linjc16/ctgov huggingface dataset:
Prevention of Hepatitis B Virus Mother-to-child Transmission by Serovaccination.

Study Overview
=================
Brief Summary
-----------------
The prevalence of HBsAg carriage in pregnant women varies in France, according to the native country, with highest rates in those originating from sub-Saharan Africa and Asia (5 to 8 % in Parisian area). The level of HBV-DNA varies according to HBe status and geographical origin, and is strongly predictive of the risk of HBV mother-to-child transmission (MTCT). It has been shown that the rate of vertical transmission (Chinese study by Yuan J et al) was 0 % in newborns to mothers whom HBV-DNA was < 105 copies/mL and up to more than 40 % in newborns to mothers with high viral loads > 108 copies/mL, despite HBIg and vaccine at birth. Thus, data are needed concerning the current practices about the prevention of HBV MTCT in France, and their results.

Detailed Description
-----------------
This monocentre, observational study will include pregnant women whom HBV-DNA is > 105 IU/mL. HBV MTCT rates will be evaluated, according to the level of HBV-DNA in the women during the last three months of pregnancy and at childbirth (between 105 and 108 IU/mL, or > 108 IU/mL), and according to the clinical practices of serovaccination in the participating center. The evaluation will be based on the rate of HBsAg positivity in infants at 9 months, despite a correct immunization at birth. The rate of detectable HBV-DNA will be also evaluated in infants at the same date.

Official Title
-----------------
Prevention of Hepatitis B Virus (HBV) Mother-to-child Transmission (MTCT): Impact of Serovaccination in Lariboisiere Hospital, Paris, France.

Conditions
-----------------
Hepatitis B

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant woman whom HBs Ag + whom HBV-DNA >105 IU/mL Exclusion Criteria: Women who have to be treated for HBV hepatitis, (AST/ALT >2 ULN without any explanation, liver biopsy performed before pregnancy showing hepatitis requiring initiation of treatment)

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

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

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 |
| --- | --- | --- |
| Rate of HBsAg positivity in infants at 9 months, despite a correct immunization at birth |  | 9 months of life | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HBV mother-to-child transmission, women with HBV DNA > 105 I.U./mL, France
Healthy Mood Internet Recruitment Study

Study Overview
=================
Brief Summary
-----------------
This study is pilot testing a self-help automated Website (similar to a self-help book) designed to help individuals to learn methods to manage their mood. The methods are cognitive-behavioral skills found effective in the treatment of depression when provided by live therapists. The purpose of the study is to determine the number of individuals who will visit the site, use the site, and respond to online surveys reporting their mood levels while using the site, and at 1, 3, and 6 months after starting to use the site. The investigators want to eventually examine whether learning these methods online would help prevent depression.

Detailed Description
-----------------
Self-help automated website in Spanish and English consisting of an 8-lesson course on mood management based on cognitive behavioral methods. Accessible via the web. Follow-up assessments conducted at 1, 3, and 6 months.

Official Title
-----------------
Depression Prevention and Management Project

Conditions
-----------------
Recruitment

Intervention / Treatment
-----------------
* Behavioral: Healthy Mood Project Website


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older valid email address fluent in English Exclusion Criteria: less than 18 years of age no valid email address not fluent in English

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Online self-help mood management<br>Healthy Mood Project Website Online self-help automated mood management course available in Spanish and English via a website. Intervention consisted of 8 cognitive-behavioral mood management lessons. | Behavioral: Healthy Mood Project Website<br>* Self-help automated online mood management course based on cognitive-behavioral methods to control depressed mood.<br>* Other names: Self-help automated Website;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment | Number of participants enrolling in the site per month | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PHQ-9 | Depression symptom measure | Screening, plus 1, 3, and 6 months later | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mood management, self-help, depression, prevention, cognitive behavioral
Effects of Exercise Training on Fatigue in Thyroid Cancer Survivors

Study Overview
=================
Brief Summary
-----------------
Researchers are trying to determine whether an exercise program reduces fatigue and improves physical activity in thyroid cancer patients.

Official Title
-----------------
Effects of Exercise Training on Fatigue in Thyroid Cancer Survivors

Conditions
-----------------
Thyroid Cancer

Intervention / Treatment
-----------------
* Other: Center-based exercise program
* Other: Home-based exercise program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults ≥18yrs of age with well-differentiated thyroid cancer and self-reported fatigue any time after initial treatment of thyroid cancer. English speaking Able to provide consent Exclusion Criteria: Pregnant Medullary thyroid cancer Anaplastic thyroid cancer Physical limitations to perform exercise

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Center-based exercise group<br>Subjects will be enrolled into a center-based exercise program. | Other: Center-based exercise program<br>* A routine individualized exercise prescription and supervised exercise sessions at a minimum of once per week for 11 weeks with an exercise prescription updated monthly.<br>|
| Experimental: Home-based exercise group<br>Subjects will be enrolled into a home-based exercise program. | Other: Home-based exercise program<br>* A one-time supervised exercise session with Cardiac Rehabilitation staff and a routine individualized exercise prescription for exercises to do at home. Additionally, weekly telephone followup calls by a clinical exercise physiologist for 11 weeks consisting of an exercise tip.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue symptoms | Change in fatigue symptoms measured using the self-reported Fatigue Symptom Inventory (FSI) survey | Baseline, 12 weeks | 
| Physical activity | Change in physical activity measured using the self-reported International Physical Activity questionnaire | Baseline, 12 weeks |
MR Quality + Diagnostic Performance for CHC Diagnosis - Gadoxetic Acid, Gadoteric Acid and P03277 Comparison

Study Overview
=================
Brief Summary
-----------------
Compare diagnostic MRI performance of gadoteric acid, gadoxetic acid and P03277 for suspected CHC nodules less than 3 cm, using LIRADS criteria

Official Title
-----------------
MR Quality + Diagnostic Performance for CHC Diagnosis - Gadoxetic Acid, Gadoteric Acid and P03277 Comparison

Conditions
-----------------
Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Diagnostic Test: MRI diagnostic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who had all three MRI scans as part of the diagnosis of the same suspected CHC lesion(s) Reference diagnosis obtained for suspected CHC nodules by a diagnostic algorithm taking into account histology, imaging and follow-up Exclusion Criteria: Delay between first MRI and 3rd MRI greater than 3 months

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: MRI diagnostic|no intervention, patient only have MRI|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| compare diagnostic MRI performance of gadoteric acid, gadoxetic acid and P03277 for suspected CHC nodules | the evaluation criteria will be the classification of each nodule according to the LiRADS citeria | 3 months |
eegCap Application in Paediatrics wiTh redUced GCS in REsus

Study Overview
=================
Brief Summary
-----------------
Children frequently present with altered or reduced consciousness levels to emergency departments. By using EEG monitoring, subclinical seizure activity may be detected, leading to earlier pharmacological intervention and improved outcomes. Post-ictal phases that may be interpreted as seizure activity may become less over-treated. A feasibility study will ascertain if EEG monitoring can be applied successfully in this cohort, within a specified time period, obtaining minimum artefact (defined as < 25% artefact). EEG recordings will not be used to guide clinical management during this feasibility study.

Detailed Description
-----------------
See study protocol attached

Official Title
-----------------
CAPTURE:eegCap Application in Paediatrics wiTh redUced GCS in REsus

Conditions
-----------------
Status Epilepticus, Altered Level of Consciousness, Non-epileptic Seizures, Epilepsy, Encephalopathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children between 0 and 15 years and 11 months who present to Resuscitation Room, ED, CUH with a Glasgow Coma Scale (GCS) < 11 or, a reduction in baseline GCS in the case of children with significant neurodisability at baseline Exclusion Criteria: Polytrauma Open head wounds Unstable airway or requirement for bag and mask ventilation, where cap application would affect clinical management

Ages Eligible for Study
-----------------
Minimum Age: 0 Months
Maximum Age: 176 Months

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of children who had EEG monitoring applied within twenty minutes and obtainment of an interpretable EEG recording with less than 25% artefact. |  | Anticipated 12 month study period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
EEG, Emergency Department, Paediatrics, Reduced Glasgow Coma Scale (GCS)
Study Assessing Dosing Time and Calcium and Vitamin D on the Relative BA of 35 mg DR Risedronate Dosed With Food

Study Overview
=================
Brief Summary
-----------------
Randomized, open-label, single dose, 3-treatment, 3-period crossover study, with a 14- to 17-day washout period between doses. The study will consist of a screening visit, study center admission (preceding Treatment Periods 1, 2 and 3), 3 treatment periods (4 days each), 1 washout period (14 to 17 days separating periods 1, 2 and 3), and exit procedures.

Official Title
-----------------
A Crossover Study to Assess the Relative BA of Delayed-release Risedronate Compared When Dosed With Either Dinner, Breakfast or Breakfast Plus a Calcium/Vitamin D Tablet

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

Intervention / Treatment
-----------------
* Drug: 35 mg risedronate DR tablet
* Drug: 35 mg risedronate DR tablet
* Drug: 35 mg risedronate DR tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female, 40 to 70 years of age non-lactating and either surgically sterile or postmenopausal body mass index less than or equal to 32 kg/m2 at screening Exclusion Criteria: no use of a bisphosphonate within 1 month no history of GI disease no use of any medications within 7-14 days prior to scheduled dosing day

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A<br>35 mg risedronate DR tablet administered within 5 minutes after completing a standard breakfast and taking one Caltrate® 600+D tablet | Drug: 35 mg risedronate DR tablet<br>* 35 mg risedronate DR oral tablet administered within 5 minutes after completing a standard breakfast and taking one Caltrate® 600+D tablet<br>|
| Experimental: Treatment B<br>35 mg risedronate DR oral tablet administered within 5 minutes after completing a standard dinner | Drug: 35 mg risedronate DR tablet<br>* 35 mg risedronate DR oral tablet administered within 5 minutes after completing a standard dinner<br>|
| Active Comparator: Treatment C<br>35 mg risedronate DR oral tablet administered within 5 minutes after completing a standard breakfast | Drug: 35 mg risedronate DR tablet<br>* 35 mg risedronate DR oral tablet administered within 5 minutes after completing a standard breakfast<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative BA of DR Risedronate dosed: After breakfast and with calcium/vitamin D tablet, compared to DR Risedronate dosed after breakfast After dinner compared to DR Risedronate administered after breakfast. |  | 72 hours post-dose |
Intrauterine Insemination and Luteal Fase Support

Study Overview
=================
Brief Summary
-----------------
The objective is to test the hypothesis that luteal phase support with vaginal progesterone leads to a higher clinical pregnancy rate (primary outcome) and live birth rate (secondary outcome) when compared to no luteal phase support in a program of intrauterine insemination (IUI) after controlled ovarian stimulation with gonadotrophins. Additionally, the length of the luteal phase will be recorded (secondary outcome) in order to detect luteal phase defects/insufficiencies in the absence of luteal phase suppletion as well as luteal phase prolongation in case of luteal phase support which may be a burden for the patients waiting for the outcome of the treatment.

Official Title
-----------------
Impact of Luteal Phase Support With Vaginal Progesterone on the Clinical Pregnancy Rate in Intrauterine Insemination Cycles Stimulated With Gonadotrophins: a Prospective Randomized Multicentre Study.

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Drug: crinone (progesterone 8%, vaginal application)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with an indication for IUI: unexplained infertility mild male factor infertility minimal-mild endometriosis Women: first IUI cycle ever normal ovulatory cycles (26-32d) age<43,BMI≤30 presence of at least one patent tube on hysterosalpingography and/or laparoscopy normal uterine cavity (ultrasound, hysterosalpingography, or laparoscopy) Men: Total motile count ≥ 5 Million/ml after capacitation Exclusion Criteria: Patients with contra-indication for pregnancy , infertility or progesterone use.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 43 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental<br>Luteal Phase support | Drug: crinone (progesterone 8%, vaginal application)<br> <br> |
| No Intervention: control<br>No luteal Phase support | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical pregnancy rate per IUI cycle |  | by ultrasound at ± 5 to 6 weeks after IUI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| live birth rate per IUI cycle |  | 40 weeks after IUI | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intrauterine insemination, luteal phase, gonadotrophins
Asthma Patient Survey Study to Assess Asthma Effect and Medication in Finland

Study Overview
=================
Brief Summary
-----------------
This study was aimed at clarifying how the asthma medication is used in practice and how asthma affects everyday life. Total of 106 GPs were asked to recruit patients using inhaled steroid as maintenance treatment for asthma to take part in a telephone survey. Altogether 142 patients were interviewed.

Official Title
-----------------
INSPIRE Asthma Patient Survey to Clarify the Use of Asthma Medication and Effects of Asthma in Everyday Life in Finland

Conditions
-----------------
Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed persistent asthma regular use of inhaled steroids and concomitant medication Exclusion Criteria: never been diagnosed COPD seasonal asthma

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 |
| --- | --- |
| 1<br>Asthma patients using inhaled steroids as maintenance treatment | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients perceptions about treatment of asthma, asthma medication and what are the most common triggers that cause exacerbations. |  | Single occasion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| How patients react to the first signs of worsening of asthma i.e. how they use asthma medication during stable phase and asthma exacerbation |  | Single occasion | 
| How asthma affects everyday life |  | Single occasion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma, use of asthma medication, asthma control, telephone survey, patient's perception
Clinical Observation of Coronary Arterial Microcirculation Dysfunction in Diabetic Patients With Non- Obstructive Coronary Artery Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the prevalence and degree of coronary arterial microcirculaiton dysfunction of non- obstructive coronary artery disease in patients with type 2 diabetes. Furthermore, the risk factors of coronary arterial microcirulation would be screened and identified.

Conditions
-----------------
Complications of Diabetes Mellitus, Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis non- obstructive coronary artery disease; Positive Treadmill exercise test; Positive Cardiac ECT test; Positive Holter test Exclusion Criteria: Diagnosis of myocardial infarction; Diagnosis heart failure; Diagnosis of chronic kidney disease; Diagnosis of heart valvular disease; Diagnosis of malignant tumor; Positive heart transplant history; Pregnant and lactating women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Non- obstructive coronary artery disease, non- diabetic<br>Clinical evidences such as Holter, Treadmill exercise test and cardiac ECT support myocardial ischemia. CAG showed 20%-70% arterial stenosis. Patients are diagnosed without diabetes. | |
| Non- obstructive coronary artery disease, diabetic<br>Clinical evidences such as Holter, Treadmill exercise test and cardiac ECT support myocardial ischemia. CAG showed 20%-70% arterial stenosis. Patients are diagnosed with type 2 diabetes. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The coronary microcirculation dysfunction is measured by index of microcirculatory resistance |  | 10 minutes after diagnosis is made by CAG |