linjc16/ctgov huggingface dataset:
Treatment of Hypercholesterolaemia in Hispanic Subjects (STARSHIP)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the effect of 6 weeks of treatment with Rosuvastatin with 6 weeks of treatment with Atorvastatin in Hispanic subjects with hypercholesterolemia

Official Title
-----------------
A 6-Week, Randomized, Open-Label, Comparative Study to Evaluate the Efficacy and Safety of Rosuvastatin and Atorvastatin in the Treatment of Hypercholesterolaemia in Hispanic Subjects.

Conditions
-----------------
Hypercholesterolemia, Dyslipidaemia

Intervention / Treatment
-----------------
* Drug: Rosuvastatin
* Drug: Atorvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fasting low density lipoprotein & triglyceride levels as defined by the protocol. Self described Hispanic race Subjects with coronary heart disease or at high risk of coronary heart disease. Exclusion Criteria: The use of lipid lowering drugs or dietary supplements after Visit 1. Active arterial disease eg Unstable angina, or recent arterial surgery Blood lipid levels above the limits defined in the protocol. Uncontrolled hypertension, hypothyroidism, alcohol or drug abuse.

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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Rosuvastatin | Drug: Rosuvastatin<br> <br> * Other names: Crestor;|
| Active Comparator: 2<br>Atorvastatin | Drug: Atorvastatin<br> <br> * Other names: Lipitor;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Low density lipoproteins cholesterol levels |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other blood lipid level changes |  | 6 weeks | 
| Safety: adverse events & abnormal laboratory markers |  | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cholesterol, low density lipoproteins, dyslipidaemia, Rosuvastatin, Crestor, Atorvastatin, Lipitor, Hispanic
Neurologic Outcome After Mitral Valve Surgery

Study Overview
=================
Brief Summary
-----------------
Reconstructive mitral valve surgery is increasingly done by minimal- invasive anterolateral thoracotomy technique in contrast to surgical approach by sternotomy. The minimal invasive approach is favourable regarding surgical trauma, length of hospital stay and amount of blood loss. This study is to investigate the neurological outcome after minimal- invasive mitral valve surgery compared to open mitral valve surgery by sternotomy. Pre-, intra- and postsurgical data from mitral valve surgery derived from the Basel mitral valve registry (collected from 2009 until now) will be analyzed.

Official Title
-----------------
Neurologic Outcome After Mitral Valve Surgery

Conditions
-----------------
Mitral Valve Reconstruction

Intervention / Treatment
-----------------
* Other: mitral valve surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: surgery for mitral valve (reconstruction or replacement) (maybe combined with surgery for tricuspid valve and/ or surgery for atrial septal defects and/or patent foramen ovale) Exclusion Criteria: other surgical interventions then the surgical interventions mentioned in the inclusion criteria pre- existing neurological deficit; neurologic limitation in daily life emergency surgery
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| mitral valve surgery<br>outcome of mitral valve surgery (stroke yes or no) | Other: mitral valve surgery<br>* assessment of ischemic or hemorrhagic stroke subsequent to mitral valve surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occurence of stroke (yes/ no) subsequent to mitral valve surgery | assessment of ischemic or hemorrhagic stroke subsequent to mitral valve surgery | post surgical from day of surgery until day of discharge from hospital (approx. 2 weeks) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mitral valve surgery, mitral valve stenosis, mitral valve insufficiency, minimal invasive mitral valve surgery, neurological outcome
Usability Comparison of a mHealth Application for Pre-anesthesia Evaluation Before and After Re-design of User Interface

Study Overview
=================
Brief Summary
-----------------
Pre-anesthesia assessment is an important part of anesthesiologists daily routine. A thorough assessment leads to an impeccable anesthesia plan. In the past, the department of anesthesiologist in NTUH (National Taiwan University Hospital) utilizes paper assessment form. As government policy leans towards digitization, the department of anesthesiologist in NTUH collaborates with the information technology office to develop an electronic pre-anesthesia assessment system called EVAN, which is an iOS based application (App). EVAN includes an anesthesia patient list, patient EMR (electronic medical record) and pre-anesthesia assessment form. EVAN was online since March, 2018. This is an observational research to investigate the user experience and improve the user interface of EVAN. This research subjects include anesthesiologists from NTUH. This research has three parts: user tasks, questionnaires, and a semi-structured interview. First, the research assistant will record how the user use the App to complete the tasks, which includes video recording and App monitoring. After the tasks is completed, the subject will write a questionnaire. Then the principal investigator will give an interview for feedbacks from the users.

Official Title
-----------------
Usability Comparison of a mHealth Application for Pre-anesthesia Evaluation Before and After Re-design of User Interface

Conditions
-----------------
Usability, Anesthesia

Intervention / Treatment
-----------------
* Other: iOS application usability test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: anesthesiologists in NTUH Exclusion Criteria: none

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| User<br> | Other: iOS application usability test<br>* user tasks, questionnaires, semi-structured interviews<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| task complete time | the time duration the user needs to complete the user tasks | the duration the user needs to complete the tasks, usually within 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| questionnaire grading | user questionnaire grading | after the user questionnaire completion, usually within 1 minutes |
Safety and Efficacy of DC-CIK in Patients With Advanced Non-Small-Cell Lung Cancer With Bone Metastases

Study Overview
=================
Brief Summary
-----------------
The purpose of this Phase I/II study is to evaluate the safety and efficacy of dendritic cells(DC) vaccine combined with cytokine-induced killer (CIK) cells in patients with Advanced Non-Small-Cell Lung Cancer with bone metastases. Experimental DC was transfected Ad5 vector coding mRNAs including suppressor of cytokine signaling (SOCS) 1, MUC1 and Survivin,are used for DC-based immunotherapy. Based on the results of our previously preclinical study with DC vaccine combined with CIK cells, the investigators plan to perform the clinical trial.

Official Title
-----------------
Safety and Efficacy of DC Vaccine Combined With Cytokine-induced Killer Cells in Patients With Advanced Non-Small-Cell Lung Cancer With Bone Metastases: a Phase I/II Study

Conditions
-----------------
Non-Small-Cell Lung Cancer With Bone Metastases

Intervention / Treatment
-----------------
* Biological: genetically modified dendritic cells + cytokine-induced killer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histopathologically confirmed diagnosis of non-small cell lung cancer Age >18 years at time of consent Received standardized treatment of Non-Small-Cell Lung Cancer with bone metastases KPS (Karnofsky performance scale) >60 Patient's written informed consent No severe viral or bacterial infections Predicted survival >3 months Exclusion Criteria: Clinically relevant diseases or infections (HBV, HCV, HIV) Females who are pregnant or nursing Immunosuppressant treatment Currently participating in another clinical trial

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- |
|Biological: genetically modified dendritic cells + cytokine-induced killer|This Phase I/II Study to evaluate clinical efficacy, safety of genetically modified dendritic cells in combination with cytokine-induced killer cell treament in NSCLC with bone metastases.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| objective response rate (CR+PR) as measured by RECIST criteria |  | one month after DC/CIK treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of participants with adverse events |  | 3 days during DC/CIK treatment] |
Endoscopic Full Thickness Resection of Gastric Subepithelial Tumors (FROST)

Study Overview
=================
Brief Summary
-----------------
Prospective observational trial. A full thickness resection of gastric subepithelial tumors is performed after application of full thickness sutures underneath the tumor with the GERDX(TM) device. Hypothesis: This endoscopic method is feasible, effective and safe.

Official Title
-----------------
Endoscopic Full Thickness Resection of Gastric Subepithelial Tumors (FROST)

Conditions
-----------------
Gastric Neoplasms, Gastrointestinal Stromal Tumors

Intervention / Treatment
-----------------
* Device: GERDX(TM)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: presence of a subepithelial gastric tumor with signs of potential malignancy in endoscopic ultrasound age 18 years or older participant has given informed consent Exclusion Criteria: tumor size > 40 mm (endosonographic measurement) or large extramural tumor mass signs of systemic dissemination of tumor current presence of a different neoplastic disease (except after successful curative treatment without continued medication) former surgery or disease of esophagus or stomach that impedes insertion of the suturing device moribund patient limited possibility to give informed consent (e.g. language barrier, psychiatric disease) pregnancy and lactation period

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 |
| --- | --- |
| EFTR-GERDX<br>Endoscopic full thickness resection of subepithelial gastric tumors using the GERDX suturing device. | Device: GERDX(TM)<br>* Endoscopic full thickness resection of subepithelial gastric tumors using the GERDX suturing device.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of cases in which a complete macroscopic en bloc resection of the gastric subepithelial tumor could be achieved |  | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of cases in which a complete microscopic resection of the gastric subepithelial tumor could be achieved |  | within one week after resection (as soon as result of pathologic analysis of resected specimen is available) | 
| Rate of complications (bleeding, perforation) |  | 6 months after resection | 
| Duration of hospitalization |  | within one week after resection | 
| Number of participants with local or systemic recidive of tumor |  | 6 months after resection | 
| Number of participants with needs of surgical therapy or endoscopic re-resection |  | 6 months after resection |
Validation of Medication Non-adherence Model (UK)

Study Overview
=================
Brief Summary
-----------------
Research has shown that nearly 50% of patients with chronic conditions around the globe do not adhere to their prescribed medicine, leading to enormous cost to the healthcare providers. Non-adherence can be due to various forms and have multiple causes. To address this need, Philips Research has developed Medication Non-adherence model. This tool will help in developing a systemic way of assessing medication non-adherence and providing decision support for targeted intervention to healthcare professionals. The aim of this study is to validate this model with 750 chronically ill patients in UK.

Official Title
-----------------
Validation of Medication Non-adherence Model (UK)

Conditions
-----------------
Diabetes Mellitus, Chronic Obstructive Pulmonary Disease, Chronic Illness, Primary Care, Medication Management at Home

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with chronic disease between 18 -89 years old. Chronic medication use (> 3 medications; excluding analgesic, ointment and eye drop medication) Patients registered with a given Pharmacy at least 1 year before entering into the study. Exclusion Criteria: Patients who are illiterate in English. Patients who are unable to give consent to the study. Enrolled in another clinical trial, which requires change in their routinely medication. Patients currently using automatic medication reminder services (excluding the pharmacy service). Patients with dementia or any other mental conditions, that might affects the accuracy of the answers provided.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 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 |
| --- | --- |
| medication non-adherence<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence determinants | Self-reported behavioral questionnaire completed at 3 monthly intervals | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication usage | Collecting refill data from the pharmacy where patients are registered to. Time Frame: 18 months (12 month prior to enrollment + 6 months during the study | 18 months |
The Relation Between Serum Ascorbic Acid Concentration and Preterm Premature Rupture of Membranes

Study Overview
=================
Brief Summary
-----------------
To study the association between maternal serum vitamin C concentration in women with preterm premature rupture of membranes (PPROM) and women without PPROM.

Detailed Description
-----------------
The micronutrient vitamin C is an effective water soluble antioxidant that scavenges several reactive oxygen species, thus reducing oxidative stress, It also acts as an enzymatic cofactor to the enzymes lysyl hydroxylase and prolyl hydroxylase, which is required for synthesis of hydroxyproline and hydroxylysine, Collagen requires hydroxyproline bridges across the triple helix to provide stability to it, Ascorbic acid also causes down regulation of the metalloproteinase-2 and biosynthesis of collagen where it is required for the formation of triple helical structure of collagen. Thus, ascorbic acid participates in the equilibrium between synthesis and degradation of collagen and this may be critical in reducing the occurrence of preterm PROM.

Official Title
-----------------
The Relation Between Serum Ascorbic Acid Concentration and Preterm Premature Rupture of Membranes

Conditions
-----------------
Preterm Premature Rupture of Membranes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Singleton pregnancies Gestational age between 28-37 weeks Rupture of membranes will be diagnosed by history, sterile speculum examination to confirm fluid leakage from the cervical canal Exclusion Criteria: Patients with multiple pregnancies Smoker Polyhydramnios Maternal diseases such as: anemia, diabetes, UTI, RTI and vaginal infection History of PPROM in previous pregnancies Evidence of chorioamnionitis in current pregnancy
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 |
| --- | --- |
| study group<br>Study group included 20 pregnant women with PPROM and fulfilled the inclusion and exclusion criteria. | |
| control group<br>Control group also included 20 pregnant women without PPROM following every recorded case of PPROM and matched for gestational age. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| relation between serum vitamin C concentration and PPROM |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vitamin c, Preterm Premature Rupture of Membranes
GMA and Peri in Moderate-late Preterms

Study Overview
=================
Brief Summary
-----------------
To analyze the relationship between the early diagnosis of cerebral palsy with the risk factors of this pathology in moderate and late premature infants

Detailed Description
-----------------
Analyze a sample of moderate and late premature infants using general movements and verify which of them would have an early diagnosis of cerebral palsy and relate it to their risk factors for this pathology.

Official Title
-----------------
Early Detection of the Cerebral Palsy in Moderate and Late Preterms Through the General Movements

Conditions
-----------------
Preterm, Assessment, Risk Factor, Cerebral Palsy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who were born between the week 32 + 0 days and the week 36 + 6 days and who are admitted to the Hospital Nuestra Señora del Prado de Talavera de la Reina or the Hospital Virgen de la Salud de Toledo. Exclusion Criteria: Any type of pre and perinatal diagnostic neurological involvement. Any type of pathology associated with prematurity. Children who have prescribed any of the following medications (10): Barbiturates Antiepileptic Indomethacin Dexamethasone

Ages Eligible for Study
-----------------
Minimum Age: 32 Weeks
Maximum Age: 36 Weeks

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 |
| --- | --- | --- |
| gestation weeks | Premature birth week | From date of Recruiting until the discharging of neonatal intensive care unit, assessed up to 40 weeks | 
| weight | measurement, World Health Organization percentile | From date of Recruiting until the discharging of neonatal intensive care unit, assessed up to 40 weeks | 
| size | measurement, World Health Organization percentile | From date of Recruiting until the discharging of neonatal intensive care unit, assessed up to 40 weeks | 
| cranial perimeter | measurement about head, World Health Organization percentile | From date of Recruiting until the discharging of neonatal intensive care unit, assessed up to 40 weeks | 
| Apgar | Outcome about Apgar Test | at birth of each preterm | 
| Magnetic resonance imaging rating scale | Outcome about Neuroimaging in preterms | From date of Recruiting until the discharging of neonatal intensive care unit, assessed up to 40 weeks | 
| general movements outcome | Outcome about General Movements Assessment. Three outcomes about movement of preterm. Normal, Poor Repertoire and Cramped Synchronized | From date of Recruiting until the discharging of neonatal intensive care unit, assessed up to 40 weeks | 
| PERI outcome | Outcome about Perinatal Risk Scale Scale. Minimum score: 0. Maximum score: 51 | through study completion, an average of 18 months |