion Criteria:

* Ability to speak and understand English or Spanish
* Diagnosis of unilateral retinoblastoma at any age, confirmed by the enrolling institution
* Treatment of retinoblastoma between 2006 or later
* Patients must between the age of 8-17 years old
* At least 1 year since completion of all cancer-directed therapy
* Treatment with enucleation of the affected eye or intra-arterial chemotherapy

Parent of patient:

* Ability to speak and understand English or Spanish
* Ability to confirm that he or she is the parent of a child treated for unilateral retinoblastoma who meets the eligibility criteria listed above
* Ability to provide informed consent

Exclusion Criteria:

* Patients, or parents of patients, treated with both enucleation and intra-arterial chemotherapy are not eligible
Reference Ranges for the Cough Responsiveness to Inhaled Mannitol

Cough is the most common reason why people seek medical attention in developed countries. The main mechanisms for prolonged cough are hypersensitivity of the cough reflex arc, sputum production, and constriction of the airway smooth muscles. Recognition of the mechanism in each cough patient is essential for the efficient management of prolonged cough. At present, there are no feasible tests for everyday clinical work to recognize cough reflex arc hypersensitivity.

Mannitol test was originally developed for asthma diagnostics. We have recently shown that it can also be used to investigate hypersensitive cough reflex arc. The purpose of the present study is to create reference ranges for normal cough responsiveness to inhaled mannitol. Without them, the test cannot be utilized in everyday clinical work. For that purpose we will perform mannitol test in 140 subjects, who are at least 18 years old and without any chronic respiratory symptoms or disorders. The subjects will be recruited in three centers: University of Eastern Finland and: John Hunter Hospital in Australia.The material will be collected 1.9.2021-31.12.2023. We apply funding for both personnel and material expences, to carry out this study.


Eligibility Criteria:
Inclusion Criteria:

* age 18 years or older
* capable to understand the purpose of the study
* female/male ratio approximately 50%/50% in both of the following age groups:
* 50% aged 18- 50 yrs, and 50 % aged 51 - 90 years

Exclusion Criteria:

* Current daily smoking
* Ex-smoking with a greater than 10 pack years' daily smoking history or with stopping of daily smoking less than one year ago
* Pregnancy and breastfeeding
* A doctor's diagnosis of any respiratory diseases, including both upper and lower airway diseases, lung parenchymal diseases and the sleep apnoea syndrome
* A doctor's diagnosis of gastro-oesophageal reflux disease or symptoms suggestive of it
* Current use of angiotensin-converting enzyme inhibitors
* Upper respiratory tract infection ('flu') within 4 weeks
* Any current (within 4 weeks) cough 8
* Chronic (over 2 months' duration) cough during the last 12 months
* Wheezing during the last 12 months
* Attacks of shortness of breath or cough at night during the last 12 months
* Symptoms of rhinitis in a prolonged fashion during the last 12 months
* Heartburn or regurgitation once a week or more often during the last 3 months
* Abnormal anatomy of the respiratory organs, which may affect the deposition of the mannitol powder
* Any previous operations to the respiratory organs that can affect the deposition of the mannitol powder
* Unable to provide written informed consent to participate in the study
Clinical and Mechanistic Study of Patients (With COVID-19 or Not) With a Recent Acrosyndrome

The recent and unexpected occurrence of patients with the development of skin lesions on the hands and/ or feet has been described recently. As these cases occurred contemporaneously with the Coronavirus Disease 2019 (COVID-19) and as it was the most often occurrence of de novo frostbites, the question raised of whether there is a direct link between the occurrence of these lesions and infection of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) the responsible for CoVID-19. Indeed, mechanisms of these lesions and the precise correlation with Sars-CoV-2 remains poorly understood. Therefore, this study aim to:

1. Determine the possible link with this virus,
2. Understand the mechanisms involved in the pathogenesis of these lesions.

In this study, the investigator designed a prospective interventional study in order to collect blood samples and skin lesion biopsy at significant time points in patients who present a skin lesion. The intervention in this study is limited to some blood samples and skin biopsies.

Two 7 mL tubes of blood will be collected at consultant time for essentially serological test for the SARS-CoV-2 and for analysing certain populations of white blood cells. The second additional blood sample of 7 mL will be collected around day 15 after inclusion in a dry tube to perform a serological test for SARS-CoV-2 at a distance from the onset of skin signs.

A biopsy for histological study is usually done in patients with acrosyndrome. This is why this type of biopsy will be done as a routine care of these patients. An immunohistochemical study could complete the histological explorations using an anti-coronavirus antibody if arguments in favour of SARS-CoV-2 are demonstrated. In this study, patients who accept and sign informed consent will be proposed a skin biopsy on a characteristic lesion for freezing. This biopsy can be used for transcriptomic analysis. This may allow a better understanding of the mechanisms of the disease.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* Consultant for the recent occurrence of lesions on the fingers and or toes
* Having signed an informed consent
* Affiliated or entitled to a social security regime

Exclusion Criteria:

* Patients under guardianship or under curate
* Patients under state medical assistance
Influence of Bag Volume Variation on the Reproducibility of Inert Gas Rebreathing

Non-invasive inert gas rebreathing (IGR) based on the Fick Principle showed promising results in the determination of pulmonary blood flow (PBF). The volume of the rebreathing bag (Vbag) is proposed by the system, however, elderly patients or those suffering from high grade pulmonary diseases might be unable to entirely rebreathe this volume and therefore fail to completely mix the test gases. The aim of our study is to evaluate the effect of adapting Vbag on the reproducibility of IGR measurements in patients with obstruction (group A), restriction (group B) and pulmonary healthy controls (group C).


Eligibility Criteria:
Inclusion Criteria:

* ability to perform rebreathing maneuver

Exclusion Criteria:
Clinical Comfort Evaluation of Two Marketed Spherical Contact Lenses

The purpose of this study was to investigate the overall clinical comfort performance of enfilcon A (test) lens and senofilcon A (control) lens over 15-minutes of lens wear.

This was a non-dispensing, single-masked, randomized, contralateral study comparing Enfilcon A (test) against Senofilcon A (control). Each subject was randomized to wear the test lens in one eye and the control lens in the other eye.

Eligibility Criteria:
Inclusion Criteria:

1. Based on his/her knowledge, must be in good general health.
2. Be 18 to 38 years old.
3. Be able and willing to adhere to the instructions set forth in this protocol and complete all specified evaluation.
4. Read, indicate understanding of, and sign Written Informed Consent.
5. Be existing or successfully adapted users of soft contact lenses, but not currently wearing either of the study lenses (Avaira or Oasys) being evaluated in this trial.
6. Require a visual correction in both eyes.
7. Require a prescription between +8.00D and -12.00D and have less than or equal to 0.75D of astigmatism in both eyes.
8. Achieve visual acuity of 20/25 or better in each eye with a spherical contact lens prescription.
9. Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:

   * No amblyopia.
   * No evidence of lid abnormality or infection (e.g. entropion, ectropion, chalazia, recurrent styes).
   * lamp findings Grade 2 or above: corneal edema, tarsal abnormalities, and conjunctival injection).
   * No other active ocular disease (e.g. glaucoma, history of recurrent corneal erosions, cornea \[infiltrates\], conjunctiva, lids, and intraocular infection or inflammation of an allergic, bacterial, or viral etiology).
   * No aphakia.

Exclusion Criteria:

1. 0.75D or greater of refractive astigmatism in either eye.
2. Presbyopic or current monovision contact lens wear.
3. Cannot be currently wearing either lenses (Avaira or Oasys).
4. Presence of clinically significant (grade 2-4) anterior segment abnormalities; inflammation such as iritis; or any infection of the eye, lids, or associated structures.
5. Presence of ocular or systemic disease or need of medication which might interfere with contact lens wear.
6. Slit lamp findings that would contraindicate contact lens wear such as:

   * Pathological dry eye or associated findings
   * Pterygium, pinguecula or corneal scars within the visual axis
   * Neovascularization \> 0.75 mm in from the limbus
   * Giant papillary conjunctivitis (GPC) worse than Grade 1
   * Anterior uveitis or iritis (past or present)
   * Seborrheic eczema, seborrheic conjunctivitis
   * History of corneal ulcer or fungal infections
   * Poor personal hygiene
   * A known history of corneal hypoesthesia (reduced corneal sensitivity)
7. Contact Lens best corrected Snellen visual acuities (VA) worse than 20/30.
8. Aphakia, Keratoconus or a highly irregular cornea.
SARS-COV-2 VARIANTS' EFFECT ON PREGNANCY AND LONG-TERM OUTCOMES AMONG PREGNANT WOMEN AND THEIR NEWBORNS IN ESTONIA

The main aim of the study is to describe the possible impacts of SARS-CoV-2 and its various genotypes on pregnancy and long-term outcomes among pregnant women and their newborns in Estonia.

All the pregnant women in Estonia who conceived and gave birth between February 27, 2020, and March 1, 2023 were included in the study. Pregnant women will be divided into 2 groups: 1. pregnant women who were diagnosed with COVID-19 during the study period, along with their newborns; 2. control group: pregnant women who did not have COVID-19 during pregnancy, along with their newborns. The following data is collected for each subject: prior vaccination, previous COVID-19 infection, underlying diseases/conditions, hospitalization, need for intensive care, need for mechanical ventilation and/or oxygen therapy, death cases, post-COVID-19 symptoms, pregnancy course and outcomes, possible virus transmission from mother to child, and the newborn's condition or accompanying health issues

Eligibility Criteria:
Inclusion Criteria:

* pregnancy (conceived and gave birth between February 27, 2020, and March 1, 2023) with COVID-19 or without and their newborns

Exclusion Criteria:

* NA
Expanded Program for Immunization, a Missed Opportunity for Postpartum Family Planning Utilization

This study is aimed to enhance postpartum family planning by integrating family planning information with infant immunization services, which is the most widely utilized health services globally.

In this study, a before-and-after type of quasi-experimental study will be conducted in purposely selected health centers Sidama region, Ethiopia. base line assessment of postpartum contraceptive utilization rate will be done which will be followed by an intervention. The intervention consists of screening, counseling for family planning and referring mothers coming for infant immunization services to family planning units. All mothers coming for infant immunization service will be screened for and counseled for family planning and those who will be voluntary to take any method will be referred to family planning unit. All mothers who will not be voluntary will be re-counseled by the next visit.

Finally, the effect of this intervention on postpartum contraceptive utilization rate will be reassessed. The expected outcome will be to see an improved contraceptive uptake during the first year after delivery.

Eligibility Criteria:
Inclusion Criteria:

* all women visiting health facilities for infant immunization for at least two times will be included.

Exclusion Criteria:

* Women who are in difficulty of communicating during the study period will be excluded.
Assessment of Physical Activity During Therapy With Regorafenib for Metastatic Colorectal Cancer

The purpose of this trial is to quantitatively assess the average amount of physical activity that patients are capable to perform while receiving regorafenib for the treatment of metastatic colorectal cancer. The assessment of this reference value, measured by CE (Conformité Européene)-certified pedometer and international physical activity questionnaire, will allow an estimation on the feasible amount of physical activity for patients in this therapeutic setting.

This study is available for patients who are included in the global non-interventional study CORRELATE (Safety and efficacy of regorafenib in metastatic colorectal cancer patients; NCT01843400) in Austria.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with mCRC who have been previously treated with, or are not considered candidates for, other locally approved standard treatment(s) and for whom the decision has been made per investigator's routine treatment practice to prescribe regorafenib.
* Patients enrolled in NIS CORRELATE in Austria
* Signed patient informed consent for local OS

Exclusion Criteria:

* Subjects unwilling to complete all questionnaires involved in the local OS
* Subjects unwilling to wear the pedometer