linjc16/ctgov huggingface dataset:
Clinical Trail to Evaluate the Efficacy and Safety of DWJ1451

Study Overview
=================
Brief Summary
-----------------
the change of sitSBP based on baseline between Treatment arm and control 1 arm [ Time Frame: 8 weeks ] the change of LDL-C based on baseline between Treatment arm and control2 arm [ Time Frame: 8 weeks ]

Official Title
-----------------
A Multi-center, Randomized, Double-Blind, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DWJ1451 in Patients With Hypertension and Dyslipidemia

Conditions
-----------------
Hypertension, Dyslipidemia

Intervention / Treatment
-----------------
* Drug: Amlodipine/Olmesartan 10/40mg (Combination drug), Ezetimibe/Rosuvastatin 10/20mg(Combination drug)
* Drug: Olmesartan 40mg, Ezetimibe/Rosuvastatin 10/20mg(Combination drug)
* Drug: Amlodipine/Olmesartan 10/40mg (Combination drug)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 19 to 80 years patients with hypertension and hyperlipidemias Exclusion Criteria: orthostatic hypotension History of ventricular tachycardia, atrial fibrillation uncontrolled diabetes mellitus

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Amlodpine, Olmesartan, Rosuvastatin, Ezetimibe<br>co-administration of Olmesartan, Amlodipine and Rosuvastatin, Ezetimibe | Drug: Amlodipine/Olmesartan 10/40mg (Combination drug), Ezetimibe/Rosuvastatin 10/20mg(Combination drug)<br>* co-administration of Sevikar tab. 10/40mg(Amlodipine/Olmesartan 10/40mg), Rosuzet Tab. 10/20mg(Ezetimibe/Rosuvastatin 10/20mg) and placebo of Olmetec Tab. 40mg(Olmesartan 40mg)<br>|
| Placebo Comparator: Olmesartan, Rosuvastatin, Ezetimibe<br>co-administration of Olmesartan and Rosuvastatin, Ezetimibe | Drug: Olmesartan 40mg, Ezetimibe/Rosuvastatin 10/20mg(Combination drug)<br>* co-administration of Olmetec tab. 40mg(Olmesartan 40mg), Rosuzet Tab. 10/20mg(Ezetimibe/Rosuvastatin 10/20mg) and placebo of Sevikar tab. 10/40mg (Amlodipine/Olmesartan 10/40mg)<br>|
| Placebo Comparator: Amlodpine, Olmesartan<br>co-administration of Olmesartan, Amlodipine | Drug: Amlodipine/Olmesartan 10/40mg (Combination drug)<br>* co-administration of Sevikar tab. 10/40mg(Amlodipine/Olmesartan 10/40mg, and placebo of Rosuzet Tab. 10/20mg(Ezetimibe/Rosuvastatin 10/20mg), Olmetec Tab. 40mg(Olmesartan 40mg)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the change of MSSBP based on baseline between Treatment arm and control 1 arm |  | 8 weeks | 
| the change of LDL-C based on baseline between Treatment arm and control2 arm |  | 8 weeks |
Gastroesophageal Reflux Disease (GERD) Segmentation: Document How Swiss General Practitioners (GPs) Allocate Their GERD Patients to the Three GERD Patient Segments

Study Overview
=================
Brief Summary
-----------------
Document how Swiss GPs allocate their GERD patients to the three GERD patient segments (according to King et al.) and how treated GERD patients are affected by their GERD treatment

Official Title
-----------------
GERD Segmentation: Document How Swiss GPs Allocate Their GERD Patients to the Three GERD Patient Segments

Conditions
-----------------
GERD

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previously diagnosed GERD patients on treatment for at least 2 weeks Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 12 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 |
| --- | --- |
| Treated GERD pts<br>Previously diagnosed GERD patients on treatment in Switzerland | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % patients per GERD patient segment |  | single visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom load |  | single visit | 
| Quality of life |  | single visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GERD, Pharmacoepidemiology
Breakthrough Pain Computer Integrated Patient Controlled Epidural Analgesia

Study Overview
=================
Brief Summary
-----------------
The computer-integrated patient controlled epidural analgesia (CIPCEA) system can automatically adjust the background infusion rate during combined spinal-epidural (CSE) analgesia based on the parturient's need as labour progresses. Analysis of parturients experiencing breakthrough pain may identify associated factors that can also be related to obstetric or foetal outcomes

Detailed Description
-----------------
Computer integrated patient controlled epidural analgesia (CIPCEA) is a novel epidural analgesic delivery system that is currently used in daily practice in KK Women's and Children's Hospital. It has enabled us to monitor the infusion pumps through wireless connection to a central monitoring system and hence, collect pump utilisation data electronically. The CIPCEA system is programmed to analyse the LA usage across the last hour and adjust the background infusion rate according to a preset algorithm. Breakthrough pain is defined as maternal complaint of pain or pressure that required and was successfully treated with supplemental epidural medications. we investigated the potential factors associated with breakthrough pain in patients who receive CSE epidural analgesia with CIPCEA, with the aim of elucidating the important associated factors.

Official Title
-----------------
Incidence and Characteristics of Breakthrough Pain in Parturients Using Computer Integrated Patient Controlled Epidural Analgesia

Conditions
-----------------
Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Nulliparous women, requested for epidural analgesia Exclusion Criteria: Multiparous women, unable to perform combined spinal epidural technique

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 45 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 |
| --- | --- | --- |
| Breakthrough Pain (Requiring unscheduled epidural supplementation by anaesthetists) | Requiring unscheduled epidural supplementation by anaesthetists | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caesarean Section (Rate of caesarean section) | Rate of caesarean section | 1 day | 
| Instrumental Delivery (Rate of instrumental delivery) | Rate of instrumental delivery | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Epidural Analgesia, Pain
Neural Circulatory Control and SUDEP Risk.

Study Overview
=================
Brief Summary
-----------------
The investigators believe epilepsy alters the way the body controls blood pressure, heart rate and breathing, and these changes increase the risk of sudden unexpected death in patients with epilepsy (SUDEP). SUDEP-7 is a risk scoring tool which may correlate with these changes to the heart and blood vessels. This research study measures those differences which may help identify new markers to help predict those patients at greatest risk in the future.

Detailed Description
-----------------
The investigators overall goals are to determine whether measures of neural-circulatory control during the interictal waking and sleep states, as well as during the ictal/peri-ictal periods, are associated with SUDEP-7 score risk profiles in refractory epilepsy patients, and to translate these measures into tools for risk-stratification and preventative strategies for SUDEP.

Official Title
-----------------
Neural Circulatory and Respiratory Control in Patients With Epilepsy and the Risk of Sudden Unexpected Death.

Conditions
-----------------
Epilepsy, Seizures

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults aged 18-90 Able to consent Exclusion Criteria: History of non-epileptic spells/seizures, Children/adolescents under age 18 years Pregnancy Non-compliance with Epilepsy Monitoring Unit safety procedures Unable to consent History of dysautonomia Chronic Obstructive Pulmonary Disease (COPD) Asthma (active requiring therapy) Pulmonary hypertension Known Structural Heart Disease Heart failure Myocardial infarction Stroke Seizures due to traumatic injury Prior surgery for epilepsy Vasculitis Raynaud's Smoking (current or within the last 6 months)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| High SUDEP-7 score<br>Patients with epilepsy who have a high SUDEP-7 score | |
| Low SUDEP-7 score<br>Patients with epilepsy who have a low SUDEP-7 score | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abnormal neural circulatory control in patients with epilepsy and high SUDEP-7 scores compared to patients with epilepsy and low SUDEP-7 scores. |  | 24 hours | 
| Abnormal neural and respiratory control in the ictal and peri-ictal phase of patients with epilepsy and a high SUDEP-7 score when compared to patients with epilepsy and a low SUDEP-7 score. |  | 3-7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SUDEP, Sudden cardiac death, Sudden unexpected death in epilepsy, Sleep, Polysomnography, Autonomic, Cardiovascular
Study To Evaluate The Safety And Efficacy Of Torcetrapib/Atorvastatin In Subjects With Familial Hypercholerolemia

Study Overview
=================
Brief Summary
-----------------
The Torcetrapib project was terminated on December 2, 2006 due to safety findings. To evaluate the efficacy and safety of torcetrapib/atorvastatin compared to atorvastatin alone in patients with heterozygous familial hypercholesterolemia

Detailed Description
-----------------
For additional information please call: 1-800-718-1021

Official Title
-----------------
Phase 3, Multi-Center, Double-Blind, Randomized, Parallel Group, Study of the Efficacy, Safety, and Tolerability of Fixed Combination Torcetrapib (CP-529,414) / Atorvastatin Administered Orally, Once Daily (QD) for Six Months, Compared With Maximally Tolerated Atorvastatin Therapy Alone, in Subjects With Heterozygous Familial Hypercholesterolemia

Conditions
-----------------
Hyperlipidemia, Hypercholesterolemia, Familial

Intervention / Treatment
-----------------
* Drug: torcetrapib/atorvastatin
* Drug: atorvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Heterozygous Familial Hypercholesterolemia At least 18 years of age Exclusion Criteria: Women who are pregnant or lactating, or planning to become pregnant. Subjects with a clinically indicated need for statin (HMG-CoA reductase inhibitor) therapy other than atorvastatin or other concomitant therapy with known lipid altering effects on LDL-C and HDL-C including fibrates and nicotinic acid (high doses) Subjects taking any drugs known to be associated with an increased risk of myositis in combination with HMG-CoA reductase inhibitors Subjects with any other medical condition or laboratory abnormality which could affect subject safety, preclude evaluation of response, or render unlikely that the subject would complete the study

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: torcetrapib/atorvastatin|nan|
|Drug: atorvastatin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HDL-C and LDL-C |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in other lipid parameters |  |  |
Time Course of Procalcitonin and C Reactive Protein in Septic Patients Under Treatment With Corticosteroids

Study Overview
=================
Brief Summary
-----------------
A systemic treatment with corticosteroids has been advocated for various bacterial infectious diseases. Since the production of CRP is down-regulated by corticosteroids, a smaller increase or a more rapid decrease of this acute phase protein will: suggest attenuated systemic inflammation, but does not necessarily reflect adequate therapy of the infection. For several reasons (good diagnostic tool for sepsis, induction not decreased by immunosuppressive therapy), procalcitonin could be a better marker for activity of sepsis in patients under corticosteroids. As this issue has not yet been examined the investigators will prospectively study the time-course of PTC and CRP in a well-defined septic patient group, that in adjunction to antibiotic therapy also received systemic corticosteroid treatment and compare it to a similar group without corticosteroid treatment.

Conditions
-----------------
Sepsis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute exacerbation of chronic obstructive pulmonary disease (COPD) due to bacterial pneumonia Exclusion Criteria: Chronic systemic use of corticosteroids

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 80 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Procalcitonin, Sepsis, Corticosteroids
Safer Warfarin Treatment

Study Overview
=================
Brief Summary
-----------------
The study is a national multicenter prospective observational study, including 200 patients. The main purpose of this study is to explore in more detail the influence of genetic variability (CYP enzymes and vitamin K dependent proteins) and dietary vitamin K status on warfarin dosing, clinical effect and adverse events with emphasis on the initial phase of treatment. The hypothesis is that genetic variability concerning CYP enzymes and vitamin K dependent proteins predict dosing and adverse events during warfarin treatment. The main aim is to individualize warfarin therapy and establish a treatment algorithm based on genotype and dietary vitamin K status to make the anticoagulation therapy with warfarin more secure.

Official Title
-----------------
Safer Warfarin Treatment - the Influence of CYP2C9 Genotyping, Genotyping of Vitamine K Dependent Proteins and Dietary Vitamine K Status on Dosing, Clinical Effect and Adverse Events With Emphasis on the Initial Phase of Treatment

Conditions
-----------------
Atrial Fibrillation, Venous Thrombosis, Pulmonary Embolism, Heart Valve Prosthesis

Intervention / Treatment
-----------------
* Other: Blood specimens (whole blood, serum, plasma)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Caucasian >18 years of age included in the study at the onset of warfarin treatment target INR (2-3 for atrial fibrillation, vein thrombosis, pulmonary embolism and 2.5-3.5 for prosthetic heart valves) standard indications for warfarin treatment Exclusion Criteria: Non-caucasian Clinical significant liver affection Heart failure, NYHA class III-IV Non-compliant - not able to accomplish protocol demands Not able to give informed consent Long-term antibiotic therapy Malabsorption conditions and inflammatory bowel disease

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 |
| --- | --- |
| Warfarin treatment group<br>Open label study. Patients in need of warfarin treatment (standard indications) are included in the study at the onset of warfarin treatment. | Other: Blood specimens (whole blood, serum, plasma)<br>* The patients follow standard warfarin treatment regimens and the only intervention is the sampling of blood specimens.<br>|

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
-----------------
warfarin, genotyping, vitamin K, dosing, adverse events, initial phase of treatment, algorithm
Insoles in Prevention of Lower Limb Injuries

Study Overview
=================
Brief Summary
-----------------
To address whether custom made foot insoles could be used for primary prevention of lower limb overuse injuries, the investigators conducted a prospective, randomized controlled study comparing the use of insoles and standard shoes in healthy young adults exposed to increased physical activity.

Official Title
-----------------
Prevention of Lower Limb Overuse Injuries by Using Custom Made Insoles: A Randomized Controlled Trial of 230 Patients

Conditions
-----------------
Lower Limb Overuse Injuries

Intervention / Treatment
-----------------
* Device: custom-made insoles (Thermo+Camel, cost for the military 20,50 euros)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: healthy conscripts without any diagnosed deformities of lower limb by physician in premilitary physical examination Exclusion criteria: major orthopaedic or medical conditions (e.g., diabetes, inflammatory arthritis, previous severe trauma (exclusion criteria for the military service) patients were excluded from our study if they already had insoles prescribed by a physician or a physiotherapist (eight patients) since only 2% of Finnish conscripts are females, they were excluded from the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 29 Years

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control group<br>Conscript used their own ankle boots instead of custom made insoles. | |
| Experimental: shoe insoles<br>The custom made insoles (Thermo+Camel, cost for the military 20,50 euros) were fabricated from firm-density polyethylene and the hard plastic shell was a three-quarter length. The insole was strong enough to fill the arch area thus providing support to the mid foot. It also influences the position of the foot. The insoles were individually customized by heating the polyethylene in form of individual foot with standing and walking in them. The conscripts were advised to use these insoles in their ankle boot. | Device: custom-made insoles (Thermo+Camel, cost for the military 20,50 euros)<br>* The custom made insoles (Thermo+Camel, cost for the military 20,50 euros) were fabricated from firm-density polyethylene and the hard plastic shell was a three-quarter length.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The main outcome measure in the present study was a lower limb overuse injury requiring a visit at the garrison physician and requiring suspension from the duty. |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
overuse injuries, conscript, prevention