linjc16/ctgov huggingface dataset:
Vitamin A and D Intake in Pregnancy, Infant Supplementation and Asthma Development

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to investigate if maternal intake of vitamins A and D from food and dietary supplements during pregnancy, and infant supplementation with these vitamins, are associated with development of asthma in the offspring.

Detailed Description
-----------------
This study was conducted as part of the research project Causal pathways for asthma funded by the Norwegian Research Council (2013-2017). The overall objective was to study if different pregnancy and early life exposures affect the risk of asthma and allergic diseases in children, and if these exposures exert their effects through epigenetic mechanisms, more specifically DNA methylation. For this project, including the current study, existing data from the Norwegian Mother and Child Study (MoBa file version 9, 115 398 children and 95 248 mothers) were linked with the Medical Birth Registry of Norway and the Norwegian Prescription Database. The MoBa study recruited pregnant women between 1999 and 2008, at approximately 18 weeks of gestation. Beginning 2002, women completed a food frequency questionnaire about dietary intake (food and supplements) in pregnancy. A panel of maternal plasma biomarkers, including plasma retinol and 25-hydroxyvitamin D2 and D3, was available for a random sample of around 3,000 women who gave birth in 2002 and 2003.

Official Title
-----------------
Norwegian Mother and Child Study - Causal Pathways for Asthma (CASPAR)

Conditions
-----------------
Asthma in Children

Intervention / Treatment
-----------------
* Other: Maternal vitamin A and D intake during pregnancy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Available maternal dietary intake data from pregnancy. Child turned 7 years by July 1st 2014. Exclusion Criteria: No maternal baseline questionnaire. Maternal energy intake <4,500 or > 20,000 kJ. No dietary supplement data. No linkage to national birth registry, or non-live births, or multiple births. Child death, or emigration, or unknown vital status.

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 7 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Maternal vitamin A and D intake during pregnancy|Dietary exposures during pregnancy and infant supplement use were assessed from maternal questionnaire report|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child asthma based on dispensed asthma medications | Dispensations of antiasthmatics (Anatomical Therapeutic Chemical Classification/ATC codes R03AC, R03BA, R03AK, and R03DC) registered in the Norwegian Prescription Database | A minimum of two dispensations around age 7 years |
Arterial Elasticity: A Substudy of Strategic Timing of AntiRetroviral Treatment (START)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find out if starting anti-retroviral therapy (ART) above 500 cluster-of-differentiation-4 (CD4)+ cells/milliliter (mL) ('early ART group') is better at reducing the stiffness of arteries than waiting to start ART until the CD4+ drops below 350 cells/mL ('deferred ART group'). Artery stiffness has been associated with an increased risk of cardiovascular (heart) disease, and could be useful as an earlier indicator of heart disease. In this study, the stiffness of arteries will be measured at study entry, months 4, 8, 12, and annually thereafter, using a tonometer on the participant's forearm.

Official Title
-----------------
Arterial Elasticity: A Substudy of Strategic Timing of AntiRetroviral Treatment (START)

Conditions
-----------------
HIV, Cardiovascular Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Simultaneous co-enrollment in the START study Signed informed consent Exclusion Criteria: Inability to ascertain waveform measurements that can be analyzed, i.e. atrial fibrillation

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 |
| --- | --- | --- |
| Change from baseline in large artery elasticity (LAE | Large artery elasticity is measured using a tonometer placed on the forearm. | baseline, Months 1, 4, 8, 12, annually thereafter | 
| Change from baseline in small artery elasticity (SAE) | Small artery elasticity is measured using a tonometer placed on the forearm. | baseline, Months 1, 4, 8, 12, annually thereafter | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in plasma markers of thrombosis and fibrinolysis | Citrated plasma will be collected and stored for central measurement of plasma markers of thrombosis and fibrinolysis in the future. | baseline, months 4, 8, 12, annually thereafter | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, cardiovascular diseases, vascular stiffness
Preoperative Highflow Nasal Oxygen Application in Cesarean Under General Anesthesia and Its Effects on Newborn.

Study Overview
=================
Brief Summary
-----------------
Preoperative Highflow Nasal Oxygen Application in Cesarean Under General Anesthesia and Its Effects on Newborn.

Detailed Description
-----------------
Patients who will undergo caesarean section under general anesthesia will be included in the study. In the study; preoxygenation is applied to the caesarean sections under general anesthesia in two ways. Group1 includes preoxygenation masked patients.

Official Title
-----------------
In the Study; Preoperative Highflow Nasal Oxygen Application in Cesarean Under General Anesthesia and Its Effects on Newborn.

Conditions
-----------------
Cesarean Delivery Affecting Newborn

Intervention / Treatment
-----------------
* Device: high flow nasal oxygen device (POİNT)
* Device: Face mask


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: over 18 years old; Patients undergoing elective ceserian operation Exclusion Criteria: Patients who refuse to participate in the study; Patients under emergency conditions.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: preoxygenation mask applied to the cesarean<br>In order to protect the mother from hypoxia, preoxygenation is performed with face mask before induction of anesthesia. | Device: Face mask<br>* In order to protect the mother from hypoxia, preoxygenation is performed with face mask before induction of anesthesia.<br>|
| Active Comparator: high flow nasal oxygenation applied to the ceserian<br>In order to protect the mother from hypoxia, preoxygenation is performed with high flow nasal oxygenation mask before induction of anesthesia. | Device: high flow nasal oxygen device (POİNT)<br>* With POINT device (peri-operative insufflatory nasal therapy); patients are heated at higher flow and applied to humidified oxygen.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| durations of stay | compare the durations of stay in the intensive care unit and in hospital | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
high flow nasal oxygen (POİNT)
Application of Real-time PCR Platform for Detection of Vittaforma Corneae Among Patients With Microsporidia Keratitis

Study Overview
=================
Brief Summary
-----------------
Diagnosis of patients with microsporiosis relies on pathological findings as well as laboratory detection of the causative organism. The conventional laboratory diagnosis of microsporiosis relies on microscopic visualization of the characteristic V. Corneae organisms. We develop a fully automated molecular platform for detection of Vittaforma corneae among patients with microsporidia keratitis.

Detailed Description
-----------------
Clinical infections due to Microsporidium spp. are protean and can be found in humans, insects, and fishes. The most common type of infection is keratitis and mostly is caused by Vittaforma corneae. Diagnosis of patients with microsporiosis relies on pathological findings as well as laboratory detection of the causative organism. The conventional laboratory diagnosis of microsporiosis relies on microscopic visualization of the characteristic V. Corneae organisms. Laboratory tools of identification of V. corneae include Gram staining, Giemsa staining, and modified Ziehl-Neelsen staining of scratching or biopsied specimens of infected cornea. However, the sensitivity of these staining methods is not acceptable due to the variation of specimen quality and quantity, processing, and low load of organisms in the specimens. The BD MAX system (Beckon Dickinson, Diagnostic Systems, Sparks, MD, USA) was introduced in clinical microbiology laboratory of NTUH in 2014 for Pneumocystis jirovecii detection. Till now, no data are available in using this system on V. corneae detection. We develop a fully automated molecular platform for detection of Vittaforma corneae among patients with microsporidia keratitis.

Official Title
-----------------
Application of Real-time PCR Platform for Detection of Vittaforma Corneae Among Patients With Microsporidia Keratitis

Conditions
-----------------
Microsporidia Keratitis, Microsporidial Keratoconjunctivitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with suspected microsporidia infection in eye Exclusion Criteria:

Ages Eligible for Study
-----------------
Maximum Age: 70 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 |
| --- | --- | --- |
| Microsporidia spp. analysis | Corneal scrapings were collected in patients. Gram stain, modiﬁed Kinyoun acid-fast stain, polymerase chain reaction (PCR) and gene analysis of the microsporidian 16S ribosomal RNA (rRNA) were examined for detection of Microsporidia spp. | 2016/1/1-2018/12/31 |
Comparison of Xtreme CT and DXA Bone Densitometry

Study Overview
=================
Brief Summary
-----------------
Dual-energy x-ray absorptiometry (DXA) is currently the most widely used tool for determining bone density. However, most experts consider DXA an imperfect and intermediate technology. DXA is subject to artifact from arthritis and body composition, and also cannot account for geometric or material properties of bone which are also important components of bone strength. Xtreme CT (high-resolution peripheral quantitative computed tomography, HR-pQCT) is a new technology with dramatically improved spatial resolution. It is able to define bones' cortical and trabecular surfaces in a three-dimensional manner, and therefore provides information on bone microarchitecture as well as bone density. As such, it may provide new information about characteristics of bone strength. The purpose of this study is to compare Xtreme CT to DXA measurements of bone density, and also to generate a normative database of healthy young adults. This cross-sectional study involves a single visit where both Xtreme CT and DXA measurements will be obtained for a single time-point. This normative database will allow us to generate clinically relevant comparisons between the two imaging technologies.

Official Title
-----------------
Comparison of Xtreme CT and DXA Bone Densitometry

Conditions
-----------------
Bone Density

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults age 20-40 years Exclusion Criteria: Pregnancy History of bone modifying diseases (hyperparathyroidism, Paget's, hyperthyroidism, renal failure, nephrolithiasis, liver disease, eating disorder) History of amenorrhea Use of chronic steroids for >3 months

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 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 |
| --- | --- |
| Normative database<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Xtreme CT | Bone imaging of forearm and lower leg | single measurement at baseline | 
| DXA | Bone imaging of spine, hip, total body, and forearm | single measurement at baseline |
Outcomes of the Adjustable Gastric Band in a Publicly Funded Obesity Program

Study Overview
=================
Brief Summary
-----------------
The majority of data documenting the outcomes for the adjustable gastric band (LAGB) originate from non-publicly funded surgical centres. The investigators aim to investigate the clinical outcomes of LAGB from a publicly funded Canadian obesity management program. This program recognized obesity as a chronic disease, providing extensive pre-operative multidisciplinary assessment and long term patient follow-up. Patients are selected for surgical management carefully by a multidisciplinary team and the LAGB is presented as one option to surgical management. Further, the investigators will investigate the operational impacts, including direct and indirect costs related the LAGB, to determine long term impacts on publicly funded hospitals within Canada.

Official Title
-----------------
Outcomes of the Adjustable Gastric Band in a Publicly Funded Obesity Program

Conditions
-----------------
Morbid Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients seen within the Weight Wise program and selected for surgical management, who have undergone LAGB will be included in this analysis. Exclusion criteria: Patients who have undergone selection for surgery outside this process, or who have had surgery elsewhere.

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 |
| --- | --- |
| LAGB patients in Weight Wise Program<br>All patients seen within the Weight Wise program and selected for surgical management, who have undergone LAGB will be included in this analysis. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Percentage Total Body Weight Loss | the percent total body weight loss between Baseline and 1 year the percent total body weight loss between Baseline and 2 years the percent total body weight loss between Baseline and 3 years | baseline to 1 year, baseline to 2 years, baseline to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % of Excess Body Weight Loss | the percent of excess body weight loss between Baseline and 1 year the percent of excess body weight loss between Baseline and 2 years the percent of excess body weight loss between Baseline and 3 years | baseline to 1 year, baseline to 2 years, baseline to 3 years |
Analysis of the Results of Treatment for Cervical Carcinoma in Limburg

Study Overview
=================
Brief Summary
-----------------
Analysis of all women treated for cervical cancer between 2000 and 2008 in Limburg, a province in the south of the Netherlands. Patient characteristics, diagnosis, treatment modalities, complications and survival will be analyzed by record review. Quality of life of the living study population will be assessed using the EORTC QLQ-C30 and QOQ-CX24 questionnaire. Patients will be identified via registration data from the Integraal Kankercentrum Limburg.

Official Title
-----------------
Retrospective Analysis of Treatment and Quality of Life of Women Treated for Cervical Carcinoma FIGO Stage IB-1 to IVb From 2000-2008 in Limburg, a Province in the South of the Netherlands.

Conditions
-----------------
Cervical Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cervical cancer FIGO stage IB-1 to IVB Treated in Limburg between 2000 and 2008 Exclusion Criteria: none
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 |
| --- | --- | --- |
| Quality of life | Quality of life of the living study population will be assessed using the EORTC QLQ-C30 and QOQ-CX24 questionnaire |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cervical cancer, retrospective, quality of life, treatment
Esophageal Hypersensitivity Study in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to compare sensitivity and sensitization of visceral pain in the esophagus using different pain stimuli

Official Title
-----------------
A Phase I, Two Centre, Double-blind, Randomized, Cross-over Study to Evaluate AZD1386 in Single Doses of 30 mg and 95 mg Compared to Placebo in a Multimodal Experimental Pain Model on Esophageal Sensitivity and Development of Sensitization in Healthy Male Volunteers

Conditions
-----------------
Pain, Esophageal Sensitivity

Intervention / Treatment
-----------------
* Drug: AZD1386
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of written consent Clinically normal physical findings Sensitization potential Exclusion Criteria: Clinically significant illness within 2 weeks prior to the first dose of investigational product History of clinically significant disease Use of prescribed medication during the 2 weeks before administration of the first dose of investigational product

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>30 mg, oral, single dose | Drug: AZD1386<br>* oral, single dose<br>|
| Experimental: 2<br>95 mg, oral, single dose | Drug: AZD1386<br>* oral, single dose<br>|
| Placebo Comparator: 3<br>Oral solution, single dose | Drug: Placebo<br>* Oral solution, single dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS scale and clock |  | Several occasions during the study days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS scale and pressure, VAS scale and current, VAS scale and acid volume |  | Several occasions during the study days | 
| Pharmacokinetic variables |  | Several occasions during the study days | 
| Safety variables (adverse events, blood pressure, safety lab, ECG and body temperature) |  | Several occasions during the study days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GERD, healthy volunteer, esophagus, pain
Vildagliptin for Treatment of Antipsychotic-induced Dyslipidemia

Study Overview
=================
Brief Summary
-----------------
Almost all antipsychotics can induce dyslipidemia, but no treatment has been established. Vildagliptin can improve lipid levels in obese patients. The investigators conducted a randomized, placebo-controlled study to test the efficacy of vildagliptin for antipsychotic-induced dyslipidemia.

Official Title
-----------------
Vildagliptin for Treatment of Antipsychotic-induced Dyslipidemia: a Randomized, Double-blind, Placebo-controlled Study

Conditions
-----------------
Schizophrenia, Dyslipidemias

Intervention / Treatment
-----------------
* Drug: Vildagliptin 50 MG
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnostic and Statistical Manual of Mental Disorder-Fourth Edition (DSM-Ⅳ) criteria for schizophrenia dyslipidemia after antipsycotic treatment the duration of illness was less than 12 months taking only one antipsychotic stable outpatient the total score of Positive and Negative Syndrome Scale (PANSS)≤60. Exclusion Criteria: liver or renal diseases pregnant or lactating women cardiovascular diseases hypertension or diabetes mellitus

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vildagliptin<br>Vildagliptin 50 mg tablet daily | Drug: Vildagliptin 50 MG<br>* Vildagliptin 50 MG tablet once daily<br>|
| Placebo Comparator: Placebo<br>Placebo tablet daily | Drug: Placebo<br>* Placebo one tablet daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| low-density lipoprotein cholesterol | low-density lipoprotein cholesterol | week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| high-density lipoprotein cholesterol | high-density lipoprotein cholesterol | week 12 | 
| Serum stem cell growth factor beta | Serum stem cell growth factor beta | week 12 | 
| FAM19A5 serum level | FAM19A5 serum level | 12 weeks | 
| TNF-alpha serum level | TNF-alpha serum level | 12 weeks | 
| Adverse drug reactions | Adverse drug reactions | 12 weeks |