linjc16/ctgov huggingface dataset:
Pilot Study of Hippocampal Function in Type 1 Diabetes Mellitus (T1DM)

Study Overview
=================
Brief Summary
-----------------
This study is an expansion of a previous study done to determine how thinking skills relate to hypoglycemia (low blood sugar) and certain regions of the brain in children and adolescents. In this study, the investigators are testing thinking skills and measuring brain activity in adolescents with and without type 1 diabetes mellitus.

Official Title
-----------------
Pilot Study of Hippocampal Function in T1DM

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 13 - 18 Right handed Diagnosis of Type 1 Diabetes OR normal sibling control If diabetic, then diagnosis for at least 2 years Exclusion Criteria: Pregnant or lactating Chronic disease other than well-controlled asthma, or Hashimoto's thyroiditis. Other current serious medical illness Co-morbid psychiatric illness Co-morbid neurological illness Pre-maturity at birth Contraindication to MRI scan orthodontic braces.

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 18 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 |
| --- | --- |
| Type 1 Diabetes Mellitus<br>Adolescents ages 13-18 with T1DM | |
| Non Controls<br>Healthy adolescents ages 13-18 without T1DM | |

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
-----------------
T1DM, MRI
National Survey on Hypertension in General Practitioner (GP) Consultation

Study Overview
=================
Brief Summary
-----------------
To evaluate (with sufficient accuracy) the profile(demographic and clinical characteristics, health care management) of hypertensive patients seen in general practitioner consultation.

Official Title
-----------------
Profile of Hypertensive Patients Seen in General Practitioner Consultation

Conditions
-----------------
Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male or female > or = 18 years old Known hypertension agree to take part in this study Exclusion Criteria: none

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 |
| --- | --- |
| 1<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographic, clinical and health care characteristics |  | Once | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension, general practitioner consultation, Patients with hypertension
Bariatric Surgery and Pharmacokinetics of Irbesartan

Study Overview
=================
Brief Summary
-----------------
Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study the pharmacokinetic effects of bariatric surgery on irbesartan are investigated.

Official Title
-----------------
Bariatric Surgery and Pharmacokinetics Irbesartan: BAR-MEDS Irbesartan

Conditions
-----------------
Obesity, Morbid

Intervention / Treatment
-----------------
* Drug: Irbesartan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway Being a Norwegian citizen Exclusion Criteria: Having previously undergone resections in the GI-tract

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

| Intervention/Treatment |
| --- |
|Drug: Irbesartan|Patients are tested for their normal prescription irbesartan medication|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Irbesartan concentration in blood serum (area under curve (AUC)) |  | From baseline to 1 year postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bariatric surgery, Gastrointestinal tract, Biological availability, Pharmacokinetics, Irbesartan
ALI/ARDS in Oncologic Pediatric Patients

Study Overview
=================
Brief Summary
-----------------
Identify pediatric oncologic patients with ALI/ARDS at GRAACC/IOP's Pediatric Intensive Care Unit and evaluate the mechanical ventilation practice in these subjects for a 48mo period.

Detailed Description
-----------------
Evaluate adequate mechanical ventilation based on protective ventilation protocols for children available so far. Evaluate and describe the subjects. Evaluate the necessity and outcome of rescue therapies (surfactant, prone position, corticosteroids, alveolar recruitment) Obtain data about ALI/ARDS' etiology, mortality rates and predictive factors related to the outcomes (PICU/ hospital discharge or death)

Official Title
-----------------
Practice of Mechanical Ventilation in Pediatric Oncologic Patients Diagnosed With Acute Lung Injury / Acute Respiratory Distress Syndrome

Conditions
-----------------
Acute Lung Injury, Acute Respiratory Distress Syndrome, Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients admitted at the intensive care unit with diagnosis of acute lung injury or acute respiratory distress syndrome and submitted to mechanical ventilation for over 24h Exclusion Criteria: mechanical ventilation less than 24h absence of ALI/ARDS criteria no neoplasm diagnosis

Ages Eligible for Study
-----------------
Minimum Age: 29 Days
Maximum Age: 17 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 |
| --- | --- |
| ALI/ARDS oncologic patients<br>Consecutively admitted patients at GRAACC's PICU with malignancy diagnosis according to IDC-10, in a 24mo consecutive period, under mechanical ventilation for over 24h and with ALI/ARDS criteria, not younger than 29 days or older than 17 years 11 months | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify pediatric oncologic patients with ALI/ARDS at GRAACC's PICU and evaluate how they are mechanically ventilated |  | 2y | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epidemiologic data about the selected patients | Type and data about their mechanical ventilation, etiologic factors for ALI/ARDS, mortality rates, predictive factors about outcomes (death/ discharge), necessity and types of rescue therapies (surfactant, prone position, corticosteroids, etc.) | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acute lung injury, respiratory distress syndrome, neoplasms, child
Relationship Between Topiramate Use and Ocular Angle Status

Study Overview
=================
Brief Summary
-----------------
We test the hypothesis whether topiramate narrows the angles which may render Asians more likely to suffer from acute angle closure glaucoma.

Detailed Description
-----------------
Topiramate is approved for the treatment of epilepsy and prophylaxis of migraine attacks. There were case reports of acute angle closure glaucoma (AACG) associated with its use. AACG is particularly common in Asians because of a higher prevalence of narrow angle., we test the hypothesis whether topiramate narrows the angles which may render them more likely to suffer from AACG.

Official Title
-----------------
Relationship Between Topiramate Use and Ocular Angle Status: A Prospective Pilot Study

Conditions
-----------------
Glaucoma, Angle-Closure

Intervention / Treatment
-----------------
* Drug: Topiramate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants aged 18-75 with an indication for starting topiramate. Exclusion Criteria: Patients with known allergy or intolerance to topiramate. Recent exposure to topiramate (<3 months). Moderate to severe renal failure. Known history of renal calculi or hepatic failure Inability to give informed consent. Pregnant women or women of child-bearing age who do not practise an acceptable means of contraception. Patients known to have angle-closure glaucoma.

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change(s) in ophthalmic parameters measured at baseline and after 4 weeks of treatment, including: |  | 4 weeks | 
| best-corrected visual acuity, refraction, Goldmann applanation tonometry, Gonioscopy, dilated fundus examination, |  | 4 weeks | 
| and ultrasound biomicroscopy of angle and anterior segment. |  | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Side effects, Topiramate
Botulinum Toxin Injection Prevent Paroxysmal Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
The aim of this prospective non-randomized study was to assess the efficacy and safety of endomyocardial botulinum toxin injection in projections of main ganglionated plexuses of left atrium for preventing drug-resistant paroxysmal atrial fibrillation.

Official Title
-----------------
Endomyocardial Botulinum Toxin Injection Can Prevent Drug-Resistant Paroxysmal Atrial Fibrillation: Pilot Study

Conditions
-----------------
Paroxysmal Atrial Fibrillation

Intervention / Treatment
-----------------
* Procedure: endomyocardial BT injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: drug-resistant PAF Exclusion Criteria: Previous heart surgery and AF ablation procedure Emergency CABG Unstable angina or heart failure Persistent AF, AF at the time of screening (planned Maze procedure or pulmonary vein isolation) Use of I or III antiarrhythmic drugs within 5 elimination half-lives of the drug (or within 2 months for amiodarone) Requiring concomitant valve surgery Left ventricle ejection fraction <35% Left atrial diameter >55 mm Unwillingness to participate

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BT injection<br> | Procedure: endomyocardial BT injection<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serious adverse events |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of paroxysms |  | 1 year |
Prognosis of Inpatients Evaluated for Palliative Radiotherapy

Study Overview
=================
Brief Summary
-----------------
Understanding patient's prognosis is of utmost importance to determine radiotherapy's indication and dose/ fractionation. The investigators plan to conduct an observational study of prognosis of inpatients evaluated for palliative radiotherapy at a large cancer hospital in Brazil.

Official Title
-----------------
Observational Study of Prognosis of Inpatients Evaluated for Palliative Radiotherapy

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All inpatients evaluated for palliative radiation therapy at ICESP (Instituto do Cancer do Estado de Sao Paulo) Exclusion Criteria: Inpatients evaluated whose intent of treatment is curative Patients who are unwilling to participate in the study or unwilling to sign informed consent
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Palliative Patients<br>Inpatients evaluated for palliative radiation therapy. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | Overall Survival in the studied population | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival in Each Indication of Palliative Radiotherapy | Overall Survival in Each Indication of Palliative Radiotherapy. The indication will be as follow: spinal cord compression brain metastases tumor bleeding tumoral mass Oncologic Pain Superior Vena Cava Syndrome/ Airway compression | 3 months and 9 months | 
| Overall Survival by Palliative Prognostic Index (PPI) | Patients will be divided into 3 subgroups according to the PPI. Survival differences between the different subgroups will be compared and analyzed | 3 months and 9 months | 
| Overall Survival by Survival Prognostic Score (SPS) | Patients will be divided into 3 subgroups according to the SPS. Survival differences between the different subgroups will be compared and analyzed | 3 months and 9 months | 
| Overall Survival by Score Index for Stereotactic Radiosurgery for Brain Metastases (SIR) | Patients will brain metastases will be divided into 3 subgroups according to SIR. They will be divided into SIR 0-3; 4-7;8-10. Survival differences between the different subgroups will be compared and analyzed | 3 months and 9 months | 
| Positive Predictive Value of PPI | Positive Predictive Value of PPI to predict death at 3 weeks and 6 weeks. | 3 weeks and 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Radiation, Prognosis, Palliative Care
Efficacy and Safety Study of Seroquel SR in the Treatment of Generalized Anxiety Disorder

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to evaluate the efficacy of (SEROQUEL SR™ ) quetiapine fumarate sustained-release (SR) compared to placebo in the treatment of anxiety symptoms in patients with generalized anxiety disorder (GAD). PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Official Title
-----------------
An International, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Active-Controlled Study of the Efficacy and Safety of Sustained-Release Quetiapine Fumarate (Seroquel SR™ ) in the Treatment of Generalized Anxiety Disorder (SILVER)

Conditions
-----------------
Generalized Anxiety Disorder

Intervention / Treatment
-----------------
* Drug: Quetiapine fumarate
* Drug: Paroxetine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female aged 18 to 65 years; A diagnosis of generalized anxiety disorder; Absence of current episode of major depression. Exclusion Criteria: The presence or history of schizophrenia and other psychotic disorders; Hypertension; A current diagnosis of cancer, unless in remission for at least 5 years

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Quetiapine fumarate|nan|
|Drug: Paroxetine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the efficacy compared to placebo in the treatment of anxiety symptoms in patients with generalized anxiety disorder (GAD) at Day 57 (= end of treatment). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate efficacy by evaluating response rate. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anxiety, GAD
Perceived Burden and Quality of Life of Primary Caregivers of Cancer Patients Aged 70 and Older After 5 Years of Management

Study Overview
=================
Brief Summary
-----------------
Cancer is a disease that requires long-term management, especially now that medical advances have transformed most cancers from an acute to a chronic condition. Most of the time, therefore, the help provided by family and friends is long-term. The negative impact of oncological care on the quality of life of family caregivers has already been studied. The UCOGB carried out a study in 2014 on the primary caregivers of cancer patients aged 70 and over at inclusion and at 3 and 6 months of oncogeriatric care. This study showed that several factors were significantly related to the caregiver's quality of life: the caregiver's age, perception of burden and patient autonomy (18). However, the evolution of quality of life and burden at 5 years has, to our knowledge, never been evaluated.

Official Title
-----------------
Perceived Burden and Quality of Life of Primary Caregivers of Cancer Patients Aged 70 and Older After 5 Years of Management

Conditions
-----------------
Quality of Life, Primary Patient Caregiver, Cancer

Intervention / Treatment
-----------------
* Other: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Person who does not object to being included in the study Primary caregiver of a cancer patient aged 70 years and over who is managed in one of the centres participating in the study, with a request for an oncogeriatric consultation between 01/06/2014 and 18/03/2015. Age ≥ 18 years old Good command of the French language Exclusion Criteria: Refusal or linguistic or psychological inability to answer the questionnaires. Caregiver whose general condition does not allow him/her to answer a questionnaire Death of the caregiver.

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 |
| --- | --- |
| primary caregiver of patients aged 70 and over<br> | Other: Questionnaire<br>* Zarit Burden Inventory French version and SF12<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the quality of life of the primary caregiver of cancer patients 70 years of age and older, 5 years after initial management. | Quality of life is measured using the SF-12 (short form) questionnaire. This is an abbreviated version of the Medical Outcomes Study Short-form General Health survey (SF-36). | Through study completion, an average of 1 year |
Compare Visual Outcomes Using a New Diagnostic Device

Study Overview
=================
Brief Summary
-----------------
Evaluation of preoperative corrected distance visual acuity (CDVA) obtained with VirtIOL device compared to postoperative CDVA.

Official Title
-----------------
Prospective Clinical Study to Compare Visual Performance Obtained With a New Diagnostic Device

Conditions
-----------------
Presbyopia

Intervention / Treatment
-----------------
* Diagnostic Test: Diagnostic device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient informed of the consequences and constraints of the protocol and who has given his/her written informed consent Patients of any gender, aged 18 years to open age Assured follow-up examinations Healthy eyes without clinically significant age-related cataract -Exclusion Criteria: Patients unable to meet the limitations of the protocol or likely of non-cooperation during the trial Patients whose freedom is impaired by administrative or legal order Concurrent participation in another drug or device investigation

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients without clinically significant age-related cataract<br> | Diagnostic Test: Diagnostic device<br>* Diagnostic test<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corrected distance visual acuity (CDVA) | Evaluation of CDVA obtained with diagnostic device | 3 months after surgery |