linjc16/ctgov huggingface dataset:
Early Intervention in Very Preterm Children

Study Overview
=================
Brief Summary
-----------------
The aim of the present study is to examine the effectiveness of a short, highly structured parent based speech intervention program on speech development in very preterm children with a Speech Sound Disorder (SSD) at 2 years of age. The hypothesis of this study is that early intervention on speech development is effective in improving the speech development in preterm children with SSD at 2 years of age compared to a no treatment group (usual care at this age).

Official Title
-----------------
Early Intervention for Speech Sound Disorder in Very Preterm Children

Conditions
-----------------
Prematurity, Speech Sound Disorder

Intervention / Treatment
-----------------
* Other: Early parent-based speech intervention program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: birth weight < 1500 grams or gestational age < 32 weeks singleton birth no major neurodevelopmental disabilities, and Dutch speaking family background

Ages Eligible for Study
-----------------
Minimum Age: 24 Months
Maximum Age: 27 Months

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br> | Other: Early parent-based speech intervention program<br>* Seven 1h sessions during a three-month period.<br>* Other names: Prematurity, Speech Sound Disorder, Early Intervention;|
| No Intervention: Control group<br> | Other: Early parent-based speech intervention program<br>* Seven 1h sessions during a three-month period.<br>* Other names: Prematurity, Speech Sound Disorder, Early Intervention;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of acquired consonants produced by the child |  | 12 months after the onset of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Speech sound development
Long-term Study to Evaluate the Safety of Dutogliptin/PHX1149T in Subjects With Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate that dutogliptin/PHX1149T is safe and tolerable.

Detailed Description
-----------------
In this study, open-label dutogliptin/PHX1149T will be offered to subjects who complete a Phase 3 core protocol and wish to continue treatment with dutogliptin. This will allow for the collection of long-term safety data and will also demonstrate long-term effects on HbA1c and fasting blood glucose.

Official Title
-----------------
An Open Label, Multi-Center, Long-Term Extension Study to Evaluate the Safety of PHX1149T/Dutogliptin in Subjects With Type 2 Diabetes Mellitus

Conditions
-----------------
Type 2 Diabetes Mellitus, Type 2 Diabetes

Intervention / Treatment
-----------------
* Drug: dutogliptin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Completion of all required visits of a qualifying Phase 3 core protocol (e.g., Visit 8/Day 196 of PHX1149-PROT301) Current treatment of Type 2 diabetes mellitus as in PHX1149-PROT301 Exclusion Criteria: Except for Type 2 diabetes, any other uncontrolled, serious pulmonary, cardiovascular, hematologic, renal, gastrointestinal, endocrine, neurological, proliferative, immunosuppressive, psychiatric, or urogenital disorder; or diseases of skin and its appendages, the eyes, ears, nose, or throat Any condition, disease, disorder or clinically relevant laboratory abnormality which, in the opinion of the investigator, would jeopardize the patient's appropriate participation in this study or obscure the effects of treatment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: dutogliptin|dutogliptin 400 mg, once daily tablet|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate safety and tolerability of dutogliptin |  | Two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate maintenance or lowering of HbA1c |  | Two years | 
| To demonstrate maintenance or lowering of fasting blood glucose |  | Two years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetes, DPP4 inhibitor, dutogliptin, PHX1149
Impact of Oropharyngeal Administration of Colostrum in the First 48 Hours of Life Term Premature Newborn ≤ 32 Weeks of Amenorrhea

Study Overview
=================
Brief Summary
-----------------
Colostrum is the first milk secreted by the mother when the tight junctions of mammary epithelium open, allowing the cellular transport of a multitude of components and immunological protective derivatives of the maternal circulation to the milk, and especially immunoglobulins A type. Colostrum is not given to preterm neonates. The assumption behind this work is that the oro pharyngeal administration of colostrum early in preterm infants could help deliver an oral immunotherapy even before the installation of enteral nutrition, through interactions with lymphoid tissues of the oropharynx and the gastrointestinal tract. This practice would improve the digestive tolerance and the establishment of enteral feeding, the decrease in mucosal inflammatory phenomena, but also to provide any protection against subsequent infections. Finally, there could be an improvement in the secondary immune tolerance with a decrease in the occurrence of allergic phenomena.

Conditions
-----------------
Infant, Premature

Intervention / Treatment
-----------------
* Biological: Colostrum feeding
* Biological: formula for preterm infants


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: New premature infant with a term weight ≤ 32 weeks amenorrhea at Nice University Hospital Mother seronegative for HIV Exclusion Criteria: Neonates with congenital pathologies immediate prenatal or neonatal diagnosis will not be included. Therapy of the mother incompatible with breastfeeding during pregnancy
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 |
| --- | --- |
| Experimental: Colostrum<br> | Biological: Colostrum feeding<br> <br> |
| Experimental: Witness<br> | Biological: formula for preterm infants<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measuring caloric intake (number of days required for the calorie intake) | number of days required for the calorie intake to 130 kcal / kg / day can be delivered exclusively enterally | 2 days |
Systemic Lupus and Adverse Pregnancy Outcome

Study Overview
=================
Brief Summary
-----------------
prospective analytical study of all pregnant ladies with systemic lupus in Beni-suef localities

Official Title
-----------------
Systemic Lupus and Pregnancy Outcome in Benisuef Localities

Conditions
-----------------
Systemic Lupus Erythematosus, Pregnancy Complications

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all pregnant ladies with settled diagnosis of systemic lupus all pregnant ladies who first diagnosed as systemic lupus during current pregnancy Exclusion Criteria: -

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 |
| --- | --- | --- |
| maternal outcome | Number of patients who have abortion,preterm labor,preeclampsia,eclampsia,accidental hemorrhage,oligohydramnios | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fetal outcome | Number of patients who have abortion,prematurity,Intrauterine growth restriction,intrauterine fetal death,still birth,low birth weight,neonatal death | 3 years |
Quality of Life Assessment in Patients Who Are Under Surveillance for IPMN

Study Overview
=================
Brief Summary
-----------------
Over 500 patients were participating in the IPMN follow up between september 2014 and august 2016 at the Helsinki University Hospital. In this study we are going to determine the effects of the IPMN surveillance on the quality of life and anxiety levels of the patients.

Detailed Description
-----------------
Intraductal papillary mucinous neoplasm (IPMN) is a cystic neoplasm of the pancreas. The incidence of the tumors has increased during the last years. Some of the IPMN-tumors develop over time increasing dysplasia and at the end IPMN associated carcinoma. All IPMN-patients are kept under surveillance because of the cancer risk. This follow up can last decades and includes MRI and blood samples every 6 to 12 months. This is very expensive and the effects on the patients quality of life have not been studied before to our knowledge. This study determines the effects of the surveillance on the patients quality of life and anxiety levels. The study will be conducted by 15D- quality of life -questionnaire and state-trait anxiety inventory (STAI) -questionaire. Both will be send to the patients before a IPMN follow up MRI and 3 months later. It is anticipated that the anxiety and the effect on the quality of life would be the highest right before the MRI and would normalize a few months after the MRI.

Official Title
-----------------
Intraduktaalisen Papillaarisen Musinoosisen Neoplasian Vuoksi Seurannassa Olevien Potilaiden elämänlaatu

Conditions
-----------------
IPMN, Quality of Life

Intervention / Treatment
-----------------
* Diagnostic Test: IPMN follow up


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients under IPMN surveillance Exclusion Criteria: no exclusion criteria, all patients under IPMN surveillance are included
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: IPMN follow up|Follow up with MRI and laboratory blood tests|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the quality of life and anxiety | 15D quality of life and STAI -questionnaire | Before and 3 months after IPMN follow up MRI |
Male Breast Cancer Summa Health System/Akron City Hospital Experience 1995-2007

Study Overview
=================
Brief Summary
-----------------
The primary goal of this retrospective study is to evaluate the male breast cancer patient population at Summa Health System/Akron City Hospital over a period of 18 years and compare the findings to historical data. The objectives are to: identify risk factors. evaluate stage and histology at the time of presentation. document treatment modalities and outcomes. analyze outcomes for comparison to historical data.

Official Title
-----------------
Male Breast Cancer Summa Health System/Akron City Hospital Experience 1995-2007

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male breast cancer patients diagnosed and/or treated at Summa Health System/Akron City Hospital from the reference year of 1995 through 2007.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| Retrospective chart review to evaluate the male breast cancer patient population at Summa Health System/Akron City Hospital over a period of years and compare the findings to historical data. |  | Chart review from 1995-2007 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
male breast cancer, Male breast cancer patients diagnosed and/or, treated at Summa Health System/Akron City Hospital, from the reference year of 1995 through 2007.
Effects of Exposure to Biomass-burning Air Pollution on Lung Function, Heart Rate Variability and Inflammatory Markers in Sugarcane Workers

Study Overview
=================
Brief Summary
-----------------
Introduction: Non-mechanized sugar cane harvesting preceded by burning, an important and prevalent professional activity of agribusiness segment of the Brazilian economy, exposes workers and people of neighboring towns to high concentrations of pollutants and, therefore, potentially several risks to health hazards. Objectives: Assessing cardiopulmonary impacts and inflammatory markers in sugarcane workers and volunteers from a nearby town in non-harvest and harvest periods.

Official Title
-----------------
Effects of Exposure to Outdoor Air Pollution From Biomass Burning on Lung Function, Heart Rate Variability and Systemic Inflammatory Blood Markers in Sugarcane Workers

Conditions
-----------------
Lung Function, Heart Rate Variability, Oxidative Stress, Systemic Inflammatory Response

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The criteria for inclusion in the study were: age between 20 and 40 years, male gender and being non-smokers (or former-smokers for at least a year and a smoking history of less than 20 pack-years). Exclusion Criteria: Exclusion criteria were history of cardiovascular or respiratory disease, the use of bronchodilator, non-steroidal anti-inflammatory drugs, anticoagulants or antiplatelet drugs and statins.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Controls<br>Healthy male volunteers, non-smokers, 20-40yo, living in the city of Mendonça, São Paulo-Brazil. | |
| Sugarcane Workers<br>Healthy male volunteers, non-smokers, 20-40yo, sugarcane workers, living in the city of Mendonça, São Paulo-Brazil. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung function | Measurements of lung function in pre harvest and during harvest period | six months | 
| Heart rate variability | To evaluate parameters of heart rate variability in pre harvest and during harvest periods | six months | 
| Oxidative stress | Measurement of blood levels of antioxidant enzymes and malonaldehyde | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Environmental evaluation | Measurement of athmospheric concentration of particulate matter. | one year |
Study of Gene Activity in Fat and Muscle in Diabetics and Healthy Controls

Study Overview
=================
Brief Summary
-----------------
The aim of the present protocol is to study gene activity in fat and muscle tissue in type 2 diabetics and healthy volunteers after injection of E. coli endotoxin.We hereby hope to gain insight in some mechanisms behind the association between inflammation and insulin resistance.

Detailed Description
-----------------
Numerous studies have shown an association between low-grade inflammation and insulin-resistance in type 2 diabetics. It is also well-known that septic patients often develop insulin-resistance. The pathogenetic mechanisms behind the association between inflammation and insulin-resistance is not fully understood. In this study we create an experimental inflammation by giving E. coli endotoxin 0,3 ng/kg iv to type 2 diabetics and healthy controls. Muscle biopsies are taken at 0, 2, 4 and 6 hours after injection, while fat biopsies are taken 0, 2, 4, 6 and 8 hours after endotoxin. mRNA for adiponectin, leptin, PPAR-gamma, PGC-1, PAI-1 and cytokines in tissue is later measured by RT-PCR. Blood samples are drawn on an hourly basis until 8 hours after endotoxin injection for common biochemical analyses including white blood cell count. Plasma is spared and later analyzed for cytokines, PAI-1 and VCAM-1/ICAM-1.

Official Title
-----------------
Study of Gene Expression in Fat and Muscle Tissue in Type 2 Diabetics and Healthy Controls During Experimental Endotoxemia

Conditions
-----------------
Healthy, Type 2 Diabetes, Endotoxemia

Intervention / Treatment
-----------------
* Drug: Escherichia Coli Endotoxin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Type 2 diabetes Exclusion Criteria: Heart failure Lung disease Anti-coagulation treatment

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Escherichia Coli Endotoxin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gene expression evaluated by measuring mRNA via RT-PCR. Plasma cytokine content, PLasma PAI-1 content, endotoxemia score |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Arterial Pressure, heart rate, Temperature, |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Low-grade inflammation, insulin resistance, Metabolism, Type 2 diabetes, Endotoxemia, Fat tissue, Muscle tissue, RT-PCR
Clinical Impact of 16S rDNA PCR

Study Overview
=================
Brief Summary
-----------------
The main objective of this study is to evaluate the impact of a positive 16S rDNA PCR in various sites on patient's management. The secondary objectives of the protocol are: to evaluate bacterial identification performance to evaluate the effect of previous antibiotic therapy to analyze the management of discordant results between 16S PCR and culture identification

Official Title
-----------------
Clinical Impact of 16S rDNA PCR, a Monocentric Retrospective Study

Conditions
-----------------
Bacterial Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients that had a 16S rDNA PCR positive result in Strasbourg University Hospital laboratory from 2014 to 2018 Patients consent for this analysis of their past medical history Legal guardians consent for the analysis of their children's medical history Exclusion Criteria: Patients who express opposition for this study Incomplete clinical record

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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 |
| --- | --- | --- |
| Study of the modification of the care of the patients by the use of the 16S PCR |  | The period from Junuary 1st, 2014 to Dcember 31, 2018 will be examined |
Does Topical Steroid Treatment Impair the Adrenal Function?

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if topical steroids treatment for different skin diseases suppress the adrenal cortisol production.

Detailed Description
-----------------
Adrenocortical suppression is a potential complication of systemic corticosteroid treatement but also of non systemic therapy like topical therapy. The normalcy of hypothalamic-pituitary-adrenal axis ( HPA axis) of patients with chronic skin diseases like atopic dermatitis, pemphigus or psoriasis which are treated with topical steroids, will be assessed with the low dose (1mcg) adrenocortocotropin ( ACTH) stimulation test. During this test serum cortisol levels are measured before, 30 and 60 mn after intravenous administration of 1mcg of ACTH (synacthen).The results will be compared with age and sex matched subjects with normal HPA axis as assessed by low dose ACTH stimulation test.

Official Title
-----------------
Low Dose (1mcg) ACTH Stimulation Test for Assessment of the Hypothalamo-Pituitary- Adrenal Axis in Patients Treated With Topical Corticosteroids

Conditions
-----------------
Hypothalamus-Pituitary-Adrenal Axis Assessement, Topical Steroid Therapy in Chronic Skin Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients receiving daily topical steroids for at least two weeks on 10% or more of body surface. Exclusion Criteria: patients treated with any form of corticosteroids except topical steroids. patients with known pituitary disease pregnant patients

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
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
-----------------
secondary adrenal insuffiency, hypothalamus-pituitary-adrenal axis impairement, topical steroids