linjc16/ctgov huggingface dataset:
Effect of Bifidobacterium Lactis HN019 on Colonic Transit Time and Digestive Symptoms

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to investigate the dose response effect of Bifidobacterium lactis HN019 supplementation on colonic transit time and gastrointestinal symptoms.

Official Title
-----------------
A Three-Arm, Placebo Controlled, Double-Blind, Single Center Study to Evaluate the Impact of Probiotic Strain Bifidobacterium Lactis HN019 on Intestinal Well-Being, Colonic Transit Time and Digestive Discomfort

Conditions
-----------------
Gastrointestinal Symptoms

Intervention / Treatment
-----------------
* Dietary Supplement: Bifidobacterium lactis HN019
* Dietary Supplement: Bifidobacterium lactis HN019
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy males and females aged 25 to 65 years stool type 2-4 on the Bristol Stool Chart 1 to 3 bowel movements per week Exclusion Criteria: use of any probiotic product intended to improve gastrointestinal function within the 2 weeks preceding study entry major chronic and uncontrolled systemic medical conditions severe gastrointestinal conditions known to prolong CTT lactose intolerance chronic diarrhea gastric bypass surgery or lap band insertion for weight loss regular laxative use pregnant or breast-feeding women

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High dose probiotic<br>Bifidobacterium lactis HN019, 10 billion cfu/day | Dietary Supplement: Bifidobacterium lactis HN019<br>* Bifidobacterium lactis HN019, 10 billion cfu/day, once a day for 14 days<br>|
| Experimental: Low dose probiotic<br>Bifidobacterium lactis HN019, 1 billion cfu/day | Dietary Supplement: Bifidobacterium lactis HN019<br>* Bifidobacterium lactis HN019, 1 billion cfu/day, once a day for 14 days<br>|
| Placebo Comparator: Placebo<br>Placebo | Dietary Supplement: Placebo<br>* Placebo, once a day for 14 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Colonic transit time |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal symptoms |  | 14 days |
Early Identification of Brain Insult in Chorioamnionitis

Study Overview
=================
Brief Summary
-----------------
Premature breaking of the amniotic fluids during pregnancy caries high risk for infection of the amniotic fluid. One of the results of chorioamnionitis is brain injury of the fetus. Fetus' brain is highly vulnerable and could be harmed even by mild inflammation before fulminant infection is developed. The aim of this study is to identify, as early as, possible signs of brain injury. S100B protein will be used as a marker for brain insult. S100b level were associated with the occurrence and size of stroke and brain trauma in adults and children. Moreover, S100B crosses the membrane and its level in women with preterm labor was associated with brain injury of preterm infant. The study question is whether the levels of S100B in women with early amniotic fluids breakdown are associated with future brain injury of the infant, as assessed by head ultrasound and neurological examination.

Official Title
-----------------
S100B as a Marker for Fetal Brain Injury in Premature Rupture of Membranes

Conditions
-----------------
Chorioamnionitis, Cerebral Palsy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Rupture of the amniotic sac before 32 weeks Gestational age less than 32 weeks Singleton Exclusion Criteria: Intrauterine growth restriction Positive TORCH Fetus' brain malformation Fetus' brain hemorrhage Maternal medication with teratogenic effect

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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 |
| --- | --- | --- |
| Developmental assessment | Developmental assessment at 18 month Vineland Adaptive Behavior Scales Griffith Mental Development Scales | 18 month | 
| Developmental assessment | Developmental assessment at term and 3 month Neurological examination Test of infant motor performance | 3 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chorioamnionitis, S100B, Brain, Neuro-development
Investigating the Postprandial Glucose Metabolism After Treatment With Faster-acting Insulin Aspart in Subjects With Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of the trial is to investigate the postprandial glucose metabolism after treatment with faster-acting insulin aspart in subjects with type 1 diabetes.

Official Title
-----------------
A Randomised Trial Investigating the Postprandial Glucose Metabolism After Treatment With Faster-acting Insulin Aspart in Subjects With Type 1 Diabetes

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

Intervention / Treatment
-----------------
* Drug: Faster-acting insulin aspart
* Drug: insulin aspart


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female aged 18-64 years (both inclusive) at the time of signing informed consent Subjects diagnosed (clinically) with type 1 diabetes mellitus at least 365 days prior to the day of screening Body mass index 18.5-28.0 kg/m^2 (both inclusive) Exclusion Criteria: Smoker (defined as a subject who is smoking at least five cigarettes or the equivalent per day) who is not able or willing to refrain from smoking or use of nicotine gum or transdermal nicotine patches during the inpatient period Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Faster aspart<br> | Drug: Faster-acting insulin aspart<br>* Administered subcutaneously (S.C., under the skin).Subjects will be individually dosed.<br>|
| Active Comparator: Insulin aspart<br> | Drug: insulin aspart<br>* Administered subcutaneously (S.C., under the skin).Subjects will be individually dosed.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in plasma glucose concentration |  | From 0-1 hour after trial product administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of endogenous glucose production |  | From 0-6 hours after trial product administration | 
| Area under the serum insulin aspart concentration-time curve |  | From 0-6 hours after trial product administration |
Lunch Time Insulin Injection by School Nurse for Poorly Controlled Diabetes

Study Overview
=================
Brief Summary
-----------------
We hypothesize that checking blood sugar and taking long and short acting insulin before lunch at school may improve overall blood sugar control, grades, and decreases school absences in children and teens with poorly controlled T1DM.

Detailed Description
-----------------
The Diabetes Control and Complications Trial (DCCT), for type 1Diabetes (T1DM), showed the importance of intensified diabetes control in helping reduce complications associated with poorly controlled diabetes. However, adolescents with T1DM continue to be a high-risk population due to the difficulties in coping with the physical, emotional, and social demands associated with managing diabetes themselves. We propose to use the school nurse to help with lunchtime blood sugar monitoring (BSM) and with a lunchtime insulin injection. We want to see if this will improve blood sugar control, improve school grades, and decrease absences from school in adolescents with poorly controlled diabetes. Subjects will receive 12 weeks of this treatment to see if they will have improved glucose control. We hope to improve blood sugar control, school grades and decrease absences from school in teens with poorly controlled diabetes.

Official Title
-----------------
A School Intervention: Lunch Time Insulin Injections in Children With Poorly Controlled Type 1 Diabetes

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

Intervention / Treatment
-----------------
* Drug: glargine insulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Child with T1DM for at least 1 year Age 10-19 years Have a Hgb A1C greater than or equal to 9.0% but less than or equal 13.9% for at least 6 months. School must have a school nurse Exclusion Criteria: Child who has Type 2 diabetes Subject receiving home schooling

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 19 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: glargine insulin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1c |  | At the start of the study and again in 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urine microalbumin |  | At the beginning and the end of the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 1 Diabetes, Poorly controlled glucose, adolescents
Human Repeat Insult Patch Test to Evaluate Personal Lubricants

Study Overview
=================
Brief Summary
-----------------
The purpose of this test is to evaluate the sensitizing potential of a personal lubricant, as a result of repeated occlusive patch. The intervention will be applied for a total of 9 induction applications, followed by an approximately 2 week rest period, then followed by a 24-72 hour Challenge applications.

Conditions
-----------------
Erythema, Edema

Intervention / Treatment
-----------------
* Device: Chameleon Personal Lubricant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: good health as determined from screener signed and dated informed consent signed and dated HIPAA Form Exclusion Criteria: subjects on test at any other research laboratory or clinic known allergy or sensitivity to cosmetics and toiletries, including sunscreens, adhesives and/or topical drugs pre-existing dermatologic conditions which have been diagnosed by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study pre-existing other medical conditions (e.g. adult asthma, diabetes). treatment with antibiotics, antihistamines or corticosteroids within two weeks prior to initiation of the test chronic medication which could affect the results of the study (e.g., insulin, corticosteroids, antihistimines, steroidal or non-steroidal anti-inflammatory drugs [except for therapeutic maintenance dosage of aspirin], antibiotics, steroid inhalers, etc.) known pregnant or nursing women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 69 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy subject<br>Healthy subjects exposed to Chameleon personal lubricant via occlusive patch | Device: Chameleon Personal Lubricant<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients That Showed Sensitization Reaction to the Test Material at Challenge |  | 24, 48 and 72 hours after patch application |
Identifying Inflammatory Biomarkers of Chronic Obstructive Pulmonary Disease

Study Overview
=================
Brief Summary
-----------------
Chronic obstructive pulmonary disease (COPD) is a condition that is characterized by airway obstruction due to inflammation. Levels of inflammatory proteins may be linked to when and to what extent COPD develops. This study will use data collected during the Tucson Epidemiological Study of Airway Obstructive Disease (TESAOD) and its 33-year follow-up to determine the relationship between inflammatory protein expression and COPD.

Detailed Description
-----------------
COPD is a term that encompasses both chronic bronchitis and emphysema, two diseases that are characterized by airway obstruction that interferes with normal breathing. Airway inflammation can stem from exposure to harmful fumes in the air, chronic bacterial infections in the airways, and a genetic predisposition to an inflammatory response to these agents. In people with COPD, the airway inflammation may extend beyond the lungs and contribute to systemic symptoms and, ultimately, to an increased mortality risk. Markers of systemic inflammation have been identified, but the relationship between these markers and when and to what extent COPD develops has not been determined. This study will use data collected during the TESAOD and its 33-year follow-up to determine the relationship between COPD and the expression of various inflammatory proteins, including pro-inflammatory cytokines (e.g., IL-6, IL-8, TNF-alpha) and acute phase proteins (e.g., C-reactive protein, soluble CD14). This study will not recruit any new participants. Detailed respiratory phenotypic information and serum samples that were collected during the TESAOD study will be evaluated in conjunction with newly generated biomarker and protein information. No new phenotypic data or biological specimens will be collected in this study.

Official Title
-----------------
Serum Inflammatory Biomarkers as Predictors of COPD Morbidity and Mortality

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Enrolled in the Tucson Epidemiological Study of Airway Obstructive Disease (TESAOD)
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 |
| --- | --- | --- |
| COPD development defined as FEV1/FVC < 70% |  | up to 50 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COPD progression defined based on decline of lung function |  | up to 50 years | 
| Mortality |  | up to 50 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, Emphysema, Chronic Bronchitis, Inflammation, CD14, TLR4, Proteomics
European Exposure Study

Study Overview
=================
Brief Summary
-----------------
The current study was designed to determine the exposure of adult smokers and non-smokers to cigarette smoke constituents through evaluation of selected biomarkers of exposure.

Detailed Description
-----------------
The purpose of the study was to provide a greater knowledge about human exposure to cigarette smoke constituents by evaluating selected biomarkers of exposure in smokers and non-smokers. This was an observational, parallel-group study to be conducted at multiple centres in the UK, Germany, and Switzerland. It was planned to enrol sufficient subjects such that at least 1440 subjects complete the study.

Official Title
-----------------
A European, Multi-centre Study to Determine the Exposure of Adult Smokers and Non-smokers to Cigarette Smoke Constituents

Conditions
-----------------
Smoking

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Smokers: Subjects who smoked commercial cigarettes exclusively (less than or equal to 10 mg ISO tar yield in Germany and the UK; less than or equal to 12 mg ISO tar yield in Switzerland) with a regular consumption of at least 1 cigarette per day over the last 12 months without change in brand over the previous 3 months. or Non-smokers: Subjects who did not smoke commercial cigarettes, hand-rolled cigarettes, cigars, pipes, bidis, and did not use other nicotine-containing products (patch, gum, lozenges etc.) within 1 year prior to Visit 1 and throughout the study duration. Exclusion Criteria: Female subjects with child-bearing potential were to be excluded if Subject was pregnant (or did not have negative pregnancy tests) or breast-feeding Subject did not agree to use an acceptable method of contraception

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- | --- |
| To determine the exposure of adult smokers and non-smokers to cigarette smoke constituents | To determine the exposure of adult smokers and non-smokers to the following cigarette smoke constituents: carbon monoxide, nicotine, acrolein, benzene, 1,3-butadiene, 4-aminobiphenyl (4-ABP), 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK), o-toluidine, pyrene (1-OHP), 2-aminonaphthalene (2-NA). | 2 consecutive visits within 14 days |
Biology of Thymic Tumors

Study Overview
=================
Brief Summary
-----------------
This is a retrospective analysis of biological characteristics of thymoma and thymic carcinoma patients.

Detailed Description
-----------------
The aim of the present study is to investigated the genetic alterations in tumor samples of a series of all WHO-defined subtypes of thymoma patients using high resolution microarray- comparative genomic hybridization (CGH) followed by hierarchical cluster analyses of the data to identify specific patterns of genetic aberrations and genes associated with each subtype. Moreover, tumor samples will be also investigated for some specific potential therapy targets by immunoistichemistry, mutation analysis, and fluorescence in situ hybridization (FISH) analysis. All these biological data will be correlated with clinical patients characteristics and survival data.

Official Title
-----------------
Biological Analysis of a Series of Thymoma and Thymic Carcinoma: Genetic Aberrations and Potential Therapy Targets.

Conditions
-----------------
Thymoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Availability of tumor tissue and patients with thymoma and thymic carcinoma Exclusion Criteria: NON Availability of tumor tissue and patients with thymoma and thymic carcinoma

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 |
| --- | --- | --- |
| Primary objective: to evaluate the presence of genetic alterations and specific potential therapy targets. |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary objective: to correlate the biological characteristics with clinical characteristics and survival data of patients. |  | one year |
Physical Fitness and Bone Structure Evaluation in Preschool Children

Study Overview
=================
Brief Summary
-----------------
Several studies have shown a high association between physical fitness and present and future health. Two of the main epidemics of the industrialized world are obesity and osteoporosis, diseases that could be prevented with early interventions from childhood. Both, physical activity and physical fitness have shown an association with these diseases, but tools for assessing them in early ages are still in development. Moreover, there is a lack of physical fitness reference values in preschool children and the relation of pathologies with physical fitness in these ages is still to be demonstrated. Therefore, through a simple and precise methodology displayed in the school and adapted for the younger we intend to: Provide a combination of safe and precise field tests to evaluate health related physical fitness in preschool children. Analyze body composition, risk of overweight, obesity and low mineral density and their relation with physical activity. The evaluation of these health-related physical fitness variables in early ages is of great interest to clinic and public health.

Official Title
-----------------
Physical Fitness and Bone Structure Evaluation in Preschool Children

Conditions
-----------------
Child, Preschool, Bone Structure, Physical Fitness

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy 3 to 5 years old Exclusion Criteria: Unhealthy Taking drugs affecting bone

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 5 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 |
| --- | --- | --- |
| Assessment of physical fitness in preschool children |  | 4 months evaluation |