linjc16/ctgov huggingface dataset:
Observational Study of Meloxicam in Mexican Patients With Rheumatic Diseases

Study Overview
=================
Brief Summary
-----------------
Observational study to evaluate the efficacy and safety of meloxicam (Mobicox®) in Mexican population with rheumatic diseases

Official Title
-----------------
Clinical and Therapeutic Evaluation of Meloxicam in Mexican Patients With Rheumatic Diseases

Conditions
-----------------
Arthritis, Rheumatoid

Intervention / Treatment
-----------------
* Drug: Meloxicam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age of 12 or older and rheumatologic disease Exclusion Criteria: Hypersensitivity to meloxicam Hypersensitivity to other Non-steroidal anti-inflammatory drugs (NSAIDS) History of asthma, angioedema or urticaria secondary to NSAIDS Pregnancy or lactation Recent or current history of peptic ulcer disease, severe renal failure and severe hepatic failure

Ages Eligible for Study
-----------------
Minimum Age: 12 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 |
| --- | --- |
| Meloxicam<br> | Drug: Meloxicam<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensity of symptoms at rest evaluated with a 4-point scale |  | 30 and 90 days | 
| Intensity of symptoms during movement evaluated with a 4-point scale |  | 30 and 90 days | 
| Medical global evaluation on a 4-point scale |  | 30 and 90 days |
Efficacy of Levocetirizine and Cetirizine in Reducing Symptoms of Seasonal Allergic Rhinitis in Ragweed Sensitive Subjects

Study Overview
=================
Brief Summary
-----------------
Controlled conditions of the EEU allow a reliable assessment of the efficacy and a determination of the action onset, action intensity and duration of effect of levocetirizine and cetirizine in order to establish the relative efficacy of these two drugs available for the treatment of SAR.

Official Title
-----------------
Trial to Compare the Efficacy of Levocetirizine and Cetirizine in Reducing Symptoms of Seasonal Allergic Rhinitis in Ragweed Sensitive Subjects Exposed to Pollen Challenge in an Environmental Exposure Unit (EEU).

Conditions
-----------------
Rhinitis, Allergic, Seasonal

Intervention / Treatment
-----------------
* Drug: levocetirizine dihydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male/Female, aged >= 16 years seasonal allergic rhinitis that required pharmacologic therapy each year during the last 2 ragweed pollen seasons documented seasonal allergy to ragweed pollen total symptom score of at least 18 points. Exclusion Criteria: nasal anatomic deformities ? 50% obstruction acute sinusitis within 30 days of Period 2 initiated or advanced an immunotherapy regimen immunotherapy injections within 48 hours of pollen exposure impaired hepatic function history of malignancy intolerance to histamines asthma requiring medication more than occasionally

Ages Eligible for Study
-----------------
Minimum 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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: levocetirizine dihydrochloride|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline in major symptom complex score over Period 2 (21-29 hours after drug intake on Day 2). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline in MSC score over each 2-hour interval. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Levocetirizine dihydrochloride, Xyzal tablet
Pioglitazone and Quetiapine XR Pharmacogenetic Study

Study Overview
=================
Brief Summary
-----------------
Obtain phenotypic data and a DNA/blood sample from mood disorder patients undergoing pioglitazone or quetiapine XR treatment as a part of an IRB approved clinical trial conducted at the Mood Disorders Program. Pioglitazone treatment is examined in metabolic syndrome comorbid with bipolar depression (IRB # 07-08-24) and unipolar depression (IRB # 07-07-20). Quetiapine XR treatment is examined in generalized anxiety disorder comorbid with bipolar depression (IRB # 10-06-19) and unipolar depression (IRB # 12-01-29). Please refer to the respective IRB protocols for more information.

Official Title
-----------------
Pharmacogenetic Study of Pioglitazone and Quetiapine XR Treatment Response in Mood Disorders

Conditions
-----------------
Bipolar Disorder, Major Depressive Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must have participated in IRB protocols 10-06-19, 12-07-29, 07-07-20, and 07-08-24 Patient must give consent to participate, sign and date the IRB approved written informed consent form prior to the initiation of any procedures for this study Patient must be diagnosed with Bipolar Disorder or Major Depressive Disorder Patient must be at least 18 years old Patient must be willing to give a blood sample Exclusion Criteria: Patient lacks the capacity to provide informed consent

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Seroquel<br>Participants who received Seroquel | |
| Pioglitazone<br>Participants who received pioglitazone | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genetic markers associated with treatment response | Genetic markers in PPARG, 5-HT2A, CYP3A4 and CYP2C8 genes known to be related in the pharmacodynamics and pharmacokinetics of pioglitazone or quetiapine XR will be associated with treatment response. | Up to 1.5 years |
Normative Data of Intra-epidermal Nerve Fiber Density

Study Overview
=================
Brief Summary
-----------------
Intra-epidermal nerve fiber density can be assessed using skin biopsy. A decrease of this density is used to diagnose small fiber neuropathy, despite the absence of normative data in a selected normal population. To establish a normative set of data matched for age and sex is absolutely needed to evaluate the sensibility and specificity of this test.

Official Title
-----------------
Establishement of Normative Intra-epidermal Nerve Fiber Density Using Skin

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Procedure: Biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Man or woman between 20-80 years old Normal subjects without pain and neurological impairment No history of neurological disorder Normal neurological examination Normal ECG Normal clotting sample from less than 6 months Available by phone Exclusion criteria : History of alcoholic intoxication or chemotherapy History of diabetes, kidney insufficiency, monoclonal gammapathy, B/C hepatitis, HIV, coeliac disease, sicca syndrome, raynaud syndrome, systemic erythematous lupus, Fabry disease, amylosis, vascularitis Contraindication to xylocaïn with adrenalin At the site of biopsy : surgery, skin pathology, infection, vascular insufficiency Innate or acquired immunosuppression Innate or acquired clotting abnormality

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

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

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: Biopsy<br> | Procedure: Biopsy<br>* 3 mm punch biopsy of the skin at the distal leg.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure density of intraepidermic nervous fibres by optical and electronic microscopy in a population of healthy witnesses according to the age and the sex. |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
volunteer
Atrial Fibrillation and Cancer: a Nationwide French Cohort Study

Study Overview
=================
Brief Summary
-----------------
Atrial fibrillation (AF) is a common complication associated with cancer but the risk of AF according to the cancer localization and status as well as the risk of thromboembolisms, bleedings and mortality are poorly known. The objective of this study is to use a very large French nationwide cohort to adress thèses questions.

Official Title
-----------------
Atrial Fibrillation and Cancer: a Nationwide French Cohort Study

Conditions
-----------------
Atrial Fibrillation, Cancer, Thromboembolism, Bleeding

Intervention / Treatment
-----------------
* Other: event occurence


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult hospitalized patients with an ICD-10 code discharge from january 2010 to december 2019 in the French national hospital discharge database (PMSI Programme de Médicalisation des Systèmes d'Information) Exclusion Criteria: children

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: event occurence|occurence of an event of interest: (AF, cancer, thromboembolism, bleeding, mortality...|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| atrial fibrillation | occurrence of atrial fibrillation | from inclusion in the cohort up to 10 years | 
| cancer | occurrence of cancer | ffrom inclusion in the cohort up to 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| thromboembolism | occurrence of thromboembolism | from inclusion in the cohort up to 10 years | 
| bleeding | occurrence of bleeding | from inclusion in the cohort up to 10 years | 
| mortality | occurrence of mortality | from inclusion in the cohort up to 10 years |
Changes in Circulating Sclerostin Levels During Acute Postsurgical Hypoparathyroidism

Study Overview
=================
Brief Summary
-----------------
To investigate changes in sclerostin levels following acute post-thyroidectomy hypoparathyroidism

Detailed Description
-----------------
Female patients with thyroid disorders, referred to the Department of Head and Neck Surgery, at Metaxa Anti-Cancer Hospital of Piraeus, for total thyroidectomy. Based on the development of biochemical hypocalcemia (cCa < 8.4 mg/dl), subjects were divided into 2 groups: Group A: without postsurgical hypoparathyroidism that served as controls and group B: subjects, with acute postsurgical hypoparathyroidism. Blood collections were performed in the morning after an overnight fast, in at least 3 different time points; preoperatively, 1st postoperative day and 7th postoperative day for the detrmination of sclerostin levels

Official Title
-----------------
Changes in Circulating Sclerostin Levels During Acute Postsurgical Hypoparathyroidism

Conditions
-----------------
Hypoparathyroidism Postprocedural

Intervention / Treatment
-----------------
* Drug: calcium carbonate and alphacalcidol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Indication for total thyroidectomy Exclusion Criteria: parathyroid disorders, chronic kidney disease (eGFR< 60 ml/min), treatment with antiosteoporosis drugs, rheumatic disease and history of long term (>1 month) or current corticosteroid use

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| group A<br>Control | |
| Group B<br>Post-surgical hypoparathyroidism | Drug: calcium carbonate and alphacalcidol<br>* treatment for hypocalcemia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in circulating serum sclerostin levels (pmol/L) during the observation period | change in circulating serum sclerostin levels (pmol/L)during the observation period | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the between groups difference in % changes of circulating sclerostin | the between groups difference in % changes of circulating sclerostin | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sclerostin, Hypoparathyroidism
Prospective Multicenter Study to Characterize the REAL-WORLD EVIDENCE Regarding Safety and Performance of the PTCA Catheters Family

Study Overview
=================
Brief Summary
-----------------
The purpose of this Post market Study is to collect clinical data of the Arthesys PTCA catheters family during angioplasty intervention of coronary vessels or coronary bypass graft stenosis to support MDR submission.

Official Title
-----------------
Prospective Multicenter Study to Characterize the REAL-WORLD EVIDENCE Regarding Safety and Performance of the PTCA Catheters Family

Conditions
-----------------
Coronary Artery Stenosis

Intervention / Treatment
-----------------
* Procedure: Percutaneous Transluminal Coronary Angioplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with a Percutaneous intervention to a native coronary or coronary bypass graft indication Patient >18 years Patient who understands the trial requirements and the treatment procedures and provides written informed consent Exclusion Criteria: - Patients will not be included if they are under judicial protection, guardianship or curatorship or if they are deprived of their liberty by judicial or administrative decision.

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: Percutaneous Transluminal Coronary Angioplasty|Angioplasty intervention of coronary vessels or coronary bypass graft stenosis|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy endpoint | Balloon successfully reaching and crossing target location, successful inflation, deflation, and retrieval in the guiding catheter | Up to end of PTCA procedure | 
| Safety endpoint | Successful balloon dilatation without device related adverse event during the dilatation procedure | Up to end of PTCA procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance - pre-dilatation | Residual stenosis < 50% and TIMI flow grade 3 | Up to end of PTCA procedure | 
| Performance - post-dilatation | Angiographic success of the device defined as <30% residual stenosis after angiography | Up to end of PTCA procedure |
An Open-Label, 18FDG-PET Pharmacodynamic Assessment of the Effect of BIIB021 in Subjects With Gastrointestinal Stromal Tumors (GIST)

Study Overview
=================
Brief Summary
-----------------
This study will examine the effect of BIIB021 on GIST growth and metabolism.

Official Title
-----------------
An Open-Label, 18FDG-PET Pharmacodynamic Assessment of the Effect of BIIB021 in Subjects With Gastrointestinal Stromal Tumors (GIST) Refractory to, Intolerant of, or Not a Candidate for Imatinib and Sunitinib Treatment

Conditions
-----------------
GIST

Intervention / Treatment
-----------------
* Drug: BIIB021


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations. Age greater than or equal to 18 years at the time of informed consent. Pathologically confirmed GIST refractory to, intolerant of, or not a candidate for imatinib and sunitinib therapy. FDG PET standard uptake value (SUVmax; averaged over a maximum of 5 lesions) greater than or equal to 2 at screening. ECOG performance status of less than or equal to 2. Lab values consistent with adequate renal hepatic and bone marrow function. Must utilize effective contraception. Exclusion Criteria: Prior treatment with imatinib, sunitinib, or sorafenib with in 14 days of day 1. Prior treatment with Hsp90 inhibitors at any time. Prior antitumor therapies including prior experimental agents, approved antitumor small molecules (excluding imatinib, sunitinib, or sorafenib) and biologics, or radiotherapy with in 28 days or <3 half lives (whichever is longer) before start of BIIB021treatment. Diabetes treated with insulin and/ or concurrent severe or uncontrolled other medical disease (i.e, systemic infection, hypertension, coronary artery disease, congestive heart failure). History of/ or predisposition to seizures.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>BIIB021 | Drug: BIIB021<br>* Dose, schedule, and duration specified in protocol<br>* Other names: CNF2024;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in FDG-PET imaging |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterize the safety profile of BIIB021 |  | Duration of study |
The Effect of Smartphone Push Notifications on Brain Power Score

Study Overview
=================
Brief Summary
-----------------
This study will examine how Brain Power Score, an objective measure of brain function, is affected by the presence of smartphone push notifications.

Detailed Description
-----------------
Smartphones are a common device integrated into the lives of many individuals around the world. Researchers have previously found a relationship between mobile phone use and changes in brain activity, reaction times and sleep patterns. Brain Power is a consumer-grade application using a proprietary combination of neurological (EEG) and behavioral (reaction time and accuracy) data to create a comprehensive score out of 1000 which allows users to have an objective evaluation of their brain performance. This study will examine how Brain Power Score is affected by the presence of smartphone push notifications.

Official Title
-----------------
Assessing the Effect of Smartphone Push Notifications on Overall Score, Accuracy and Reaction Time of Brain Power Score

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Behavioral: Smartphone push notifications


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers ≥19 years old Must be proficient in English Must be able to understand the study procedure and give informed consent Exclusion Criteria: Unable to provide informed consent

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Push Notifications<br>Push notification number (0, 1, 3, 5) will be counter balanced within-subjects. | Behavioral: Smartphone push notifications<br>* The purpose of this study is to assess how smartphone push notifications can impact the overall score, accuracy and reaction time of participants using the Brain Power Score application (app). Push notification quantity will be varied and counter-balanced.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Brain Power Score | Brain Power Score combines neurological (EEG) and behavioral (reaction time and accuracy) data to create a comprehensive score out of 1000. | 20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy | Percentage of correctly classified instances | 20 minutes | 
| Reaction time | Time to respond to the stimulus (milliseconds) | 20 minutes |