linjc16/ctgov huggingface dataset:
Register of Patients With Prader-Willi Syndrome

Study Overview
=================
Brief Summary
-----------------
Prader-Willi Syndrome (PWS) is a rare syndrome with a prevalence of 15 to 20 000 at birth. PWS represents a large fraction of mental retardation syndromes due to a genetic cause and the most frequent cause of genetic obesity. The majority of the patients are seen by paediatricians. This syndrome is responsible for severe physical, psychological and social impairments. The diversity and the severity of the manifestations of this disease explain the requirement of multidisciplinary care which deserve specific evaluation. Today the follow-up and management of a great proportion of these patients are greatly insufficient if not absent. Teams strongly lack information on the natural history of this severe disease and on the factors involved in its evolution and the outcome of these patients throughout life. The present project is to implement a register in the whole country for children and adult patients

Official Title
-----------------
Implementation of a National Register of Children and Adults Presenting Prader-Willi Syndrome

Conditions
-----------------
Prader-Willi Syndrome

Intervention / Treatment
-----------------
* Other: Data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all subjects with a Prader-Willi Syndrome Exclusion Criteria: -
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Data collection|This register will follow the evolution of the clinical practices and their consequences in the health of the patients, in all regions of France in order to have a national register. for Children and adults.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| collect data about patients | Circumstances of diagnosis, genetic diagnosis, modalities of follow-up and clinical management and a questionnaire to evaluate quality of life of the family and social data | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| collect data about patients | modalities of follow-up and clinical management and a questionnaire to evaluate quality of life of the family and social data | During 10 years at least |
Utilization Patterns of Pulmicort in Real Life Practice

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify the potential issues during short and mid term utilization of Pulmicort hydro fluoroaklane (HFA) pressurized metered-dose inhaler (pMDI)and describe associated factors.

Official Title
-----------------
Utilization Patterns of Pulmicort HFA in Real Life Practice

Conditions
-----------------
Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Asthmatic patients with a diagnose of at least 12 months of duration before study inclusion Patients previously treated with Pulmicort CFC who have changed their treatment to Pulmicort HFA Exclusion Criteria: Disability that, from investigator point of view, prevent from complying the follow up schedule To have participated in any clinical study in the past 6 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 |
| --- | --- |
| 1<br>Asthmatic patients with a diagnose of at least 12 months of duration before study inclusion, previously treated with Pulmicort chlorofluorocarbons (CFC) who have changed their treatment to Pulmicort HFA | |

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
-----------------
asthma treatment, utilization, real life practice
Systemic Immunomodulatory Effects and Pharmacogenetics of Atorvastatin in Early Atherosclerosis

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to test whether atorvastatin (also known as Lipitor) has anti-inflammatory effects in people with no known heart disease or high cholesterol. We also are investigating whether or not genetic differences between people plays a role in the drug response.

Detailed Description
-----------------
All subjects received 16 weeks of Atorvastatin after a two week run in. Key dependent variables were the 16 week value minus the baseline value (post run-in). Last observation carried forward was used for missing values. The key comparisons are for two groups OATP1B1 reduced carriers and on-carriers and their association with Cytokines and Lipids. Secondarily, we were interested in changes over the 16 weeks for the pooled sample, irrespective of genetics.

Official Title
-----------------
Systemic Immunomodulatory Effects and Pharmacogenetics of Atorvastatin in Early Atherosclerosis

Conditions
-----------------
Inflammation

Intervention / Treatment
-----------------
* Drug: Atorvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18+ years old Normocholesterolemic Exclusion Criteria: Cardiovascular disease or risk equivalents Malignancy Active alcohol abuse Contraindications to statins Interacting drugs Chronic anti-inflammatory drugs

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: atorvastatin<br>80mg of atorvastatin given once daily for 16 weeks | Drug: Atorvastatin<br>* atorvastatin 80mg tablets given by mouth once daily for 16 weeks with follow-up visits every 4 weeks<br>* Other names: Lipitor;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in Level: Week 16-baseline in Ena-78 | We take difference week 16 minus week 0 for ENA-78 and use a one sample t comparison. | 16 weeks after baseline |
Safety and Biologic Activity Study of Gevokizumab to Treat Erosive Osteoarthritis of the Hand

Study Overview
=================
Brief Summary
-----------------
The purpose of this proof-of-concept study is to determine whether gevokizumab is effective in the treatment of active inflammatory, erosive osteoarthritis of the hand.

Official Title
-----------------
A Phase 2 Proof-of-Concept Study of Gevokizumab in Active Inflammatory, Erosive Osteoarthritis of the Hand

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: gevokizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of hand osteoarthritis Joint tenderness and/or redness At least one erosion by X-ray (as determined by the central reader) Contraceptive measures adequate to prevent pregnancy during the study Exclusion Criteria: History of inflammatory disease other than hand EOA including: secondary post-traumatic OA; rheumatoid arthritis; spondylarthropathies; erosion of the ulnar styloid process; psoriatic arthritis; skin psoriasis; erosions of the wrist; fibromyalgia History of gout, pseudogout, or hemochromatosis History of allergic or anaphylactic reactions to monoclonal antibodies History of recurrent or chronic systemic infections Known allergy to acetaminophen Female subjects who are pregnant, planning to become pregnant, have recently delivered, or are breast-feeding Other protocol-defined inclusion/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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Solution for subcutaneous injection<br>|
| Experimental: gevokizumab<br> | Drug: gevokizumab<br>* Solution for subcutaneous injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change from baseline in AUSCAN pain score at Day 84 | The Australian/Canadian (AUSCAN) Osteoarthritis Hand Index is a self-report assessment of pain, stiffness, and function in patients with hand osteoarthritis. | Baseline and Day 84 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Erosive Osteoarthritis, Osteoarthritis, Osteoarthritis of the Hand
Bariederm Cream in Chronic Contact Dermatitis

Study Overview
=================
Brief Summary
-----------------
We intend to evaluate the efficiency and tolerability of a barrier cream (bariederm) in protecting hands of individuals with hand dermatitis, either due to allergy or irritation. We believe that the use of the cream would benefit with the skin.

Detailed Description
-----------------
The aim of the study is the evaluation of the effectiveness, tolerance and cosmetic acceptability of Bariéderm cream among patients presenting with chronic allergic or irritant contact dermatitis of the hands. We shall enrol adults presenting with CONTACT DERMATITIS EXCLUDING FLARE-UPS of the hands: whether allergic or irritant, able to understand the protocol and agrees to sign the information and informed consent form. Bariéderm cream will be applied minimum twice daily over 21 days. Response will be evaluated by self and physician filled questionnaires. effectiveness, tolerance and cosmetic acceptability will be evaluated by a scale of 1-10, 1 meaning not at all and 10 meaning very much. Statistics will be performed by SPSS software with suitable statistical tests. In case of an adverse event caused by the product, patch-test with ingredients of Bariéderm cream will be performed.

Official Title
-----------------
Bariederm Cream in Chronic Contact Dermatitis

Conditions
-----------------
Contact Dermatitis

Intervention / Treatment
-----------------
* Device: bariederm cream


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with dermatitis of the hands Exclusion Criteria: pregnant ladies, known allergy to ingredients -

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bariederm, barrier cream<br>one arm study: use of bariederm cream on hands twice daily for 21 days | Device: bariederm cream<br>* patients are asked to apply twice a day a barrier cream on their hands for 3 weeks only<br>* Other names: use of bariederm cream on hands twice daily for 21 days;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| self evaluation of effectiveness and tolerance in a 1-10 scale | effectiveness tolerance and acceptability in adults with hand dermatitis, evaluated by a self reported and a physician reported questionaires, using a 1-10 scale for evaluation. | 21 days |
A Trial Assessing Changes in Blood Sugar and the Number of Periods Where Supplementation of Carbohydrate is Needed to Treat Low Blood Sugar, During Two Different Treatment Regimens of NN1250 in Type 1 Diabetics

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim is to compare changes in blood sugar and the number of periods where carbohydrate supplementation is needed to treat low blood sugar, during two different treatments with NN1250 (insulin degludec), a soluble insulin basal analogue (SIBA) in subjects with type 1 diabetes.

Official Title
-----------------
A Trial Assessing the Number of Hypoglycaemic Episodes and Glycaemic Variability During Two Different Regimens of SIBA 200 U/ml in Subjects With Type 1 Diabetes

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

Intervention / Treatment
-----------------
* Drug: insulin degludec
* Drug: insulin degludec
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 diabetes mellitus for at least 12 months Glycosylated haemoglobin (HbA1c) between 7.5 and 9% (both inclusive) Exclusion Criteria: Donation or loss of more than 500 ml blood or plasma within three months prior to this trial Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day) or not able or willing to refrain from smoking and the use of nicotine gum or transdermal nicotine patches during the in-house periods Prior or current treatment with metformin or thiazolidinediones

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: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SIBA 3W<br> | Drug: insulin degludec<br>* Insulin degludec injected s.c. (under the skin) three times weekly<br>Drug: placebo<br>* Placebo injected s.c. (under the skin) four times weekly<br>|
| Experimental: SIBA OD<br> | Drug: insulin degludec<br>* Insulin degludec injected s.c. (under the skin) once daily for one week<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of periods where carbohydrate supplementation is needed during the treatment |  | Assessed every day of the two in-house stays of nine days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of adverse events (AEs) |  | Assessed every day of the two in-house stays of nine days and one follow-up by telephone | 
| Number of periods with low blood sugar during treatment |  | Assessed every day of the two in-house stays of nine days and one follow-up by telephone |
Loiasis Cross-reactive Antigenemia and Treatment-related Adverse Events

Study Overview
=================
Brief Summary
-----------------
This study seeks to determine which Loa loa antigens are released into circulation when infected individuals are treated with ivermectin.

Detailed Description
-----------------
A cohort of up to 50 participants with Loa loa microfilarial levels between 5,000 and 18,000 per ml/blood will be treated with ivermectin in an inpatient setting. Participants will be monitored for treatment-related adverse events for seven days post-treatment, and will have blood drawn on days 0, 1, 2, 3, and 7 post-treatment to assess for microfilarial load, cytokine, and antigen levels.

Official Title
-----------------
Loiasis Cross-reactive Antigenemia and Treatment-related Adverse Events

Conditions
-----------------
Loiasis

Intervention / Treatment
-----------------
* Drug: Ivermectin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Loa loa blood microfilariae of between 5,000 - 18,000 per mL Exclusion Criteria: known allergy to ivermectin; severe comorbidities

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ivermectin<br>All eligible participants received a single dose (150 ug/kg) ivermectin by mouth | Drug: Ivermectin<br>* single dose, 150 ug/kg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cross-reactive Antigenemia | N of participants with detectable Loa loa antigens in sera that cross-react with diagnostic tests for lymphatic filariasis (Filariasis Test Strip) on either day 1, 2, 3, or 7 post-treatment | 7 days |
Prospective Quality Register of Patients With Confirmed Covid-19 at Oslo University Hospital

Study Overview
=================
Brief Summary
-----------------
Covid-19 is a recently emerging infectious disease with a very large impact on health care world-wide. The disease is still poorly described. It is an urgent need for better clinical characteristics. A prospective, quality register is therefore established for increasing the knowledge about the disease, the covid patients and the prognosis.

Detailed Description
-----------------
All patient hospitalized at Oslo University Hospital, Ullevål, is prospectively registered in the approved quality register. Background, clinical and paraclinical data is harvested and registered, as well as treatment and mortality.

Official Title
-----------------
Prospective Quality Register of Patients With Confirmed Covid-19 at Oslo University Hospital

Conditions
-----------------
COVID-19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed covid-19 hospitalized Exclusion Criteria: None
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 hospitalized with confirmed Covid-19<br>All patients hospitalized with confirmed Covid-19 | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Mortality in hospitalized covid patients | 3 month | 
| Severe disease | Number of patients with severe disease | 2 weeks |
Course and Complications of Invasive Out-of-hospital Ventilation

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine the frequency and management of respiratory incidence in patients with invasive out-of-hospital ventilation, either living at home for elderly people allay to a weaning centre or at home. Further, the mortality and the frequency of hospital admission will be analyzed.

Detailed Description
-----------------
Background: There has been arise in a number of patients requiring long term ventilation both in the in-hospital as well as the out-of-hospital setting. Despite this, little is known about the subsequent political course of this patients following hospital discharge. Interventions: This is an observational prospective study over a period of one year in a sample of 50 to 70 invasively ventilated patients living either in a nursing home specialized in the care of ventilated patients or at home. Protocol had been developed containing 20 suspected emergency incidences in respiratory care. The nursing staffs are instructed about the study and how to complete the protocol. The protocol was placed at each patient and every time an emergency occurred, the nursing staff registered the incidence. If an emergency fulfils more than one criterion in the protocol, every applicable criterion was marked. The data will be analyzed using non-parametric descriptive statistics.

Official Title
-----------------
Verlauf Und Respiratorische Zwischenfälle Bei Patienten Mit außerklinischer Beatmung

Conditions
-----------------
Indication for Invasive Out-of-hospital Ventilation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >=18 years existing out-of-hospital ventilation >6h in 24h Exclusion Criteria: Age <18 years absence of declaration 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 |
| --- | --- |
| Patients with invasive out-of-hospital ventilation<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory Incidences | Incidences comprise: permanent alarming by the ventilator, malfunction of the ventilator, use of an AMBU bag, dyspnoea, worsening of general condition, desaturation of 5 % or more in relation to average saturation of the patients, disconnection of the ventilator, increase of tracheal secretion, reanimation, replacement of tracheal canula, other emergency, call of emergency doctor, call of pneumologist, unscheduled home visit of the patient by a doctor, use of antibiotics, use ov steroids, use of opiates, changing of the ventilator settings, hospital transfer, death. | Over a 12-month period, monthly |