cyrilzakka/clinical-trials huggingface dataset:
Predictors of Sepsis in Ex-Preterm Infants

The aims of this study are to:

* Assess whether ex-preterm infants have a persistently immature immune system, which may decrease their ability to respond to infections, when they reach term-corrected gestational age.
* Examine whether clinical history, nutrition status, and microbiome composition are linked to the immune composition of term and ex-preterm infants and whether these variables can be used to predict the risk of developing sepsis or having an immunologic disease.

Preterm infants have increased numbers of viral infections in childhood. They are also more likely to die from infection during the neonatal and infant periods than infants born at term. While studies have demonstrated that premature infants have decreased adaptive and innate immune responses compared with infants born at term, there has been little investigation into whether this impaired immunity improves and becomes similar to full term infants once the ex-preterm infants reach term-corrected gestational age. There have likewise not been studies to determine whether specific immune markers may predict the risk of developing sepsis. Given the immaturity of the preterm immune system and the many potential infectious and inflammatory insults they are exposed to during the preterm period (infections, poor nutrition, stress, steroid therapy), there is also a possibility that the relative immune deficiency experienced by preterm infants may persist into infancy.

The goal of this study is to determine whether former preterm infants have sustained differences in immunity compared to age-matched controls, which would have significant implications for infection risk and response to vaccination. Additionally, this study hopes to examine whether certain immune system abnormalities make certain babies more likely to have a serious infection. The present study will assess composition and function of T and B cell compartments in preterm and former preterm infants.

Eligibility Criteria:
Inclusion Criteria Ex-Preterm Infant Group:

* Infants born less than 37 weeks gestational age

Exclusion Criteria for Ex-Preterm Infant Group:

* Infants born greater than 37 weeks gestational age

Inclusion Criteria for Term Infant Group:

* Infants born greater than 37 weeks gestational age

Exclusion Criteria for Term Infant Group:

* Infants born less than 37 weeks gestational age
Digital Health for Caregivers Emotional and Self-management Support

This feasibility study builds upon mental health and technology acceptance theoretical frameworks. It seeks to examine potentials of a novel mobile Health (mHealth) solution based on emotional and behavioral change techniques, to provide emotional and self-management tailored support to caregivers of children undergoing Growth Hormone treatment (GHt).

This feasibility study builds upon mental health and technology acceptance theoretical frameworks. It seeks to examine potentials of a novel mobile Health (mHealth) solution based on emotional and behavioral change techniques, to provide emotional and self-management tailored support to caregivers of children undergoing Growth Hormone treatment (GHt).

Primary Objectives:

* To gather qualitative information enabling to better understand individualized experiences of caregiving children undergoing GHt and perceived barriers/facilitators for adoption of the mHealth solution.
* To assess positive mood states of caregivers of GHt patients as an indicator of emotional wellbeing related to the use of the mHealth solution.

Secondary Objectives:

To explore whether the mHealth solution applied to caregivers of children undergoing GHt might affect:

* Broader emotion-related parameters: Distress (emotional disturbance), self-efficacy (perceived own capability of managing stress), and general psychological wellbeing of caregivers.
* Perceived Health-related quality of life (HRQoL) of children (evaluated from the caregivers' perspective).
* Behavioral parameters: Usability / engagement with the mHealth solution and children's adherence to treatment measured by Easypod-Connect.
* Growth parameters: height of the child.

Eligibility Criteria:
The study targets caregivers of GHt patients.

Inclusion Criteria:

* Adherence to GHt monitored in the last month prior enrollment indicates a ratio less than 85%.
* Legal guardian of children who receive GHt in accordance with approved indications in Spain.
* Explicit agreement on data sharing regarding adherence to GHt gathered through the Easypod Connect.
* Participants must be able to interact with a smart phone and willing to install the mHealth solution of the study in their smart phone.
* Participants must sign the specific informed consent form for the study.

Exclusion Criteria:

* Candidates without an smart phone or not being able to interact with it.
* Only one legal guardian per child can participate in the study.
* Participants of SS1 will not take part in SS2.
Key Information Can Influence Clinician Ordering of Brain CTs

The frequency of head computed tomography (CT) imaging for mild head trauma patients has raised safety and cost concerns. Validated clinical decision rules exist in the published literature and on-line sources to guide medical image ordering but are often not used by emergency department (ED) clinicians. Using simulation, we explored whether the presentation of a clinical decision rule (i.e. Canadian CT Head Rule - CCHR), findings from malpractice cases related to clinicians not ordering CT imaging in mild head trauma cases, and estimated patient out-of-pocket cost might influence clinician brain CT ordering. Understanding what type and how information may influence clinical decision making in the ordering advanced medical imaging is important in shaping the optimal design and implementation of related clinical decision support systems.

Multi-center, double-blinded simulation-based randomized controlled trial. Following standardized clinical vignette presentation, clinicians made an initial imaging decision for the patient. This was followed by additional information on decision support rules, malpractice outcome review, and patient cost; each with opportunity to modify their initial order. The malpractice and cost information differed by assigned group to test the any temporal relationship. The simulation closed with a second vignette and an imaging decision.

Eligibility Criteria:
Inclusion Criteria:

* Clinician (physician, nurse practitioner, physician assistant) licensed to deliver health care.
* Actively employed to deliver health care in the emergency department of Greenville health System (South Carolina) or Emory University (Georgia)

Exclusion Criteria:

* None
Development of Positive Psychotherapy for Smoking Cessation

The primary objective of this study is to test a manualized adaptation of positive psychotherapy (PPT) for smoking cessation (PPT-S). The investigators will conduct a preliminary randomized clinical trial (N = 80) to examine the feasibility, acceptability, and efficacy of PPT-S over 26 weeks of follow up in comparison to a standard smoking cessation treatment. Both treatments will be delivered in individual 6 sessions over 6 weeks, and will include provision of transdermal nicotine patch. The effect size estimates from this Stage 1b research will provide the foundation for a future application to conduct a large-scale, Stage II, randomized clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* smoke at least 5 cigarettes per day for longer than one year with no other ongoing tobacco product use
* willing to use the transdermal nicotine patch
* report at least a 5 on a 0 to 10 scale rating the importance of quitting smoking.

Exclusion Criteria:

* are currently experiencing psychotic symptoms, affective disorder (major depression, dysthymia, or mania) or substance use disorder (other than nicotine dependence)
* taking prescribed psychotropic medication or receiving other forms of psychotherapy
* concomitantly using other pharmacotherapies for smoking cessation
* have any contraindications for use of the transdermal nicotine patch.
Vitamin D Supplementation and Acute Respiratory Infection in Older Long-Term Care Residents

This study will test the role of high dose vitamin D supplementation in prevention of acute respiratory infection in older nursing home residents. The investigators hypothesize that residents on high dose vitamin D supplementation will have a lower incidence of acute respiratory infection that those on standard dose vitamin D supplementation.

This study is a double-blinded, parallel group, randomized controlled phase II trial of oral high vs. standard dose vitamin D3 supplementation administered monthly for 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Age 60+ years
* Resides in nursing home

Exclusion Criteria:

* Terminal illness (expected survival \<6 months)
* Anticipated discharge within 12 months
* Unable to take whole or crushed tablets
* Active cancer, except squamous/basal cell carcinoma
* Severe malnutrition (body mass index \<18 kg/m2)
* Current immunosuppressive medications (including corticosteroids)
* Renal failure (estimated glomerular filtration rate \< 15 mL/min/1.73m2)
* Currently taking \>1,000 IU/d vitamin D supplementation
* History (or strong family history) of kidney stones
* History of sarcoidosis or other granulomatous disorders associated with hypercalcemia
* Elevated baseline hypercalcemia (albumin-adjusted serum calcium \>10.5 mg/dL)
* Baseline serum 25OHD level ≥ 100 nmol/L
* Inability to provide informed consent and no available healthcare legally authorized representative
* Inability of participant or legally authorized representative to speak/understand English
Dose Ranging Study to Determine the Safety, Reactogenicity and Immunogenicity of Typhoid Fever Vaccine (Ty800) in Healthy Adult Subjects

The purpose of this trial is to examine the safety and immunogenicity of Ty800 oral vaccine in healthy adult subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Males or Females aged 18 to 55 years, inclusive
* Capable of understanding and complying with the protocol requirements and be available for the duration of the protocol

Exclusion Criteria:

* History of malignancy, immunocompromised conditions or currently receiving immunosuppressive treatment including systemic steroids
* History of Typhoid Fever infection, vaccination against typhoid fever or participation in a Clinical Trial using S.typhi organism at any time
* History of travel to a typhoid endemic region within the last 5 years or history of raising a child from an endemic area. Endemic regions are South and East Asia, the Indian Subcontinent, Africa and Central and South America including Mexico
* History of persistent diarrhea, blood in stool, peptic ulcer disease, or inflammatory bowel disease
* Allergies or sensitivities to antibiotics, notably quinolones, penicillins, sulfonamides, cefalosporins and chloramphenicol, and components of the buffer solution, notably aspartame.
* People who are commercial food handlers, day care workers, or health care workers involved in direct patient care. Also people with young children under 2 years of age at home or household contacts who are immunocompromised, pregnant or breast-feeding
Safety, Tolerability and Efficacy of Evolocumab (AMG 145) in Children With Inherited Elevated Low-density Lipoprotein Cholesterol (Familial Hypercholesterolemia)

The main purpose of this study is to describe the safety and tolerability of 80 weeks of subcutaneous (SC) evolocumab when added to standard of care in children 10 to 17 years of age with familial hypercholesterolemia.


Eligibility Criteria:
Inclusion Criteria:

Heterozygous Familial Hypercholesterolemia (HeFH):

-Completed Study 20120123 (NCT02392559) while still on assigned investigational product and did not experience a treatment-related serious adverse event

Homozygous Familial Hypercholesterolemia (HoFH):

* Male or female, ≥ 10 to ≤ 17 years of age at time of enrollment
* Diagnosis of HoFH
* On a low-fat diet and receiving background lipid-lowering therapy
* Lipid-lowering therapy unchanged for ≥ 4 weeks prior to LDL-C screening; fibrates must be stable for at least 6 weeks prior to screening.
* Fasting LDL-C at screening ≥ 130 mg/dL (3.4 mmol/L)
* Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L)

Exclusion Criteria:

-Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(s); except Study 20120123

HoFH:

* Moderate to severe renal dysfunction
* Active liver disease or hepatic dysfunction,
* Creatine kinase \> 3 times the upper limit of normal (ULN) at screening
P200TE US Reference Database Study

The objective of this study is to collect Optical Coherence Tomography (OCT) data to construct a reference database for the P200TE.

The objective of this study is to collect Optical Coherence Tomography (OCT) data on healthy eyes in order to develop a reference database for the P200TE device in order to determine the reference limits for the P200TE

Eligibility Criteria:
Inclusion Criteria:

1. Subjects 22 years of age or older on the date of informed consent
2. Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
3. Subjects presenting at the site with normal eyes (Cataracts, LASIK, PRK (photorefractive keratectomy), and peripheral pathology that does not affect the posterior pole region, for example lattice and peripheral drusen, are allowed.
4. BCVA (best corrected visual acuity) 20/40 or better(each eye)
5. Subject is able to comply with the study procedures

Exclusion Criteria:

1. Subjects unable to tolerate ophthalmic imaging
2. Subject has a condition or is in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
3. Subject with ocular media not sufficiently clear toobtain acceptable OCT images
4. .History of leukemia, dementia or multiple sclerosis
A Feasibility Study of the Bone@BC App Version 3.0

Introduction Due to improvements in diagnostics and treatments, the 5-year survival for patients with breast cancer is 80-90% after initial diagnosis. During treatments, patients typically have consultations weekly and then gradually reduce to annual visits. During this transition from hospital-based care to health self-management, the breast cancer survivors are encouraged to e.g. exercise because of accumulating evidence for the efficacy of exercise training in cancer survivorship, and in the majority of cases, adhere to endocrine treatments to reduce the risk of breast cancer recurrence.

Design and methods The study is a one-arm convergent parallel mixed-methods feasibility intervention study. The quantitative data will be the use of the Bone@bc app (intervention) and questionnaires (n=50) and the Qualitative data will be semi-structured interviews (n= 15 - 20)

AIM The aim is to investigate the feasibility and user satisfaction of an app Bone@BC version 3.0 and if the app Bone@BC can enhance self-efficacy and investigate user statistics and traffic in the app Bone@BC by using a convergent parallel Mixed-Methods design.

Recruitment and procedure For the quantitative data, the recruitment will follow a consecutive sampling strategy, the follow-up group with the electronic patient-reported outcome (ePRO) and systematic consultations (n= 50) will be recruited from the Endocrinology Out-Clinic at Rigshospitalet, Denmark. For the qualitative data, the participants will be recruited from the group participating in the quantitative data following a nested sampling. The patients will be recruited by the principal investigator Trine Lund-Jacobsen (TLJ), or clinical physicians from the Department of Endocrinology, Rigshospitalet, Denmark. The identification of patients will be given to the principal investigator (TLJ) in case the patients are accepted to be contacted for further written and oral information about the project, letter for the subject's rights is handed out and then be provided for obtaining written consent from the patient. The patients who regret or refuse to give consent to participate in the study will be registered and we will note the reason why the patients refuse or regret participating in the study.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women
* Age 50-70 years
* Danish speaking
* Diagnosed with EBC, stage I-III
* Eligible to receive (neo-) adjuvant chemotherapy or adjuvant treatments
* Access to an E-mail address
* Access to smart mobile electronic devices connected to the internet
* Willingness to have the app installed on the smart mobile electronic devices
* Ability to work with the app

Exclusion Criteria:

* Prior malignancy
* Pre-existing type 2 diabetes or other metabolic diseases
* Withdrawn or not given a consent form
Safety and Effectiveness of a Novel Enteral Feeding System: Prospective Study.

The goal of this interventional study is to obtain information on the safety and effectiveness of a novel enteral feeding system in adult users requiring at least a portion of their nutritional intake via enteral feeding. The main questions it aims to answer are:

* Can the device be used safely and effectively?
* Does use of the device impact on patient's quality of life?

Participants will use Mobility+ enteral feeding system as their enteral feeding method for the duration of the study and will record their experiences.

The study will allow 25 participants to use the Mobility+ system for their feeding sessions over the course of 14 consecutive days, following an initial 7-day period where participants have time to trial and get used to the new system. Participants' homes are the setting for the 21-day study duration.

Eligibility Criteria:
Inclusion Criteria:

* Participants with Gastrostomy (G) tube or Jejunostomy (J) tubes
* Participant must require enteral tube feeding every day, as determined at the time of study enrolment
* Participant must use commercially available enteral formula with standard enteral feeding system(s) (gravity bag, bolus, pump or combination(s)), for some or all of their tube feeds, for daytime or day and night-time feeding
* Participant must be EN dependent i.e., 500 ml minimum daily feed intake from EN
* Participants must be able to swap from current system to Mobility+ for a minimum of two daily feeds per day for duration of study (Study days 1 -14)
* Participant must be \>= 18 to reflect the subset of the intended use population being evaluated
* Participant must be willing to participate in the study and provide consent).
* Participants must have been on an enteral feeding regime for a minimum of 10 weeks
* Participants clinical functional capacity is adequate as determined by operator clinical judgement, to enable them to participate fully in the study
* Participants are suitable candidates for using Mobility+ as determined by operator clinical judgement on participant enteral feeding needs (as per prescription) and alignment with Mobility+ Flow Rate Guide

Exclusion Criteria:

* Participants who do not use commercially available enteral formula for some or all their formula needs
* Participants unable/unwilling to provide consent
* Participants whose enteral feeding needs do not match the offering of the Mobility+, as determined by operator clinical judgement
* Participants who have inadequate clinical functional capacity, as determined by operator clinical judgement to participate fully in the study e.g. neuromuscular or neurodegenerative disorders, or developmental delay
* Participants with very limited mobility, as determined by operator clinical opinion
A Study of OMP-305B83 in Subjects With Metastatic Colorectal Cancer

The purpose of this study is to test the safety and efficacy of an experimental drug, OMP-305B83, when given in combination with FOLFIRI or FOLFOX. OMP-305B83 is a humanized bispecific monoclonal antibody and was developed to target cancer stem cells. Based on preclinical studies, it is believed that OMP-305B83 may block the growth of cancer stem cells and may also impair the productive growth of new blood vessels, which tumors need to grow and spread.

The study is sponsored by OncoMed Pharmaceuticals, which is referred to as OncoMed or the Sponsor.

This is an open-label, Phase 1b dose escalation and expansion study of OMP-305B83 plus FOLFIRI or FOLFOX to evaluate the safety, efficacy, and pharmacokinetics of OMP-305B83 in combination with FOLFIRI or FOLFOX in patients with metastatic Colorectal Cancer. This study consists of a screening period, a treatment period, and a post-treatment follow-up period in which patients will be followed for survival for up to 5 years. Patients will be enrolled in two stages: a dose-escalation stage and an expansion phase.

Eligibility Criteria:
Inclusion Criteria:

* Measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1
* Age \>21 years
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Adequate organ and marrow function
* For women of childbearing potential and men with partners of childbearing potential, agreement (by patient and/or partner) to use two effective forms of contraception from study entry through at least 6 months after the termination visit.
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Receiving any other investigational agents or any other anti-cancer therapy
* Receiving prior hepatic intra-arterial chemotherapy
* Known significant clinically significant gastrointestinal disease
* Patients with brain metastases (treated or untreated) leptomeningeal disease, uncontrolled seizure disorder, or active neurologic disease
* Significant intercurrent illness that will limit the patient's ability to participate in the study or may result in their death over the next 18 months
* Pregnant or nursing women
* Inability to comply with study and follow up procedure
Early Identification of Clinical Deterioration Using a Wearable Monitoring Device

This study aims to provide myriad of physiological parameters in patients admitted in an internal medicine department, and which are defined as being in an increased risk of clinical deterioration within the first 72-hours after admission. The investigators will also conduct a retrospective comparison between physiological changes in patients who did deteriorate to those who did not. This will form the basis for the development of an algorithm for early prediction and warning of physiological and clinical deterioration during the first 72-hours of admission.


Eligibility Criteria:
Inclusion Criteria:

* Males and females 18 years old and above admitted to the internal medicine department
* On admission, the primary investigator assess their risk to deteriorate during the first 72 hours after admission as reasonably high
* The patient is assigned to a "monitoring bed" within the department
* The patient has signed an informed consent form

Exclusion Criteria:

* Lack of informed consent
* It is known in advance that the patient cannot take part in the study for a 72-hours period (e.g. a patient that will be taken to surgery within the next 24 hours)
* Technical inability to attach the Biobeat patch (BB-613PW) to the patients chest