linjc16/ctgov huggingface dataset:
Age of Red Blood Cells in Premature Infants Study (ARIPI)

Study Overview
=================
Brief Summary
-----------------
To determine if the age of blood transfused to new borns in the NICU setting has an impact on their outcome.

Official Title
-----------------
Age of Red Blood Cells in Premature Infants Study (ARIPI)

Conditions
-----------------
Premature Birth

Intervention / Treatment
-----------------
* Biological: Transfusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: birthweight of less than 1250g admitted to participating NICU consent acquired from proxy for the patient Exclusion Criteria: already received one or more transfusions requirement for an exchange transfusion will be receiving directed donations have rare blood types/difficult cross-match proxy has refused consent moribund on admission to NICU/expected to die mitigating child protection issues

Ages Eligible for Study
-----------------
Minimum Age: 1 Minute
Maximum Age: 37 Weeks

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biological<br>PRBCs that are less than 7 days old are considered 'fresh'. | Biological: Transfusion<br>* PRBC blood transfusions.<br>* Other names: non applicable;|
| Experimental: Standard PRBCs<br>PRBCs 'stored' as per hospital policy. | Biological: Transfusion<br>* PRBC blood transfusions.<br>* Other names: non applicable;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. Composite Outcome of Necrotizing Enterocolitis, Intraventricular Hemorrhage, Bronchopulmonary Dysplasia and Retinopathy of Prematurity at 30 and 90-days. 2. Mortality | The primary outcome was a composite outcome composed of mortality and major neonatal morbidities associated with acute organ dysfunction or failure. In addition to death, the 4 major morbidities comprising the composite outcome were bronchopulmonary dysplasia, retinopathy of prematurity, necrotizing enterocolitis, and intraventricular hemorrhage. | 2 weeks, 4 weeks, 12 weeks, 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinically Suspected Infection and Culturally Confirmed Infections | Infection was categorized as clinically suspected and positive cultures. | 90 days | 
| Length of Stay | Length of Stay in neonatal intensive unit | until last participants left neonatal intensive care unit | 
| Number of Participants Using Mechanical Ventilation. | Number of Participants using Mechanical Ventilation | whether a mechanical ventilation was used at any time point during 90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Transfusion
Clinical Comparison of Two Daily Disposable Lenses Among Daily Disposable Lens Wearers

Study Overview
=================
Brief Summary
-----------------
The primary objective of this trial is to evaluate the subjective performance of two different daily disposable contact lenses in a population of daily disposable lens wearers.

Conditions
-----------------
Myopia

Intervention / Treatment
-----------------
* Device: nelfilcon A
* Device: filcon II 3


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Currently wearing any spherical daily disposable lens in daily wear, daily disposable modality for at least 3 months prior to enrollment with the exception of the 2 study products Currently Wearing lenses at least 8 hrs/day and 5 days/week. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Eye injury or surgery within twelve weeks immediately prior to enrollment for this trial. Pre-existing ocular irritation that would preclude contact lens fitting. Currently enrolled in any clinical trial. Evidence of systemic or ocular abnormality, infection, or disease which is likely to affect successful wear of contact lenses or use of their accessory solutions as determined by the investigator. Any use of medications for which contact lens wear could be contraindicated as determined by the investigator. Prior history of corneal or refractive surgery. Requires monovision correction. Other protocol-defined exclusion criteria may apply.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: nelfilcon A / filcon II 3<br>Nelfilcon A contact lenses worn first, with filcon II 3 contact lenses worn second. Both products worn in both eyes on a daily wear, daily disposable basis for one week each. | Device: nelfilcon A<br>* Commercially marketed, single-vision, soft contact lens for daily disposable wear<br>Device: filcon II 3<br>* Commercially marketed, single-vision, soft contact lens for daily disposable wear<br>|
| Other: filcon II 3 / nelfilcon A<br>Filcon II 3 contact lenses worn first, with nelfilcon A contact lenses worn second. Both products worn in both eyes on a daily wear, daily disposable basis for one week each. | Device: nelfilcon A<br>* Commercially marketed, single-vision, soft contact lens for daily disposable wear<br>Device: filcon II 3<br>* Commercially marketed, single-vision, soft contact lens for daily disposable wear<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| subjective ratings and preferences |  | 2 weeks |
Humanin Isoforms in Cardiac Muscle and Blood Plasma and Major Complications After Cardiac Operation

Study Overview
=================
Brief Summary
-----------------
Objective of the study is to clarify humanin-like peptide concentration in myocard tissue and in blood and to study if its concentration level is related to early complication occurrence and frequency after cardiac operation. Hypothesis of the study is that previously described elements are related to each other.

Detailed Description
-----------------
Data collection: Historical medical and preoperative data, operation data (type of operation performed and its details), detailed postoperative course (occurrence of complications). Specimen collection: Tissue sample is taken during the operation from the right atrial appendage of the heart and the sample is frozen at -80 C. Blood samples are taken just before the operation, one hour after aortic cross-clamp removal and the next morning after the operation. Samples are processed and blood plasma is frozen at -80 C.

Official Title
-----------------
Prospective Clinical Observational Study of Humanin Isoforms in Cardiac Muscle and Blood Plasma and Their Association to Major Complications After Cardiac Operation

Conditions
-----------------
Myocardial Ischemia, Coronary Artery Bypass Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age at least 18 years Ischemic heart disease in medical history Planned on-pump coronary artery bypass graft (CABG) operation Signed informed consent by patient Exclusion Criteria: Age <18 years Planned isolate valve or aortic operation Patient is in another study with an intervention Absence of signed informed consent

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 |
| --- | --- | --- |
| Mortality | 30-day all-cause mortality | 30 days | 
| Major complications: myocardial infarction. | Diagnosed myocardial infarction. | 30 days | 
| Major complications: acute kidney injury. | Diagnosed acute kidney failure (KDIGO stage). | 30 days | 
| Major complications: stroke. | Diagnosed stroke. | 30 days |
Effect of Nitrate on Red Blood Cell Function in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
To investigate the effect of nitrate supplementation on red blood cell function in patients with type 2 diabetes.

Official Title
-----------------
The Effect of Dietary Nitrate Supplementation on Red Blood Cell Function in Patients With Type 2 Diabetes

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Dietary Supplement: Beet root juice
* Dietary Supplement: Placebo juice


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes Exclusion Criteria: Acute coronary syndrome Vegetarian diet Impaired renal function Absolute indication for proton pump inhibitor Ongoing treatment with organic nitrate Heart failure (ejection fraction <35%) Any condition that interferes with the possibility to fulfill the study protocol

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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nitrate-rich beet root juice<br>Nitrate-rich Beet root juice 70 ml bid | Dietary Supplement: Beet root juice<br>* 70 ml bid<br>|
| Placebo Comparator: Placebo<br>Nitrate-depleted beet root juice 70 ml bid | Dietary Supplement: Placebo juice<br>* 70 ml bid<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage recovery of left ventricular function | Red blood cells are administered to an isolated rodent heart subjected to 25 min global ischemia and 60 min reperfusion. The percentage recovery during reperfusion is determined. | 1 week |
Risk Factors for Atherogenesis in Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
To determine risk factors for atherogenesis in Type 1 diabetes.

Detailed Description
-----------------
BACKGROUND: Individuals with Type 1 diabetes have substantially higher risk for premature atherosclerotic vascular disease (ASVD) than the general population. Risk factors for the development of ASVD have been identified, but linking them to initiation of atherosclerosis was not feasible until recently. Advances in non-invasive imaging now permit early detection of changes in blood vessel function and structure. This imaging provides an opportunity to evaluate risk factors for ASVD and vascular status in a cohort at a critical time for development and early progression of ASVD. DESIGN NARRATIVE: Subjects were enrolled from 1987-1992 and were followed from diabetes diagnosis. Standardized protocols for examinations and interviews were implemented and the data base included a valuable longitudinal plasma bank. Because incident cases were enrolled, information was collected from diagnosis on children, adolescents and young adults currently without symptoms of atherosclerosis. The existing database was expanded, the existing resources were used including the plasma bank, and promising new and well established clinical research techniques were incorporated by: (i) measuring plasma lipid levels on stored plasma and on newly collected blood samples, (ii) measuring triglyceride levels on newly collected blood samples, (iii) measuring urinary albumin excretion rates on newly collected specimens (already measured from diagnosis to date), and (iv) assessing endothelial function by brachial artery ultrasound, (v) measuring the intima medial thickness (IMT) of the carotid artery by ultrasound, and (vi) measuring coronary calcium by computed tomography scanning. These activities allowed pursuit of the following specific aims: 1) to determine the relationship between established risk factors for atherosclerosis and the development of pre-clinical atherosclerosis, 2) to determine the relationship between endothelial dysfunction and carotid IMT, and 3) to determine the relationship between coronary artery calcification and carotid IMT. Such information was critical in directing further efforts toward primary prevention of atherosclerosis in individuals with Type 1 diabetes mellitus.

Conditions
-----------------
Atherosclerosis, Cardiovascular Diseases, Diabetes Mellitus, Insulin-dependent, Heart Diseases, Diabetes Mellitus

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 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 Experiences of Parents Learning Physiotherapy Techniques for Their Child

Study Overview
=================
Brief Summary
-----------------
The experiences of learning from paediatric physiotherapists were explored through unstructured interviews applying Colazzi's method to interpret the data. In this hermeneutic phenomenological study, six parents responsible for a physiotherapy home programme for their child were selected through convenience sampling. The purpose of this study was to obtain rich and valid information that could be analysed. The phenomenon of their learning experiences was formed and explored, its implications discussed and inferences made in light of current physiotherapy service delivery.

Official Title
-----------------
The Experiences of Parents Learning Physiotherapy Techniques for Their Child

Conditions
-----------------
Developmental Disabilities

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: parent/main carer of a child with a long term physical condition receiving physiotherapy in the United Kingdom for at least six months. Exclusion Criteria: parents experiencing physiotherapy outside UK practice. parents to whom English is not their first language. parents under 16 years of age

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

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 |
| --- | --- |
| parental experiences<br>interviews | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the learning experiences of parents | using Colazzi's analysis interviews are coded and relevant data formed into themes that form the phenomenon. | after six months of physiotherapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
home programmes, children with physical disabilities, home activity programs, learning, therapeutic relationship, phenomenology, physiotherapy, clinicians who teach, parent perspective, parent-professional relationships, Parents/carers, long term physiotherapy needs
A Real World Study Based on NGS (TRUMPRWS)

Study Overview
=================
Brief Summary
-----------------
This is a descriptive observational study, in which data are collected in an epidemiological fashion. This study does not intend to alter or intervene the current medical practice of the recruited patients. Data will be collected in prospective manner.

Detailed Description
-----------------
This is a descriptive observational study, in which data are collected in an epidemiological fashion. This study does not intend to alter or intervene the current medical practice of the recruited patients. Data will be collected in prospective manner. The eligible patients will be recruited after NGS analysis for tumor tissue and the inform-consent is obtained. The study required information will be collected (every 3 months).

Official Title
-----------------
TRUMPRWS: A Non-interventional Study on Genetic Variants and Its Clinical Relevance in Chinese Patients With Advanced NSCLC (TRUMPRWS)

Conditions
-----------------
Non-Small Cell Carcinoma of Lung, TNM Stage 4

Intervention / Treatment
-----------------
* Other: No treatment is included in this protocol.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must be ≥20 years of age. Provision of fully informed consent prior to any study specific procedures. Histologically or cytologically confirmed, unresectable stage IIIB or stage IV NSCLC. Genetic variants of tumor tissue detected by NGS. Exclusion Criteria: None.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No treatment is included in this protocol.|No drug intervention or tissue sampling will be included in this study.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical relevance between genomic profiling and overall survival | Kaplan-meier analysis of overall survival based on different genetic alteration | [ Time Frame: From registration onto that step until death, or censored at the date of last contact, assessed up to 3 years] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The characteristics of genomic variation and dynamic changes during different anti-tumor treatment | Subtypes, incidence and dynamic changes of genomic variants during treatment process. | 24 months |
Use of Cooled Radiofrequency for the Treatment of Hip Pain Associated With OA of the Hip Compared to Intra-articular Steroid Injections

Study Overview
=================
Brief Summary
-----------------
This will be a single-center, prospective, single-blinded randomized clinical trial to investigate the effectiveness of using cooled RFA for the treatment of OA hip pain and function in subjects treated with cooled RFA compared with standard of care intra-articular steroid injections

Official Title
-----------------
Use of Cooled Radiofrequency for the Treatment of Hip Pain Associated With OA of the Hip Compared to Intra-articular Steroid Injections

Conditions
-----------------
Osteo Arthritis of Hip

Intervention / Treatment
-----------------
* Procedure: Cooled RFA treatment
* Drug: Steroid Drug


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects presenting with radiographic evidence of hip OA and demonstrating hip pain for at least 30 days will be targeted. Radiographic evidence of hip OA is defined as Kellegran-Lawrence grade 2-4 Not an operative candidate as per RI joint replacement surgeon OR Subjects who do not desire joint replacement surgery after consultation with RI joint replacement surgeon Male or non-pregnant female older than 18 years of age willing and able to sign the IRB-approved informed consent document. Exclusion Criteria: Any steroid injection in hip within 90 days Local infection at injection site or active systemic infection Anticoagulation status with inability to discontinue medication for appropriate duration for nerve blocks and RFA given proximity to major artery. (No anticoagulation contraindications for joint injection) AICD with inability to utilize magnet for RFA per treating cardiologist Body habitus does not allow for placement of longest needles and electrodes (approximately 15cm) to successfully administer treatment Allergy or severe renal impairment precluding iodionated contrast or magnavist injection despite standard premedication protocol

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cooled RFA treatment<br> | Procedure: Cooled RFA treatment<br>* cooled radiofrequency ablation<br>|
| Active Comparator: Steroid injection<br> | Drug: Steroid Drug<br>* steroid injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Visual Analog Scale | 24 weeks following treatment |