linjc16/ctgov huggingface dataset:
Suturable DuraGen™ PMCF Study

Study Overview
=================
Brief Summary
-----------------
The primary goal of this study is to retrospectively collect data on the safety and efficacy of Suturable DuraGen™.

Detailed Description
-----------------
This is a multicenter, non-randomized, non-interventional, retrospective Post-Market Clinical Follow-up (PMCF) study to evaluate the occurrence of post-operative cerebrospinal fluid (CSF) leaks within 30 days (and up to 90 days) after use of Suturable DuraGen™ for a supratentorial, infratentorial, or spinal procedure.

Official Title
-----------------
A Multicenter, Retrospective, Post-Market Clinical Follow-Up Study to Evaluate the Performance and Safety of Suturable DuraGen™

Conditions
-----------------
Cerebrospinal Fluid Leak

Intervention / Treatment
-----------------
* Device: Suturable DuraGen™


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is between 18 and 80 years of age Subject has undergone either a supratentorial, an infratentorial, or a spinal procedure with the use of Suturable DuraGen™ prior to trial initiation Availability of post-operative assessment results. Exclusion Criteria: 1. There are no exclusionary criteria for this study population

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Supratentorial Procedure Group<br>Subjects that have undergone a supratentorial procedure with the use of Suturable DuraGen™. | Device: Suturable DuraGen™<br>* Suturable DuraGen™ Dural Regeneration Matrix, an absorbable implant for repair of dural defects.<br>|
| Infratentorial Procedure Group<br>Subjects that have undergone a infratentorial procedure with the use of Suturable DuraGen™. | Device: Suturable DuraGen™<br>* Suturable DuraGen™ Dural Regeneration Matrix, an absorbable implant for repair of dural defects.<br>|
| Spinal Procedure Group<br>Subjects that have undergone a spinal procedure with the use of Suturable DuraGen™. | Device: Suturable DuraGen™<br>* Suturable DuraGen™ Dural Regeneration Matrix, an absorbable implant for repair of dural defects.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Outcome | Occurrence of post-operative cerebrospinal fluid (CSF) leaks post-procedure | post-up to 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of Adverse Event | Adverse event that occurred between days 30-90 post-operatively | Between days 30-90 |
Impact of Respiratory Muscle Unloading on Respiratory Muscle Endurance

Study Overview
=================
Brief Summary
-----------------
This study investigates how different degrees of muscular unloading during mechanical ventilation impact endurance of succeeding spontaneous breathing trials

Detailed Description
-----------------
Liberation from mechanical ventilation in difficult to wean patients is best accomplished by intermittent spontaneous breathing trials (1). Optimal respiratory muscle rest in-between breathing trials however has never been investigated. Using a crossover design, patients are to be ventilated with complete and partial respiratory muscle unloading for a period of ten hours respectively. Respiratory muscle activity is being monitored by oesophageal balloon technique using a commercially available System (Avea, Viasys, Conshohocken, PA, USA). Time of spontaneous breathing, respiratory- and ABG parameters are being determined to characterize the course of each spontaneous breathing trial. References 1. Esteban, A., F. Frutos, M. J. Tobin, I. Alia, J. F. Solsona, I. Valverdu, R. Fernandez, M. A. de la Cal, S. Benito, R. Tomas, and et al. 1995. A comparison of four methods of weaning patients from mechanical ventilation. Spanish Lung Failure Collaborative Group. N Engl J Med 332(6):345-50.

Official Title
-----------------
Impact of Respiratory Muscle Unloading on Respiratory Muscle Endurance

Conditions
-----------------
Chronic Respiratory Failure

Intervention / Treatment
-----------------
* Device: positive pressure ventilation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hypercapnic respiratory failure Exclusion Criteria: upper Gi pathology renal failure (creatinin > 2 mg/dl) Sepsis or infection age < 18 years

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: Crossover Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: positive pressure ventilation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endurance time |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PCO2, respiratory parameters |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
weaning, work of breathing, spontaneous breathing trial, rapid shallow breathing
Vitamin D and Grass Pollen Specific Immunotherapy

Study Overview
=================
Brief Summary
-----------------
Allergen-specific immunotherapy is the only causal therapy of Immunoglobulin E-induced allergies like allergic rhinoconjunctivitis. Despite progress during the last decades it is limited by a long treatment time and high non-responder frequency. Based on experimental and epidemiological evidences we hypothesize that vitamin D can act as an effective immunomodulatory adjuvant to overcome these limitations.

Conditions
-----------------
Allergic Rhinoconjunctivitis

Intervention / Treatment
-----------------
* Drug: Cholecalciferol
* Other: middle-chain fatty acids (carrier)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: written informed consent relative Vitamin D deficiency clinical relevant grass pollen allergy positive intradermal test with grass pollen forced expiratory volume at one second (FEV1) > 70% Exclusion Criteria: current specific immunotherapy instable allergic asthma pregnancy and lactation treatment with immunomodulators or immunosuppressive drugs sarcoidosis, chronic diseases, malignancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vigantol<br> | Drug: Cholecalciferol<br>* given orally, once daily, before grass pollen season<br>* Other names: Vitamin D;|
| Placebo Comparator: neutral oil (vigantol carrier)<br> | Other: middle-chain fatty acids (carrier)<br>* given orally, once daily, before grass pollen season<br>* Other names: neutral oil;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| wheal diameter in the intradermal test after SIT in the comparison between vitamin D and placebo |  | three years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vitamin D, SIT, Grass pollen, allergic rhinoconjunctivitis
Patient Understanding of LiverMultiScan

Study Overview
=================
Brief Summary
-----------------
This is a qualitative study to determine which factors affect the patient experience of having a liver MRI, what information patients would like to receive after their MRI, and how patients would like this information communicated to them.

Detailed Description
-----------------
This is a qualitative study to determine which factors affect the patient experience of having a liver MRI, what information patients would like to receive after their MRI, and how patients would like this information communicated to them. Each individual will receive at least an MRI scan (LiverMultiScan), with many also receiving a FibroScan (Transient Elastography). Patients will then undergo a focused qualitative interview, as well as filling out a questionnaire. The interviews will be thematically analysed and trends identified by significance.

Official Title
-----------------
Patient Understanding of LiverMultiScan

Conditions
-----------------
Liver Diseases

Intervention / Treatment
-----------------
* Device: MRI
* Device: Transient Elastography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals with experience of liver disease. Individuals over the age of 16. Individuals willing to give informed consent for participation in the study. Exclusion Criteria: Individuals with any contraindication to magnetic resonance imaging.

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 |
| --- | --- |
| Experience of liver disease<br>This is defined as either those who have had direct experience of liver disease as sufferers, or the carers of those who have had liver disease. Each individual receives an MRI (LiverMultiScan), with many also receiving a FibroScan. | Device: MRI<br> <br> * Other names: LiverMultiScan;Device: Transient Elastography<br> <br> * Other names: FibroScan;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Factors effecting MRI experience and understanding. | This will be analysed based on themes and trends emanating from answers within the focused interview and questionnaire following the scan, and results feedback. | Immediately (within 1 hour) after undergoing the MRI scan, and receiving results feedback. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of MRI to ultrasound scan in terms of patient experience. | This will be analysed based on themes and trends emanating from answers within the focused interview and questionnaire following the scan, and results feedback. | Immediately (within 1 hour) after undergoing an MRI scan, and ultrasound (FibroScan) scan. |
Prediction and Detection of Occult Atrial Fibrillation in Patients After Acute Cryptogenic Stroke and TIA

Study Overview
=================
Brief Summary
-----------------
PROACTIA is a prospective, event-driven observational study. It aims to propose a composite scoring system in order to evaluate the risk of paroxysmal atrial fibrillation (PAF) in patients after acute cryptogenic stroke and transient ischemic attack (TIA).

Detailed Description
-----------------
It will be enrolled 250 participants of both sexes within two weeks after diagnosed cryptogenic stroke and/or TIA at Akershus University Hospital, Oslo area, Norway. Evaluation of participants' comorbidity with CHADS2-VASc score, ECG, Holter ECG, echocardiography, detection of biochemical cardiac markers and screening for obstructive sleep apnea syndrome will be performed. All participants will be monitored with a continuous cardiac rhythm during one year by implantation of implantable cardiac rhythm monitors (ICRM). All patients without high bleeding risk will get prescribed oral anticoagulants (OAC) after detection of PAF. A biobank will be established in order to store the sampled biological material.

Official Title
-----------------
Prediction and Detection of Occult Atrial Fibrillation in Patients After Acute Cryptogenic Stroke and Transient Ischemic Attack

Conditions
-----------------
Cerebrovascular Stroke, Atrial Fibrillation

Intervention / Treatment
-----------------
* Device: Implantation of ICRM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patients diagnosed with cryptogenic stroke and/or TIA, in accordance to the TOAST (Trial of Org 10172 in Acute Stroke Treatment) classification. Exclusion Criteria: Patients with known or newly detected AF on initial examination including 24 h Holter ECG. Patients on oral anticoagulants (OAC) for non-AF indications. Patients with strong contraindications for OAC, even if the presence of underlying AF is detected. Patients with atrial- or ventricular thrombi, or atheromas of the aortic arch greater than 4 mm, detected by transesophageal echocardiography. Patients unable to sign the informed consent or with a life expectancy due to comorbidities of less than two years.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with cryptogenic stroke and TIA<br>Implantation of ICRM in all participants. | Device: Implantation of ICRM<br>* All patients will be implanted with ICRM in order to detect an occult PAF.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of paroxysmal atrial fibrillation |  | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cryptogenic stroke, Occult paroxysmal atrial fibrillation
Developmental Profile of Ocular Refraction in Patients With Congenital Cataract

Study Overview
=================
Brief Summary
-----------------
The purpose of prospective cohort study is to describe the developmental profile of refraction change in a large cohort of Chinese CC patients. The decisive factors to the range of myopic shift in unilateral CC appeared to be different from that in bilateral CC, indicating dramatic differences in the etiopathogenesis and refractive prognosis between bilateral and unilateral CC.

Detailed Description
-----------------
The refractive status is crucial to visual function and may change throughout life. For patients with congenital cataract (CC), the developmental profile of refraction is complicated due to the potential influences of diverse clinical manifestations and various treatments, and has not yet been fully characterized. The investigator described the developmental profile of refraction change in a large cohort of Chinese CC patients. The decisive factors to the range of myopic shift in unilateral CC appeared to be different from that in bilateral CC, indicating dramatic differences in the etiopathogenesis and refractive prognosis between bilateral and unilateral CC. The refraction data from CC patients provided in the study are of clinical significance to the guidelines for CC treatment, especially for IOL calculation concerning the laterality of CC.

Official Title
-----------------
Developmental Profile of Ocular Refraction in Patients With Congenital Cataract: A Prospective Cohort Study

Conditions
-----------------
Cataract

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children with uncomplicated surgeries Children with unilateral/bilateral cataract Exclusion Criteria: Corneal diseases Lens luxation Glaucoma Retinal diseases Nystagmus and nanophthalmos
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 refraction status (presented as spherical equivalent, SE) | Refractions were conducted with objective retinoscopy and cycloplegia, and performed by experienced optometrists. | Baseline |
Pegfilgrastim Given Same Day As or Day After Carboplatin and Docetaxel in Advanced Metastatic Non-Small Cell Lung Cancer (NSCLC)

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to evaluate the safety and effectiveness of Neulasta® (pegfilgrastim) in reducing infection when given on the same day versus one day after the completion of chemotherapy (docetaxel and carboplatin) in patients with advanced or metastatic non-small cell lung cancer (NSCLC). This study is considered to be investigational because previous studies with Neulasta® used next day dosing and not same day dosing.

Official Title
-----------------
Pegfilgrastim Given Same Day as or Day After Carboplatin and Docetaxel in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer

Conditions
-----------------
Lung Cancer, Non-Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Other: PI Discretion


Participation Criteria
=================
Eligibility Criteria
-----------------
Eligibility Criteria: - Age 18 years or older - Diagnosis of advanced or metastatic non-small cell lung cancer (NSCLC) - Have not received any prior chemotherapy - Have not received radiation therapy or undergone major surgery within the past 2 weeks

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pegfilgrastim<br> | Other: PI Discretion<br>* PI Discretion<br>|
| PLACEBO<br> | Other: PI Discretion<br>* PI Discretion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of infection |  | during treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metastatic Cancer, Neulasta®, pegfilgrastim
Augmented Reality Enhanced Surgery: Use of Holographic Technology in Cranial and Spinal Surgery

Study Overview
=================
Brief Summary
-----------------
To demonstrate the feasibility of integrating holographic technology as a heads-up display for navigated cranial and spinal neurosurgical procedures. This entails simply displaying the navigation screen currently used by Medtronic Stealth or Brainlab systems as a holographic image that can be positioned closer to the operative field. To develop a systematic, efficient communication and registration process allowing holographic technology to be potentially utilized as a navigation tool in cranial and spinal neurosurgery. This entails developing software, optimizing connection parameters, and devising registration techniques incorporating line-of-sight fiducial markers to allow the holographic device to function as a navigation instrument.

Official Title
-----------------
Augmented Reality Enhanced Surgery: Proof-of-concept Study for the Use of Holographic Technology in Cranial and Spinal Surgery

Conditions
-----------------
Surgery

Intervention / Treatment
-----------------
* Device: Augmented Reality Headset


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age >= 18 must be able to read and understand English, and sign the informed consent form Exclusion Criteria: emergent/emergency procedures pediatric patients pregnant patients vulnerable populations

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Single cohort - navigated cranial and spine surgery<br> | Device: Augmented Reality Headset<br>* Patients undergoing navigated cranial or spine procedures will acquire standard of care clinical high-resolution imaging to be used for registration purposes intraoperatively. VGA output on the navigation machine will be utilized to project imaging information to the augmented reality headset. The holographic image will then be recorded to assess feasibility and ease of use.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of holographic technology in the operating room using a feasibility scale ranging from 1-10 | To demonstrate the feasibility of integrating holographic technology as a heads-up display for navigated cranial and spinal neurosurgical procedures. This entails simply displaying the navigation screen currently used by Medtronic Stealth or Brainlab systems as a holographic image that can be positioned closer to the operative field. | 2 years |