linjc16/ctgov huggingface dataset:
Study of KOS-862 (Epothilone D) in Metastatic Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to study KOS-862 in men with metastatic prostate cancer who have failed a docetaxel-containing regimen.

Detailed Description
-----------------
This study is a Phase 2, single arm study of KOS-862 in men with metastatic prostate cancer who have failed a docetaxel-containing regimen. PSA response is the primary end-point and objective responses will be checked as available.

Official Title
-----------------
A Phase 2 Study of KOS-862 Administered Intravenously Weekly for 3 Weeks Every 4 Weeks, in Patients With Hormone Resistant Prostate Cancer Who Have Progressed Following Initial Therapy for Metastatic Disease

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

Intervention / Treatment
-----------------
* Drug: KOS-862


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years of age. Metastatic disease. One previous treatment including docetaxel (Taxotere). At least 3 weeks since last surgery/radiation/chemotherapy ECOG Performance Status of 0, 1 or 2 Exclusion Criteria: Active brain metastases

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

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

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: KOS-862|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prostate cancer |  |  | 
| prostate-specific antigen (PSA) response |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prostate
Fetal Electrocardiogram Extraction-Pilot Study

Study Overview
=================
Brief Summary
-----------------
This is a pilot study utilizing trans-abdominal ECG and Doppler Ultrasounds to assess the feasibility of extracting fECGs in a volunteer population.

Official Title
-----------------
Fetal Electrocardiogram Extraction-Pilot Study

Conditions
-----------------
Pregnancy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must be pregnant women at least 18 years of age. Subject's fetus must be between the gestational ages of 16 weeks and term. Subjects must be able to tolerate 20 minutes (per fetus for which trans-abdominal ECG and Doppler ultrasounds will be performed) in the supine position. Subjects are willing to provide informed consent and are willing to participate in all procedures necessary to complete the study. Exclusion Criteria: Subjects must not have a physical or mental condition, in the opinion of the investigator, which will limit their ability to provide adequate consent.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnancy<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beat-to-beat fetal heart rate will be compared to the Doppler result. | Beat-to-beat fetal heart rate will be compared to the Doppler result using Pearson Correlation. Timing of PR, QT, and QS, if visible, will be compared with published normative values from the neonatology literature as these values are not otherwise obtainable in an ongoing pregnancy. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the presence of other fECG intervals. | The fECG Separation Algorithm used in this research incorporates the filtering of noise of very high level as compared with the signal to be retrieved , in combination with employment of SVD (Singular Value Decomposition) methods. | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pregnant, fetal ecg, ecg
The Effect of Insulin Detemir on Blood Glucose Control in Taiwanese Patients With Type 2 Diabetes Failing on OAD

Study Overview
=================
Brief Summary
-----------------
The trial is conducted in Asia. The aim of the trial is to evaluate the effect of insulin detemir on blood glucose control in Taiwanese patients with type 2 diabetes failing on OAD with/without once-daily NPH Insulin treatment.

Official Title
-----------------
Safety and Therapeutic Effect of Insulin Detemir in Taiwanese Patients With Type 2 Diabetes Mellitus Not Achieving Glycaemic Targets With OAD With/Without Once-daily NPH Insulin Treatment

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

Intervention / Treatment
-----------------
* Drug: insulin detemir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes HbA1C: 7.0-11.0% Previous diabetes treatment for at least 6 months BMI max. 35 kg/m2 Treatment with an oral anti-diabetic drug (OAD) Exclusion Criteria: Type 1 diabetes Receipt of any investigational drug within the last three months prior to this trial

Ages Eligible for Study
-----------------
Minimum Age: 30 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: insulin detemir|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of serious adverse events, including major hypoglycaemic events |  | during 16 weeks of insulin detemir therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1C |  | after 16 weeks | 
| Change in weight |  |  | 
| Change in fasting plasma glucose (FPG) |  |  | 
| Incidence of hypoglycaemic episodes |  |  |
The Effects of Inhaled Iloprost on Congenital Heart Disease With Eisenmenger Syndrome

Study Overview
=================
Brief Summary
-----------------
Identification of the pathophysiology associated with Eisenmenger's syndrome has led to the evaluation of targeted therapies. Iloprost, a prostacyclin analogue, is one such targeted therapy used in patients with Eisenmenger's syndrome. The purpose of our study is to assess the effects of inhaled iloprost on patients with Eisenmenger's syndrome.

Official Title
-----------------
Study of the Effects of Inhaled Iloprost on Congenital Heart Disease With Eisenmenger Syndrome

Conditions
-----------------
Eisenmenger's Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with Eisenmenger's syndrome diagnosed by right side cardiac catheterization 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
-----------------
Iloprost, Eisenmenger's syndrome
Markers for Chronic Obstructive Pulmonary Disease (COPD)

Study Overview
=================
Brief Summary
-----------------
The primary aim of this study is to exploit a difference between COPD patients, chronic smokers without COPD and healthy non-smoking subjects. This will help to assess the utility of inflammatory and oxidative markers in exhaled air and sputum and to compare them with the lung function, clinical parameters and computerised tomography (CT).

Official Title
-----------------
Non-Invasive Markers for Chronic Obstructive Pulmonary Disease (COPD)

Conditions
-----------------
Healthy Non-smokers, Current Smokers, COPD Patients

Intervention / Treatment
-----------------
* Procedure: Spirometry
* Procedure: Exhaled Nitric Oxide and Carbon Monoxide
* Procedure: Exhaled Breath Condensate
* Procedure: Induced Sputum
* Procedure: CT Scan
* Procedure: Blood test
* Procedure: St Georges Questionnaire
* Procedure: Bodypletysmography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy non-smokers FEV1 >80% predicted FEV1 reversibility of <10% after inhaled (beta2-agonists Current smokers FEV1 no less than 80% predicted FEV1 reversibility of <10% after inhaled (beta2-agonists Smoking history of > 10 pack-years Moderate COPD FEV1 40-59% predicted FEV1 reversibility of <10% after inhaled (beta2-agonists Smoking history of > 10 pack-years** Severe COPD FEV1 <40% predicted FEV1 reversibility of <10% after inhaled (beta2-agonists Smoking history of > 10 pack-years Exclusion Criteria: FEV1 increases by 200 ml and 15% of the baseline value after inhaled (beta2-agonists Asthma unstable disease (FEV1 <35% predicted) and/or current, or within the last 4 weeks, respiratory tract infection.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 75 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Spirometry|nan|
|Procedure: Exhaled Nitric Oxide and Carbon Monoxide|nan|
|Procedure: Exhaled Breath Condensate|nan|
|Procedure: Induced Sputum|nan|
|Procedure: CT Scan|nan|
|Procedure: Blood test|nan|
|Procedure: St Georges Questionnaire|nan|
|Procedure: Bodypletysmography|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
United Coronary Biobanks

Study Overview
=================
Brief Summary
-----------------
The UNICORN consists of two collaborating biobanks, one in Utrecht and one in Singapore. From these two sites we include all patients who undergo a coronary catheterization for any reason. At the moment of catheterization we draw blood, which will be stored in a biobank and we collect clinical characteristics. Patients are followed-up for 5 years for the occurrence of major cardiovascular events. By including from two sites in the world we include 4 major ethnic groups: Caucasians, Chinese, Indians and Malays. We aim at including at least 2000 patients per ethnic group. Our hypothesis is that there are differences in the risk factor burden, clinical presentation of CAD, and biochemical patterns in the blood among the ethnic groups. Furthermore, this biobank offers a platform for multi-ethnic biomarker discovery.

Official Title
-----------------
United CORoNary Biobanks

Conditions
-----------------
Coronary Artery Disease, Acute Coronary Syndrome, Myocardial Infarction, Stable Angina

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing coronary angiography Exclusion Criteria: < 21 years of age Hemoglobin levels <7 g/dL in women, or hemoglobin levels <8 g/dL in men

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- |
| Ethnicity<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause death |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major cardiovascular events |  | 5 years |
Non-invasive Spinal Cord Stimulation for Spasticity Control and Augmentation of Voluntary Motor Control in Individuals With Multiple Sclerosis

Study Overview
=================
Brief Summary
-----------------
Epidural spinal cord stimulation (SCS) is currently regarded as one of the most promising intervention methods to improve motor function in individuals with severe spinal cord injury. In parallel, an increasing number of studies is suggesting that noninvasive SCS can improve spasticity and residual motor control in the same subject population. The present study explores whether single sessions of noninvasive SCS would improve walking performance and ameliorate spasticity in individuals with multiple sclerosis.

Official Title
-----------------
Non-invasive Spinal Cord Stimulation for Spasticity Control and Augmentation of Voluntary Motor Control in Individuals With Multiple Sclerosis

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Device: transcutaneous spinal cord stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: confirmed diagnosis of relapsing-remitting, primary- or secondary-progressive MS lower-limb spasticity Exclusion Criteria: acute relapse of MS other neuromuscular diseases active and passive implants at vertebral level T9 or caudally dermatological issues at stimulation site pregnancy

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: transcutaneous spinal cord stimulation|electrical stimulation of the lumbosacral spinal cord through surface electrodes|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Ashworth Scale |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 10-m walk test |  | 24 hours | 
| 2-min walk test |  | 24 hours | 
| Timed up an go test |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
spasticity, spinal cord stimulation, neuromodulation, walking function
Inflammatory Biomarkers of Pediatric Pulmonary Hypertension

Study Overview
=================
Brief Summary
-----------------
To investigate if the inflammatory protein, high mobility group box 1 (HMGB1), along with other inflammatory mediators, is elevated in pediatric patients with congenital heart disease (CHD) and pulmonary hypertension as compared to those with CHD alone, or with healthy controls.

Official Title
-----------------
Inflammatory Biomarkers of Pediatric Pulmonary Hypertension: a Prospective Cohort Study

Conditions
-----------------
Hypertension, Pulmonary

Intervention / Treatment
-----------------
* Other: Blood test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -patients of any age with congenital cardiac disease coming for catheterization of the right heart, or both the right and left heart. Exclusion Criteria: active systemic infection current active cancer active cancer treatment prior bone marrow transplant prior solid organ transplant

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 18 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 |
| --- | --- |
| Pulmonary Hypertension and Congenital Heart Disease<br>Pulmonary Hypertension and Congenital Heart Disease | Other: Blood test<br>* Blood test<br>|
| Congenital Heart Disease<br>Congenital Heart Disease | Other: Blood test<br>* Blood test<br>|
| Healthy Controls<br>Healthy Controls | Other: Blood test<br>* Blood test<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of HGMB1 | Measurement of HGMB1 | 1 day |
Biochemical Mediators After Implant Loading

Study Overview
=================
Brief Summary
-----------------
This study evaluates the nitric oxide and arginase levels in patients with dental implants. Peri-implant sulcular fluid and saliva samples were collected after loading of the implants

Detailed Description
-----------------
Nitric oxide (NO) metabolism is associated with the clinical inflammatory state of peri-implant tissues and also affected by the mechanic stimulus. Therefore, The NO content of PISF reflects two different measures and can serve as an indicator of peri-implant soft tissue inflammation and/or bone response to force application and loading Arginase may reduce NO production by depleting the common substrate. Thus, increased salivary arginase activities detected in periodontitis patients may cause decreased NO synthesis and lead to a decrease in the antibacterial property of saliva.

Official Title
-----------------
Nitric Oxide and Arginase Levels in Peri-Implant Tissues After Delayed Loading

Conditions
-----------------
Implant Loading

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with ≥ 20 teeth, no systemic diseases that could affect bone metabolism, no smoking habits, and had one or more implants

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 |
| --- | --- | --- |
| Biochemical parameters (nitric oxide and arginase) in periimplant sulcular fluid and saliva | The changes in nitric oxide and arginase levels after implant loading were determined. | Baseline and 1, 3 and 6 months after implant loading | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plaque index | The changes in plaque index after implant loading. Plaque index was recorded for determining and classifying oral hygiene status. | Baseline and 1, 3 and 6 months after implant loading | 
| Gingival index | The changes in gingival index after implant loading. Gingival index was recorded for classifying and evaluating gingival inflammation. | Baseline and 1, 3 and 6 months after implant loading | 
| Probing depth | The changes in probing pocket depth after implant loading.Probing pocket depth was measured for determining periimplant health. | Baseline and 1, 3 and 6 months after implant loading | 
| Bleeding on probing | The changes in bleeding on probing after implant loading. Bleeding on probing was recorded for evaluating gingival inflammation. | Baseline and 1, 3 and 6 months after implant loading | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nitric oxide, arginase, loading
Human Papillomavirus in Cervical Cancer and Pre-cancer in Switzerland: The CIN3+Plus Study

Study Overview
=================
Brief Summary
-----------------
This study will investigate the types of HPV in samples from women with cervical pre-cancer and cancer and gather information to help investigate the impact of HPV vaccination in Switzerland.

Official Title
-----------------
Human Papillomavirus-Associated Cervical Neoplasia in Switzerland at the Start of a National Vaccination Programme: Crosssectional Study

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant is willing and able to give informed consent for participation in the study. Participant is literate in German, French, Italian or English. Female, aged 18 years or above. Histologically confirmed CIN3+ lesions, i.e. CIN3, adenocarcinoma in situ and invasive carcinoma of the cervix. Participant resides in the canton Zurich, Geneva, Basel, Baselland, Luzern or Ticino. Exclusion Criteria: None

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Human papillomavirus presence and type |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HPV, cervical cancer, human papillomavirus, cervical pre-cancer, cervical neoplasia