linjc16/ctgov huggingface dataset:
A Clinical Trial Comparing Torcetrapib/Atorvastatin to Ezetimibe/Simvastatin In Subjects With A Cholesterol Disorder.

Study Overview
=================
Brief Summary
-----------------
The Torcetrapib project was terminated on December 2, 2006 due to safety findings. Cholesterol levels will be measured over six weeks in subjects being treated with two different kinds of combination cholesterol medications to see how the different treatments compare to one another.

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

Official Title
-----------------
Phase 3, Open-Label, Multi-Center, Double-Blind, Randomized, Parallel Group Study Efficacy and Safety of Fixed Combination Torcetrapib/Atorvastatin, Administered Once Daily (QD) Compared to Fixed Combination Ezetimibe/Simvastatin for 6 Weeks in Subjects With Dyslipidemia.

Conditions
-----------------
Hyperlipidemia, Dyslipidemia

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Specific LDL-C levels based on CHD risk after a six-week washout period. Exclusion Criteria: Women who are pregnant or lactating, or planning to become pregnant. Subjects taking any drugs known to be associated with an increased risk of myositis in combination with HMG-CoA reductase inhibitors. Subjects requiring systemic steroids 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: ezetimibe/simvastatin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in LDL-C and HDL-C from baseline, after six weeks of treatment. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in other lipid parameters and other biomarkers. |  |  |
Tear Film Innovations iLux Safety Study

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to measure the temperature of the cornea and surrounding eye tissue temperature immediately after heating the eyelids with the iLux device using the protocol treatment profile. Eligible participants attended one treatment visit, with follow-up one day following the procedure.

Detailed Description
-----------------
Alcon Research, LLC, acquired TearFilm Innovations, Inc., in December 2018. This study was designed and conducted by TearFilm Innovations, Inc. The study results were collected, analyzed, and provided by TearFilm Innovations, Inc., to Alcon Research, LLC.

Official Title
-----------------
Tear Film Innovations iLux Safety Study

Conditions
-----------------
Meibomian Gland Dysfunction, Evaporative Dry Eye

Intervention / Treatment
-----------------
* Device: iLux 2020 System


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: - Sign written informed consent prior to study participation Key Exclusion Criteria: History of ocular surgery within 1 year Active ocular infection Ocular surface abnormality; lid surface abnormalities Pregnant, nursing or not utilizing adequate birth control measures Other protocol-specified exclusion criteria may apply

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iLux 2020 System<br>Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual | Device: iLux 2020 System<br>* Medical device that applies localized heat and pressure therapy to the eyelid in order to express melted meibum from obstructed glands<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Overall Maximum Temperature of the Cornea and Surrounding Eye Tissue Immediately Post-treatment | Post-heating values were obtained by infrared camera for each participant. The cornea, the eyelid, and the surface tissue surrounding the eye were measured. Both eyes contributed to the analysis. No formal hypothesis testing was specified. | Day 0 immediately post-treatment |
Nagasaki and Tokushima

Study Overview
=================
Brief Summary
-----------------
we analyzed the relationship between oxidative stress, immunoglobulin G antibody titers, cytokines, and periodontitis through community-based study held in the Goto city, Japan.

Official Title
-----------------
Oxidative Stress in Community-dwelling Adults

Conditions
-----------------
Periodontitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: more than 15 teeth Exclusion Criteria: less than 15 teeth

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Nagasaki<br>Sample collection | |
| Tokushima<br>Oxidative stress, cytokine | |
| Kanagawa<br>oxidative stress | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oxidative stress and periodontitis | reactive oxygen metabolites were measured. immunoglobulin G antibodies were measured by enzyme-linked immunosorbent assay. | participants will be followed by an expected average of 1 year. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
oxidative stress, antioxidant, periodontitis, serum immunoglobulin G, antibody titer
Efficacy of Diuretics in Kidney Disease

Study Overview
=================
Brief Summary
-----------------
This study will determine the efficacy of diuretics in patients with chronic kidney disease.

Detailed Description
-----------------
Participants with chronic kidney disease will undergo two 1-week study periods (diuretic versus placebo) separated by 1-2 weeks of washout in a cross-over design. Blood and urine samples will be collected at the end of each study period to determine the effect on urine output and to assess the kidney clearance and levels of uremic solute. Participants will weigh themselves daily and complete quality of life questionnaires.

Official Title
-----------------
Efficacy of Diuretics in Kidney Disease

Conditions
-----------------
Chronic Kidney Disease, End Stage Renal Disease

Intervention / Treatment
-----------------
* Drug: Metolazone
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: stable chronic kidney disease patients able to provide consent stable dialysis patients who produce urine and able to provide consent Exclusion Criteria: use of antibiotics for last two months or expected antibiotic use recent hospitalization or other event resulting in instability of food intake

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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Metolazone then placebo<br>Metolazone will be taken orally during the first week, followed by washout of 1-2 weeks, then placebo will be taken the following week. | Drug: Metolazone<br>* Participants will be given a metolazone for the 1-week study period.<br>|
| Placebo Comparator: Placebo then Metolazone<br>Placebo will be taken orally during the first week, followed by washout of 1-2 weeks, then metolazone will be taken the following week. | Drug: Placebo<br>* Participants will be given a placebo for the 1-week study period.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in urine output | average volume of urine produced in 24 hours | Change from baseline urine output at 1 week for each study arm | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in kidney clearance of uremic solutes | kidney clearance of uremic solutes in ml/min | Change from baseline kidney clearance of uremic solutes at 1 week for each study arm | 
| Change in quality of life questionnaire score | Kidney Disease Quality of Life 36 Questionnaire (KDQOL36) | Change from baseline quality of life score at 1 week for each study arm |
HIV and HCV Intervention In Drug Treatment Settings - 1

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test two strategies to reduce the risk of contracting Human Immunodeficiency Virus (HIV) or Hepatitis C Virus (HCV) by reducing risk behaviors in patients undergoing drug detoxification.

Official Title
-----------------
HIV and HCV Intervention in Drug Treatment Settings

Conditions
-----------------
Behavior Therapy

Intervention / Treatment
-----------------
* Behavioral: Behavior Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Volunteers will be IV drug users already enrolled in drug detoxification treatment.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Design Details

Primary Purpose: Prevention


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Behavior Therapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV/HCV injection risk behaviors |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
behavioral intervention
Dose Finding Study of Pramipexole (Sifrol) in Patients With Idiopathic Restless Legs Syndrome (RLS)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to evaluate the efficacy and safety of different doses of pramipexole (Sifrol) on subjective and objective symptoms of idiopathic Restless Legs Syndrome (RLS) and also to determine the optimal dose of pramipexole in patients with RLS by polysomnography and evaluation of clinical improvement.

Official Title
-----------------
Evaluation of the Effect of Different Doses of Pramipexole on Subjective and Objective Symptoms of Idiopathic Restless Legs Syndrome (RLS).

Conditions
-----------------
Restless Legs Syndrome

Intervention / Treatment
-----------------
* Drug: Pramipexole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female 18-80 years Confident diagnosis of RLS according to International RLS Study Group criteria RLS rating scale for severity score >15 PLM (during time in bed ) index at least 5 per hour Weekly presence of RLS symptoms within last three months Written Informed consent Exclusion Criteria: Women of childbearing potential, who do not use adequate protection such as barrier protection, intrauterine device, or hormonal (oral or subcutaneous) contraception Postmenopausal women less than 6 months after last menses, surgically sterilised, oophorectomised or hysterectomised less than 3 months after operation and not using adequate protection Women neither using adequate protection nor being postmenopausal and their partner is not sterilised at least 6 months post operation or does not use condom Any women not having negative serum pregnancy test at screening

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Pramipexole|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in periodic limb movements during time in bed index (PLMI) in the polysomnography (PSG). |  | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary outcomes of the study were other PSG-derived endpoints (changes in the RLS symptom rating scale (RLSRS), and patient reported outcomes). |  | 3 weeks |
Thymidine Kinase 1 in Risk Assessment for Hereditary Breast /Ovarian Cancer

Study Overview
=================
Brief Summary
-----------------
This study aimed to compare the activity of Thymidine Kinase 1 in serum of two groups of woman at high and normal risk for breast/ovary cancer.

Detailed Description
-----------------
Hereditary breast/ovarian cancer syndrome is associated with mutations in tumor suppressor BRCA1 and BRCA2 genes. Products of these genes play an important role in the repair of DNA double-strand breaks. Mutations in BRCA1 and BRCA2 genes could impair DNA repair. In resting or G1 cells, where the de novo synthesis of DNA precursors is absent, the salvage pathway is the sole provider of deoxyribonucleotides to be used in DNA repair. For this process a sufficient supply of deoxynucleotides and activity of Thymidine Kinase 1 are essential. TK1 is an important component of adaptive response of cells to DNA damage. Mutations in genes directly engaged in the DNA repair process could lead to the accumulation of DNA damage and in turn cause an adaptive cell reaction manifesting as permanently increased Thymidine Kinase 1 activity. A recently developed new high-sensitive assay DiviTum® allows to investigate the contribution of this enzyme to DNA repair processes and to make a comparison of Thymidine kinase 1 activity in women with normal and impared DNA repair system.

Official Title
-----------------
Thymidine Kinase 1 in Risk Assessment for Hereditary Breast /Ovarian Cancer

Conditions
-----------------
Breast Cancer, Ovarian Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women from family with more than two breast cancer cases and one or more cases of ovarian cancer diagnosed at any age; women from family with more than three breast cancer cases diagnosed before the age 50; women from family withsister pair in which one of the following combinations was diagnosed before the age of 50: two breast cancers, two ovarian cancers, or a breast and ovarian cancer. Exclusion Criteria:• pregnant women; women with generalized CMV and HZV infections; women with severe B12 deficiency and megaloblastic anaemia; women with severe rheumatoid arthritis.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| 1<br>With BRCA1 or BRCA2 mutations | |
| 2<br>Without BRCA1 or BRCA2 mutations | |

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
-----------------
Thymidine Kinase 1, BRCA1 and BRCA2 mutations, hereditary breast/ovarian cancer
A Comparison of the Control of Asthma Provided by Symbicort® Turbuhaler® Versus Symbicort® Turbuhaler® Plus Pulmicort® Turbuhaler® Plus Terbutaline Turbuhaler®

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if a flexible dose of Symbicort has a similar effect on the airways of patients with asthma as a higher fixed-dose of Symbicort with additional glucocorticosteroids added.

Official Title
-----------------
A Comparison of the Inflammatory Control of Asthma Provided by One Inhalation of Symbicort® Turbuhaler® 160/4.5 µg/Inhalation b.i.d. Plus As-needed Versus One Inhalation of Symbicort® Turbuhaler® 320/9 µg/Inhalation b.i.d. + One Inhalation of Pulmicort® Turbuhaler® 400 µg/Dose b.i.d. Plus Terbutaline Turbuhaler® 0.4 mg/Inhalation As-needed. A 12-month, Randomised, Double-blind, Parallel-group, Active Controlled, Multinational, Phase IIIB Study in Adult Patients With Asthma, EOS

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

Intervention / Treatment
-----------------
* Drug: Budesonide/Formoterol Turbuhaler
* Drug: Budesonide Turbuhaler (Pulmicort)
* Drug: Terbutaline Turbuhaler


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of asthma for at least 6 months Prescribed daily use of glucocorticosteroids for at least 3 months prior to visit one Exclusion Criteria: Respiratory infection affecting asthma within 30 days prior to study Intake of oral, rectal, or parenteral glucocorticosteroids within 30 days prior to study Any significant disease or disorder that may jeopardize the safety of the patient

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

| Intervention/Treatment |
| --- |
|Drug: Budesonide/Formoterol Turbuhaler|nan|
|Drug: Budesonide Turbuhaler (Pulmicort)|nan|
|Drug: Terbutaline Turbuhaler|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in eosinophils in bronchial biopsies (first and last visit) and in sputum (5 times during the 12-month treatment period) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunopathology and remodeling in biopsies |  |  | 
| Immunopathology and mediators in induced sputum |  |  | 
| Severe asthma exacerbations (number of and time to first) |  |  | 
| Forced expiratory volume in 1 second (FEV1) |  |  | 
| As-needed use |  |  | 
| Safety variables, including adverse events and vital signs |  |  | 
| All variables assessed over the 12-month treatment period |  |  |
Effect of Age and Device on Delivery of Fluticasone

Study Overview
=================
Brief Summary
-----------------
To determine the effect of age and device on delivery of HFA-Fluticasone Propionate (FP) in children of different ages. Hypothesis -- passive inhalation in younger children through a valved holding chamber/mask (VHC) will reduce the relative amount of FP delivered to airways.

Detailed Description
-----------------
The objective was to determine the effect of age and device on delivery of fluticasone propionate delivered by HFA-pMDI in children of different ages. The one-hour steady-state fluticasone plasma concentration which is an indirect measure of airway delivery and direct measure of systemic exposure, was determined. Sixty children with well-controlled persistent asthma received two actuations of 110 mcg twice daily for at least 3 days. A blood sample was collected one hour after the last dose when 100% adherence was documented by electronic monitor. Five groups of 12 each were studied: 1) 12-18 yr by actuator alone; 2) 5-9 yr by actuator alone; 3) 5-9 yr by antistatic VHC/mouthpiece; 4) 5-9 yr by antistatic VHC/mask and 5) 1-4 yr by antistatic VHC/mask. Fluticasone concentrations were measured by LC-MS/MS assay. Fluticasone plasma concentration between groups was compared using one way ANOVA.

Official Title
-----------------
Relative Amount of Fluticasone Delivered by HFA-MDI Through Chamber/Mask to Young Children With Asthma

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

Intervention / Treatment
-----------------
* Drug: HFA FP MDI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:children 1-18 yr, adequately controlled persistent asthma, demonstrate effective administration technique in accordance with the group assigned - Exclusion Criteria:inadequately controlled asthma: nocturnal awakening >2 nights/month, prn albuterol use >2x/week, more than 2 short courses of oral corticosteroids in previous 3 months, missing a dose on more than one occasion, increase in asthma symptoms during study, inability to discontinue intranasal or dermal fluticasone for 3 days -

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: HFA FP MDI|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| One-hour steady-state plasma concentration of fluticasone |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fluticasone, asthma therapy, spacer inhaler, HFA-134a