linjc16/ctgov huggingface dataset:
Effects of Oral Stimulation in Preterm Infants

Study Overview
=================
Brief Summary
-----------------
Preterm infants with gestational age inferior to 34 weeks were included in the study. A prospective experimental group received the oral stimulation protocol and the effects of the intervention were compared with a historical control group that did not receive any oral stimulation intervention. The study hypothesis is that oral stimulation in preterm infants has beneficial effects on the feeding performance, the length of hospitalization and anthropometric variables, including weight at discharge, height at discharge and head circumference at discharge.

Official Title
-----------------
Effects of Oral Stimulation on Feeding Performance, Length of Hospital Stay and Anthropometric Variables of Preterm Infants

Conditions
-----------------
Premature Infant, Eating Disorder

Intervention / Treatment
-----------------
* Other: Oral manual stimulation of feeding in preterm infants


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Preterm infants with gestational age inferior to 34 weeks Exclusion Criteria: Instability caused by respiratory, cardiac or gastrointestinal issues Orofacial malformations.

Ages Eligible for Study
-----------------
Maximum Age: 7 Days

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral stimulation<br>Oral stimulation protocol: manual stimulation of the oral sucking | Other: Oral manual stimulation of feeding in preterm infants<br>* Manual stimulation of the cheeks (internal and external), lips, gums, tongue and palate by finger-strokin.<br>|
| No Intervention: Control<br>No intervention | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational age at the initiation of oral feeding |  | Up to 46 weeks | 
| Weight at discharge (g) |  | Up to 46 weeks | 
| Height at discharge (cm) |  | Up to 46 weeks | 
| Head circumference at discharge (cm) |  | Up to 46 weeks | 
| Days of enteral nutrition |  | Up to 46 weeks | 
| Gestational age at discharge (weeks) |  | Up to 46 weeks | 
| Total length of hospitalization |  | Up to 46 weeks |
A Year Long Study to Evaluate the Safety of the Combination of Valsartan (320 mg) and Amlodipine (5 mg) in Patients With Hypertension

Study Overview
=================
Brief Summary
-----------------
A ONE YEAR SAFETY STUDY FOR PATIENTS WHO COMPLETE STUDY VAA489A2307.

Official Title
-----------------
A 54 Week, Extension to the Double-blind, Multicenter, Multifactorial, Placebo-controlled, Study to Evaluate the Efficacy and Safety of Valsartan (160 mg and 320 mg) and Amlodipine (10 mg) Combined and Alone in Hypertensive Patients

Conditions
-----------------
HYPERTENSION

Intervention / Treatment
-----------------
* Drug: valsartan + amlodipine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: SUCCESSFUL COMPLETION OF VAA489A2307 CORE TRIAL VISIT 7 BLOOD PRESSURE MUST BE MSDBP ≤ 95 mmHg AND MSSBP ≤ 150 mmHg Exclusion Criteria: PATIENTS WHO EXPERIENCED ANY ADVERSE EVENTS CONSIDERED SERIOUS AND DRUG RELATED IN VAA489A2307 CORE Other protocol-defined exclusion criteria may apply.

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

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

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: valsartan + amlodipine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events and serious adverse events at each study visit for 6 or 12 months |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in diastolic blood pressure from baseline after 6 or 12 months |  |  | 
| Change from baseline in systolic blood pressure from baseline after 6 or 12 months |  |  | 
| Change from baseline in standing diastolic and systolic blood pressure after 6 or 12 months |  |  | 
| Change from baseline in sitting and standing pulse after 6 or 12 months |  |  | 
| Hematology and blood chemistry after 6 or 12 months |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HYPERTENSION, VALSARTAN, AMLODIPINE< SAFETY
Electrical Patient Reported Outcome of Prostate Cancer RadioTherapy

Study Overview
=================
Brief Summary
-----------------
This is an observational study where prostate cancer related PROMs (EPIC-26) is collected using two different methods (by paper questionnaires and electronically) and patient experience and preference is asked.

Detailed Description
-----------------
Prostate cancer patients that are treated with radiation therapy for local prostate cancer receive EPIC-26 before treatment and during follow-up. EPIC-26 is collected both traditionally using paper questionnaires and electronically. Patients experience and preference for these are asked.

Official Title
-----------------
Electrical Patient Reported Outcome of Prostate Cancer RadioTherapy

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Other: electronic PROMs questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cT1-4N0M0, gleason 6-10, PSA < 100, WHO ≤ 2 prostate cancer eligible for radiation therapy willing to complete EPIC-26 questionnaires both in paper and electronically willing to consent for the study Exclusion Criteria: not able to complete EPIC-26 both in paper and electronically

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| EPIC-26 follow-up<br>All men will receive EPIC-26 in paper and also an electronic version. | Other: electronic PROMs questionnaire<br>* Patients are asked to complete EPIC-26 questionnaire in paper and electronically<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| preference | patient preference for type of questionnaire (paper versus electronic) | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QoL as measured using the validated EPIC-26 questionnaire | Patient QoL after RT (EPIC-26, scale 0-100) | through study completion, an average of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PROM, EPIC-26, electronic, questionnaire, mobile, quality of life, radiation therapy
Knowledge, Attitude and Practices of Flemish Midwifes Regarding Spontaneous Abortion

Study Overview
=================
Brief Summary
-----------------
KAP-study in Flemish midwives with intramural employment

Detailed Description
-----------------
The study will be conducted using a self designed questionnaire administered in midwives who are employed within a Flemish hospital in one of the following departments: maternity, maternal intensive care, (intensive) neonatology, reproductive medicine, gynaecology, delivery and prenatal care. The questionnaire assesses the knowledge, attitude and practices of the midwives regarding spontaneous abortion.

Official Title
-----------------
Knowledge, Attitude and Practices of Flemish Midwifes Regarding Spontaneous Abortion

Conditions
-----------------
Spontaneous Abortion

Intervention / Treatment
-----------------
* Other: survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: midwives who are employed within a Flemish hospital in one of the following departments: maternity, maternal intensive care, (intensive) neonatology, reproductive medicine, gynaecology, delivery and prenatal care Exclusion Criteria: all others

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: survey|questionnaire assessing the knowlegde, attitude and practices regarding spontaneous abortion|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| knowledge, attitude and practices regarding spontaneous abortion | Based on previous published KAP-studies, a questionnaire was designed and tested using a single Delphi procedure with experts and lay persons. The knowledge items include questions on the definition, treatment, side effects, risk factors and legal aspects of spontaneous abortion. The attitude items include questions about the attitude of midwives when confronted with women with spontaneous abortion, and how they perceive the role of midwives in delivering various aspects of care to women with spontaneous abortion. The practices items include questions about the extent to which midwives are confronted with women with spontaneous abortion, and about the characteristics of these cases. In addition, midwives are asked about the availability of training and protocols to deliver care to women with spontaneous abortion. Each item will be treated as a categorical variable. A sum score will be calculated counting the correct answers of the knowledge questions. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
miscarriage, Flanders, spontaneous abortion, KAP, midwives
Oxaliplatin/CPT-11 for Extensive Stage Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and effectiveness of the combination of oxaliplatin and irinotecan (CPT-11) in patients with previously untreated, advanced small cell lung cancer.

Official Title
-----------------
Phase II Study of Oxaliplatin and CPT-11 as First Line Treatment for Extensive Stage Small Cell Lung Cancer

Conditions
-----------------
Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: Irinotecan (CPT-11)
* Drug: Oxaliplatin (Eloxatin)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previously untreated extensive small cell lung cancer No prior chemotherapy No prior radiotherapy except for the treatment of brain metastases Exclusion Criteria: Prior treatment for extensive stage small cell lung cancer Known hypersensitivity to any of the components of oxaliplatin or CPT-11 Greater than grade 2 peripheral neuropathy Known HIV or Hepatitis B or C (active, previously treated or both)

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Irinotecan (CPT-11)|nan|
|Drug: Oxaliplatin (Eloxatin)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Understanding GMK Sphere Implant Tibiofemoral Kinematics by Means of Dynamic Videofluoroscopy

Study Overview
=================
Brief Summary
-----------------
The objective of this research project is to perform a comparative study on the in vivo kinematics of the GMK Sphere prosthesis in comparison to the conventional GMK PS Fixed Bearing TKA and the GMK UC Fixed Bearing TKA.

Official Title
-----------------
Understanding GMK Sphere Implant Tibiofemoral Kinematics by Means of Dynamic Videofluoroscopy

Conditions
-----------------
Arthroplasty, Replacement, Knee

Intervention / Treatment
-----------------
* Other: Dynamic videofluoroscopic analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: subjects bearing a TKA with one of the studied prosthesis male and female older than 18 years old patients who are willing and able to sign an informed consent form Exclusion Criteria: any case not described in the inclusion criteria

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 |
| --- | --- |
| GMK Sphere<br>Patients who underwent total knee replacement using GMK Sphere implants. Patients underwent surgery before the inclusion in the study. | Other: Dynamic videofluoroscopic analysis<br>* Patients bearing 3 different prosthesis (3 groups) will be prospactively assessed with videofluoroscopy.<br>|
| GMK PS Fixed Bearing<br>Patients who underwent total knee replacement using GMK PS Fixed Bearing implants. Patients underwent surgery before the inclusion in the study. | Other: Dynamic videofluoroscopic analysis<br>* Patients bearing 3 different prosthesis (3 groups) will be prospactively assessed with videofluoroscopy.<br>|
| GMK UC Fixed Bearing<br>Patients who underwent total knee replacement using GMK UC Fixed Bearing implants. Patients underwent surgery before the inclusion in the study. | Other: Dynamic videofluoroscopic analysis<br>* Patients bearing 3 different prosthesis (3 groups) will be prospactively assessed with videofluoroscopy.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2D/3D videofluoroscopy |  | 1 year |
Genetic Epidemiological Study of Lung Cancer in Taiwan and Clinical Applications

Study Overview
=================
Brief Summary
-----------------
Lung adenocarcinoma in Chinese females is hypothesized to be determined by both genetic and environmental factors. In this grant proposal, we propose to map the loci of susceptibility genes of female lung adenocarcinoma based on multiplex families recruited in Taiwan. We focus on a unique pathological type of a unique population in order to reduce heterogeneity of the genetic background. Compared with western women, female Chinese population has a high prevalence of lung adenocarcinoma. Our reasoning is that if we focus on a specific sub-type, which has a familial basis, we will increase the probability of identifying genes associated with female lung adenocarcinoma. The primary goal of this study is to identify the genetic and environmental determinants of female lung adenocarcinoma, and study the relationship between gene polymorphisms and clinical manifestation profiling of lung cancer.

Detailed Description
-----------------
This research proposal intends to integrate epidemiologists, biostatisticians, clinicians, molecular biologists/geneticists to identify susceptible genes for lung cancer, especially for female lung adenocarcinoma, and to study the relationship between gene polymorphisms and clinical outcomes of lung cancer patients. Our objective is to find gene markers for developing useful screening tools for the high risk group in order to prevent or early detect lung cancer, especially female lung adenocarcinoma. The specific aims of this subproject include: Establish and maintain the research network that will recruit and follow up the subjects and families for the GEFLAC study; keeping control of the progress of the study. Coordinate all the subprojects such as integrating genotyping data with clinical data and environment data. Continue to employ the candidate gene approach to examine the contribution of specific genes to the lung cancer. Generate genotyping data for candidate genes in the exploring stage and prioritize SNPs of candidate genes for large scale studies. Identify susceptible genes/candidate genes to develop multiplex PCR for screening.

Official Title
-----------------
Genetic Epidemiological Study of Lung Cancer in Taiwan and Clinical Applications-focusing on Female Lung Adenocarcinoma (GEFLAC)

Conditions
-----------------
Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: lung adenocarcinoma Exclusion Criteria: -
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
-----------------
lung adenocarcinoma, genetic epidemiology, environmental factors, genetic map, coordination center
Genetic Variant in Apolipoprotein C3 Gene and Fatty Liver in Obese Children

Study Overview
=================
Brief Summary
-----------------
In the past decades, obesity in children is much more prevalent in the world. Given the increasing prevalence of pediatric obesity worldwide, fatty liver incidence is on the rise. Genetic variant in apolipoprotein C3 (APOC3) gene is associated with increased liver fat content in adults. The aim of this study is to find out whether APOC3 single nucleotide polymorphism (SNP) influence fatty liver in obese children and adolescent.

Detailed Description
-----------------
The primary aim of this study is to assess the associations between to investigate the association of rs2854117 C > T and rs2854116 T > C SNPs of the APOC3 gene with liver steatosis, as measured by liver ultrasound. As a secondary aim, the investigators will examine the associations between APOC3 rs2854117 C > T and rs2854116 T > C SNPs and serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels. In addition, the investigators will further analyze the association with other biomarkers, such as body mass index, adiponectin and insulin resistance.

Official Title
-----------------
The Influence of Apolipoprotein C3 Variants on Liver Steatosis and Serum Liver Enzyme Values in Obese Children

Conditions
-----------------
Fatty Liver, Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 6-18 years old Obesity definition: BMI > 95% according to the age- and gender-specific standard suggested by National Health Institute in Taiwan Willing to give written informed consent by parents Exclusion Criteria: Alcohol consumption Chronic liver diseases, including hepatitis B, hepatitis C, Wilson disease and autoimmune hepatitis Major systemic diseases, including cardiopulmonary disease, renal failure, cancer, and psychotic disorder

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum 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 |
| --- | --- | --- |
| genotype distribution of APOC3 rs2854117 and rs2854116 polymorphisms in subjects with and without liver steatosis |  | Oct 2013   Dec 2014 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| genotype distribution of APOC3 rs2854117 and rs2854116 polymorphisms in subjects with and without insulin resistance |  | Oct 2013   Dec 2014 |
Relationships and Health in the OEF/OIF Veteran Population

Study Overview
=================
Brief Summary
-----------------
The current study will explore relationships and health in the OEF/OIF Veteran population. Specifically, this study will examine PTSD symptom severity, traumatic brain injury, relationship satisfaction, leisure, general health ratings, feelings of burdensomeness and belongingness, and suicidal ideation.

Detailed Description
-----------------
United States military troops returning home from Operation Enduring Freedom and Operation Iraqi Freedom deployments are presenting with invisible wounds. These invisible wounds include mental health conditions such as posttraumatic stress disorder and traumatic brain injury. Recent literature has begun to explore how PTSD affects the service member, as well as their significant others. Several studies have shown that Veteran endorsement of PTSD symptoms is associated with decreased relationship satisfaction. Prior literature has shown that spending time together and engaging in pleasurable activities as a couple are important strategies for enduring relationship quality and satisfaction. Literature has demonstrated moderate relationships between PTSD and suicidal ideation. A previous study conducted by two of the investigators in this population showed that perceived feelings of burdensomeness and belongingness and identification of suicide as a potential strategy for dealing with these feelings. Joiner has hypothesized that acquired capacity of painful experiences, perceived burdensomeness and thwarted belongingness are the three components of increased suicide risk. Yet few studies exist that examine these constructs in the military population, though research indicates the clinical utility for exploring these constructs and related consequences.

Official Title
-----------------
Relationships and Health in the OEF/OIF Veteran Population

Conditions
-----------------
Stress Disorder, Marriage, Suicidal Ideation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: OEF/OIF Veteran (at least one OEF/OIF deployment) Currently receiving or eligible to receive health care services at DVAMC In a current, established relationship for a duration of at least one year Age of 18-50 Exclusion Criteria: Inability to provide informed consent. Inability to adequately respond to questions regarding the informed consent procedure. Do not meet the inclusion criteria listed above.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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 |
| --- | --- | --- |
| Relationship satisfaction | Four item relationship satisfaction survey | One study visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
OEF/OIF Veterans, Relationships