linjc16/ctgov huggingface dataset:
Quantification of Fetal Brains' Sulci Along Gestation

Study Overview
=================
Brief Summary
-----------------
Gyrogenesis is an ontogenic process that transforms the smooth (lissencephalic) cortex toward its mature, convolved (gyrencephalic) state. A tortuous, branching and deepening pattern of sulci and fissures outlines for a well-developed cortex. The aim of this study is to find an algorithm that can detect the sulci in ultrasound images of fetus' brain and measure the length of it. This algorithm can be used for research demands like learning the development of the brain from embryo stages until the birth of the baby

Official Title
-----------------
Detecting and Quantifying Sulci and White Matter in Fetus' Brain Along the Third Stage of Gestation

Conditions
-----------------
Fetal Brain Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women between the ages of 18-35 Gestational age between 25-40 weeks Low risk pregnancies Exclusion Criteria: Multiple gestation Fetal brain abnormality

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

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

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 |
| --- | --- | --- |
| morphological changes of the developing fetal brain | Ultrasound measurements of the fetal brain sulcation by a computerized algorithm | 9 months |
Study of AK156 in Primary Osteoporosis Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the efficacy and safety of AK156 in Japanese patients with primary osteoporosis.

Official Title
-----------------
Phase 3 Study of AK156 in Primary Osteoporosis Patients

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Drug: AK156
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with primary osteoporosis Patients who have vertebral fractures at the time of screening Exclusion Criteria: Patients diagnosed with secondary osteoporosis Patients with a current uncontrolled medical disorder or other condition which makes the patient unsuitable for the study

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 89 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 |
| --- | --- |
| Experimental: 1.<br> | Drug: AK156<br>* zoledronic acid (i.v.)/year + daily calcium and vitamin D for 2 years<br>|
| Placebo Comparator: 2.<br> | Drug: Placebo<br>* placebo (i.v.)/year + daily calcium and vitamin D for 2 years<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New vertebral fractures | Reduction in the incidence rate of new fragility vertebral fractures | 2 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vertebral fractures (worsening and new) | The incidence rate of fragility vertebral fractures (worsening and new) | 2 Years | 
| Clinical fractures | The incidence rate of Clinical fractures | 2 Years | 
| Bone mineral density | The percent change from baseline in bone mineral density of lumbar spine and hip | 2 Years | 
| Bone metabolic marker | The percent change from baseline in bone metabolic marker | 2 Years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AK156
CHD Risk, Behavioral Stress and Reproductive Hormones

Study Overview
=================
Brief Summary
-----------------
To determine the effects of behavioral stress and reproductive hormones on coronary heart disease (CHD) risk.

Detailed Description
-----------------
DESIGN NARRATIVE: The behavioral study determines whether sex differences in stress responses may assist in explaining sex differences in CHD. The ongoing research program has documented differences in psychological responses to acute stress between men and women and among women who vary in reproductive hormone status. Building on these findings, but also departing from previous efforts in strategy and design, five studies are conducted. Study 1 measures hemodynamic measures that underlie sex differences in cardiovascular responses to behavioral challenge. Using longitudinal designs, Study 2 compares women's stress responses prior to and three months after surgical menopause, whereas Study 3 compares healthy women's stress responses prior to and three months after a temporary menopause due to the administration of a GnRH agonist. In both studies, some women after the second testing are administered estrogen replacement therapy and stress responses are again measured. Thus, Studies 2 and 3 also address the effects of estrogen replacement therapy on stress responses. These studies gain significance from the fact that surgical menopause is associated with heightened risk for CHD, whereas estrogen replacement therapy is associated with protection from CHD. Study 4 describes the extent of sex differences in exposure to psychological stressors among men and women from two levels of social class. Social class is included in the design because it is a risk factor for psychological stress and for CHD. The final study tests the hypothesis that sex differences in stress responses are attenuated during a task within a feminine area of competency and accentuated during a task within a masculine area of competency. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Coronary Disease, Heart Diseases, Menopause

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- | --- |
LGG/BB12-pastille Study

Study Overview
=================
Brief Summary
-----------------
We want to study the effect of short-term consumption of probiotics (a mixture of L. rhamnosus GG and B. lactis BB-12)on the composition of the oral flora.

Official Title
-----------------
LGG/BB12-pastille Study

Conditions
-----------------
Probiotics

Intervention / Treatment
-----------------
* Dietary Supplement: Probiotics in an pastille
* Dietary Supplement: Control pastille


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects healthy, 20-30 yrs of age Exclusion Criteria: Subjects not healthy, too old/young

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 30 Years

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

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

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

Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic pastille<br>Test group | Dietary Supplement: Probiotics in an pastille<br>* Test group<br>|
| Active Comparator: Control pastille<br>Control group | Dietary Supplement: Control pastille<br>* Control group<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Counts of mutans streptococci |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of plaque |  | 4 weeks |
Helium:Oxygen Noninvasive Positive Pressure Ventilation in Patients Exposed to Sulfur Mustard

Study Overview
=================
Brief Summary
-----------------
to assess the effect of Heliox with Noninvasive positive pressure ventilation to decrease dyspnea and improve physiologic and respiratory measures in patients with a previous exposure to Sulfur Mustard gas.

Official Title
-----------------
Helium:Oxygen Versus Air:Oxygen Nonivasive Positive Pressure Ventilation in Patients Exposed to Sulfur Mustard

Conditions
-----------------
Bronchiolitis, Chronic Bronchitis

Intervention / Treatment
-----------------
* Drug: helium:oxygen mixture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: exposure to sulfur mustard worsening dyspnea during the last 10 days respiratory rate of >25/min arterial pH<7.35 PaCO2 of >50 mmHg PaO2 of <50 mmHg Exclusion Criteria: recent pneumothorax (<1 month) severe respiratory failure or hemodynamic instability with forthcoming intubation FIO2 of <0.4 impaired consciousness or absence of patient cooperation facial lesions precluding NIPPV

Ages Eligible for Study
-----------------
Minimum Age: 38 Years
Maximum Age: 59 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: helium:oxygen mixture<br> <br> |

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
-----------------
noninvasive ventilation, helium, oxygen, sulfur mustard, chronic bronchitis, bronchiolitis
The Suitability of Sniff Dog as a Tool in Screening Tumors

Study Overview
=================
Brief Summary
-----------------
Previous studies have demonstrated that sniff dogs can identify cancer patients from healthy subjects through sniffing exhaled breath air or blood or serum or urine or feces. It is hypothesized that sniff dogs may be used as a tool in screening cancer patients in health examination. Trained dogs will sniff serum from participants who are attending the annual health examination to identify potential or high risk subjects, and the results will be compared with the outcome of the traditional health examination, and the high risk subjects will be followed periodically for at least five years.

Official Title
-----------------
The Suitability of Sniff Dog as a Tool in Screening Tumors-- a Prospective Observational Study

Conditions
-----------------
Neoplasia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: old than 20 years currently without cancer diagnosed with pathological examination allow the study team to examine his/her case history and incoming record Exclusion Criteria: cancer patients with pathological diagnosis who does not allow the study team to examine his/her case history and incoming record

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| faculty staff and their adult family members<br>faculties and their adult family members of the Third Xiang-Ya Hospital | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity in screening cancer patients | The results that obtained from the dogs will be compared with these of the pathological examinations. Sensitivity = the No. of patients identified by the dogs as cancers / the No. of patients suffering from cancer confirmed by pathological examination. Specificity = No. of subjects signaled by the dog as non-cancers / No. of subjects confirmed by pathological examination or the currently used methods as non-cancer subjects or at the end of the study, 5 years later still without cancer. | up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behavior patterns of sniff dogs to different diseases | The behavior (lying before the tank for positive, neglecting the tanks) of the dog will be recorded and compared with the results of the pathological examination. | up to 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lung cancer, breast cancer
Specific Clinical Experience Investigation for Long-term Use of Exenatide (Byetta Subcutaneous Injection)

Study Overview
=================
Brief Summary
-----------------
The purpose of this investigation is to describe general safety profile of type II Diabetes Mellitus (DM) Japanese patients under exenatide therapy in real world medical practices

Detailed Description
-----------------
Specific Clinical Experience Investigation for long-term use of exenatide (Byetta subcutaneous injection).

Official Title
-----------------
Specific Clinical Experience Investigation for Long-term Use of Exenatide (Byetta Subcutaneous Injection)

Conditions
-----------------
Type 2 Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patient diagnosed with Type 2 Diabetes Mellitus and who is naive patient with Byetta.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Byetta<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event incidence. | Number of Adverse Drug Reactions | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change of HbA1c. | Change value of HbA1c from baseline as mean / median / minimum / max. | 3 years | 
| Amount of change of total score of Diabetes Treatment Satisfaction Questionnaire (DTSQs). | The Diabetes Treatment Satisfaction Questionnaire (DTSQs) was designed to make the initial assessment of total diabetes treatment satisfaction, treatment satisfaction in specific areas, and perceived frequencies of hyperglycemia and hypoglycemia. Each of the 8 items are scored on a scale of 0-6 where 0= very dissatisfied and 6= very satisfied. The higher score, the greater satisfaction with the treatment. | 3 years | 
| Mean change in weight. |  | 3 years | 
| Mean change in blood pressure. |  | 3 years. | 
| Mean change in lipid metabolism. | Change value of lipid metabolism from baseline as mean / median / minimum / max. | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes Mellitus (DM), Byetta, Exenatide
Early Post-marketing Study of Daclatasvir (Daklinza®) + Asunaprevir (Sunvepra®) in the Treatment of Chronic Hepatitis C (CHC) in Adults

Study Overview
=================
Brief Summary
-----------------
The primary objective of the study is to determine the number of adverse events (AEs) reported by chronic hepatitis C (CHC) patients receiving at least 1 dose of daclatasvir (DCV) and asunaprevir (ASV) at the 2 sentinel sites and that have been reported through the Mexican Health Authority's AE surveillance system during a specified 24-month study period. The secondary objective is to describe AEs reported by CHC patients receiving treatment with DCV and ASV treated by doctors at participating sentinel sites for the National Pharmacovigilance Center (CNFV) in Mexico during a specified 24-month study period.

Official Title
-----------------
Early Post-marketing Study of Daclatasvir (Daklinza®) + Asunaprevir (Sunvepra®) in the Treatment of Chronic Hepatitis C (CHC) in Adults

Conditions
-----------------
Hepatitis C

Intervention / Treatment
-----------------
* Other: Non-Interventional


Participation Criteria
=================
Eligibility Criteria
-----------------
For more information regarding Bristol-Myers Squibb (BMS) Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: at least 18 years of age with CHC, GT-1 treatment-naïve and treatment-experienced (null or partial) responders intolerant to interferon (IFN) with or without cirrhosis Exclusion Criteria: patients who received DCV and ASV as part of a clinical trial patients who received DCV and ASV for any indication other than that which is locally approved contraindications included in the approved Mexican prescribing information Other protocol defined inclusion/exclusion criteria could apply

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 |
| --- | --- |
| DCV + ASV at a sentinel site<br>patients with chronic hepatitis C (CHC) who are being given at least 1 dose of daclatasvir (DCV) and asunaprevir (ASV) for the treatment and cure of CHC at the sentinel sites for the National Pharmacovigilance Center (CNFV) in Mexico. | Other: Non-Interventional<br>* Non-Interventional<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of adverse events (AEs) reported by patients treated with at least one dose of daclatasvir (DCV) and at least one dose of asunaprevir (ASV) and reported to the Health Authority (HA) during a specified period. |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The adverse events (AEs) reported to the Health Authority (HA) during a specified period in table format identifying the report number, patient Identification number, and type of adverse event (AE). |  | 24 months |
Secondary Prevention After Coronary Bypass Surgery

Study Overview
=================
Brief Summary
-----------------
Despite immediate symptomatic success after coronary bypass surgery in patients with coronary artery disease, this effect is not sustained over time since risk factors for coronary artery disease are still in place. The role of secondary prevention becomes increasingly important as it can potentially decrease or eliminate the need for another intervention in these high risk subjects. This project seeks to evaluate the effect of emphasizing secondary prevention measures in this patient population during hospital admission and through six months post-discharge.

Official Title
-----------------
Secondary Prevention After Coronary Bypass Surgery: A Pilot Study

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Other: Education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects over the age of 18 who will undergo a CABG procedure and who have given written informed consent Exclusion Criteria: Subjects under the age of 18 or who are unable to give consent on their own behald

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: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br>Standard care | |
| Experimental: 2<br>Educational session with pharmacist, nutritionist, and cardiac rehabilitation nurse | Other: Education<br>* Educational session with pharmacist, nutritionist, and cardiac rehabilitation nurse<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| compliance with medications and lifestyle changes |  | Month 1, 3, 6 and 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
coronary artery disease, CABG
Implementation of a Multidimensional Quality Model

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to measure the experiences about the current care of the patients, their kin and staff by a quickscan based on a multidimensional quality model. Further more we want to define the psychometric characteristics of the quickscan.

Official Title
-----------------
Implementation of a Multidimensional Quality Model

Conditions
-----------------
Management Systems, Quality Improvement, Public Health

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years old Treated/working in the hospital Exclusion Criteria: Do not understand Dutch

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Quickscan for patients and their kin<br>Patients and/or kin who are treated in the hospitals will be invited to fill in the quickscan. | Other: No intervention<br>* Measure the experiences of the current care<br>|
| Quickscan for healthcare professionals<br>Healthcare professionals working in the hospitals will be invited to fill in the quickscan. | Other: No intervention<br>* Measure the experiences of the current care<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perception of the organisation of care | Patients, kin and healthcare professionals will give their perception regarding the organisation of care | During their treatment or work experience in the hospital |