linjc16/ctgov huggingface dataset:
Impact of Stent Length on Short Term Outcomes in Patients With Stable Coronary Disease Undergoing PCI

Study Overview
=================
Brief Summary
-----------------
Impact of stent length on short term outcomes in patients with stable coronary artery disease undergoing PCI

Detailed Description
-----------------
Impact of stent length on short term outcomes in patients with stable coronary artery disease undergoing PCI. The investigators will follow up patient clinically and use lab investigation.

Official Title
-----------------
Impact of Stent Length on Short Term Outcomes in Patients With Stable Coronary Artery Disease Undergoing PCI

Conditions
-----------------
Stable Chronic Angina

Intervention / Treatment
-----------------
* Device: Stent more than 26 mn length
* Device: Stent equal to or less than26 mn length


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient was CAD referred for elective PC as single vessel Exclusion Criteria: patients admitted ACS patients with primary PCI PTCA without stenting No complete revascularization PCI-related coronary complication (diessaction,no really)

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 80 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients with coronary artery diseas undergoing PCI<br>Effect of stent length on patients with coronary artery undergoing PCI | Device: Stent more than 26 mn length<br>* stent length in patients undergoing PCI (Drug Eluting Stent)<br>Device: Stent equal to or less than26 mn length<br>* stent length in patients undergoing PCI (Drug Eluting Stent)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of stent length on short term outcomes in patients with stable coronary artery disease undergoing PCI | to study effect of stent length in patients undergoing PCI | 3 months |
GDM Screening During COVID Pandemic. IADPSG vs WHO '99 Criteria

Study Overview
=================
Brief Summary
-----------------
All pregnant women who performed an OGTT following Italian Guidelines and then delivered at our University Hospital from march 2020 to march 2021 were prospectively enrolled in this study. Primary outcome of the study was the number of women to whom was diagnosed GDM with only the fasting glucose value (≥ 92 mg/dl), following Italian Diabetes Societies recommendations for COVID 19 pandemic period. In the same time, we prospectively collected the data of women who became diabetic following the criteria of WHO 1999 (fast glucose value ≥ 120 mg/dl, 2 hours later ≥ 140 mg/dl) still in use in some large countries like India. From the clinical charts, we reported the distribution of risk factors for GDM (maternal age ≥ 35 years, family history for diabetes type 2, ethnia, BMI ≥ 25, previous GDM) and clinical outcomes such as hypertensive disorders, preterm birth, macrosomia, intrauterine growth restriction and Caesarean section in emergency. These data will be compared between the 2 groups consisting in those diagnosed with only IADPSG criteria versus those diagnosed with only WHO '99 criteria.

Official Title
-----------------
Screening of GDM During COVID Pandemic in an Italian Setting. Comparison Between IADPSG and WHO '99 Criteria

Conditions
-----------------
GDM Screening During COVID Pandemic, Comparison Between IADPSG vs WHO '99 Criteria

Intervention / Treatment
-----------------
* Procedure: GDM screening criteria


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women who perform GDM screening - Exclusion Criteria: Twin pregnancies -

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| IADPSG<br> | Procedure: GDM screening criteria<br>* difference in risk factors and clinical outcomes between groups<br>|
| WHO '99<br> | Procedure: GDM screening criteria<br>* difference in risk factors and clinical outcomes between groups<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalence of women with a diagnosis of GDM following guidelines during COVID pamdemic | evaluation of fast glucose level in the period recommended for GDM screening following Italian guidelines | from march 2020 to march 2021 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GDM diagnosis with IADPSG criteria versus WHO '99 criteria | difference in risk factors and clinical outcomes between groups | from March 2020 to March 2021 |
Prevalence of Subclinical Atherosclerosis and Its Associated Factors in Hyperlipidemic Korean Adults With Diabetes

Study Overview
=================
Brief Summary
-----------------
This study is to investigate correlation between Carotid Intima Media Thickness (cIMT) and several factors such as; hs C-reactive protein (CRP), HbA1c, lipid profile in Korean diabetic patients with atherosclerosis. Total 360 patients will be enrolled through 6 sites.

Detailed Description
-----------------
MC MD

Official Title
-----------------
Prevalence of Subclinical Atherosclerosis and Its Associated Factors in Hyperlipidemic Korean Adults With Diabetes

Conditions
-----------------
Diabetes Mellitus, Dyslipidemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with Diabetic Mellitus patients with dyslipidemia Exclusion Criteria: patients who have established cardiovascular disease patient using NSAID

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 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 |
| --- | --- |
| 1<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of intima media thickness, visit 1 |  | Visit 1 | 
| Measurement of intima media thickness, visit 2 |  | Visit 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hs-C-Reactive Protein, visit 1 |  | Visit 1 | 
| hs-C-Reactive Protein, visit 2 |  | Visit 2 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cIMT, hs CRP (C-reactive protein), DM (Diabetic Mellitus), Korea, Corelation between cIMT (carotid intima media thickness), Cardio Vascular risk in Diabetic Mellitus
Observational Study on the Treatment of Trigeminal Neuralgia by Radiosurgery

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate the outcome of patient treated by radiosurgery on LINAC with high dose rate for classical trigeminal neuralgia

Detailed Description
-----------------
This retrospective and prospective case-series hospital-based study will be conducted in all patients with trigeminal neuralgia treated by radiosurgery on LINAC at the Centre Hospitalier Princesse Grace from april 2018 to january 2028. Patients will be treated with frameless technic and receive 90 Gy delivered with high dose rate on the intra cisternal portion of the trigeminal nerve.

Official Title
-----------------
Observational Study on the Treatment of Trigeminal Neuralgia by Radiosurgery

Conditions
-----------------
Trigeminal Neuralgia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Classical trigeminal neuralgia according the International Classification of Headache Disorders Trigeminal neuralgia resistant to the maximum tolerated medical therapy, with pain intensity according to the Barrow Neurological Institute (BNI) score IV or V. Patients aged > 18 Exclusion Criteria: Patients suffering from secondary Trigeminal neuralgia (tumour in the cerebellopontine angle, arteriovenous malformation or multiple sclerosis) Previous history of radiosurgery procedure

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 |
| --- | --- | --- |
| Pain relief | Barrow Neurological Institute pain intensity scale - score I to V - V is the worst Barrow Neurological Institute (BNI) pain intensity scale Barrow Neurological Institute (BNI) pain intensity scale | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity of radiosurgery | Common Terminology Criteria for Adverse Events version 5.0 - grade 1 to 5 - 5 is the worst | 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years | 
| Variation of quality of life | Short Form 36 Health Survey - score 0 to 100 - 0 is the worst | 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Trigeminal Neuralgia, Radiosurgery, LINAC, Pain relief, Hypesthesia
Observational Study of ALNA® (Tamsulosin) in Patients With Benign Prostatic Hyperplasia (BPH)

Study Overview
=================
Brief Summary
-----------------
The objectives of this post marketing surveillance study were to document the comorbidity and comedication during prescription of ALNA® (Tamsulosin) for patients with BPH (Benign Prostatic Hyperplasia).

Official Title
-----------------
Comorbidity and Comedication During Prescription of ALNA® (Tamsulosin) for Patients With BPH (Benign Prostatic Hyperplasia)

Conditions
-----------------
Prostatic Hyperplasia

Intervention / Treatment
-----------------
* Drug: Tamsulosin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Indication for the treatment with ALNA according to its summary of product characteristics (SPC) Exclusion Criteria: Patients fulfilling one of the general or specific contraindications listed in the ALNA SPC, particularly patients with known hypersensitivities against tamsulosin hydrochloride or any other ingredient of the product, orthostatic dysregulation or severe liver insufficiency cannot be included in the study
Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Benign prostatic hyperplasia<br>Patients with symptomatic BPH to whom ALNA was prescribed | Drug: Tamsulosin<br> <br> * Other names: ALNA;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collection of information on concomitant diseases |  | day 1 | 
| Collection of information on concomitant treatment |  | day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with adverse drug reactions |  | up to 6 months |
Retrospective Study of 110 Cases of Uterine Rupture to Determine Obstetric and Neonatal Complications

Study Overview
=================
Brief Summary
-----------------
This study has for objective to collect medical data from patients with uterine rupture at the childbirth.

Detailed Description
-----------------
This is a retrospective study, gathering data of five maternity in the department of Val d'Oise in France, during 13 years (between 01/01/2000 an 31/12/2013). The incidence of uterine rupture increases with increasing cesarean rates. It occurs at a rate of 0.08% across all childbirths in France, and 0.5 to 1% of the childbirths on cicatricial uterus in France. Although the risk factors are known, it is usually unexpected. This is a serious complication for the mother (mortality <1%, severe morbidity at 15% ) and for the child (mortality for 3 to 6 % for childbirth at term, neonatal asphyxia for 6 to 15%) that can occur during pregnancy or during labor.

Official Title
-----------------
Retrospective Study of 110 Cases of Uterine Rupture to Determine Obstetric and Neonatal Complications

Conditions
-----------------
Anomaly Uterus

Intervention / Treatment
-----------------
* Other: Childbirth with uterine rupture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Childbirth with uterine rupture Exclusion Criteria: Childbirth in a maternity which do not participate to the study

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Childbirth with uterine rupture<br>No intervention. Follow-up of women with uterine rupture at the childbirth. | Other: Childbirth with uterine rupture<br>* No intervention. Follow-up of women with rupture uterine at the childbirth.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify maternal and foetal risk factors associated to an uterine rupture ; by the report of events during pregnancy, pathology, lifestyle, Concomitant pathology... |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of maternal and foetal adverse events associated to an uterine rupture at the childbirth. |  | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Uterine rupture
Way To Drive Validation Study

Study Overview
=================
Brief Summary
-----------------
Way to Drive is a smart phone-based driving telematics application. Research participants are invited to download the app, which uses phone sensors to track driving behaviors including mileage, hard breaking events, and handheld phone use while driving, measured as the phone screen being unlocked while the phone is in the hand and the vehicle is in motion. Before the study team launches a clinical trial using the app, the researchers will test its capabilities and reliability.

Official Title
-----------------
Validation Study of Penn's Way to Drive Telematics Research Application

Conditions
-----------------
Validity, Distracted Driving, Driving Behaviors

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 or older (only adult drivers will be invited) Willing to download Way to Drive and allow it to track the user's location while the user is in motion (i.e. over 5mph) Will make at least 4 driving trips per week for the duration of the study. Able to provide informed consent Exclusion Criteria: Under 18 Cannot complete online surveys Does not have smart phone Not willing to download Way to Drive app and allow location tracking while in motion Will not be driving at least 4 times per week during the study.

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of driving trips classified correctly (driver/passenger) by the Way to Drive Telematics App | Measured by the driving and behavior when the car is in motion by the Way to Drive app. | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of driving events accurately captured (trip captured or missing) by Way to Drive Telematics App | Measured using phone sensor data to detect when the vehicle is in motion. | 28 days |
A Study to Compare the Efficacy and Safety of Ziprasidone and Risperidone for the Treatment of Schizophrenia in Chinese Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the efficacy and safety of ziprasidone and risperidone for the treatment of schizophrenia in Chinese patients

Official Title
-----------------
A Six Week, Multicenter, Double Blind, Double-Dummy, Parallel, Comparative Study To Compare The Efficacy, Safety And Tolerability Of Ziprasidone With Risperidone In The Treatment Of Chinese Subjects With Acute Exacerbation Of Schizophrenia

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: Risperidone
* Drug: Ziprasidone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospitalized patients with schizophrenia Miminum PANSS score of 60 when randomized Exclusion Criteria: Planned, regular use of antipsyhotics within 1 week of randomization Previous treatment with risperidone that resulted in intolerance or lack of response to risperidone

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br> | Drug: Risperidone<br>* Oral risperidone capsules 1 and 2 mg; doses were 1 mg once daily on Days 1-2, 2 mg once daily on Days 3-4, 3 mg once daily on Days 5-7, and 1, 2, or 3 mg twice daily during Weeks 2-6<br>|
| Experimental: B<br> | Drug: Ziprasidone<br>* Oral ziprasidone capsules 40, 60, and 80 mg; doses were 40 mg twice daily on Days 1-2, 60 mg twice daily on Days 3-7, and 40, 60, or 80 mg twice daily during Weeks 2-6<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score |  | Week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events, laboratory test changes, movement disorder scale scores |  | Weeks 1, 2, 4, and 6 | 
| Change from baseline in PANSS negative subscale score |  | Weeks 1, 2, 4, and 6 | 
| Change from baseline in PANSS general psychopathology subscale score |  | Weeks 1, 2, 4, and 6 | 
| PANSS responder rate |  | Weeks 1, 2, 4 and 6 | 
| Clinical Global Impression-Severity (CGI-S) score |  | Baseline and Weeks 1, 2, 4, and 6 | 
| Change from baseline in Brief Psychiatric Rating Scale derived (BPRSd) score |  | Weeks 1, 2, 4, and 6 | 
| Change from baseline in PANSS positive subscale score |  | Weeks 1, 2, 4, and 6 | 
| Clinical Global Impression-Improement (CGI-I) score |  | Weeks 1, 2, 4, and 6 |
Phase 3 Clinical Trial to Evaluate of the Efficacy and Safety of DW9801 in Patients With Primary Dysmenorrhea

Study Overview
=================
Brief Summary
-----------------
A Multi-center, Randomized, Placebo-controlled, Double-blind, Cross-over, Phase 3 Clinical Trial to Evaluate of the Efficacy and Safety of DW9801 in Patients with Primary Dysmenorrhea

Official Title
-----------------
A Multi-center, Randomized, Placebo-controlled, Double-blind, Cross-over, Phase 3 Clinical Trial to Evaluate of the Efficacy and Safety of DW9801 in Patients With Primary Dysmenorrhea

Conditions
-----------------
Primary Dysmenorrhea

Intervention / Treatment
-----------------
* Drug: Pelubiprofen 45mg
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patients, age between 19 years to 44years Patients with menstrual pain over 4 out of 6 menstrual cycles before screening Patients with moderate or severe menstrual pain for recent 2 menstrual cycles Patients with regular menstrual cycles(28±7 days) for a year Exclusion Criteria: Patients diagnosed or suspected of secondary dysmenorrhea Previous adverse reaction or known allergy to NSAIDs Breast feeding woman Patients who are not willing to use proper contraception during clinical trial period

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 44 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group 1<br> | Drug: Pelubiprofen 45mg<br>* Pelubiprofen 45mg 1 tab for moderate or severe menstrual pain, bid for 3days(prn)<br>Drug: Placebo<br>* Placebo1 tab for moderate or severe menstrual pain, bid for 3days(prn)<br>|
| Other: Group 2<br> | Drug: Pelubiprofen 45mg<br>* Pelubiprofen 45mg 1 tab for moderate or severe menstrual pain, bid for 3days(prn)<br>Drug: Placebo<br>* Placebo1 tab for moderate or severe menstrual pain, bid for 3days(prn)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TOTPAR-8 | Time weighted sum of total pain relief | Day 1 | 
| SPID-8 | Sum of pain intensity difference | Day 1 |