linjc16/ctgov huggingface dataset:
Estimation of Off-Label Use of XGEVA® (Denosumab) Using Population-Based Databases in Denmark

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate off-label XGEVA use in Denmark using data linked from registries and other sources in Northern Jutland Region and Copenhagen. This will allow for accurate assessment of prescriptions and diagnoses, especially those related to cancer patients during the first year post the initial market availability of XGEVA.

Official Title
-----------------
Estimation of Off-Label Use of XGEVA® (Denosumab) Using Population-Based Databases in Denmark

Conditions
-----------------
XGEVA Off-label Use

Intervention / Treatment
-----------------
* Drug: Database assessment of off-label XGEVA use


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The study will include patients with a prescription for XGEVA® given in secondary care with a minimum of 108 XGEVA users, in the Northern Jutland Region and Copenhagen during the first 1-year post XGEVA market availability, defined as 12 months after RADS opinion on 24th January 2013 or after the minimum sample has been achieved. Exclusion Criteria: n/a

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br> | Drug: Database assessment of off-label XGEVA use<br>* No intervention is planned during this study as it involves analyses of patient electronic records from Northern Jutland Region and Copenhagen<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| on or off label individual prescription type | Yes/no regarding whether an individual prescription was on (or off) label | 12 months | 
| on or off label patient treatment | Yes/no regarding whether the patient was treated on (or off) label | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| type of off-label use | XGEVA prescription for each type of off-label use | 12 months | 
| off-label use stratified by administering department | Prescriptions that are for off-label use stratified by department that administers treatment | 12 months |
Low Dose Aspirin Studied With the AggreGuide

Study Overview
=================
Brief Summary
-----------------
This study is to determine whether the AggreGuide platelet aggregometer can discern the effect of low dose aspirin on subjects platelet aggregation using arachidonic acid as the agonist.

Official Title
-----------------
Low Dose Aspirin Study With the AggreGuide

Conditions
-----------------
Platelet Aggregation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults Exclusion Criteria: aspirin contraindications anticoagulants aspirin past week

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
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
-----------------
platelet, aggregation, aspirin, inhibition, reactivity
Self Reduction of Shoulder Dislocation

Study Overview
=================
Brief Summary
-----------------
Anterior dislocation of the shoulder (glenohumeral joint) is one of the most prevalent dislocations. Following a first dislocation recurrence rates of up to 80% have been reported. Many patients will seek medical assistance for reduction of the shoulder after each of these recurrent dislocations. The investigators describe the results of reduction of anterior glenohumeral dislocation using a modified self manipulated Milch technique that can be performed by the patients themselves after simple guidance and demonstration. This method is directed to patients who are not willing or cannot have surgical stabilization and may be in a place where medical assistance is not available.

Official Title
-----------------
Patients Education of a Self-reduction Technique for Anterior Dislocation of Shoulder

Conditions
-----------------
Anterior Shoulder Dislocation

Intervention / Treatment
-----------------
* Procedure: shoulder dislocation self reduction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: anterior shoulder dislocation acute (24 hours) shoulder dislocation Exclusion Criteria: shoulder fracture non-cooperative patient

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Milch<br>modified Milch technique for self reduction | Procedure: shoulder dislocation self reduction<br>* shoulder dislocation self reduction using one of three methods in the study<br>|
| Experimental: Boss Holtzach<br>Boss Holtzach technique for self reduction | Procedure: shoulder dislocation self reduction<br>* shoulder dislocation self reduction using one of three methods in the study<br>|
| Experimental: Stimson<br>Stimson technique for self reduction | Procedure: shoulder dislocation self reduction<br>* shoulder dislocation self reduction using one of three methods in the study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of successfull self reduction | the number/rate of successful reductions using each technique will be calculated | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain using VAS during reduction | patients will be asked to report pain levels using VAS during the self reduction procedure | 10 minutes | 
| patient satisfaction from self reduction process using VAS | patients will be asked to report their satisfaction from self reduction process using VAS | 10 minutes |
Evaluation of Heart Rate Variability in Third Lower Molars Surgeries

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to use heart rate variability as a monitor of cardiovascular safety during third molar surgeries, using the Polar heart rate-meter.

Official Title
-----------------
Evaluation of Heart Rate Variability in Third Lower Molars Surgeries

Conditions
-----------------
Healthy Patients

Intervention / Treatment
-----------------
* Device: Use the Polar Cardiac rate meter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Patients (ASA I) Need to remove one of Lower Third Molar. Exclusion Criteria: smoking pregnant

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| Screening<br>this first day, the patient will be evaluated with polar and blood pressure monitor. These data will be the basal one. | Device: Use the Polar Cardiac rate meter<br> <br> |
| Intervation<br>One week later the screening, the patient underwent to the surgery to remove his lower third molar. In this day, will be analyzed 4 points: basal, after the anesthesia, after the avulsion and 20 minutes after the surgery. | Device: Use the Polar Cardiac rate meter<br> <br> |
| Post operative<br>One week later the surgery, the patients will be evaluated again. | Device: Use the Polar Cardiac rate meter<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of cardiac safety during third molar surgeries |  | 3 weekes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| study of heart rate variability during third molars surgeries with the Polar Cardiac Rate-meter. |  | 3 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ASA I patients
Trends in Breastfeeding Disparity in U.S. Infants by WIC Eligibility and Participation

Study Overview
=================
Brief Summary
-----------------
This is a secondary data analysis study that uses nationally representative data to examine the trends in breastfeeding disparities between Women, Infants, and Children (WIC) program eligible children vs. non-eligible children and eligible participants vs. eligible non-participants.

Official Title
-----------------
Trends in Breastfeeding Disparity in U.S. Infants by WIC Eligibility and Participation: Evidence From NHANES 1999-2014

Conditions
-----------------
Breast Feeding

Intervention / Treatment
-----------------
* Other: WIC program participation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: infants or children surveyed in NHANES 1999-2014 aged younger than 72 months Exclusion Criteria: infants or children with missing information in breastfeeding, WIC participation, or other major socio-demographics, such as income

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 72 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 |
| --- | --- |
| birth cohorts<br>born in 1994-1997, 1998-2001, 2002-2005, 2006-2009, 2010-2014 | Other: WIC program participation<br>* WIC program is a welfare program in the U.S. to provide nutritional supplements to low-income women, infants, and children.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Everbreastfeeding | whether the child has ever been breastfed | till age 5 | 
| Breastfeeding at 6 months | whether the child was breastfed at age 6 months | till age 6 months |
Strep A Fluorescent Immunoassay and Analyzer Field Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate the ability of the Strep A Fluorescent Immunoassay Analyzer to accurately detect a throat swab specimen for the presence or absence of Strep A when compared to culture.

Official Title
-----------------
Strep A Fluorescent Immunoassay and Analyzer Field Study

Conditions
-----------------
Strep Throat

Intervention / Treatment
-----------------
* Device: In Vitro Diagnostic Device aid in diagnosing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female subjects three (3) years of age or older Must currently be exhibiting one or more of the following symptoms characteristic of pharyngitis Extreme sore throat Redness of the posterior pharyngeal wall Difficulty Swallowing Fever, >38.7C (100F) at presentation or within past 24 hours Pharyngeal exudate Tender cervical lymphadenopathy Absence of cough or other upper respiratory symptoms Exclusion Criteria: Subjects currently under treatment with antibiotics are not to be included in this study. At clinical sites requiring informed consent, unable to understand and consent to participation; for minors this includes parent or legal guardian.

Ages Eligible for Study
-----------------
Minimum Age: 3 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: In Vitro Diagnostic Device aid in diagnosing|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Streptococcus Group B identification | The purpose of this study was to identify via immunofluorescence technology, Group A Streptococcus, which was successfully done. | Immediate |
Influence of PARAmedical Interventions on Patient ACTivation in the Cancer Care Pathway

Study Overview
=================
Brief Summary
-----------------
The aim is to implement the Patient Activation Measure in paramedical practices as a tool to measure activation of patients in cancer care

Official Title
-----------------
Influence of PARAmedical Interventions on Patient ACTivation in the Cancer Care Pathway

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

Intervention / Treatment
-----------------
* Behavioral: Patient Activation Measure Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age over 18 years Cancer patient with an estimated life expectancy of at least one year Patient requiring immunotherapy or intravenous chemotherapy for any cancer according to the decision of the Multidisciplinary Consultation Meeting Patient affiliated or entitled to a social security scheme Exclusion Criteria: Refusal to participate, protected adult patient under guardianship. Patient disability to understand the course of the study Patient with documented history of cognitive or psychiatric disorders. Patient not understanding French

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: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient Activation Measure (PAM)<br>completion of the PAM questionnaire | Behavioral: Patient Activation Measure Questionnaire<br>* Measure the level of patient engagement in cancer care pathway<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Activation Measure Questionnaire |  | 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Activation Measure Questionnaire |  | 6 and 12 months | 
| Visual Analog Scale for confidence level measurement about treatment |  | 6 and 12 months | 
| Anxiety and Depression HAD Questionnaire |  | 6 and 12 months | 
| REALM Health Literacy Test |  | 6 and 12 months | 
| Quality of Life Questionnaire EQ-5D |  | 6 and 12 months |
Hope Theory as Ability Determinant to Permanently Change the Adapted Physical Activity (APA) in Type 2 Diabetic Patients

Study Overview
=================
Brief Summary
-----------------
The control of diabetes is related both to food, treatment but also to physical activity. Despite these recommendations and these positive findings, patients are always sedentary because of brakes in the practice of a regular physical activity. It is therefore interesting to consider the representations of patients and particularly on the way of establishment in order to reach a goal. The Hope Theory highlights the hope as the sum of the will and means that an individual has to achieve its goals. Will be discussed in this study to identify a relationship between the level of hope for patients and their ability to permanently change their behavior in regular physical activity as part of the goals set during the week of therapeutic education patient.

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Behavioral: Hope theory


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Major Topic Type 2 Diabetic Topic Inactive Topic Subject of CHU ANGERS hospitalized for a week Diab'Equilibre, Diabetology Service Subject participating in the service of the APA program Subject who understands and reads French Subject has given its consent to participate signed the protocol Exclusion Criteria: Removing the participation of consent; Severe heart failure Severe respiratory failure Bone metastases

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: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hope theory<br> | Behavioral: Hope theory<br>* Adapted Physical Activity<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IPAQ-SF questionnaire for measure of Physical Activity |  | 6 month |
High Tibial Osteotomy (HTO) With or Without Arthroscopy of the Knee Joint

Study Overview
=================
Brief Summary
-----------------
Participants will be randomized to undergo a High Tibial Osteotomy (HTO) with or without a knee scope. Patients will be tested in the Gait Lab, will fill out quality-of-life questionnaires, and have a clinical evaluation done preoperative and at each follow-up visit.

Official Title
-----------------
A Randomized Clinical Trial to Compare the Effectiveness of High Tibial Osteotomy (HTO) With or Without Arthroscopy of the Knee Joint on Quality of Life, Function, Pain and Swelling for Patients With Medical Compartment Osteoarthritis of the Knee

Conditions
-----------------
Medial Compartment Osteoarthritis of the Knee

Intervention / Treatment
-----------------
* Procedure: knee Arthroscopy
* Other: No arthroscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients booked for an HTO due to OA Grades II to IV severity of OA by radiographic evaluation (Kellgren & Lawrence grade) OA of the knee primarily involving the medial compartment Exclusion Criteria: Imaging evidence of significant knee joint pathology that would change the decision to do an HTO An arthroscopy of the knee within 2 years of planned surgery Active joint or systemic infection, Major medical illness that would preclude undergoing surgery, Patients who are unwilling or unable to be assessed according to study protocol for two years following surgery Major psychiatric illness, developmental handicap or inability to read and understand the English language

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 |
| --- | --- |
| Active Comparator: Knee Arthroscopy + HTO<br> | Procedure: knee Arthroscopy<br>* Patient undergoes a knee arthroscopy and HTO<br>|
| Active Comparator: HTO Alone<br> | Other: No arthroscopy<br>* Patient undergoes an HTO without knee arthroscopy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WOMAC |  | Preoperatively; 3, 6, 12, 18 and 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Lower Extremity Functional Scale (LEFS) |  | Preoperatively; 3, 6, 12, 18 and 24 months | 
| Patient Diary to asses swelling, pain and frequency of analgesic and NSAID use. |  | Daily x 2 weeks post surgery; Weekly x 3 months | 
| SF-12 |  | Preoperatively; 3, 6, 12, 18 and 24 months | 
| Gait Testing Procedures |  | 6, 12 and 24 months post-operatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HTO, Arthroscopy, Quality-of-Life, Gait Analysis
Study of Safety and Efficacy of an Oral Contraceptive

Study Overview
=================
Brief Summary
-----------------
This is a non-comparative study. the primary objective of the study is to assess the efficacy of a low dose oral contraceptive in the prevention of pregnancy. The secondary objectives are to assess the incidence of intracyclic bleeding; and to assess the safety and tolerability of the product.

Official Title
-----------------
An Open Label Study of the Contraceptive Efficacy of Norethindrone and Ethinyl Estradiol.

Conditions
-----------------
Contraception

Intervention / Treatment
-----------------
* Drug: Norethindrone/ethinyl estradiol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Women Age 18-45 At risk for pregnancy History of regular cycles Exclusion Criteria: Contraindications for use of hormonal contraception Conditions which affect the absorption or metabolism of steroid hormones BMI>35

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Norethindrone/ethinyl estradiol<br>1 tablet per day | Drug: Norethindrone/ethinyl estradiol<br>* 1 tablet per day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pearl Index, 18-35 Years, MITT Population | Pregnancy rate in women 18-35 years old, Pearl Index - number of pregnancies per 100 women-years of treatment | 13 cycles (28 days each), approximately 364 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Number of Days of Intracyclic Bleeding & Spotting, Cycles 2-13, MITT Population |  | 12 cycles (28 days each), approximately 336 days | 
| Mean Median Duration (Days) of Intracyclic Bleeding & Spotting, Cycles 2-13, MITT Population | Each IB episode has a unique duration, with 0, 1, 2, 3 or more episodes per cycle. To obtain mean median duration of episodes during a cycle, take the median duration of all episodes in each cycle. If there are no episodes in the cycle, then median duration is undefined/missing for that cycle. 1 episode - median duration = duration of that episode, 2 episodes - median duration = average of 2 durations, more than 2 episodes, calculated in usual way for median of an ordered set of numbers. Once median determined for each cycle/subject, the mean & SD of those quantities calculated. | 12 cycles (28 days each), approximately 336 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Contraception