linjc16/ctgov huggingface dataset:
Non-interventional Study Comparing Targiniq and Oxycodone/Laxatives

Study Overview
=================
Brief Summary
-----------------
The objective of the non-interventional study is to compare the quality of life, health care resource use and costs between the use of a combination of oxycodone and naloxone (Targiniq) versus oxycodone and laxatives for patients with severe pain, and to evaluate the cost-effectiveness of treatment with Targiniq.

Official Title
-----------------
An Observational Study of Quality of Life, Resource Use and Costs Associated With Treatment of Severe Pain - a Comparison of a Combination of Oxycodone and Naloxone (Targiniq) Versus Oxycodone and Laxatives

Conditions
-----------------
Pain, Opioid Induced Constipation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Male or non-pregnant female ≥18 years of age Malignant or non-malignant opioid sensitive pain Must sign an informed consent form (ICF) Must have a stable daily dose of oxycodone prolonged release formulation titrated to analgesic effect (as to be assessed by clinical experts) Use of laxatives for concomitant opioid-induced constipation in an adequate dose and length of time and without sufficient effect BFI ≥30 and state a discomfort caused by the constipation at screening Ability to answer the patient questionnaires and have an estimated overall life expectancy of at least six (6) months Exclusion criteria: History of, or on-going, abuse of alcohol and/or drugs Inability to read and understand written instructions, ICF or questionnaires Constipation not related to opioid use Unsuitable patient for other reason(s) in the opinion of the investigator Inpatients, if admission and/or discharge is expected during study 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | Two visits performed over 8 weeks | 8 Weeks |
Korean Idiopathic Pulmonary Fibrosis Registry

Study Overview
=================
Brief Summary
-----------------
This is a multicenter prospective registry of IPF patients in South Korea. The Seoul National University Bundang Hospital is the coordination center for the Korean IPF Registry built by a collaboration of the Korean Interstitial Lung Diseases (ILD) Study Group.

Detailed Description
-----------------
Korean ILD Study Group includes investigators of 30 hospitals. Demographic, pulmonary function, laboratory data, chest CT findings and hospital course of IPF patients are collected.

Official Title
-----------------
Korean Idiopathic Pulmonary Fibrosis Registry

Conditions
-----------------
Idiopathic Pulmonary Fibrosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: IPF patients diagnosed by multidisciplinary discussion Exclusion Criteria: Other interstitial lung diseases except for IPF connective tissue disease-related ILD exposure-related ILD

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 100 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 |
| --- | --- | --- |
| survival of IPF | lung function change (FVC, DLCO) | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival | death rate | through study completion, an average of 1 year | 
| acute exacerbation | rate of acute exacerbation | through study completion, an average of 1 year | 
| incidence of comorbidity | incidence of lung cancer | through study completion, an average of 1 year |
Real-life Data of Cardiovascular Events Occuring During Degarelix Therapy for Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
Patients with prostate cancer and a history of cardiovascular disease treated with degarelix for their prostate cancer, will be followed for a period of one year. In this real-life, non-interventional trial, any cardiovascular events occurring during degarelix therapy will be documented.

Conditions
-----------------
Advanced Hormone Sensitive Prostate Cancer

Intervention / Treatment
-----------------
* Drug: degarelix


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with prostate cancer and a history of cardiovascular disease, prescribed degarelix for the treatment of their prostate cancer Exclusion Criteria: Patients who have received a form of androgen deprivation therapy for their prostate cancer, during the 12 months preceding this study are excluded Planned intermittent or short-term (< 12 months) degarelix treatment Planned addition of, or switch to another form of androgen deprivation therapy during 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 |
| --- | --- |
| Degarelix<br>Treatment according to standard clinical practice. | Drug: degarelix<br> <br> * Other names: Firmagon®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular event rate in hormone naïve prostate cancer patients with cardiovascular comorbidity at baseline, treated with degarelix in daily practice |  | Up to 1 year |
A Study to Assess the Efficacy of XEN-D0501 in Reducing the Cough Frequency in Patients With COPD

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effectiveness of XEN-D0501 over placebo in reducing the daytime cough frequency in patients with chronic obstructive pulmonary disease (COPD). The effectiveness of XEN-D0501 placebo in reducing capsaicin cough responses, objective 24-hour cough frequency, hourly change in cough frequency, cough severity (via visual analogue scale [VAS]), urge to cough (via VAS), global rating of change scale, Clinical COPD Questionnaire (CCQ), Leicester Cough Questionnaire (LCQ), and St George's Respiratory Questionnaire (SGRQ-C) will be evaluated.

Official Title
-----------------
A Double-blind, Randomised, Placebo-controlled, Crossover Study to Assess the Efficacy of XEN-D0501, a Transient Receptor Potential Vanilloid Receptor 1 (TRPV1) Antagonist, in Reducing the Frequency of Cough in Patients With Chronic Obstructive Pulmonary Disease

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Drug: XEN-D0501
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male/female subjects aged 40 or over with COPD Exclusion Criteria: Clinically significant medical history Abnormal laboratory results, ECGs or vital signs

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: XEN-D0501<br>4mg BID Days 1-13, 4mg once daily (OD) Day 14 | Drug: XEN-D0501<br> <br> |
| Placebo Comparator: Placebo to Match<br>BID Days 1-13, once daily (OD) Day 14 | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline at the end of each treatment period in objective daytime cough frequency |  | 12 weeks |
Asthma in the Elderly: The Role of Exhaled Nitric Oxide Measurements

Study Overview
=================
Brief Summary
-----------------
This study will investigate the importance of exhaled nitric oxide measurements in subjects with asthma age 65 and older. This group of patients has been ignored in most previous asthma studies.

Official Title
-----------------
Asthma in the Elderly: The Role of Exhaled Nitric Oxide Measurements

Conditions
-----------------
Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with asthma over the age of 65 followed in our practice, non-smokers and able to give informed consent to participate in the study Exclusion Criteria: Smokers, subjects of diminished mental capacity

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- | --- |
| Exhaled Nitric Oxide (FENO) levels and their changes with time |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlations of FENO with subjects' demographics, comorbidities, treatment, symptoms, or spiromentric values |  | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma in subjects over the age of 65
Type III Dysbetalipoproteinemia

Study Overview
=================
Brief Summary
-----------------
Evaluation of the efficacy of rosuvastatin 10mg, rosuvastatin 20mg and pravastatin 40mg in subjects with dysbetalipoproteinemia.

Official Title
-----------------
An 18-week, Randomized, Multicenter, Phase 3b, Double-blind, Crossover Study, Followed by an 18-week Open-Label Period to Evaluate the Efficacy & Safety of the Lipid-Regulating Agents, Rosuvastatin & Pravastatin in the Treatment of Subjects With Dysbetalipoproteinemia (Frederickson Type III Hyperlipoproteinemia)

Conditions
-----------------
Hyperlipoproteinemia Type III

Intervention / Treatment
-----------------
* Drug: Rosuvastatin
* Drug: rosuvastatin
* Drug: pravastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of dysbetalipoproteinemia defined as VLDL-C/VLDL-TG mass ratio >0.35 at Visit 2 or the concurrence of mixed hyperlipidemia (fasting TC ≥ 200mg/dL, fasting TG ≥ 200mg/dL at Visits 2 and 3) and a genotype of ApoE published to be associated with dysbetalipoproteinemia Exclusion Criteria: Use of cholesterol-lowering drugs, lipid lowering dietary supplements or food additives after Visit 1 except in accordance with the protocol as co-administered therapy (i.e., a fenofibrate) with rosuvastatin 40mg at Weeks 30 to 36; current active liver disease or hepatic dysfunction, serum CK ≥ 3 times ULN (unless explained by exercise) anytime during dietary period, serum creatinine > 2.0 mg/dL or a history of renal transplantation before the treatment phase, fasting triglyceride > 1000 mg/dL at any time during the dietary lead-in or a history of pancreatitis while on treatment for dysbetalipoproteinemia.

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: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Rosuvastatin|10mg|
|Drug: rosuvastatin|20mg|
|Drug: pravastatin|40mg|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change from baseline in non-HDL-C after 6 weeks of treatment at a given dose during the 18-week randomized crossover period. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of once daily treatment with rosuvastatin 10mg, rosuvastatin 20mg and provastatin 40mg in subjects with dysbetalipoproteinemia after 6 weeks of treatment at any given dose during the 18-week randomized crossover period. |  |  |
VEGF in Iris Tissue in Primary Congenital Glaucoma

Study Overview
=================
Brief Summary
-----------------
Estimation of vascular endothelial growth factor (VEGF) in iris tissue specimen in primary congenital glaucoma through Immunohistochemistry.

Detailed Description
-----------------
Combined trabeculotomy with mitomycin C will done in infants with primary congenital glaucoma with histopathological examination of the the peripheral iris tissue specimen and vascular endothelial growth factor (VEGF) estimation in iris tissue specimen through Immunohistochemistry. Estimation of vascular endothelial growth factor (VEGF) in iris tissue specimen taking from ocular trauma or congenital cataract used as control.

Official Title
-----------------
Estimation of Vascular Endothelial Growth Factor (VEGF) in Iris Tissue in Primary Congenital Glaucoma

Conditions
-----------------
Iris

Intervention / Treatment
-----------------
* Other: Immunohistochemistry analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primary congenital glaucoma Exclusion Criteria: Infants with history of previous surgery. Secondary glaucoma. Glaucoma associated with other congenital anomalies.

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 1 Year

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: VEGF in iris tissue in primary congenital glaucoma<br>Estimation of VEGF grade in iris tissue in primary congenital glaucoma through Immunohistochemistry | Other: Immunohistochemistry analysis<br>* Estimation of VEGF through Immunohistochemistry<br>|
| Other: VEGF in iris tissue from ocular trauma or congenital cataract<br>Estimation of VEGF grade in iris tissue from ocular trauma or congenital cataract through Immunohistochemistry | Other: Immunohistochemistry analysis<br>* Estimation of VEGF through Immunohistochemistry<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VEGF | Estimation of VEGF grade in iris tissue through Immunohistochemistry, The grades is arranged from 0 to 5, with 0 being the lowest level and 5 being the highest level | 6 month |
Procyanidin B2 Enriched Cocoa Effects on Mitochondrial Biogenesis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test how cocoa-rich procyanidin B2 affect the mitochondrial exercise adaptations.

Official Title
-----------------
Procyanidin B2 Enriched Cocoa Effects on Mitochondrial Biogenesis

Conditions
-----------------
Athletes

Intervention / Treatment
-----------------
* Dietary Supplement: procyanidin B2 enriched cocoa


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men/Women Age between 18 and 45 years Aerobic power of oxygen consumption greater than or equal to 55 mL / kg / min Exclusion Criteria: Smoke Any chronic disease Intake of nutritional or ergogenic supplements Chronic medication Cocoa allergy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Procyanidin B2 enriched cocoa<br>Participants receiving cocoa capsules | Dietary Supplement: procyanidin B2 enriched cocoa<br>* Volunteers will intake 5 grams per day of dietary supplement for 10 weeks<br>|
| Placebo Comparator: Placebo group<br>Participants maltodextrin capsules | Dietary Supplement: procyanidin B2 enriched cocoa<br>* Volunteers will intake 5 grams per day of dietary supplement for 10 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in mitochondrial number | Number of mitochondria in blood cells measured by qPCR using mitochondrial COX1 gene and beta globin as housekeeping nuclear gene | 10 weeks | 
| Difference in exercise performance | Maximum oxygen consumption of incomplete pulmonary gas exchange on VO2 max - Powers - Citado por 318 determination of cardiorespiratory fitness and training … - Clark - Citado por 180 Maximum oxygen consumption | 10 weeks |
Effect of Goal-directed Fluid Therapy Based on Stroke Volume Variation on Metabolic Acidosis in Patients Undergoing Brain Tumor Surgery

Study Overview
=================
Brief Summary
-----------------
In patients undergoing craniotomy, 0.9% normal saline is commonly administered in order to reduce cerebral edema. Excessive administration of 0.9% normal saline has been to reported to cause hyperchloremic metabolic acidosis. On the other hand, hypovolemia due to insufficient fluid replacement for perioperative loss can also result in metabolic acidosis by lactic acid accumulation. However, the guideline for perioperative fluid management has not been yet established. The investigators hypothesized that intraoperative fluid management according to SVV(Stroke Volume Variation)could reduce perioperative metabolic acidosis compared to those by CVP(Central Venous Pressure). Therefore, the study is trying to determine if intraoperative fluid administration based on SVV could reduce metabolic acidosis when compared with CVP in patients undergoing craniotomy due to brain tumor who receive 0.9% normal saline as main fluid regimen.

Conditions
-----------------
Brain Tumor

Intervention / Treatment
-----------------
* Drug: SVV
* Drug: CVP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing craniotomy due to brain tumor American Society of Anesthesiologists physical status I or II aged from 20 to 65 Exclusion Criteria: compromised cardiopulmonary function diabetes mellitus symptom or sign with increased intracranial pressure liver or renal disease pre-existing metabolic acidosis pregnant or breast-feeding patients who cannot understand the statements for subjects

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group C<br>intraoperative fluid management based on CVP | Drug: CVP<br>* Patients in group C receive additional fluids (400 ml of normal saline or 200 ml of colloid) when CVP is less 8 during the surgery.<br>|
| Experimental: group S<br>intraoperative fluid management based on SVV | Drug: SVV<br>* During the surgery, patients in group S receive additional fluids (400 ml of normal saline or 200 ml of colloid) when SVV is less than 13.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standard base excess point |  | at the suturing of scalp |
Trial of SVTampons vs Glass Vaginal Dilators in Treatment of Vaginismus

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to compare the success rates of vaginismus therapy using a tampon or a dilator during exposure

Detailed Description
-----------------
Tampon Group Exercises will be performed with tampon Dilator Group Exercises wil be performed with dilator

Official Title
-----------------
Trial of Simple Vaginal Tampons vs Glass Vaginal Dilators in Treatment of Genitopelvic Penetration Disorder

Conditions
-----------------
Vaginismus

Intervention / Treatment
-----------------
* Device: Simple Vaginal Tampon
* Device: Glass Vaginal Trainer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: non-pregnant/non lactating women aged between 18-50 diagnosed with primary vaginismus of Lamont level II or higher Exclusion Criteria: hymenal abnormalities, congenital vaginal abnormalities, vulvodynia, secondary vaginismus following physical or psychological trauma, infection, menopausal period or pelvic pathology and with any psychiatric or physiological disease. Patients with husbands possessing a history of sexual dysfunction (erectile dysfunction or premature ejaculation, for example)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Simple Vaginal Tampon<br>Dilation exercises will be performed with tampon | Device: Simple Vaginal Tampon<br>* Use of single use vaginal tampons<br>* Other names: SVT;|
| Experimental: Glass Vaginal Dilator<br>Dilation exercises will be performed with vaginal dilator | Device: Glass Vaginal Trainer<br>* Use of glass vaginal trainers<br>* Other names: GVT;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sucessfull Intercourse-Diary | 3 point scale: 1-did not try. 2- try but unseccesfull. 3- successfull intercourse | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GRISS: Golombuk Rust Inventory of Sexual Satisfaction | Higher scores indicate greater problems | 30 day | 
| FSFI Score | Higher scores indicate less problem | 30 day | 
| Fear of Coitus Subscale | Fear of sexuality | 30 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
genitopelvic pain disorder, vaginismus