linjc16/ctgov huggingface dataset:
Quality of the Detection & Treatment of Osteoporotic Fractures in a Swiss Trauma Center

Study Overview
=================
Brief Summary
-----------------
As a tertiary hospital the Traumatology department at the Kantonsspital Aarau looks after about 500 fracture patients hospitalized with an age over 50 years a year. First, we were interested in the effective rate of osteoporotic fractures in this cohort. As to this objective we offered subsequent diagnostics in suspected patients. 2012 we introduced a diagnostic pathway for every patient over 50 years of age with a fracture, including dual energy x-ray absorptiometry (DXA), a questionnaire about risk factors concerning osteoporosis and risk of fracture, the WHO Fracture Risk Assessment Tool (FRAX) and a laboratory workup focusing on this topic. Considering all these information we sent a detailed therapy-plan to the responsible General practitioner. The main goal of this study is to verify the persistence and compliance of the osteoporosis therapy 12-15 months after fracture and to clarify any obstacles potentially impeding therapy (prejudice, adverse events, contraindication overlooked, financial problems etc.). The investigators use a postal questionnaire provided to the patient and the general practitioner. Data collection is undertaken by a study nurse, in addition phoning for missing data by phone-call. With the aim to ameliorate the implementation of treatment, patients and general practitioners will be provided with the specifically tailored information found to be missing.

Official Title
-----------------
Osteoporotic Fractures in a Swiss Trauma Center - Observational Study to Improve the Diagnosis and Management of and the Persistence to Therapy.

Conditions
-----------------
Osteoporosis, Postmenopausal, Osteoporosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: age over 50 years any peripheral fracture, which led to hospitalisation in Kantonsspital Aarau, traumatology department Exclusion Criteria: no informed consent age under 50 years not treated by traumatology department

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Persistence and compliance with treatment for osteoporosis | percentage of persons receiving prescription vs. following completely / partially treatment advice both, according to self declaration vs. general practitioner information collection of arguments if therapy was not undertaken | 12-15 month after initial fracture | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoporotic fracture, treatment for osteoporosis, adherence and compliance
The Basophil Activation Test as a Diagnostic Tool in Pediatric Food Allergy

Study Overview
=================
Brief Summary
-----------------
Background: The need for an oral food challenge (OFC) surrogate is growing in line with the continuous increase in the prevalence and severity of paediatric food allergy. The basophil activation test (BAT) has recently been reported as a promising tool for predicting the outcome of OFC in children. Objective: We make the hypothesis that BAT might improve the sensitivity of food allergy diagnosis and spare part of current OFC in paediatric patients attending allergy departments in Marseille APHM University hospitals. Methods: BAT will be performed in parallel with OFC in 100 paediatric patients receiving OFC during a diagnostic or follow-up procedure. Expected results: Good concordance of BAT and OFC results leading to potential OFC replacement by BAT in at least 50% of the study population

Official Title
-----------------
Evaluation of Technical and Predictive Value of the Basophil Activation Test for Food Allergy Diagnosis in Children

Conditions
-----------------
FOOD ALLERGY

Intervention / Treatment
-----------------
* Diagnostic Test: The basophil activation test (BAT)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 0 - 18 years Attending La Timone Paediatric Hospital for OFC Social insurance Parents and if possible child have received information and signed the consent form Exclusion Criteria: Patients not receiving an OFC Lack of social insurance Inability to understand the study information Unwilling to participate

Ages Eligible for Study
-----------------
Maximum Age: 18 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: Children receiving OFC during a diagnost<br>paediatric patients attending food allergy | Diagnostic Test: The basophil activation test (BAT)<br>* Single sample: 5 mL of venous blood<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BAT positive and negative predictive values as compared with OFC | BAT versus OFC | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BAT quantitative results as compared with the minimal reacting dose for OFC | BAT versus OFC | 2 years |
Use of Quetiapine as an Add on Therapy in the Treatment of Post Traumatic Stress Disorder

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate how effective quetiapine versus placebo is when added to an existing therapy, in reducing the symptoms of PTSD.

Official Title
-----------------
A Multicentre, Parallel Group, Randomised, Double Blind, Placebo Controlled Study of the Use of Quetiapine as an Add on Therapy in the Treatment of Post Traumatic Stress Disorder

Conditions
-----------------
Post-Traumatic Stress Disorder

Intervention / Treatment
-----------------
* Drug: Quetiapine Fumarate
* Drug: quetiapine fumarate placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospitalised and non-hospitalised patients / Veteran or Civilian / Have had symptoms of PTSD for a minimum of 12 months prior to giving consent to the study Exclusion Criteria: History of psychotic condition / quetiapine or other anti-psychotics not worked previously / Taking prohibited medications (mood stabilizers / substance abuse)

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Placebo Seroquel + existing therapy | Drug: quetiapine fumarate placebo<br>* oral 0 mg<br>|
| Experimental: 2<br>Seroquel + existing therapy | Drug: Quetiapine Fumarate<br>* oral flexible dose<br>* Other names: Seroquel;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Administered PTSD Scale (CAPS2) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Depression Scale (HAM-D) |  |  | 
| Hamilton Anxiety Scale (HAM-A) |  |  | 
| Posttraumatic Stress Disorder Checklist (PCL) |  |  | 
| Clinical Global Impressions (CGI) |  |  |
Treatment of PCNSL With R-IDARAM and Intrathecal Immunochemotherapy

Study Overview
=================
Brief Summary
-----------------
This study suggests that R-IDARAM combined with intrathecal immunochemotherapy may be high effective in primary central nervous system lymphoma (PCNSL) patients.

Detailed Description
-----------------
The investigators will evaluate response rate, progression free survival (PFS), overall survival (OS), and toxicity in primary central nervous system lymphoma (PCNSL) after systemic and intrathecal immunochemotherapy with deferred radiotherapy.

Official Title
-----------------
Treatment of Primary CNS Lymphoma With Systemic R-IDARAM Chemotherapy and Intrathecal Immunochemotherapy

Conditions
-----------------
Primary Central Nervous System Lymphoma

Intervention / Treatment
-----------------
* Drug: R-IDARAM plus intrathecal chemotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Newly diagnosed histologically proven non-Hodgkin's lymphoma (NHL). Exclusion criteria: Involved sites other than the brain, meninges, CSF, or the eyes. Age less than 18 years or greater than 75 years. Inadequate bone marrow capacity (defined as neutrophils<1.5 ×10^9/L, platelets <100 ×10^9/L, and hemoglobin level< 8 g/dL). Known cause of immunosuppression (ie, HIV type I infection). Any previous malignancy. Creatinine clearance below 60 mL/min. Heart insufficiency (NYHA IIIB or IV). Uncontrolled infection. Noncompensated active pulmonary or liver disease. Previously treated for PCNSL, except by corticosteroids.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: R-IDARAM plus intrathecal chemotherapy<br>Patients will be treated with systemic R-IDARAM plus intrathecal immunochemotherapy | Drug: R-IDARAM plus intrathecal chemotherapy<br>* R-IDARAM comprised of rituximab 375 mg/m2 (day 1), idarubicin 10 mg/m2(day 2 and 3); dexamethasone 100 mg/m2 (12 h.infusion in day 2, 3 and 4); cytarabine 1 g/m2 (1 h. infusion in day 2 and 3); methotrexate 2 g/m2 (6 h. infusion in day 4 with folinic acid rescue). Intrathecal Immunochemotherapy comprised of rituximab 10mg, MTX 15mg, dexamethasone 5mg and Ara-c 50mg once a week.<br>* Other names: R-IDARAM plus intrathecal immuochemotherapy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | 3 year Overall survival | 3 year Overall survival |
A Prospective Assessment of Loss of Grip Strength by Baseline BMI in Breast Cancer Patients Receiving Adjuvant Aromatase Inhibitors and Tamoxifen

Study Overview
=================
Brief Summary
-----------------
The Logribmet study is a prospective study that evaluate grip strength changes in both hands of postmenopausal women with breast cancer receiving treatment with tamoxifen or an aromatase inhibitor. Patients included in the study will undergo a grip strength measurement and receive a rheumatological questionnaire prior to the start of treatment, then at 3 and 6 months and at year 1 into therapy. Furthermore, BMI will be measured to assess if BMI is a predictor for the decrease in grip strength. IGF-I, GH and IGFBP-3 serum levels will also be measured at all time points.

Official Title
-----------------
A Prospective Assessment of Loss of Grip Strength by Baseline BMI in Breast Cancer Patients Receiving Adjuvant Third-generation Aromatase Inhibitors and Tamoxifen

Conditions
-----------------
Breast Cancer, Arthralgia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with early breast cancer who are scheduled to receive endocrine therapy with tamoxifen or any of the third-generation aromatase inhibitors, anastrozole, letrozole or exemestane. No major rheumatological disorders such as severe rheumatoid arthritis. Patients must have provided informed consent for participation in this study. Exclusion Criteria: Concomitant endocrine therapy for breast cancer. Concomitant intake of sex hormone containing drugs such as hormone replacement therapy.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| tamoxifen<br>100 postmenopausal women with early breast cancer treated with tamoxifen in the adjuvant setting | |
| aromatase inhibitors<br>200 postmenopausal women with early breast cancer treated with an aromatase inhibitor in the adjuvant setting | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the effect of BMI on loss of grip strength measured by a modified sphygmomanometer with baseline, month 3, month 6 and month 12 measurements. | measurements occur at baseline, 3 months, 6 months and 12 months | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IGF-I, GH and IGFBP-3 levels | Serum levels of IGF-I, GH and IGFBP-3 will be measured at baseline, 3, 6 and 12 months after start of treatment. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast cancer, postmenopausal, aromatase inhibitors, tamoxifen, arthralgia, IGF-I, BMI, grip strength
Prospective Cohort With Hemopathy in Languedoc-Roussillon

Study Overview
=================
Brief Summary
-----------------
Prospective Cohort Study of clinical and laboratory data of patients with hemopathy.

Detailed Description
-----------------
Prospective Cohort Study of clinical and laboratory data of patients with hemopathy in LR.

Official Title
-----------------
Prospective Cohort Study of Clinical and Laboratory Data of Patients With Hemopathy in Languedoc-Roussillon

Conditions
-----------------
Hematologic Malignancy

Intervention / Treatment
-----------------
* Biological: hematologic malignancy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Age over 18 Consultant or hospitalized patient for suspected malignant hemopathy and justifying further exploration or patient with a diagnosis of malignant hemopathy less than 6 months old at the time of signing the consent Having signed an informed consent Affiliated with a social security scheme Exclusion criteria: Minor or major protected Patients who have received treatment for hematological pathology

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 |
| --- | --- |
| hematologic malignancy<br>hematologic malignancy with a sampling of blood | Biological: hematologic malignancy<br>* hematologic malignancy with a sampling of blood<br>* Other names: hematologic malignancy with a sampling of blood;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival with 2 years | Prospective Cohort Study of clinical and biological data Analysis Biological, clinical and questionnaire EORTC_QLQ-C30 | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival with 5 years | Prospective Cohort Study of clinical and biological data Analysis Biological, clinical and questionnaire EORTC_QLQ-C30 | 5 years | 
| Survival with 10 years | Prospective Cohort Study of clinical and biological data Analysis Biological, clinical and questionnaire EORTC_QLQ-C30 | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lymphoma,, leukemia,, multiple myeloma,, hodgkin disease
Treatment With Atomoxetine Hydrochloride in Children and Adolescents With ADHD

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the efficacy and safety of atomoxetine administered once daily in the treatment of children and adolescents with ADHD and comorbid dyslexia.

Official Title
-----------------
Open-Label Treatment With Atomoxetine Hydrochloride in Child and Adolescents With Attention-Deficit/Hyperactivity Disorder and Comorbid Dyslexia

Conditions
-----------------
Attention-Deficit/Hyperactivity Disorder, Comorbid Dyslexia

Intervention / Treatment
-----------------
* Drug: Atomoxetine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with ADHD only or ADHD and Dyslexia At least 10 years old and no more than 16 years old IQ score of 80 or more Must be able to swallow capsules Exclusion Criteria: Have received treatment within last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry Weigh less than 25 kg or greater than 70 kg Pregnant or breast feeding Documented history of bipolar I or II disorder, or psychosis Documented history of autism, Asperger's syndrome or pervasive developmental disorder

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 16 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Atomoxetine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the effect of atomoxetine,given for approximately 16 weeks, in the treatment of ADHD with Dyslexia as measured by the ADHDRS-IV-Parent:Inv |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the effect of atomoxetine on educational testing, working memory,and adaptive functioning throughout 16 weeks. |  |  |
Expanded Access [11C] Methionine PET Imaging

Study Overview
=================
Brief Summary
-----------------
The participants are being asked to get this PET scan because the participants have or may have cancer in the central nervous system (head, neck, or spine), and the investigator and the patient's physician thinks that this scan may provide useful information for the participant's treatment. Primary Objective To provide expanded access to L-[11C]methionine as a positron-emitting tracer in children and young adults for the positron emission tomography (PET) imaging of neoplasms of the central nervous system (CNS) and head and neck to guide therapeutic management of disease.

Detailed Description
-----------------
Participants receive an intravenous injection of a small (tracer) dose of L-[11C]methionine. Approximately 10 minutes later, patients undergo PET scanning to evaluate localization of the tracer.

Official Title
-----------------
Expanded Access [11C] Methionine PET Imaging

Conditions
-----------------
Central Nervous System Tumor, Head and Neck Neoplasms

Intervention / Treatment
-----------------
* Drug: L-(11C) methionine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All participants under the care of a SJCRH physician with known or suspected neoplastic disease of the CNS or head and neck are eligible for participation. No limit on age. Patients of all genders and all ethnic groups under the care of a SJCRH physician. Female participants of child-bearing age must not be lactating due to theoretical potential harm to the infant from exposure to radiation. Informed consent signed by participant, parent, or guardian according to the guidelines of the Institutional Review Board. Exclusion Criteria: More than six L-[11C]methionine PET scans within the previous 12 months. Inability or willingness of patient, parent, or guardian to consent.
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: L-(11C) methionine|Injected intravenously with 20 mCi/1.7 sq m body surface area of L-[methyl-11C]methionine (maximum prescribed dose: 20 mCi).|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
QT-Logs : Artificial Intelligence for QT Interval Analysis of ECG From Smartwatches in Patient Receiving Treatment for Covid-19

Study Overview
=================
Brief Summary
-----------------
This observational pilot prospective study will evaluate a new method for remote monitoring of corrected QT measurement using an artificial intelligence (AI)-based solution and ECG data collected via smartwatches (AI-QTc), in patients ambulatory treated with the HC-AZ combination, at the early stage of COVID-19 infection, at a tertiary hospital center. Daily ECGs will be performed via the smartwatches. AI-QTc will be compared to standard manual QTc reviewed by cardiologist. Correlation and agreement between measures will be assessed.

Official Title
-----------------
QT-Logs : a Clinical Study to Monitor Cardiac Safety, With Artificial Intelligence for QT Interval Analysis of ECG Data From Smartwatches, in Patients Receiving Hydroxychloroquine Treatment for COVID-19

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient over 18 years old SARS-COV-2 confirmed infection by positive nasopharyngual PCR Prescription of association hydroxychloroquine and azythromycine for COVI-19 therapy Patient's smartphone able to download the smartwatches application Exclusion Criteria: Presence of a pacemaker Pregnant or breastfeeding females Refusal to participate Incapacity Adult under legal protection (trusteeship, guardianship)

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corrected QT (QTc) interval measurement | Measurement of QTc using an artificial intelligence (AI)-based solution and ECG data collected via smartwatches, compare to standard 12 leads ECG reviewed by cardiologist | 10 days |