linjc16/ctgov huggingface dataset:
A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a Single Anti-TNF Inhibitor.

Study Overview
=================
Brief Summary
-----------------
This single arm study will evaluate the safety and efficacy of MabThera in patients with active rheumatoid arthritis who are receiving methotrexate treatment, and who have had an inadequate response to one anti-TNF alpha therapy. All patients will receive MabThera 1000mg i.v. on days 1 and 15, in addition to concomitant methotrexate. Patients who achieve a clinically relevant response to the first course of treatment may be eligible to receive one re-treatment course of MabThera between weeks 24 and 48. The anticipated time on study treatment is 3-12 months, and the target sample size is 100 individuals.

Official Title
-----------------
An Open Label Study to Evaluate the Safety and Effect on Treatment Response of MabThera in Patients With Rheumatoid Arthritis Following Inadequate Response to One Prior Anti-TNF Inhibitor

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: Methotrexate
* Drug: rituximab [MabThera/Rituxan]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients, 18-80 years of age; moderate to severe active rheumatoid arthritis; inadequate response to previous or current treatment with 1 anti-TNF agent; receiving methotrexate at a dose of 10-25mg/week for 12 weeks prior to start of study, at a stable dose for >=4 weeks. Exclusion Criteria: previous treatment with MabThera; use of an anti-TNF alpha agent within 8 weeks of study start; concurrent treatment with any DMARD other than methotrexate; active infection, or history of serious recurrent or chronic infection.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Methotrexate<br>* As prescribed<br>Drug: rituximab [MabThera/Rituxan]<br>* 1000mg iv on days 1 and 15<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AEs, including infusion-related adverse events |  | For 48 weeks after initial treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of re-treatment (AEs) |  | For 24 weeks after re-treatment. | 
| Laboratory parameters, vital signs. |  | Throughout study | 
| ACR 20/50/70, Eular response rates, DAS 28, ACR core components, HAQ, FACIT. |  | For 48 weeks after initial treatment. |
Prevalence of Antiphospholipid Antibodies Among Women With Preeclampsia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the prevalence of positive antiphospholipid antibodies among women with preeclampsia and to determine the effect of antiphospholipid antibodies on the severity of preeclampsia and the obstetric outcomes

Detailed Description
-----------------
For all women included in the study, blood samples will be tested for anticardiolipin antibodies and lupus anticoagulant. The clinical details of all women will be collected by reviewing their hospital and prenatal records. The following clinical characteristics will be evaluated: maternal age, previous gestations, parity, past or family history of preeclampsia, gestational age at the onset of preeclampsia, gestational age at delivery and birth weight. The following pregnancy and delivery complications will be assessed: placental insufficiency, intrauterine growth restriction, fetal loss (stillbirth) and early neonatal death.

Official Title
-----------------
Prevalence of Antiphospholipid Antibodies Among Women With Preeclampsia

Conditions
-----------------
Preeclampsia

Intervention / Treatment
-----------------
* Other: Testing for antiphospholipid antibodies


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women with preeclampsia. Exclusion Criteria: Women with systemic autoimmune disease. Women with active thromboembolic disorders. Women with history of previous thromboembolic disorders.

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Pregnant women with preeclampsia<br>Testing for antiphospholipid antibodies (anticardiolipin antibodies and lupus anticoagulant) will be performed in pregnant women with preeclampsia. | Other: Testing for antiphospholipid antibodies<br>* Blood samples will be tested for anticardiolipin antibodies and lupus anticoagulant<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of positive antiphospholipid antibodies | Number of women having positive antiphospholipid antibodies per total number of women | 20 weeks to 42 weeks gestational age | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Preeclampsia, Antiphospholipid Antibodies
Sedentary Screen Time Activities on Food Intake

Study Overview
=================
Brief Summary
-----------------
The purpose is to investigate the effect of sedentary screen time activities on food intake and subjective appetite in 9- to 14-year old normal weight and overweight/obese girls. The investigators hypothesize that pre-meal exposure to screen time activities for 45 minutes increases subjective appetite and food intake at the next meal. Food intake will be measured immediately following screen-time exposure, and subjective appetite measured throughout the study period at 0, 15, 30, 45 and 75 minutes.

Official Title
-----------------
Effect of Sedentary Screen Time Activities Before a Meal on Food Intake in Girls

Conditions
-----------------
Exogenous Obesity

Intervention / Treatment
-----------------
* Behavioral: Television Viewing before mealtime
* Behavioral: Video Game Playing
* Behavioral: Computer Use
* Behavioral: Sitting quietly


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy girls with no emotional, behavioral or learning problems Exclusion Criteria: boys

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 14 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Television Viewing<br>Television viewing before mealtime | Behavioral: Television Viewing before mealtime<br> <br> |
| Experimental: Video Game Playing<br>Video Game Playing before mealtime | Behavioral: Video Game Playing<br> <br> |
| Experimental: Computer Use<br>Computer Use before mealtime | Behavioral: Computer Use<br> <br> |
| Experimental: Sitting Quietly<br>Sitting Quietly before mealtime | Behavioral: Sitting quietly<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Food Intake (kcal) |  | measured at 45 minutes after the treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective appetite | Subjective appetite (in mm) determined by visual analogue scale | 0-75 minutes |
The Supplementary Effects of the Extract of Agaricus Blazei Murril on Type II Diabetes Mellitus (DM)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine whether the extract of the Agaricus blazei Murill mushroom is effective in the supplementary treatment of type II DM patients.

Detailed Description
-----------------
The researchers have the animal model that the extract of the Agaricus blazei Murill mushroom is effective in the treatment of type II DM mice conducted on 2002. The dose effects were also found. The researchers conducted the pilot study also showing the same effects in 2003. So the researchers designed this trial. The elixir of the Agaricus blazei Murill mushroom is popular in Taiwan for chronic diseases, such as type II DM.

Conditions
-----------------
Diabetes Mellitus, Type II

Intervention / Treatment
-----------------
* Drug: Extract of Agaricus blazei Murill


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type II DM Age 20-75 years old Treat with Gliclazide and Metformin Signed informed consent Exclusion Criteria: GOT/GPT >80/80 Creatinine > 2.0 Lactating or pregnant women

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Extract of Agaricus blazei Murill|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent reduction of glycated hemoglobin (HAb1C) and insulin resistance(HOMA-IR) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose, cholesterol, triglyceride, leptin, adiponectin comparisons |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Agaricus Blazei Murill, type II DM, insulin index
AMP as a Better Delivery System of Adenosine

Study Overview
=================
Brief Summary
-----------------
Adenosine and AMP are substances normally present in the body. Adenosine is also given for the treatment of some heart rhythm problems and may be used to reduce heart damage during heart attacks. The problem in using adenosine is that it is taken up by cells and, therefore, very little of the adenosine we give by vein or in the artery actually reaches the tissue. We propose to use AMP as a way to improve delivery of adenosine. AMP is inactive by itself, but is converted to adenosine in tissue. We hope that by giving AMP we will increase levels of adenosine in tissue. To see if this is true, we will give either adenosine or AMP into the forearm artery while we measure how much adenosine reaches the forearm tissue.

Official Title
-----------------
Use of AMP to Improve Tissue Delivery of Adenosine

Conditions
-----------------
Ischemia

Intervention / Treatment
-----------------
* Drug: Adenosine
* Drug: Adenosine Mono Phosphate (AMP)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers Age 18-65 Non smokers Exclusion Criteria: Smokers Any chronic disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adenosine then Adenosine Mono Phosphate (AMP)<br>Intrarterial infusion of adenosine then same subject switch to AMP one month apart. | Drug: Adenosine<br>* Adenosine intrarterial (intrabrachial) infusion at 3 diferent doses for 15 minutes each<br>* Other names: Ado;Drug: Adenosine Mono Phosphate (AMP)<br>* Intraterial infusion of AMP at 3 different doses for 15 minutes each (at equimolar doses as adenosine)<br>* Other names: AMP;|
| Experimental: Adenosine Mono Phosphate (AMP) then adenosine<br>Intrarterial infusion of AMP then same subject switch to Adenosine one month apart. | Drug: Adenosine<br>* Adenosine intrarterial (intrabrachial) infusion at 3 diferent doses for 15 minutes each<br>* Other names: Ado;Drug: Adenosine Mono Phosphate (AMP)<br>* Intraterial infusion of AMP at 3 different doses for 15 minutes each (at equimolar doses as adenosine)<br>* Other names: AMP;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interstitial Adenosine Levels |  | Microdyalysis samples for adenosine, were collected for 15 minutes at each stage of the study (baseline and each dose of adenosine or AMP) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adenosine, AMP, Microdialysis, Blood Flow
Physical,Histological,and Genetic Analyses of Lipid-rich Atherosclerotic Plaques

Study Overview
=================
Brief Summary
-----------------
Lipid-rich atherosclerotic plaques, or vulnerable plaques are prone to rupture, causing local intravascular thrombosis, with subsequent grave clinical consequences. Atherosclerotic plaques normally removed during surgery, and peripheral blood samples will be studied to achieve the following objectives: 1 Define histological features of the vulnerable plaque, analyze its physical characteristics, and investigate selected gene expression. 2 Study biomarkers of inflammation in conjunction with the presence of vulnerable plaques. 3 Explore the potential role of infection in atherogenesis.

Official Title
-----------------
Physical,Histological,and Genetic Analyses of Lipid-rich Atherosclerotic Plaques

Conditions
-----------------
Atherosclerosis, Aortic Aneurysm, Peripheral Vascular Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Evidence of symptomatic carotid stenosis exceeding 60%(TIAs or stroke within the last 6 months), and asymptomatic carotid artery stenosis (presenting with progressive carotid stenosis, exceeding 70%) Abdominal aortic aneurysm, and aortic occlusive disease Peripheral occlusive or aneurysmal disease Exclusion Criteria: Non-compliant patients, incapable of granting approval by informed consent

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 |
| --- | --- | --- |
| To uncover mechanisms of cardiovascular diseases |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atherosclerosis, Carotid plaque, Abdominal aortic aneurysm, Vulnerable plaque, Angiogenesis, Intraplaque hemorrhage, Carotid artery atherosclerosis
PulseHaler Drug Deposition Study in Chronic Obstructive Pulmonary Disease Patients

Study Overview
=================
Brief Summary
-----------------
This study is aimed at finding the effect of PulseHaler™ with Albuterol on Lung Deposition of Aerosol and on Pulmonary Functions in COPD Patients

Official Title
-----------------
Preliminary Assessment of the Effect of PulseHaler™ With Albuterol on Lung Deposition of Aerosol and on Pulmonary Functions in COPD Patients

Conditions
-----------------
COPD

Intervention / Treatment
-----------------
* Device: Pulsehaler
* Drug: Nebulizer & Albuterol 0.5ml


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Chronic Obstructive Pulmonary Disease (COPD), established for at least 1 year Post-bronchodilator FEV1/FVC < 0.7 Post-bronchodilator FEV1 in the range 30% - 70% predicted Age: 40 years or older Patient signed the informed consent form Exclusion Criteria: Pneumothorax in the past, per anamnesis. Women at the age of fertility, who are pregnant, or plan pregnancy, or do not use contraceptive. Severe cardiac disease, e.g., Congestive Heart Failure (CHF) grade 3 or higher Coronary Artery Bypass Graft (CABG) or Acute Myocardial Infarction (MI) within last 3 months Other severe systemic disease Non-cooperative or non-compliant patient

Ages Eligible for Study
-----------------
Minimum Age: 40 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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pulsehaler<br>Fully operational Pulsehaler, with protocol enabled | Device: Pulsehaler<br> <br> Drug: Nebulizer & Albuterol 0.5ml<br>* Albuterol aerosolized by a nebulizer<br>|
| Active Comparator: Nebulizer<br>Deactivated Pulsehaler (protocol disabled), so only the nebulizer is active | Drug: Nebulizer & Albuterol 0.5ml<br>* Albuterol aerosolized by a nebulizer<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung deposition | Lung deposition of the albuterol-containing aerosol | 1 hour | 
| Pulmonary functions | Pulmonary function tests by spirometry | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dyspnea | Dyspnea measured by the modified Borg scale | 1 hour |
Probiotic Versus Placebo as Adjuvant for Bacterial Vaginosis Treatment During Pregnancy

Study Overview
=================
Brief Summary
-----------------
Bacterial vaginosis is a common vaginal condition involving a reduction in the amount of Lactobacilli, the normal bacteria colonizing the vagina, and an overgrowth of pathogenic bacteria. The presence of bacterial vaginosis in pregnancy is associated with an increased risk of preterm delivery. After a course of antibiotic treatment, recurrence of bacterial vaginosis has been reported in 10-70% of cases. This study aims to verify if administration of vaginal Lactobacilli may reduce the occurrence rate after antibiotic treatment of bacterial vaginosis during pregnancy.

Official Title
-----------------
Randomised Control Trial of Probiotics Versus Placebo as Adjuvant to Oral Clindamycin Treatment for Bacterial Vaginosis During Pregnancy

Conditions
-----------------
Bacterial Vaginosis

Intervention / Treatment
-----------------
* Drug: Lactobacillus acidophilus
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: singleton pregnancy gestational age 12-32 weeks diagnosis of bacterial vaginosis treatment of bacterial vaginosis with oral clindamycin 300 mg, twice-daily for 7 days Exclusion Criteria: multiple pregnancy allergy to clindamycin

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vaginal lactobacilli<br> | Drug: Lactobacillus acidophilus<br>* Lactobacillus acidophilus 500 million colony-forming units/tablets. One vaginal tablet daily for 10 days.<br>* Other names: Pregyn-S;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* One vaginal tablet daily for 10 days.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal lactobacillus recolonization |  | 3-5 weeks | 
| Recurrence rate of bacterial vaginosis |  | 3-5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preterm delivery <37 weeks |  | within 43 weeks of gestation |
Machine Learning Predict Renal Replacement Therapy After Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
Cardiac surgery-associated acute kidney injury (CSA-AKI) is a major complication which may result in adverse impact on short- and long-term mortality. The researcher here developed several prediction models based on machine learning technique to allow early identification of patients who at the high risk of unfavorable kidney outcomes. The retrospective study comprised 2108 consecutive patients who underwent cardiac surgery from January 2017 to December 2020.

Official Title
-----------------
Using Machine Learning to Predict Acute Kidney Injury Requiring Renal Replacement Therapy After Cardiac Surgery

Conditions
-----------------
Machine Learning, Acute Kidney Injury, Renal Replacement Therapy, Prediction Models

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age over 18 years who underwent cardiac surgery Exclusion Criteria: data miss greater than 10%

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 |
| --- | --- | --- |
| patients required renal replacement therapy | The primary outcome was patients with the requirement for acute dialysis within 14 days after cardiac surgery. Renal replacement therapy is recommended for patients with severe acute kidney injury as well as hemodynamic instability or severe electrolyte disturbances (e.g. blood potassium > 6) or acid-base balance disturbances (e.g. H value less than or equal to 7.15). Prior to the start of renal replacement therapy, the investigator invited a consultation with the nephrology department to assess the condition | 14 days |