linjc16/ctgov huggingface dataset:
Vitamin D Levels and Survival in Cancer Patients

Study Overview
=================
Brief Summary
-----------------
Using the population-based data sources in Iceland and the well-characterized AGES-Reykjavik cohort, our overarching aims are on exploring whether pre-diagnostic serum levels of 25-hydroxyvitamin D (25(OH)D) among older individuals living in Iceland were associated with survival after cancer diagnosis. We also wanted to assess the risk of being diagnosed with cancer in association with 25(OH)D levels. In this population living just south of the arctic circle, vitamin D levels largely depend on dietary- and supplemental sources.

Official Title
-----------------
Association of Pre-diagnostic Vitamin D Levels and Survival in Older Individuals With Cancer

Conditions
-----------------
Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: To be part of the AGES-Reykjavik Study, initiated between 2002 and 2006. Exclusion Criteria: Diagnosed with cancer at study entry

Ages Eligible for Study
-----------------
Minimum Age: 66 Years
Maximum Age: 98 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall mortality among cancer patients | We tested the association between pre-diagnostic 25(OH)D levels and total survival | Patients were followed from date of diagnosis since 2002 until death or censored at end of the follow-up (December 31, 2014) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cancer-specific mortality among cancer patients | We tested the association between pre-diagnostic 25(OH)D levels and cancer survival | Patients were followed from date of diagnosis since 2002 until death or censored at end of the follow-up (December 31, 2014) |
Prevalence of Conjunctivitis and Indentification of Risk Factors With and Without Prophylactic Antibiotic Treatment in Neonates

Study Overview
=================
Brief Summary
-----------------
The French guidelines for the use of Rifamycine eye drops in delivery room to prevent neonatal conjunctivitis have been actualized. Only newborns exposed to risk factors of conjunctivitis should be treated, compared to previous guidelines, treating all newborns. currently, there are no data describing risk factors for neonatal conjunctivitis. This study evaluated the incidence of conjunctivitis with or without Rifamycine eye drops treatment in the delivery room. Then risk factors for neonatal conjunctivitis where analyzed.

Official Title
-----------------
Conjunctivitis Incidence in the Newborn Within the First Week of Life: Impact of the Prophylactic Use of Rifamycine(CRY NOT).

Conditions
-----------------
Ophthalmia Neonatorum

Intervention / Treatment
-----------------
* Other: Rifamycine treatment
* Other: whithout Rifamycine treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newborns at the University Hospital of Amiens> 36SA, Admitted in maternity at the exit of nursery Exclusion Criteria: Newborns at the Amiens University Hospital <36SA Eye drops for any medical reason within the first day of life.

Ages Eligible for Study
-----------------
Minimum Age: 36 Weeks
Maximum Age: 36 Weeks

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prophylaxis group<br>Newborns treated with rifamycin eye drops systemically two months before change of practices in delivery room. | Other: Rifamycine treatment<br>* Phone prospecting: occurrence of conjunctivitis in newborns treated with rifamycine treatment in delivery room.<br>|
| no-antibiotic group<br>Newborns not treated with antibiotic prophylaxis in a systemic way, according to the new french guidelines of January 1st, 2015. | Other: whithout Rifamycine treatment<br>* Phone prospecting: occurrence of conjunctivitis in newborns did not receive eye drop treatment in delivery room according to new guidelines.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of conjunctivitis during the first 8 days of life in newborns |  | 8 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
neonate, infant; eyewash; delivery room; prophylaxis; risk factor's
ANSeR- The Algorithm for Neonatal Seizure Recognition Study

Study Overview
=================
Brief Summary
-----------------
A Multicentre Clinical Evaluation of a Decision Support Algorithm for Neonatal Seizure Detection: ANSeR

Detailed Description
-----------------
This is a multi-centre study. It will be based on routine clinical practice but will also allow for the off-line retrospective application of ANSeR to a well-defined clinical population in order to establish the potential diagnostic utility of the algorithm.

Official Title
-----------------
A Multicentre Clinical Evaluation of a Decision Support Algorithm for Neonatal Seizure Detection

Conditions
-----------------
Neonatal Seizures

Intervention / Treatment
-----------------
* Device: Algorithm for Neonatal Seizure Recognition


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All term neonates at risk of seizures are eligible for the ANSeR study. Neonates ≥ 36 weeks gestation will be recruited if: They have a need for EEG monitoring. Exclusion Criteria: Consent of parents not obtained.

Ages Eligible for Study
-----------------
Minimum Age: 36 Weeks

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Term neonates<br>Term neonates who are undergoing continuous video amplified Electroencephalogram (aEEG)/Electroencephalogram (EEG) monitoring for clinical purposes (e.g. because seizures were suspected, or the neonate is being treated with therapeutic hypothermia). EEGs will be analysed off line by 'Algorithm for Neonatal Seizure Recognition' | Device: Algorithm for Neonatal Seizure Recognition<br>* Software system for neonatal seizure detection recognition<br>* Other names: ANSeR;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To quantify the overall diagnostic accuracy of the Algorithm. | To measure diagnostic accuracy of ANSeR (Algorithm) and clinicians (in routine clinical practice or optimised clinical practice) during the initial up to but not limited to 72 hour period of post-natal EEG monitoring, using an expert panel as the reference standard. | up to 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inappropriate use/non-use of Anti Epileptic Drugs (AEDs) | To quantify the degree and duration of inappropriate use/non-use of AEDs with the off-line application of the ANSeR algorithm and routine clinical practice. To compare (a) and (b). | up to 72 hours | 
| To examine factors that influence diagnostic accuracy in clinical practice. | To examine factors that influence diagnostic accuracy in clinical practice. | up to 72 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Decision Support Algorithm, Neonatal Seizures, EEG
Diagnosis and Treatment of Acute Coronary Syndrome in the ED & the Impact of Rapid Bedside cTnl on Outcome.

Study Overview
=================
Brief Summary
-----------------
The primary outcome in this study will be time to discharge for low-risk patients and therapeutic turnaround time for patients with NSTEMI or unstable angina.

Detailed Description
-----------------
Phase IV prospective, randomized (1:1), parallel-group trial utilizing concurrent controls. Assess the reduction in time taken to dispostion or discharge patients. Assess the ability of POC testing to satisfy guidelines for a 30 minute turn around time of results. Assess and differences in clinical decision-making for other diagnostic procedures including nuclear imaging, echo, and stress treadmill, disposition from the ED, time to catherterization lab, PCI, and CafBG based on the cardiac troponinn results from the bedside analyzer and the central lab instrument.Assess the difference for in-hospital and 30 day post hospital discharge cardiac events including all-cause and cardiac-specific deaths, CHF, cardiomyopathy, and atrial and ventricular arrhythmia, beween the bedside analyzer and the central lab instrument. Assess the differences in hospital care costs for the hospitalization period, and assess direct medical and indirect productivity costs in the 30 day post hospital discharge period to patients who are diagnosed, using the bedside cTnl test and the central lab cTn tests, and subsequently treated as per the guidelines.

Official Title
-----------------
Diagnosis and Treatment of Acute Coronary Syndrome in the Emergency Department- The Impact of Rapid Bedside cTnl on Outcome.

Conditions
-----------------
Unstable Angina, Non-ST-Elevation Myocardial Infarction

Intervention / Treatment
-----------------
* Device: iSTAT point of care analyzer


Participation Criteria
=================
Eligibility Criteria
-----------------
Patient must be 21 years old or older with chest pain or other symptoms that lead to drawing cardiac biomarkers.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: iSTAT point of care analyzer|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to discharge for low-risk patients |  |  | 
| Therapeutic turnaround time for patients with NSTEMI or unstable angina |  |  |
Isolating and Testing Circulating Tumor DNA and Soluble Immune Markers During the Course of Treatment for Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to explore the detection of circulating tumor DNA, soluble immune markers, and the evaluation of peripheral blood mononuclear cells (PBMC).

Detailed Description
-----------------
Our plan is to collect blood from patients with advanced stage lung cancer who are scheduled to undergo systemic therapy. In this study we will utilize a novel technology for circulating tumor DNA detection in order to evaluate their presence in patients with lung cancer by comparing blood samples at six time points. We will obtain baseline blood and then collect blood at five time points during the course of the patient's chemotherapy treatments and at the end of treatment. These same blood collections will be used for the detection of soluble immune markers and evaluation of PBMCs.

Official Title
-----------------
Isolating and Testing Circulating Tumor DNA and Soluble Immune Markers During the Course of Treatment for Lung Cancer

Conditions
-----------------
Lung Cancer, Lung Neoplasms, Cancer of Lung, Cancer of the Lung, Neoplasms, Lung, Neoplasms, Pulmonary, Pulmonary Cancer, Pulmonary Neoplasms, Carcinoma, Non-small-cell Lung, Adenocarcinoma, Squamous Cell Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Advanced (non-resectable) malignancy in the thorax Age >18 years old Willing and able to provide consent No prior history of neoadjuvant therapy Exclusion Criteria: Age <18 years old Unable to provide consent Patients with hemoglobin less than 10 g/dL (to minimize the impact of potential iatrogenic anemia)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary end point is the number and type of mutations detectable in the circulating tumor DNA blood samples. |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chemotherapy
Amino Acids Profiles in Premature Infants Receiving Nutritional Support

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate the changes of amino acid metabolic profiles in different nutritional stages of preterm infants and determine the effects of nutritional intervention on the amino acid metabolic status of preterm infants.

Official Title
-----------------
A Prospective Study of Amino Acids Profiles in Premature Infants Receiving Nutritional Support

Conditions
-----------------
Premature Infant

Intervention / Treatment
-----------------
* Other: Collection of blood and urine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Premature infants, and admitted to hospital within 24 hours after birth; Documentation of informed consent; In need of receiving parenteral nutrition after birth; Exclusion Criteria: Premature infants with a parenteral nutrition period of less than 3 days; Inborn error of metabolism; Chromosomal abnormalities or multiple malformations;
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Extremely preterm infants<br> | Other: Collection of blood and urine<br>* Collection of blood and urine before nutritional support, during total parenteral nutrition, during partial parenteral nutrition and during enteral nutrition<br>|
| Very preterm infants<br> | Other: Collection of blood and urine<br>* Collection of blood and urine before nutritional support, during total parenteral nutrition, during partial parenteral nutrition and during enteral nutrition<br>|
| Moderately preterm infants<br> | Other: Collection of blood and urine<br>* Collection of blood and urine before nutritional support, during total parenteral nutrition, during partial parenteral nutrition and during enteral nutrition<br>|
| Late preterm infants<br> | Other: Collection of blood and urine<br>* Collection of blood and urine before nutritional support, during total parenteral nutrition, during partial parenteral nutrition and during enteral nutrition<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amino acid profiles in blood | Amino acid levels in blood | through the transition to enteral nutrition, an average of 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight |  | Until the corrected gestational age is 37 weeks or discharged | 
| Height |  | Until the corrected gestational age is 37 weeks or discharged | 
| Head circumference |  | Until the corrected gestational age is 37 weeks or discharged |
AZD5438 in Patients With Advanced Solid Malignancies

Study Overview
=================
Brief Summary
-----------------
Purpose of this study is to assess the safety and tolerability of AZD5438 given orally to patients with advanced solid malignancies A review of the emerging clinical tolerability and exposure data from this study in conjunction with preclinical and the available clinical pharmacodynamic data relating to AZD5438, led to a decision by AstraZeneca that the development of AZD5438 as a potential anti-cancer agent would be discontinued.

Official Title
-----------------
Phase I Study to Assess the Safety and Tolerability of AZD5438 in Patients With Advanced Solid Malignancies

Conditions
-----------------
Neoplasms

Intervention / Treatment
-----------------
* Drug: AZD5438


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Advanced solid malignancy Cancer refractory to standard treatments or for which no standard therapy exits Exclusion Criteria: Radiotherapy within 3 weeks of the start of treatment Investigational product within the last 3 weeks Systemic cytotoxic anti-cancer therapy within the last 3 weeks Any significant clinical disorder that makes it undesirable for the patient to participate

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: AZD5438|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
advanced, solid, malignancies
Evaluation of Peripheral Blood Protein Biomarkers for Colorectal Cancer Screening

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to validate the value of value of peripheral blood protein biomarkers in colorectal cancer screening, and to identify new ones

Official Title
-----------------
Evaluation of Peripheral Blood Protein Biomarkers for Colorectal Cancer Screening

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: blood sampling for screening of biomarkers


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient aged 50 years or older referred for screening colonoscopy after a positive FIT test or for endoscopic resection of a previously identified suspicious colorectal lesion Exclusion Criteria: Very high risk of colorectal cancer: Lynch syndrome, Familial adenomatous polyposis, Peutz-Jeghers syndrome, Familial polyposis associated with a MutYH gene defect Other solid cancers or haematological malignancies that are progressive and/or undergoing treatment (apart from basal cell skin carcinoma) Contraindication to total colonoscopy

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient referred for screening colonoscopy or for endoscopic resection<br>Patient aged 50 years or older referred for screening colonoscopy after a positive fecal immunochemical test or for endoscopic resection of a previously identified suspicious colorectal lesion will have a blood sampling for biomarkers detection | Diagnostic Test: blood sampling for screening of biomarkers<br>* Patient aged 50 years or older referred for screening colonoscopy after a positive fecal immunochemical test or for endoscopic resection of a previously identified suspicious colorectal lesion will have a blood sampling for biomarkers detection<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patient with advanced neoplasia at colonoscopy |  | Day 1 | 
| Number of patient with presence of best isolated serum biomarkers selected from different candidates |  | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patient with presence of other isolated serum biomarkers selected from different candidates |  | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
biomarkers
Bariatric Surgery and Pharmacokinetics of Paracetamol

Study Overview
=================
Brief Summary
-----------------
Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study the pharmacokinetic effects of bariatric surgery on paracetamol are investigated.

Official Title
-----------------
Bariatric Surgery and Pharmacokinetics of Paracetamol: BAR-MEDS Paracetamol

Conditions
-----------------
Obesity, Morbid

Intervention / Treatment
-----------------
* Drug: Paracetamol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway Being a Norwegian citizen Exclusion Criteria: Having previously undergone resections in the GI-tract

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Paracetamol|Patients are tested for their normal prescription paracetamol medication|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Paracetamol concentration in blood serum (area under curve (AUC)) |  | From baseline to 1 year postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bariatric surgery, Gastrointestinal tract, Biological availability, Pharmacokinetics, Acetaminophen