linjc16/ctgov huggingface dataset:
Survey of Postoperative Pain and Pain Management in Norwegian Hospitals

Study Overview
=================
Brief Summary
-----------------
The study is a national survey of pain and pain management to surgical patients in Norwegian Hospitals. Data on pain management are gathered from patient records and data on pain and patient satisfaction are gathered as patients' self report.

Official Title
-----------------
Survey of Postoperative Pain and Pain Management in Norwegian Hospitals

Conditions
-----------------
Pain, Postoperative

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Surgery previous day Exclusion Criteria: Declined participation Unable to communicate (delirious, sedated, intubated) Does not read and speak Norwegian Patient not available (for instance having physiotherapy og examinations during data collection)

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 |
| --- | --- |
| Surgical patients<br>PAtients who had surgery the previous day and are still hospitalized | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain | Proportion of patients who report average pain intensity >3 on 11 point pain Numerical Rating scale for the first 24 hours after surgery | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Administered analgesic therapy
Study Evaluating Gefitinib (IRESSA®) in Subjects With Solid Malignancies That Are Locally Advanced, Recurrent or Metastatic

Study Overview
=================
Brief Summary
-----------------
This study will determine the safety profile and maximum tolerated dose (MTD) of orally administered gefitinib on a weekly and twice weekly schedule.

Official Title
-----------------
A Phase I, Open-Label, Dose Escalation Study Evaluating High-Dose Gefitinib (IRESSA®) on Weekly and Twice Weekly Schedules in Subjects With Solid Malignancies That Are Locally Advanced, Recurrent or Metastatic

Conditions
-----------------
Tumors

Intervention / Treatment
-----------------
* Drug: Gefitinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed solid tumor refractory to conventional treatment or whom no standard of treatment exists Life expectancy of > 12 weeks World Health Organization (WHO) performance status of < 2 Exclusion Criteria: Known severe hypersensitivity to gefitinib or any of the excipients of this product Less than 4 weeks since completion of prior chemotherapy or radiation therapy (except nitrosoureas or mitomycin-C which must have a wash out period of 6 weeks) Incomplete healing from previous oncologic or other major surgery

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Gefitinib (IRESSA®) | Drug: Gefitinib<br>* Oral tablet<br>* Other names: IRESSA®;|

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
-----------------
Solid Tumors
Daptomycin for the Treatment of Infections Due to Gram-Positive Bacteria

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to provide daptomycin, an antibiotic, to patients who are failing conventional therapy, or who cannot take approved antibiotics for one reason or another.

Official Title
-----------------
A Compassionate Use Protocol for Intravenous Daptomycin for the Treatment of Infections Due to Gram-Positive Bacteria That Cannot be Adequately Treated With Currently Available Therapy

Conditions
-----------------
Gram-Positive Bacterial Infections

Intervention / Treatment
-----------------
* Drug: daptomycin


Participation Criteria
=================
Eligibility Criteria
-----------------
Main Inclusion Criteria: Infection caused by Staphylococcus aureus, Staphylococcus epidermidis, Enterococcus faecalis, or Enterococcus faecium that requires inpatient hospitalization and treatment with injectable antibiotics** Site of infection: complicated skin and skin structure infection; urinary tract infection; intra-abdominal infection; infective endocarditis; or bloodstream infection (including catheter-related). Pathogen resistant to, or patient intolerant of: beta-lactams, vancomycin, quinupristin/dalfopristin, or linezolid. Unable to receive any other standard commercially available antibacterial therapy for the infection. Main Exclusion Criteria: Creatinine clearance less than 40 mL/min** Hemodialysis or peritoneal dialysis Admitted to the hospital for drug overdose or other conditions associated with rhabdomyolysis, or is expected to require repeated intramuscular injections Creatine phosphokinase (CPK) level greater than 2.5 times above the upper limit of normal (ULN) at screening; if the elevation in CPK can be attributed to an obvious cause (eg, surgery)** Central nervous system infection Pulmonary infection. (**) An exemption may be granted for patients not satisfying these criteria following a conversation with the Medical Monitor.

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
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: daptomycin|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
-----------------
Gram positive bacterial infections, expanded access program, resistant infections, bacteremia, Bacterial and fungal infections, bacterial infections
Skin Tests in Cat Allergic Patients With Cat Dander Samples Obtained Before and After Vaccinating the Cat

Study Overview
=================
Brief Summary
-----------------
Determination of allergenicity of cat dander samples obtained before and after vaccinating the cat

Official Title
-----------------
Evaluation of Skin Prick Tests in Cat Allergic Patients With Cat Dander Samples Obtained Before and After Vaccinating the Cat

Conditions
-----------------
Hypersensitivity

Intervention / Treatment
-----------------
* Other: Diagnostic skin testing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed Consent as documented by signature (Appendix Informed Consent Form) Male or female between 18 years to 65 years Confirmed cat allergy (positive skin prick test) Exclusion Criteria: Diseases or medications, influencing the skin tests or impairing the correct conduct and evaluation of the study History of anaphylactic reaction Pregnancy Skin irritations in test area Participation in another clinical trial within the last 30 days and during the present study

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Diagnostic skin testing<br>Diagnostic skin testing with cat dander samples on volar forearms. | Other: Diagnostic skin testing<br>* 14 Skin prick tests on each volar forearm with cat dander samples.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wheal size of allergic skin reaction in mm² measured 15 minutes after application of test substance | The primary variable will be the wheal size area of the immediate phase reaction in mm² measured after 15 minutes. Determination of the concentration threshold at which no more skin reactivity can be observed. | 15 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cat, allergy, dander, Fel d 1, Felis domesticus
Efficacy and Safety Study of GX-I7 Plus Adjuvant Temozolomide Combination in Patients With Newly Diagnosed Glioblastoma

Study Overview
=================
Brief Summary
-----------------
This is a phase 1/2, randomized, placebo-controlled study to evaluate safety, tolerability, anti-tumor activity and impact on absolute lymphocyte count of GX-I7 plus adjuvant temozolomide combination regimen in patients with newly diagnosed with glioblastoma who completed standard concurrent chemo-radiation therapy (CCRT)

Detailed Description
-----------------
In dose escalation stage (Phase 1 part), low/intermediate/high dose of GX-I7 will be administered in combination with adjuvant temozolomide to find recommended phase 2 dose. Phase 2 part will be randomized, placebo controlled study and GX-I7 or Placebo will be administered in combination with adjuvant temozolomide treatment.

Official Title
-----------------
A Phase 1/2, Randomized, Placebo-controlled Study to Evaluate Safety, Tolerability, Anti-tumor Activity of GX-I7 Plus Adjuvant Temozolomide Combination Regimen in Patients With Newly Diagnosed With Glioblastoma

Conditions
-----------------
Newly Diagnosed Glioblastoma

Intervention / Treatment
-----------------
* Biological: GX-I7
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed Informed Consent Form (ICF) Age ≥ 19 years Gross total resection equal to or greater than 80% based on post-op MRI, compared to pre-op MRI (Patients requiring biopsy only is not eligible) Patients newly diagnosed with glioblastoma either by imaging or pathology testing, requiring concurrent chemo-radiotherapy (CCRT) and adjuvant temozolomide chemotherapy with curative intent Karnofsky score ≥ 60 Life expectancy > 12 weeks Exclusion Criteria: Gliomatosis cerebri Isocitrate dehydrogenase 1 & 2 mutation Pregnant or breast feeding women

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Phase 1: sequential dose escalation Phase 2: randomized, placebo controlled, parallel arm
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GX-I7<br>GX-I7 administered until Progression of Disease | Biological: GX-I7<br>* Investigational drug<br>|
| Placebo Comparator: Placebo<br>Placebo administered until Progression of Disease | Other: Placebo<br>* Placebo drug<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lymphocyte count | Change in absolute lymphocyte count | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Median overall survival | 36 months | 
| Progression free survival | Median progression free survival | 24 months |
Catestatin and Hypertension in Pregnancy

Study Overview
=================
Brief Summary
-----------------
Catestatin is a kind of protein involved with cardiovascular disease. Accumulated evidence shows that Catestatin may be a predictor of primary hypertension, but whether it plays the same role in pregnant hypertensive disorders needs to be determined. By measuring the plasma level of Catestatin, main biochemical marks and UCG in healthy pregnancy and pregnancy with hypertension, the research may contribute to this problem.

Official Title
-----------------
Relationship Between Catestatin and Pregnant Hypertensive Disorders

Conditions
-----------------
Pre-Eclampsia, Eclampsia, Hypertension, Pregnancy-Induced, Hypertension in Pregnancy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy pregnancy women Pregnancy women with hypertension Despite the pregnant gestational age , systolic blood pressure ≥140 mm Hg OR a diastolic blood pressure of ≥90 mm Hg measured three times more than 24 hours apart Pregnant gestational age > 20 weeks, systolic blood pressure ≥140 mm Hg OR a diastolic blood pressure of ≥90 mm Hg measured twice more than 4 hours apart Exclusion Criteria: Lack of blood sample at the specified enrollment period Women who refuse the study Other illness which needs medications interfering with blood pressure (eg: Asthma requiring systemic steroids) Known coronary artery disease or heart failure Serious medical illness (eg: renal insufficiency, congestive heart disease, chronic respiratory insufficiency, uncontrolled infection). multiple endocrine neoplasia or Cushing's syndrome or mixed tumours or pheochromocytoma or medullary thyroid carcinoma. previous history of malignant tumour, with the exception of carcinoma in situ of the uterine cervix or non-melanoma skin cancer renal insufficiency
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hpertension<br> | |
| Health<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma level of Catestatin | plasma level of Catestatin with the unit mmol/l | once at the specified enrollment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood pressure | systolic and diastolic blood pressure with the unit mmHg | the specified enrollment period,42 days and 2 months after the pregnancy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension, Pregnancy, Catestatin
Clinical Effectiveness of Osteopathic Manipulative Treatment in Chronic Migraine

Study Overview
=================
Brief Summary
-----------------
The aim of the present study is to determine the extend to which OMT is effective on a sample of subjects affected by migraine evaluated using the headache impact test (HIT-6) questionnaire.

Official Title
-----------------
Clinical Effectiveness of Osteopathic Manipulative Treatment Versus Sham Therapy and Usual Care in Chronic Migraine: 3 Armed RCT

Conditions
-----------------
Migraine

Intervention / Treatment
-----------------
* Other: osteopathic manipulative treatment
* Other: sham treatment
* Drug: triptans


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged between 18 and 60 years old chronic migraine Exclusion Criteria: secondary forms of headache, chronic illness, psychiatric illness, post-menopausal women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: sham therapy<br>subtracting serial sevel (McPartland 2003) | Other: sham treatment<br>* Sham therapy was administered with subjects lying supine on the treatment table while the operator used light manual contact to treat the subject. The practitioner's attention was distracted by subtracting serial seven calculation in silence<br>* Other names: sham;Drug: triptans<br>* administration of triptans drug treatment according to international guidelines<br>|
| Other: usual care<br>triptans treatment only | Drug: triptans<br>* administration of triptans drug treatment according to international guidelines<br>|
| Experimental: OMT<br>8 sessions of osteopathic manipulative treatment | Other: osteopathic manipulative treatment<br>* It consists of 8 sessions in 6 months. Each osteopathic session is based on a structural evaluation and an indirect technique treatment.<br>* Other names: OMT;Drug: triptans<br>* administration of triptans drug treatment according to international guidelines<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| difference in HIT-6 score |  | at entry and after 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of migraine attacks |  | 26 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
osteopathic manipulative treatment, migraine
Physiological Response to Prone Position in COVID-19 Associated Acute Respiratory Distress Syndrome (ARDS)

Study Overview
=================
Brief Summary
-----------------
Retrospective study in COVID-19 ARDS patients hospitalised in the ICU. Investigators aim to explore the effects of prone positioning on oxygenation, dead space ventilation and mortality.

Official Title
-----------------
Physiological Response to Prone Position in Intubated Adults With COVID-19 Associated Acute Respiratory Distress Syndrome (ARDS): a Retrospective Study

Conditions
-----------------
ARDS, Sars-CoV-2 Infection

Intervention / Treatment
-----------------
* Procedure: Prone positioning


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COVID-19 associated moderate to severe ARDS Invasive mechanical ventilation Prone positioning admitted to ICU Exclusion Criteria: already sustained prone positioning in referring hospital pronation during ECMO only denied consent for data analysis

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Prone positioning|Prone position during invasive mechanical ventilation|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PaO2/FiO2 | Arterial partial pressure of oxygen / Fraction of inspired oxygen | Within 2 hours before pronation and 2 hours before supination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alveolo-arterial oxygen gradient change |  | Within 2 hours before pronation and 2 hours before supination | 
| Ventilatory Ratio |  | Within 2 hours before pronation and 2 hours before supination | 
| Mortality or Extracorporeal membrane oxygenation (ECMO) support |  | Once between ICU admission and extubation |
A Trial Investigating NN1218 in Subjects With Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this trial is to investigate the absorption and effect in the body of NN1218 in subjects with type 1 diabetes.

Official Title
-----------------
A Trial Investigating the Pharmacokinetic Properties of NN1218 in Subjects With Type 1 Diabetes

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

Intervention / Treatment
-----------------
* Drug: NN1218
* Drug: insulin aspart
* Drug: NN1218
* Drug: NN1218
* Drug: NN1218
* Drug: NN1218


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 diabetes mellitus for more than 12 months Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for more than 12 months Body mass index (BMI) between 18.0-28.0 kg/m2 (both inclusive) Exclusion Criteria: Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to trial start Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day) Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period

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: NN1218, formulation A<br> | Drug: NN1218<br>* 0.2 U/kg body weight injected subcutaneously (under the skin)<br>|
| Experimental: NN1218, formulation B<br> | Drug: NN1218<br>* 0.2 U/kg body weight injected subcutaneously (under the skin)<br>|
| Experimental: NN1218, formulation B (high)<br> | Drug: NN1218<br>* 0.4 U/kg body weight injected subcutaneously (under the skin)<br>|
| Experimental: NN1218, formulation C<br> | Drug: NN1218<br>* 0.2 U/kg body weight injected subcutaneously (under the skin)<br>|
| Experimental: NN1218, formulation D<br> | Drug: NN1218<br>* 0.2 U/kg body weight injected subcutaneously (under the skin)<br>|
| Active Comparator: insulin aspart<br> | Drug: insulin aspart<br>* 0.2 U/kg body weight injected subcutaneously (under the skin)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the serum NN1218 concentration-time curve |  | From 0-1 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the serum NN1218 concentration-time curve |  | From 0-10 hours |