linjc16/ctgov huggingface dataset:
Outcomes Comparison of Robotic, Retropubic, and Perineal Prostatectomy

Study Overview
=================
Brief Summary
-----------------
Compare peri-operative and postoperative outcomes of the three different surgical approaches to prostatectomy

Detailed Description
-----------------
Existing data collected from Prostatectomy Database study and Urology Database study will be analyzed. Compare peri-operative and postoperative outcomes of the three different surgical approaches to prostatectomy

Official Title
-----------------
Outcomes Comparison of Robotic, Retropubic, and Perineal Prostatectomy

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Procedure: Prostatectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age Radical Prostatectomy at William Beaumont Hospital Exclusion Criteria: Dementia

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

Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Prostatectomy|Patients undergoing prostatectomy.|

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
-----------------
Prostate Cancer, Prostatectomy
Videolaryngoscopy in Patients With Cervical Spine Immobilisation

Study Overview
=================
Brief Summary
-----------------
Tracheal intubation is more difficult in patients in whom cervical spine immobilisation is maintained during tracheal intubation. The McGrath Series 5 videolaryngoscope offers a potential solution. The relatively short radius of the blade curvature combined with the internal arrangement of optimal components means that the glottis can be seen without the need for alignment of the oral, pharyngeal and tracheal axes. The investigators propose that the McGrath Series 5 videolaryngoscope will improve the view of the larynx in patients with limited neck movements, making intubation quicker, easier and possibly safer.

Official Title
-----------------
A Randomised Crossover Trial Comparing the McGrath Series 5 Videolaryngoscope With the Macintosh Laryngoscope in Patients With Cervical Spine Immobilisation

Conditions
-----------------
Intubation; Difficult

Intervention / Treatment
-----------------
* Device: Laryngoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective procedure requiring tracheal intubation Over 16 years of age Exclusion Criteria: Emergency procedure Less than 16 years of age Unable to consent Symptomatic gastro-oesophageal reflux disease Evidence of raised intracranial pressure Known pharyngeal pathology

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: McGrath Series 5<br>Videolaryngoscope used to perform indirect (video) laryngoscopy and tracheal intubation | Device: Laryngoscopy<br>* After establishing full monitoring, inducing general anaesthesia and ensuring paralysis, laryngoscopy is performed and the patient's trachea is intubated.<br>|
| Active Comparator: Macintosh<br>Laryngoscope used to perform direct laryngoscopy and tracheal intubation | Device: Laryngoscopy<br>* After establishing full monitoring, inducing general anaesthesia and ensuring paralysis, laryngoscopy is performed and the patient's trachea is intubated.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cormack and Lehane laryngoscopy grade |  | 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to intubation |  | 5 minutes | 
| Rate of successful tracheal intubation |  | 5 minutes | 
| Incidence of complications |  | 5 minutes |
Safety of Treatment Initiation With Biphasic Insulin Aspart 30 in Hospitalised Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Europe. The aim of this study is to evaluate the safety and efficacy of biphasic insulin aspart (NovoMix® 30) in hospitalised patients with type 2 diabetes with the aim of intensifying their treatment.

Official Title
-----------------
Multicenter, Open Label, Non-randomized, Non-interventional Observational Study of Safety of Treatment Initiation With a Biphasic Insulin Aspart (NovoMix® 30) in Hospitalized Patients With Type 2 Diabetes Mellitus

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: biphasic insulin aspart 30


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with type 2 diabetes Treated with oral anti-diabetics and/or human insulin Exclusion Criteria: Persons previously included in the trial Hypersensitive to biphasic insulin aspart or any of the excipients Pregnant or lactating women, or those who plan to get pregnant within the next 12 months
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NovoMix® 30 users<br> | Drug: biphasic insulin aspart 30<br>* Biphasic insulin aspart 30 prescribed solely on the basis of clinical judgement. Initial dose, frequency of injections and further dosage amendments at the discretion of the treating physician.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of severe hypoglycaemic episodes |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of severe hypoglycaemic episodes |  |  | 
| Number of mild hypoglycaemic episodes |  |  | 
| Postprandial glucose concentration after breakfast, lunch, and dinner |  |  | 
| Average fasting glucose concentration after waking and before main meals |  |  | 
| Average plasma glucose level at bedtime and at night |  |  |
Zilver Flex Post-Market Study in Japan

Study Overview
=================
Brief Summary
-----------------
Japanese post market clinical study of the Zilver Flex device.

Official Title
-----------------
Zilver PTX Post-Market Surveillance Study of Bare Metal Stents for Treating Femoropopliteal Artery Disease in Japan

Conditions
-----------------
Peripheral Arterial Disease (PAD)

Intervention / Treatment
-----------------
* Device: Zilver Flex Bare Metal Stent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Symptomatic peripheral arterial disease (PAD) involving the above-the-knee femoropopliteal arteries Exclusion Criteria: -
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zilver<br> | Device: Zilver Flex Bare Metal Stent<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of stent fracture |  | 3 years | 
| Rate of adverse events |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
drug-eluting stent, paclitaxel-eluting stent, peripheral artery disease, peripheral vascular disease, superficial femoral artery, popliteal artery
AZD8330 First Time in Man in Patients With Advanced Malignancies

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this protocol is to investigate the safety and tolerability of AZD8330 (ARRY-424704) in patients with Advanced Malignancies

Official Title
-----------------
A Phase I, Open-Label, Multi-centre Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Oral Doses of AZD8330 in Patients With Advanced Malignancies

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Drug: AZD8330


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cancer which is refractory to standard therapies, or no therapies exist; Exclusion Criteria: Participated in radiotherapy, biological or chemotherapy within 21 days prior to study start; Hasn't participated in investigation drug study within 30 days; Brain metastases/spinal cord compression unless treated and stable, Off steroids/anticonvulsants.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: AZD8330|oral tablet|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess safety and tolerability of AZD8330 in patient with advanced malignancies. |  |  | 
| Outcome variables: Adverse Events, Clinical Chemistry, Haematology, Urinalysis, Vital signs, MUGA scans/echocardiography, ECGs, Ophthalmologic examination, O2 saturation |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the PK of AZD8330. |  |  | 
| To investigate possible PD/PK relationships |  |  | 
| To investigate effect of AZD8330 on pERK in PBMCs |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Advanced Malignancies
Effect of a Probiotic on Grass Pollen Allergic Rhinitis Subjects

Study Overview
=================
Brief Summary
-----------------
Various studies in animals and humans have shown a potential beneficial effect of probiotics consumption on allergy. However, few studies exist that document their efficacy for upper airways allergies such as allergic rhinitis. The objective of this study is to investigate the effect of short-term oral administration of a Lactobacillus paracasei on a nasal provocation test (NPT) with grass pollen, performed out of pollen season. Adult volunteers with allergic rhinitis are enrolled in a randomized, double-blind, placebo-controlled study, based on two 4-weeks cross-over periods of product consumption (probiotic-fermented milk versus placebo), separated by a washout period of 6-8 weeks. Objective and subjective clinical parameters of NPT as well as systemic and nasal immunological parameters are compared between the two treatment periods.

Official Title
-----------------
Double Blind Randomised Comparison of Two Preparations, One Enriched in Probiotics and One Without Probiotics (Placebo) in Grass Pollen Allergic Rhinitis Patients, Using a Nasal Provocation Test

Conditions
-----------------
Allergic Rhinitis

Intervention / Treatment
-----------------
* Dietary Supplement: L. paracasei fermented milk


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18 to 35 years history of allergic rhinitis to grass pollen confirmed by either a positive skin prick test (wheal diameter >3 mm) or specific IgE for grass pollen (>0.35 kU/L) as titrated by UniCAP 100 (Pharmacia Diagnostics, Uppsala, Sweden) and no history of perennial rhinitis a nasal reaction threshold of 10'000 standardized quality units (SQs)/ml grass pollen or less at the screening phase Exclusion Criteria: any medical condition that could influence the study (pregnancy, viral or bacterial airway infection, active allergic rhinitis) uncontrolled asthma (peak expiratory flow <20% of volunteer's best personal value) treatment with antihistamine or antibiotic treatment less than two weeks before enrolment or during the trial

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

Design Details

Intervention Model: Crossover Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: probiotic fermented milk<br> | Dietary Supplement: L. paracasei fermented milk<br> <br> |
| Placebo Comparator: placebo<br> | Dietary Supplement: L. paracasei fermented milk<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Osseous Setting Improvement With Co-implantation of Osseous Matrix and Mesenchymal Progenitors Cells From Autologous Bone Marrow

Study Overview
=================
Brief Summary
-----------------
Sometime osseous reconstruction needs allogeneic bone, in this study we use Ostéopure™ from Ostéobanque d'Auvergne, which is a osseous matrix. However Ostéopure™ integration lasts a long time. To optimize this integration we purpose to associate mesenchymal progenitors cells from autologous bone marrow.

Detailed Description
-----------------
All patients will be treated for tibia or femur pseudo-arthrosis. At the beginning of chirurgical intervention, autologous bone marrow will be sampling and will be concentrated during this one. Meanwhile osseous matrix (Ostéopure™ ) will be incubated in autologous blood serum and finally implanted in the fracture site. And after (at the end of chirurgical intervention), concentrate autologous bone marrow will be injected in the same place.

Official Title
-----------------
Osseous Setting Improvement With Co-implantation of Osseous Matrix and Mesenchymal Progenitors Cells From Autologous Bone Marrow

Conditions
-----------------
Tibia or Femur Pseudo-arthrosis

Intervention / Treatment
-----------------
* Procedure: Chirurgical procedure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: tibia or femur pseudo-arthrosis, patient who needs bone graft Exclusion Criteria: - contra indications for chirurgical intervention or bone graft

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Chirurgical procedure|Chirurgical procedure to treat pseudo-arthrosis, with of osseous matrix implantation and autologous bone marrow injection.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate osseous setting at 3-months follow-up and compare our results with past studies |  | at 3-months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility and tolerance of this therapeutic strategy |  | at 3-months follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pseudo-arthrosis, osseous matrix, cell therapy
Evaluation of Calcinosis in Systemic Sclerosis

Study Overview
=================
Brief Summary
-----------------
Systemic sclerosis is a rare pathology characterized by fibrosis and vascular lesion with skin, pulmonary, digestive and cardiac localisation. Calcinosis cutis is commonly described, but its prevalence and appear few documented in literature. Moreover, this studies used clinical observation to determine presence or absence of calcification, and rarely radiography, in particular for feet localisation. In the same way, skin calcification and organ injury association appear unclear. The aim of the study is firstly to determine prevalence of calcinosis cutis, with hand and feet radiography realisation in a cohort of systemic sclerosis patient. Secondly, will be determine the correlation between calcinosis and organ injury.

Official Title
-----------------
Evaluation of Calcinosis Prevalence in Systemic Sclerosis : a Cross Sectional Study Evaluating Calcinosis Cutis Prevalence by Hand and Feet Radiographic Assessment in Systemic Sclerosis Patients and Study Their Correlation With Organ Injury

Conditions
-----------------
Systemic Sclerosis

Intervention / Treatment
-----------------
* Radiation: Radiography
* Procedure: Veinous punction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Systemic sclerosis presenting ACR-EULAR 2013 criteria Given their consent Titulary of health insurance Exclusion Criteria: Dermatomyositis overlap Pregnant or breastfeeding women Imprisoned person Refuse of 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Systemic sclerosis patients<br> | Radiation: Radiography<br>* Radiography of the hand and feet (face incident) the day of the inclusion<br>Procedure: Veinous punction<br>* Blood sample to analysis VEGF, endothelin 1, endostatin and P/GF, (ELISA method)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calcinosis cutis prevalence by radiographic assessment |  | at inclusion ( baseline) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographic data |  | at inclusion ( baseline) | 
| Rodnan score |  | at inclusion ( baseline) | 
| Visceral localisation evaluation (cardiac, pulmonary, digestive) |  | at inclusion ( baseline) | 
| EUSTAR score |  | at inclusion ( baseline) | 
| Medsger score |  | at inclusion ( baseline) | 
| Quality of life evaluation (HAQ modified questionary) |  | at inclusion ( baseline) | 
| Biologic vascular markers : VEGF, endothelin 1, endostatin and P/GF, (ELISA method) |  | at inclusion ( baseline) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Systemic sclerosis, Calcinosis cutis
Safety/Efficacy of Systane Free vs Refresh Liquigel

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the safety and efficacy of Systane Free FID 105783 when compared to Refresh Liquigel Lubricant Eye Drops (Allergan) in a specified population of dry eye patients.

Official Title
-----------------
An Evaluation of the Safety and Efficacy of Systane Free FID 105783

Conditions
-----------------
Dry Eye

Intervention / Treatment
-----------------
* Other: Systane Free Lubricant Eye Drops
* Other: Refresh Liquigel Lubricant Eye Drops


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >/= 3 corneal staining score using NEI scoring system. Need artificial tears at least some of the time. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: History or evidence of ocular or intraocular surgery in either eye within the past six months. History of intolerance or hypersensitivity to any component of the study medication. Use of Restasis within 30 days of Visit 1. Participation in an investigational drug or device study within 30 days of entering this study. Other protocol-defined exclusion criteria may apply.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Systane<br> | Other: Systane Free Lubricant Eye Drops<br>* 1-2 drops per eye four times per day for 42 days<br>|
| Active Comparator: Refresh<br> | Other: Refresh Liquigel Lubricant Eye Drops<br>* 1-2 drops per eye four times per day for 42 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in corneal staining at Day 28 from baseline (Day 0) |  | Day 28 |
Prediction of Jaundice in Term Infants

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to describe total bilirubin production in healthy term infants as a means of understanding the differences in jaundice pigment production associated with various common clinical circumstances.

Detailed Description
-----------------
Jaundice occurs in most human neonates during the several days after birth. The objective of this study was to describe total bilirubin production in healthy term infants as a means of understanding the differences in jaundice pigment production associated with various common clinical circumstances.

Official Title
-----------------
BilirubinProduction in Healthy Term Infants as Measured by Carbon Monoxide in Breath

Conditions
-----------------
Infant, Newborn, Jaundice

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants born via cesarean delivery (to ensure subjects would still be hospitalized and available for ETCOc measurement and blood sampling on day 3 postpartum) Delivery within each center's scheduled recruitment period (to maximize nursing availability and minimize cost) Birth weight >2500 g Gestational age >37 weeks Exclusion Criteria: Any illness that would require admission to the neonatal intensive-care unit (NICU) within 8 hours of birth

Ages Eligible for Study
-----------------
Maximum Age: 8 Hours

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 |
| --- | --- |
| Cohort 1<br>Term infants >2500g birthweight. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| End-tidal carbon End-tidal carbon monoxide levels corrected for ambient air (ETCOc) | An index of bilirubin production | 2-8 hours of age | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NICHD Neonatal Research Network, Term infant, Hyperbilirubinemia