linjc16/ctgov huggingface dataset:
Atrial Fibrillation and the Risk for Neurological Complications

Study Overview
=================
Brief Summary
-----------------
B8: Atrial fibrillation and the risk of neurological complications Twenty-five thousand acute strokes are caused by atrial fibrillation every year. But even more frequent than symptomatic strokes are silent infarctions of the brain. Silent strokes remain undetected in most cases, but cumulate over time and progressively impair cognition. The impact of atrial fibrillation on subacute brain infarctions is not yet known. Moreover, it has not been elucidated so far how effective different therapeutic strategies in the treatment of atrial fibrillation prevent cognitive impairment. Thus, this study aims at evaluating the influence of different types of atrial fibrillation on silent strokes and the related impairment in cognitive functions. Other risk factors and cardiovascular diseases that are known to provoke the development of strokes will be assessed as well. So, it will be possible to isolate the contribution of atrial fibrillation to silent strokes and related cognitive impairment in segregation to other relevant factors. AF patients and controls will be examined twice in two years in order to evaluate the role of atrial fibrillation and differential therapeutic interventions with regard to the progression of silent strokes and cognitive impairment in a within subject-design.

Official Title
-----------------
Atrial Fibrillation and the Risk for Neurological Complications

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of permanent, paroxysmal or episodic atrial fibrillation in the past or at present Exclusion Criteria: Pacemaker Metal implants History of acute stroke Diagnosis of vascular or degenerative dementia History of brain tumors History of severe brain injury History of psychiatric disorders Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 85 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
-----------------
Atrial fibrillation, Stroke, Vascular Dementia, Mild Cognitive Impairment
Safety and Tolerability of BVS857 in Subjects With Insulin Resistance

Study Overview
=================
Brief Summary
-----------------
The study will assess the safety, tolerability, drug label and effect in subjects with and without insulin resistance.

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Explore the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Parenterally Administered BVS857 in Healthy Subjects Without and With Insulin Resistance

Conditions
-----------------
Insulin Resistance

Intervention / Treatment
-----------------
* Drug: BVS857
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and female subjects with insulin resistance Subjects with controlled hypertension and hyperlipidemia Exclusion Criteria: Smokers History of drug or alcohol use Autonomic dysfunction Significant illness or cardiovascular disease Immunodeficiency disease Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BVS857<br> | Drug: BVS857<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood glucose |  | Continuously up to 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Safety, BVS857, insulin resistance
Association Between Prolactin Levels in Pregnant Women in COVID-19. Gether With Rates of Breastfeeding and the Covid-19 Virus

Study Overview
=================
Brief Summary
-----------------
Background: Currently in the world, 41% of children under 6 months are exclusively breastfed. The Covid-19 pandemic has had a major impact on breastfeeding.; Methods: A statistical analysis of linear regression, prolactin analysis in the 3rd trimester of pregnancy and 15 days 15 after delivery was performed in women with Covid- 19 infection and healthy, finally the rates of 16 breastfeeding were evaluated. The sample was made up of 680 pregnant women from the Valladolid 17 Health Area, central region of Spain.

Official Title
-----------------
Association Between Prolactin Levels in Pregnant Women to- 2 Gether With Rates of Breastfeeding and the COVID-19 Virus. A 3 Randomised Trial

Conditions
-----------------
Breastfeeding, COVID-19 Infection

Intervention / Treatment
-----------------
* Procedure: blood prolactin levels


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant women under the coding of the clinical process of normal pregnancy or diagnosis of Covid-19 infection Exclusion Criteria: No informed consent. No pregnant women. Older than 50 years old. Younger than 16 years old.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 50 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 |
| --- | --- |
| Pregnant women<br>pregnant women infected by Covid-19 | Procedure: blood prolactin levels<br>* The extraction technique was performed by venipuncture in 110 veins located in the antecubital area with a 21G butterfly nut with a Vacutainer Safety 111 Lok@ adapter, a 2.5x45cm latex venous compressor and a tube with separating gel 112 (yellow cap)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prolactin value | ng/ml. 0 mimimun, 100 maximum | 15 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Covid-19 infection, Pregnant women, Prolactin levels, Breastfeeeding
A Behavioral Trial for the Treatment of Methamphetamine Dependence. - 1

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine behavioral treatment for methamphetamine dependence.

Detailed Description
-----------------
To characterize meth. withdrawal symptoms using a multidimensional withdrawal questionnaire; to field test and investigate the effect of using an algorithm developed for discriminating between new use and residual carry-over of meth metabolites in urine and to evaluate the treatment response of meth. users to participation in the thrice weekly psychosocial protocol to be used as a platform in future pharmacotherapy trials.

Official Title
-----------------
Behavioral Trial for the Treatment of Methamphetamine Dependence

Conditions
-----------------
Substance-Related Disorders

Intervention / Treatment
-----------------
* Behavioral: Behavior Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or Female at least 18 yrs of age; DSM-4 diagnosis of methamphetamine (METH) dependence; be willing to comply with study procedures; verbalize understanding of consent and provide written consent and willingness to complete study procedures; be seeking treatment for METH dependence. Exclusion Criteria: Additional criteria available during screening at the site.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Behavior Therapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Withdrawal symptoms |  |  | 
| New Use algorithm |  |  |
Electroencephalography in Patients Resuscitated From Cardiac Arrest

Study Overview
=================
Brief Summary
-----------------
Sudden cardiac death can occur due to a multitude of causes. The underlying case can affect the overall prognosis. A return of spontaneous circulation not exceeding 30 minutes following a successful cardiopulmonary resuscitation is usually deemed imperative, if the patient is to survive. Monitors for evaluating the cardiac function during and after resuscitation are implemented on a daily basis (ekg, pulseoxymetry, blood pressure monitoring, cardiac sonography), but no devices for registration of the cortical brain activity exist. The aim of this study is to provide a 3-channel electroencephalogram using a prototype EEG/EKG adapter, connected to a Physio-Control LifePak 15 monitor/defibrillator, in patients who regain spontaneous circulation following non-traumatic cardiac arrest.

Official Title
-----------------
Electroencephalography in Patients Resuscitated From Cardiac Arrest

Conditions
-----------------
Heart Arrest, Cardiac Arrest

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Witnessed Cardiac Arrest Return of spontaneous circulation following cardiac arrest 10-40 min Exclusion Criteria: traumatic cardiac arrest no consent from next-of-kin

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 |
| --- | --- | --- |
| prehospital EEG value in regard to patient discharge |  | 60-min | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Electroencephalography
Study Evaluating Etanercept in Patients With Rheumatoid Arthritis Who Completed Trial 0881A1-301-EU in Spain

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate long-term safety of etanercept in patients with rheumatoid arthritis who successfully have completed open-label safety study 0881A1-301-EU

Official Title
-----------------
Long-Term Safety Study of Etanercept in Patients With Rheumatoid Arthritis Who Completed Trial 0881A1-301-EU in Spain

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

Intervention / Treatment
-----------------
* Drug: Etanercept


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: To have completed 0881A1-301-EU study in Spain Clinical diagnosis by ACR revised criteria of rheumatoid arthritis. Exclusion Criteria: Hypersensibility to etanercept or any of its components Significant concurrent medical disease

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 |
| --- |
|Drug: Etanercept|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rheumatoid Arthritis
Correlation Between Continuous Glucose Monitoring and Intermittent Glucose Monitoring Values and Pregnancy Outcomes

Study Overview
=================
Brief Summary
-----------------
We wish to find out if in non-diabetic pregnancies, as well as diabetic pregnancies, additional data obtained by Continuous Glucose Monitoring improves perinatal risk prediction.

Detailed Description
-----------------
Patients are recruited for 3 day continuous glucose monitoring (CGM) plus self-blood glucose monitoring followed by routine diabetes screening at 26-28 weeks gestation to determine if maternal blood glucose excursions correlate with deviation from optimized birth weight.

Official Title
-----------------
Correlation Between Continuous Glucose Monitoring and Intermittent Glucose Monitoring Values and Pregnancy Outcomes

Conditions
-----------------
Insulin Resistance

Intervention / Treatment
-----------------
* Device: Continuous Glucose Monitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Pregnant patients under 28 weeks gestation Exclusion Criteria: - Pre-gestational diabetes

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Continuous Glucose Monitor|Subjects are fitted with a CGM system and perform self blood glucose measures three or more times per day for 3 days.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Birthweight centile |  | Delivery |
Psychometric Validation of the Hemophilia Functional Ability Scoring Tool (Hemo-FAST)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to validate the newly developed Hemophilia Functional Ability Scoring Tool (Hemo-FAST), which is a fast and simple scoring in haemophilia able to assess patient-reported functional mobility.

Detailed Description
-----------------
The purpose of this study is to validate the newly developed Hemophilia Functional Ability Scoring Tool (Hemo-FAST), which is a fast and simple scoring in haemophilia able to assess patient-reported functional mobility for adult haemophilia patients.

Official Title
-----------------
Psychometric Validation of the Hemophilia Functional Ability Scoring Tool (Hemo-FAST)

Conditions
-----------------
Hemophilia A, Hemophilia B

Intervention / Treatment
-----------------
* Diagnostic Test: Hemophilia Joint Health Score (HJHS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:A patient must fulfil the following criteria in order to be included in the study: Age ≥18 years. Diagnosis of haemophilia A or B. Capable of completing the study Patient-Reported Outcome (PRO) questionnaires in French. Signed informed consent. Exclusion Criteria: The presence of any of the following criteria will exclude a patient from inclusion in the study: Joint replacement within last 6 months. Patients with a non-resolved joint or muscle bleeding event at the enrolment visit or ≤ 7 days prior to the enrolment visit. Patients with comorbid illnesses such as juvenile arthritis, muscular dystrophy, neurologic illness/cognitive impairment, or other illnesses that may independently affect HJHS and Hemo-FAST scores and/or limit the ability of the patient to participate in the study as determined by the investigator.

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 |
| --- |
|Diagnostic Test: Hemophilia Joint Health Score (HJHS)|Joint examination with Hemophilia Joint Health Score (HJHS)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychometric validation of the Hemophilia Functional Ability Scoring Tool (Hemo-FAST). | Statistical analysis to confirm the psychometric validation of the Hemo-FAST questionnaire | Baseline |
TTFields in General Routine Clinical Care in Patients With Pleural Mesothelioma Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this post-authorisation medical device study is to obtain real life data on the use of Tumor Treating Fields (TTFields) in patients with pleural mesothelioma in routine clinical care. Patients with pleural mesothelioma and clinical indication for TTFields treatment will be enrolled in the study after signing Informed consent to use their data and process it centrally for research purposes. The clinical indication for TTFields is one of the inclusion criteria and is defined prior to inclusion by the treating physician.

Official Title
-----------------
TTFields in General Routine Clinical Care in Patients With Pleural Mesothelioma Study - TIGER Meso Study

Conditions
-----------------
Pleural Mesothelioma

Intervention / Treatment
-----------------
* Device: TTFields


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥ 18 years of age Histologically confirmed pleural mesothelioma without any option of curative resection Planned treatment with NovoTTF-200T System according to IFU and medical guidelines Life expectancy more than 3 months at day of enrollment Signed informed consent for use and processing of data Exclusion Criteria: • Previous treatment with NovoTTF-200T for more than 1 week at day of enrollment

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 |
| --- | --- |
| Group 1<br>all patients will receive routine clinical care and TTFields | Device: TTFields<br>* all patients will receive routine clinical care and TTFields<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from diagnosis of pleural mesothelioma to death of any cause as median overall survival time. |  | 54 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of TTFields treatment-related SAEs, as assessed by the CEC, within total observation period, standardized to average annual incidences. |  | 3 years + 18 months follow up | 
| Changes in quality of life comparing baseline with 3 and 6 months after start of TTFields therapy. |  | QoL will be assessed at baseline, 3 and 6 months. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TTFields, Pleural Mesothelioma
Weight Gain Prevention

Study Overview
=================
Brief Summary
-----------------
The specific aim of the proposed project is to test two separate self-regulation interventions to prevent weight gain in young adults, one based on making sustained small changes in behavior to prevent weight gain and the other on making periodic larger behavior changes resulting in weight loss.

Official Title
-----------------
Study to Prevent Weight Gain

Conditions
-----------------
Weight Gain

Intervention / Treatment
-----------------
* Behavioral: large changes in eating and activity
* Behavioral: small changes in eating and activity


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-35 Body mass index between 23 and 30 Interested in preventing weight gain Exclusion Criteria: BMI outside of range specified Age outside of range specified History of or current eating disorder or substance abuse Recent weight loss greater than 5% of weight Currently in another research study that would interfere

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>One arm is a large changes group in which participants will be asked to make periodic large changes in their eating and activity, aimed at producing initial weight loss, in order to prevent weight gain over time. | Behavioral: large changes in eating and activity<br>* Behavioral self-regulation interventions to prevent weight gain in young adults.<br>|
| Experimental: 2<br>The second arm is a small changes group in which participants will be asked to make small changes to their eating and activity and maintain these changes forever in order to prevent weight gain. | Behavioral: small changes in eating and activity<br>* Behavioral self-regulation interventions to prevent weight gain in young adults.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight change |  | 8 weeks and 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| frequency of weighing, adherence to intervention, diet, activity |  | 8 weeks and 16 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
overweight, prevention of weight gain, young adults, self-regulation, daily weighing, weight gain prevention