linjc16/ctgov huggingface dataset:
Special Survey for Type 1 or Type 2 Diabetic Patients

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Japan. The aim of this study is to evaluate the incidence of severe hypoglycaemia episodes under normal clinical practice for patients with type 1 or type 2 diabetes.

Official Title
-----------------
Special Survey for Type 1 or Type 2 Diabetic Patients

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with diabetes requiring insulin therapy Exclusion Criteria: Patients who had not been treated more than 3 months at the same investigational site Patients who had treatment history of NovoRapid® (insulin aspart)
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Insulin Aspart<br> | Drug: insulin aspart<br>* Adminstered subcutaneously (s.c., under the skin). Prescribed by physician as a results of normal clinical practice<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c (glycosylated haemoglobin) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of servere hypoglycaemia |  |  | 
| Total dose of insulin (aspart/human insulin) infused subcutaneously |  |  | 
| Physical examination |  |  | 
| Adverse events |  |  |
Comparison of Conventional Dialysis and the Allient System

Study Overview
=================
Brief Summary
-----------------
The purpose of the study to determine whether the level of inflammation may be decreased, the lifespan of red blood cells increased and the clearance of waste products in the blood improved through the use of the Allient System as compared to conventional hemodialysis.

Official Title
-----------------
Uremic Toxin Removal, Blood Cell Kinetics, and Inflammatory Response in Patients Treated With the Allient System

Conditions
-----------------
End Stage Renal Disease, Chronic Kidney Failure

Intervention / Treatment
-----------------
* Device: Allient System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Maintenance in-center hemodialysis Age greater than or equal to 18 years Has been on hemodialysis for at least 4 months Uses a standard single-pass dialysis machine with a high-flux dialyzer Exclusion Criteria: Hospitalization during the 8 weeks preceding enrollment Infection requiring antibiotic treatment during the 8 weeks preceding enrollment Central venous cather as dialysis access Uncontrollable blood coagulation anomalies Smokers Dialysis regimen other than 3 times weekly In ability to understand the English language and give informed consent for participation in the study

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Subject will continue conventional hemodialysis therapy for one week (no intervention phase) and then swtich to the Allient system for two weeks (active comparator phase). | Device: Allient System<br>* The Allient System uses a different type of blood pump and a lower volume of dialysate.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clearance of specific waste products from blood determined through subject blood and dialysate samples |  | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammation as determined by levels of specific inflammatory markers |  | 3 weeks | 
| Red blood cell lifespan determined through a measurement of CO in the subject's breath |  | 3 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hemodialysis
CHAIN1 : Dental Wear and Musculoskeletal Disorders - Association?

Study Overview
=================
Brief Summary
-----------------
This study aims to explore the relationships between tooth wear (TW) and musculoskeletal disorders (MSDs). The null hypothesis is that TW is not associated to MSDs. It also explores the influence of bruxism signs, life habits and stress on TW and MSDs.

Detailed Description
-----------------
This study is based on questionnaires and clinical examination performed by a dentist.

Official Title
-----------------
CHAIN1 : Dental Wear and Musculoskeletal Disorders - Association?

Conditions
-----------------
Tooth Wear, Musculoskeletal Disorder

Intervention / Treatment
-----------------
* Diagnostic Test: Tooth Wear and Musculoskeletal Disorders evaluation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Between 18 and 80 years old Have the mental abilities to participate in study Understand the language of the survey (French) Sign free and informed consent Exclusion Criteria: Consult for a painful dental emergency Do not have at least 8 teeth per maxilla, with natural dental tissues in contact with the antagonistic teeth Being in the process of an orthodontic treatment Wear of a bimaxillary orthognathic nightguard

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Tooth Wear and Musculoskeletal Disorders evaluation|Evaluation of dental wear by BEWE (Basic Erosive Wear Examination: score 0-3) examination and Musculoskeletal disorders are listed by the NORDIC questionnaire developed by Kuorinka et al. (2001)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of musculoskeletal disorders (MSDs) | Nordique Questionnaire: validated self-report questionnaire to evaluate musculo skeletal health, particularly MSD on 9 different zones | through study completion, an average of 1 year | 
| Tooth wear following BEWE index | Clinical examination will give a global score on 18 following Basic Erosive Wear Examination (BEWE) index. | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Life habits and stress | 10-points likert scale self-report questionnaire | through study completion, an average of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tooth Wear, Musculoskeletal Disorders
The Utility of Pulse Pressure Variation to Predict the Fluid Responsiveness During Pneumoperitoneum and Reverse-Trendelenburg Position

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the validity of pulse pressure variation to predict fluid responsiveness in patients undergoing robotic or laparoscopic gastrectomy.

Conditions
-----------------
General Anesthesia

Intervention / Treatment
-----------------
* Procedure: Fluid infusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients aged over 19 years who are scheduled for robotic or laparoscopic gastrectomy Exclusion Criteria: cardiac arrhythmia valvular heart disease ischemic heart disease left ventricular ejection fraction less than 40% Pulmonary disease esophageal disease upper gastrointestinal bleeding Body mass index more than 40 kg/m2.

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Pulse pressure variation<br>Pulse pressure variation will be recorded via an arterial catheter after anesthetic induction, before pneumoperitoneum, after pneumoperitoneum, before infusion of 6% hydroxyethyl starch, and after infusion of 6% hydroxyethyl starch. Stroke volume will be also measured to differentiate the fluid responders. | Procedure: Fluid infusion<br>* Fluid infusion will be performed using 6% hydroxyethyl starch. Pulse pressure variation and stroke volume will be measured before and after fluid infusion.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulse pressure variation | Ability of pulse pressure variation to predict fluid responsiveness will be evaluated. | During the surgery. At Day 0. |
Repeat Nasal Allergen Challenge

Study Overview
=================
Brief Summary
-----------------
This is a non-drug, biomarker study to assess the utility of the model of repeated nasal allergen challenges in subjects with atopic rhinitis as a method of inducing an increased response to inhaled allergen, which will more closely resemble the responses seen during the hayfever season.

Detailed Description
-----------------
This is a non-drug, biomarker study to assess the utility of the model of repeated nasal allergen challenges in subjects with atopic rhinitis as a method of inducing an increased response to inhaled allergen, which will more closely resemble the responses seen during the hayfever season.

Official Title
-----------------
Assessment of Inflammatory Mediator and Cellular Changes Following Repeated Nasal Allergen Challenge in Subjects With Allergic Rhinitis Sensitive to Timothy Grass Pollen - a Validation Study

Conditions
-----------------
Hayfever

Intervention / Treatment
-----------------
* Procedure: Skin Prick Test
* Procedure: Nasal allergen challenge
* Procedure: Nasal filter paper placement
* Procedure: Nasal lavage
* Procedure: Nasal scrape
* Procedure: Nasal symptoms score


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female subjects with a history of seasonal (intermittent) atopic rhinitis, aged 18-40 years. Otherwise healthy with no health problems that may jeopardize the subjects participating in the study, absence of history of other significant allergies. Exclusion Criteria: Smokers (use of tobacco products in the previous 3 months). Presence of any respiratory disease other than a history of mild stable asthma not requiring treatment and associated with normal lung function (FEV1 > 80% predicted at screening).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Skin Prick Test|nan|
|Procedure: Nasal allergen challenge|nan|
|Procedure: Nasal filter paper placement|nan|
|Procedure: Nasal lavage|nan|
|Procedure: Nasal scrape|nan|
|Procedure: Nasal symptoms score|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
-----------------
Nasal allergen challenge, Allergic rhinitis, Timothy grass pollen, inflammatory mediators
Audiological Evaluation of Anesthetists

Study Overview
=================
Brief Summary
-----------------
The investigators aim to investigate the effect of operating room noise on anesthetist hearing

Official Title
-----------------
the Effects of Noise in Operating Rooms on Anesthetists Hearing

Conditions
-----------------
Hearing Loss

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: anesthetist doctor and non-anesthetist doctor less than 40 years Exclusion Criteria: doctors above 40 years

Ages Eligible for Study
-----------------
Minimum Age: 28 Years
Maximum Age: 40 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 |
| --- | --- |
| anesthetist group<br>anesthetist doctor who subjected to noise in operating rooms | |
| control group<br>doctors in the same hospital who are not subjected to noise in operating rooms | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extended high frequency audiometry | pure tone audiometry in the frequency range from 250Hz-20,000Hz | 20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transient Evoked Otoacoustic Emission | stimulus induced cochlear echos in the frequency range from 1000-4000 Hz | 10 minutes |
Comparison of Neo-adjuvant Weekly Paclitaxel With or Without Carboplatin in Early Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether neo-adjuvant weekly paclitaxel with carboplatin is better than paclitaxel alone in efficiency and safety in early breast cancer, and to explore whether ultrasound and magnetic resonance imaging can predict the efficiency of neo-adjuvant chemotherapy.

Official Title
-----------------
A Phase II Randomized Clinical Trial of Neo-adjuvant Weekly Paclitaxel With or Without Carboplatin in Early Breast Cancer

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Drug: carboplatin+ paclitaxel
* Drug: paclitaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female patients between 18 and 65 years old pathological diagnosed invasive breast cancer; medium and high risk primary breast cancer according to St. Gallen 2007 able and willing to give consent to participate in the study Exclusion Criteria: pregnant or lactating females previous treatment for breast cancer other tumor history instable complication (e.g., myocardial infarction within 6 months, arrhythmia, unstable diabetes, hypercalcemia) or uncontrolled infection allergy history to similar drugs concurrent disease or condition that would make the patient inappropriate for study participation resist to participate in the study

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

Sexes Eligible for Study
-----------------
Female

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 |
| --- | --- |
| Experimental: Experimental<br> | Drug: carboplatin+ paclitaxel<br>* carboplatin AUC 2mg/mL*min/week, 3 week cycle up to 4 cycles; paclitaxel 80mg/m2/week, 3 week cycle up to 4 cycles<br>* Other names: A;Drug: paclitaxel<br>* paclitaxel 80mg/m2/week, 3 week cycle up to 4 cycles<br>* Other names: B;|
| Active Comparator: Active Comparator<br> | Drug: paclitaxel<br>* paclitaxel 80mg/m2/week, 3 week cycle up to 4 cycles<br>* Other names: B;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| significant effect rate (the proportion of G4 and G5, graded by Miller & Payne Method); null effect rate (the proportion of G1 and G2) |  | within the first 14 days (plus or minus 3 days) after surgery |
is Dietary Manipulation of Human Milk Total Fat and Caloric Content Feasible?

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to verify whether dietary manipulations in lactating women allow increasing the fat and caloric content of human milk.

Detailed Description
-----------------
The aim of this study is to verify whether dietary manipulations in lactating women allow increasing the fat and caloric content of human milk. specifically, we will test the following hypotheses:1) at constant caloric intake, 2 high fat (40% fat, 45% CHO) diets ( margarine e nriched versus butter enriched) lead to higher fat and caloric content of human milk than the low fat diet (5% fat, 80% CHO); and 2) All 3 groups will have strikingly different milk fatty acid profiles (mirroring the dietary fatty acid profile).

Official Title
-----------------
is Dietary Manipulation of Human Milk Total Fat and Caloric Content Feasible?

Conditions
-----------------
Breastfeeding

Intervention / Treatment
-----------------
* Behavioral: Fat and calorie controlled diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: breast feeding women healthy on no medications Exclusion Criteria: women on medications

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 46 Years

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Fat and calorie controlled diet|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
-----------------
diet, breast milk fat
Post Intensive Care Syndrome

Study Overview
=================
Brief Summary
-----------------
Barthel Index and demographic variables of patients were collected to investigate the question whether the improvements of the functionality improves the Barthel Index over the years.

Detailed Description
-----------------
idem

Official Title
-----------------
Do Improvements in Functionality on the ICU Give a Reduction of Post Intensive Care Syndrome

Conditions
-----------------
Post Intensive Care Syndrome, Barthel Index

Intervention / Treatment
-----------------
* Other: Barthel index for functionality


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years and older length of stay longer than 48 hours Exclusion Criteria: no exclusion criteria if inclusion is correct

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 |
| --- | --- |
| cohort 2012 - 2014<br>all patients admitted for > 48 hours on the Intensive Care Unit in 2012, 2013 and 2014 | Other: Barthel index for functionality<br>* The Barthel Index for functionality is done standard in all patients after intensive care admission<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Barthel Index | barthel index is analyzed over the years 2012 - 2014 | from januari 2012 until decembre 2014 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relation between Barthel Index and length of stay in ICU |  | from januari 2012 until decembre 2014 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intensive care, functionality
Fascia Iliaca Compartment Block in Acute and Chronic Pain Management in Hip Fracture Patients

Study Overview
=================
Brief Summary
-----------------
This study evaluates the effect of fascia iliaca compartment block (FICB) in the management of acute post -surgical pain in hip fracture patients and in the appearance of chronic post -surgical hip pain, by means of von Korff Graded Chronic Pain Scale -modified for hip pain in Greek. Half of the patients will not receive fascia iliaca compartment block.

Official Title
-----------------
The Effect of Fascia Iliaca Compartment Block in Acute and Chronic Pain Management in Hip Fracture Patients

Conditions
-----------------
Chronic Hip Pain

Intervention / Treatment
-----------------
* Drug: Fascia iliaca compartment block
* Drug: Ropivacaine
* Device: ultrasound
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I-III (American Society of Anesthesiologists classification) intertrochanteric fractures fractures of femoral neck Exclusion Criteria: existing pain in hip Joint to be operated cognitive or mental disorder administration of analgesic drugs prior surgery contraindications of spinal anesthesia refusal to participate in the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fascia iliaca compartment block (FICB)<br>Under ultrasound guidance performing fascia iliaca compartment block, in which 40 ml ropivacaine 0,5% are injected under the fascia iliaca. | Drug: Fascia iliaca compartment block<br>* 40 ml ropivacaine 0,5% injected under fascia iliaca using ultrasound<br>Drug: Ropivacaine<br> <br> Device: ultrasound<br> <br> |
| Placebo Comparator: Placebo (not FICB)<br>Half of the patients will not receive FICB | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute postsurgical pain after hip fracture surgery | Acute pain will be evaluated using the Numeric Rating Scale- NRS (0=no pain, 10= Extremely strong pain) at rest and in motion. | 48 hours | 
| Chronic postsurgical pain after hip fracture surgery | 3 and 6 months after surgery the patient or patient's relative will be asked on telephone to complete Von Korff Graded Chronic scale modified for hip pain | 6 months |