linjc16/ctgov huggingface dataset:
The Effect of Prebiotics on the Microbiome in Irritable Bowel Syndrome Patients: The Diet and Microbiome Study

Study Overview
=================
Brief Summary
-----------------
Irritable bowel syndrome (IBS) is a chronic gastrointestinal illness of unknown cause whose symptoms include abdominal pain, bloating and altered bowel pattern. Diet has been shown to influence the bacteria gut interaction. Our aim is to determine if components of the diet affect IBS symptoms by changing the bacteria gut interaction. In particular, we will measure whether after being on a diet high or low on certain factors there is a change in the timing and amount of hydrogen and methane produced by bacteria digesting lactulose and on IBS symptom severity.

Official Title
-----------------
The Effect of Prebiotics on the Microbiome in Irritable Bowel Syndrome Patients: The Diet and Microbiome Study

Conditions
-----------------
Irritable Bowel Syndrome

Intervention / Treatment
-----------------
* Dietary Supplement: Factor Altered Diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meet Rome III criteria for IBS Willing to undergo dietary intervention Exclusion Criteria: History of Gastric, Small Bowel or Colonic Surgery History of Inflammatory Bowel Disease Celiac Disease Unable to come off following medications: antibiotics, laxatives, narcotics, sedatives On a pre specified diet Pregnant

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High Factor Diet<br>Patients will be on a factor altered diet to see effects on their lactulose breath test and symptoms. | Dietary Supplement: Factor Altered Diet<br> <br> |
| Active Comparator: Low Factor Diet<br>Patients will be on a factor altered diet to assess its effects on symptoms and lactulose breath test. | Dietary Supplement: Factor Altered Diet<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the Curve of Hydrogen Gas on Lactulose Breath Test |  | 5 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Area Under the Curve on Lactulose Breath Test from Baseline |  | 5 hours | 
| Change in IBS Symptom Severity Score from Baseline |  | 3 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diet
Detecting Atrial Fibrillation in Patients With an Embolic Stroke of Undetermined Source (From the DAF-ESUS Registry)

Study Overview
=================
Brief Summary
-----------------
The presence of interatrial block (IAB) is associated with the development of atrial fibrillation (AF). The aim of this study was to determine whether P-wave duration and presence of IAB before the implantation of a cardiac implantable electronic device (CIED) are associated with the presence of atrial high rate episodes (AHRE), during long-term follow-up.

Detailed Description
-----------------
The presence of interatrial block (IAB) is associated with the development of atrial fibrillation (AF). The aim of this study was to determine whether P-wave duration and presence of IAB before the implantation of a cardiac implantable electronic device (CIED) are associated with the presence of atrial high rate episodes (AHRE), during long-term follow-up.

Official Title
-----------------
Detecting Atrial Fibrillation in Patients With an Embolic Stroke of Undetermined Source (From the DAF-ESUS Registry)

Conditions
-----------------
Fibrillation, Atrial

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients in sinus rhythm with or without previous paroxysmal AF with dual-chamber pacemakers (PMs), implantable cardioverterdefibrillators (ICDs), and devices for cardiac resynchronization therapy (CRT) capable of atrial activity monitoring were included in the study Exclusion Criteria: -Previous documented atrial fibrillation

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrial high rate new episodes | New episodes of atrial high rate episodes | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiac implantable electronic devices, interatrial block, P-wave duration
QuickVue Influenza A+B Clinical Field Trial

Study Overview
=================
Brief Summary
-----------------
A comparative study of different swab types used for collection of specimens for rapid inluenza testing

Official Title
-----------------
Comparison of Swab Types for Specimen Collection

Conditions
-----------------
Influenza

Intervention / Treatment
-----------------
* Device: Swab Specimen Collection (QuickVue)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must have: Fever (>38°C) (at time of visit or within the previous 48 hrs by history) and at least two of the following symptoms: Chills/sweats Cough Dyspnea (labored, difficult breathing) Fatigue Headache Myalgia (deep muscle aches) Nasal congestion Runny nose Sore throat Exclusion Criteria: Patients who are undergoing treatment with antivirals, now or within the last 7 days cannot be included in this study.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Swab Specimen Collection (QuickVue)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and Specificity |  | five months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and Specificity |  | Positive and Negative Predictive Values |
Ultrasound Assessment of Gastric Content and Volume

Study Overview
=================
Brief Summary
-----------------
Anesthesiologists try to avoid complications with significant peri -operative morbidity and mortality such as bronchoaspiration in patients requiring a surgical procedure under anesthesia. Currently, this is achieved based on experts recommendations from the American Society of Anesthesiologists. However, there are tools like ultrasound that allow assessment of gastric content and volume. This tool allows to individualize each patient and base the decisions objectively. The investigators will assess gastric content and volume by ultrasound in patients who have fasted and require surgery at two University Hospitals.

Official Title
-----------------
Ultrasound Assessment of Gastric Content and Volume After Complete Fasting in Patients Undergoing Surgery at Two University Hospitals: A Multicentric Study

Conditions
-----------------
Fasting

Intervention / Treatment
-----------------
* Device: Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults ≥ 18 years perioperative fasting time between 8 and 14 hours American Society of Anesthesiologists status I, II, III Scheduled surgery Exclusion Criteria: Abdominal pathology surgical emergency Unable to adopt right lateral decubitus position Altered gastrointestinal tract anatomy excluding hiatal hernia Body mass index greater than 40 Patients on enteral nutrition probe or with nasogastric probe Pregnancy

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Ultrasound|Ultrasound assessment of gastric content and volume|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric content | Ultrasound assessment of gastric content (empty, fluids, or solid) of patients undergoing surgery after complete fasting (more than 8 hours) | June to December | 
| Gastric volume | Ultrasound assessment of gastric volume (in milliliters) of patients undergoing surgery after complete fasting (more than 8 hours) | June to December | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association of gastric content and volume with special conditions as assessed by Anova or Kruskal as appropriate | To identify the association between gastric content and volume with conditions such as diabetes, obesity, hiatal hernia, among others. | June to December | 
| Association with fasting time | To identify the association between gastric content and volume and preoperative fasting time. | June to December | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gastric volume, gastric content, ultrasound, perioperative fasting
Study Comparing Two Alternatives of Antiretroviral Therapy as Post-exposure Prophylaxis to HIV-1: Tenofovir + Emtricitabine + Lopinavir/Ritonavir Versus Tenofovir + Emtricitabine + Raltegravir (RAL-PEP)

Study Overview
=================
Brief Summary
-----------------
As a measure of secondary prophylaxis, and with the final objective of avoiding the infection, it has been suggested to use antiretroviral therapy. This is known as post-exposure prophylaxis (PEP). Although there are different recommendations, almost every guideline recommend using 3 drugs as PEP both in USA and Europe. Toxicity is one of the main limitations of PEP. Side effects during PEP are very usual, are attributed mainly to PI and are the main reasons for poor adherence or lost of follow-up. A current standard regimen is AZT+3TC (Combivir®) or tenofovir+emtricitabine (Truvada®) plus the PI lopinavir/r. Toxicity associated with this regimens are high (31-85% of cases),with a high tolerability, a integrase inhibitor (raltegravir)could be an adequate drug for PEP.

Official Title
-----------------
Open Randomized Study Comparing Two Alternatives of Antiretroviral Therapy as Post-exposure Prophylaxis to HIV-1: Tenofovir + Emtricitabine + Lopinavir/Ritonavir Versus Tenofovir + Emtricitabine + Raltegravir

Conditions
-----------------
HIV Infection

Intervention / Treatment
-----------------
* Drug: Tenofovir, Emtricitabine, Lopinavir/r
* Drug: Tenofovir, Emtricitabine, Raltegravir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Potentially sexual exposition to HIV Exclusion Criteria: Pregnancy Source case with antiretroviral resistances any treatment contraindicated with the drugs of study

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tenofovir + emtricitabine + lopinavir/r<br>Standard postexposure prophylaxis combination | Drug: Tenofovir, Emtricitabine, Lopinavir/r<br>* Combination drug<br>|
| Experimental: Tenofovir + Emtricitabine + Raltegravir<br>new postexposure prophylaxis combination | Drug: Tenofovir, Emtricitabine, Raltegravir<br>* Combination drug<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients dropping out before the 28 days of postexposure prophylaxis | Proportion of patients droppping out before the 28 days of postexposure prophylaxis considering death, lost to folow-up and stopping or changing treatment for any reason | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV Infection, Postexposure prophylaxis
Relationship Between Adipose Tissue Distribution and Arterial Stiffness in HFpEF

Study Overview
=================
Brief Summary
-----------------
Heart failure with preserved ejection fraction (HFpEF) was considered as a heterogeneous disease with multi-organ and multi-system design, which is related to various complications, such as hypertension, obesity and arteriosclerosis. Studies have found that hypertension and obesity are respectively associated with increased arterial stiffness. However, there is still no research investigating the the relationship between lipids distribution and arterial stiffness in HFpEF patients.

Detailed Description
-----------------
Before the 21st century, Heart failure with preserved ejection fraction (HFpEF) was considered as a disease with simple diastolic dysfunction, but after the 21st century, HFpEF was considered as a heterogeneous disease with multi-organ and multi-system design, which is related to various complications, such as hypertension, obesity and arteriosclerosis. Other studies have found that hypertension and obesity are respectively associated with increased arterial stiffness. However, there is still no research investigating the the relationship between lipids distribution and arterial stiffness in HFpEF patients.

Official Title
-----------------
Relationship Between Adipose Tissue Distribution and Arterial Stiffness in Heart Failure With Preserved Ejection Fraction(HFpEF)

Conditions
-----------------
Heart Failure With Preserved Ejection Fraction, Arterial Stiffness, Lipid Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult aged >=18years old; Diagnosed with HFpEF. Diagnostic criteria including: left ventricular ejection fraction ≥50%； with the symptoms and/or signs of heart failure； BNP≥35 pg/mL and/or NTproBNP≥125 pg/mL； at least one additional criterion: relevant structural heart disease(LVH and/or LAE) or diastolic dysfunction Exclusion Criteria: LVEF less than 45% at any time; Severe liver failure; 3/Other causes of shortness of breath, such as severe pulmonary disease or severe chronic obstructive pulmonary disease; 4.Primary pulmonary hypertension; 5.Severe valvular disease of the left heart; 6.Chronically bedridden or incapacitated; 7.Age <18 years old.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- | --- |
| Arterial stiffness | The baPWV(cm/s) of HFpEF patients | 1 day after admission | 
| adipose tissue distribution | The visceral fat area(cm^2) in HFpEF patients | 1 day after admission |
An RCT for the Effect of Biofeedback Therapy the Prevention of AR Syndrome in Rectal Cancer Patients

Study Overview
=================
Brief Summary
-----------------
In patients who underwent sphincter preserving surgery with toal mesorectal excision and diverting stoma after neoadjuvant chemoradiation therapy for rectal cancer, the inestigators would evaluate the effect of a biofeedback therpy before stoma closure on their anorectal function after stoma closure.

Official Title
-----------------
A Randomised Controlled Trial for the Effect of Biofeedback Therapy for the Preveintion of Anterior Resection Syndrome in Rectal Cancer Patients Who Have Undergone Low Anterior Resection With Total Mesorectal Excision Following Neoadjuvant Chemoradiation Therapy

Conditions
-----------------
Rectal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: rectal cancer patients neoadjuvant chemoradiation therapy (+) sphincter saving surgery with total mesorectal excision (+) temporary loop stoma (+) adult who is 17 years or older patinet who aggree with our study if woman is childbearing age, her pregnancy test shoud be indentified 'negative' Exclusion Criteria: patients who have been enrolled to other clinical studies related to this study patients who underwent diverting stoma before neoadjuvant chemoradiation temporary end -ostomy (+) uncontrolled metabolic or systemic disease patients who do not understand the purpose of this study because of dementia or pshycologic problem MRSA or Clostridium difficille (+) Pregnant or during breast feeding serious complication after sphincter saving surgery

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 |
| --- | --- |
| Biofeedback<br>Patients will undergo biofeedback therapy between 1st adjuvant chemotherapy and stoma closure(= after 3rd ajduvant chemotherapy) | |
| Kegel<br>Patients will be trained to take excersise for their anal sphincter by Kegel. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of anterior resection syndrome after stoma closure |  | 1 year after stoma closure |
Iodine Nutrition During Pregnancy and Related Neonatal Physical Development

Study Overview
=================
Brief Summary
-----------------
Recent studies have found, in both developed and developing countries, there is still a considerable number of pregnant women in iodine deficiency status.Our overall aim is to monitor iodine status of pregnant women in China, and to examine the correlation between maternal urine iodine concentration (UIC) and newborn physical development level.

Detailed Description
-----------------
Background: Recent studies have found, in both developed and developing countries, there is still a considerable number of pregnant women in iodine deficiency status. Our overall aim is to monitor iodine status of pregnant women in China, and to examine the correlation between maternal urine iodine concentration (UIC) and newborn physical development level. Design: prospective cohort study Methods: During August - December 2015,250 participants(28-32 weeks' gestation) were selected to participate in the study.The investigators collect the spot urine samples(n=750) once every two weeks. Setting: Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine. Participants: 150 normal pregnant women and 100 pregnant women with gestational diabetes (28-32 weeks' gestation) and their newborns were selected to participate the study.

Official Title
-----------------
Iodine Nutrition During Pregnancy and Related Neonatal Physical Development

Conditions
-----------------
Pregnancy, Iodine Deficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 22-35 years, 28-32 weeks' gestation, Exclusion Criteria: a known history of thyroid disease in the non-pregnant state and previous.

Ages Eligible for Study
-----------------
Minimum Age: 22 Years
Maximum Age: 35 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| normal pregnant women<br>150 normal pregnant women (28-32 weeks' gestation) | |
| pregnant women with gestational<br>100 pregnant women with gestational diabetes (28-32 weeks' gestation) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| urinary iodine (UI) concentrations |  | up to three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| thyroid stimulating hormone level of newborns |  | up to three months | 
| daily iodine intake of pregnant women | Daily iodine intake was estimated using the total diet study approach | up to three months |