linjc16/ctgov huggingface dataset:
A Study to Evaluate the Effect of Ketoconazole and Rifampicin on the Pharmacokinetics of Fimasartan in Healthy Male Volunteers

Study Overview
=================
Brief Summary
-----------------
To evaluate the effect of ketoconazole and rifampicin on the pharmacokinetics of fimasartan.

Official Title
-----------------
An Open-label, Three-treatment, Three-period, One-sequence, Crossover Study to Evaluate the Effect of Ketoconazole and Rifampicin on the Pharmacokinetics of Fimasartan in Healthy Male Volunteers

Conditions
-----------------
Essential Hypertension

Intervention / Treatment
-----------------
* Drug: Fimasartan, Ketoconazole, Rifampicin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age: 20 - 45 years sex: male body weight: greater than 55 kg written informed consent Exclusion Criteria: known allergy to Fimasartan, ketoconazole and rifampicin existing cardiac or hematological diseases existing hepatic and renal diseases existing gastrointestinal diseases acute or chronic diseases which could affect drug absorption or metabolism history of any serious psychological disorder positive drug or alcohol screening smokers of 10 or more cigarettes per day 3 month ago participation in a clinical trial during the last 2 months prior to the start of the study

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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

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

Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fimasartan, Ketoconazole, Rifampicin<br> | Drug: Fimasartan, Ketoconazole, Rifampicin<br>* Fimasartan (1 day) Ketoconazole (3 days) Ketoconazole + Fimasartan (1 day) Rifampicin (9 days) Rifampicin + Fimasartan (1 day)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax, AUClast, AUCinf, CL/F, Tmax, t1/2 |  | 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 32, (48, 56) h |
Fluoxetine as a Quit Smoking AID for Depression Prone

Study Overview
=================
Brief Summary
-----------------
To test whether adding fluoxetine pharmacotherapy to behavioral cessation treatment improves the depression-prone smoker's ability to quit.

Detailed Description
-----------------
DESIGN NARRATIVE: The research was a treatment-matching study to test whether adding fluoxetine pharmacotherapy to behavioral cessation treatment improved the depression-prone smoker's ability to quit. The investigators randomized 144 smokers with a prior history of depression and 206 smokers who lack such a history to a double-blind treatment with either 60 mg fluoxetine or placebo, while they underwent cognitive behavioral treatment to quit smoking. The main study outcome was biologically verified abstinence 6 months after treatment. The administration of placebo and fluoxetine began 3 weeks before the quit smoke date and continued for 2 months post-quit date (totaling 11 weeks on drug/placebo). Cognitive behavioral treatment were weekly before quitting and biweekly after quitting. There were monthly follow-up evaluations for six months after the quit date. The research tested both the Selective Benefit Hypothesis and the Generalized Benefit Hypothesis of fluoxetine's effects. The hypothesis of the mechanism of action was that the drug diminished compulsive smoking behavior, obsessional cigarette craving, and nicotine withdrawal dysphoria that occurred independently of depressive vulnerability. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases

Intervention / Treatment
-----------------
* Drug: fluoxetine
* Behavioral: cognitive behavioral therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
An estimated 144 smokers with a prior history of depression and 206 smokers who lacked such a history.

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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

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

Design Details

Primary Purpose: Prevention
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: fluoxetine|nan|
|Behavioral: cognitive behavioral therapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Effect of Hydroxyethylstarch 6% 130/0.4 Administration on Renal Function After Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
Recent studies have shown an increased incidence of renal replacement therapy after the use of Hydroxyethylstarchs (HES) in patients admitted in the intensive care unit. However, studies showing detrimental effects of HES have been conducted in mostly non-surgical subjects. There are very few studies analyzing the effects of HES on renal function after cardiac surgery, a population already at risk of renal dysfunction.

Official Title
-----------------
Effect of Hydroxyethylstarch 6% 130/0.4 Administration on Renal Function After Cardiac Surgery

Conditions
-----------------
Kidney Function Tests

Intervention / Treatment
-----------------
* Drug: Hydroxyethylstarch 6% 130/0.4
* Other: standard volume therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients undergoing cardiac surgery Exclusion Criteria: Heart transplantation Ventricular assist devices Patients requiring extracorporeal life support before or after cardiac surgery Patients revised for bleeding and/or tamponnade presenting with hemodynamic instability Patients in whom the administered volume therapy was not completely available Subjects who required renal replacement therapy before surgery Trauma patients who were put on cardiopulmonary bypass Patients who died intra-operatively or soon after arrival in the intensive care unit in whom no postoperative creatinine measurements were available

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydroxyethylstarch 6% 130/0.4<br>These patients have received Hydroxyethylstarch 6% 130/0.4 intraoperatively or postoperatively in addition to standard volume therapy. | Drug: Hydroxyethylstarch 6% 130/0.4<br>* Use of Hydroxyethylstarch intraoperatively, for cardiopulmonary bypass use and postoperatively in the intensive care unit<br>* Other names: Any volume therapy has been recorded;Other: standard volume therapy<br> <br> |
| Active Comparator: No Hydroxyethylstarch 6% 130/0.4<br>These patients have not received Hydroxyethylstarch 6% 130/0.4 at any time point. Only standard volume therapy has been used. | Other: standard volume therapy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal dysfunction based on RIFLE (Risk; Injury; Failure; Loss; End-stage) criteria. |  | Up to 45 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | Up to 45 days |
Survival Rate of Lithium Disilicate Crowns

Study Overview
=================
Brief Summary
-----------------
A retrospective clinical study will be performed evaluating a large number of partial ceramic restorations (IPS e-Max press, Ivoclar, Liechtenstein) placed in general practice. Evaluation will be based on the well established Hickel criteria (Hickel et al, 2010). Rationale: IPS-e-max press has been made available to the market since 2006. Although millions of these restorations have been placed worldwide, clinical data are available of less than 200 single restorations only, covering observation periods of 2-8 years.(Guess et al, 2009; Etman en Woolford, 2010; Gehrt et al, 2012; Esquivel-Upshaw et al, 2012). Objective: Study the survival of lithium disilicate restorations during regular check-ups in a private dental practice.

Detailed Description
-----------------
Study the survival of lithium disilicate restorations during regular check-ups in a private dental practice. All included patients were followed-up with special emphasis on the partial restoration(s), every time they visited the dental practice for regular dental check-ups between 2015 and 2017. To assess these restorations a light photograph with a digital camera (Nikon (D7100, 60mm lens), Nikon, Amsterdam, The Netherlands) and an x-ray were taken from the partial posterior crowns and evaluated according to the modified United States Public Health Service (USPHS) criteria.

Official Title
-----------------
Clinical Evaluation of Partial Ceramic Posterior Restorations Cemented Using Immediate Dentin Sealing - a (#) Year Follow up From a Retrospective Study.

Conditions
-----------------
Survival, Immediate Dentin Sealing

Intervention / Treatment
-----------------
* Procedure: Partial Ceramic Indirect restoration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: In order to be eligible to participate in this study, a patient must received one or more lithium disilicate restorations between 2006 and today. Exclusion Criteria: No patients will be excluded from the study.

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Partial Ceramic Indirect restoration|Placement of an partial ceramic indirect restoration with the use of immediate dentin sealing as an adjunct to adhesive cementation.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rate |  | from 2006 to 2018 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of survival | according to Hickel | from 2006 to 2018 |
Mometasone and Markers of Airway Inflammation

Study Overview
=================
Brief Summary
-----------------
A post-marketing study to look at the effects of Asmanex on markers of airway inflammation.

Detailed Description
-----------------
Patients with asthma and not treated with anti-inflammatory medications were studied. This was a parallel, randomized, placebo-controlled study to investigate the effects of Asmanex on markers of airway inflammation including exhaled nitric oxide, airway reactivity, FEV1 and nitrates/nitrites and pH in exhaled breath condensate.

Official Title
-----------------
The Effects of Mometasone on Markers of Airway Inflammation

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

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: Mometasone Furoate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Asthma non-smoker FEV1 of at least 60% predicted Exclusion Criteria: Pregnancy or lactation Corticosteroid use in past 30 days

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 50 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo, 2 puffs, bid | Drug: Placebo<br>* 2 puffs, qd<br>|
| Experimental: Memetasone<br>Mometasone | Drug: Mometasone Furoate<br>* 400 mcg, qd for 8 weeks<br>* Other names: asmanex;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exhaled Nitric Oxide |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Airway Reactivity |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma, Nitric Oxide, Exhaled Breath Condensate, Methacholine Challenge
Treatment Satisfaction in Implantable Cardioverter Defibrillator Recipients

Study Overview
=================
Brief Summary
-----------------
Remote monitoring of implantable cardioverter defibrillators (ICD) is a promising new development in ICD therapy and has been shown to be technically feasible and safe.While data on safety and feasibility of remote monitoring are in favour of this technology, patients´ treatment satisfaction has not been sufficiently investigated. To date, there is only one small, non-randomised study investigating patients´ treatment satisfaction in highly selected and highly motivated patients at the time of implantation and 12 months thereafter7. Therefore, the aim of the San Remo Trial is to investigate factors that are associated with patients´ willingness to accept the new method of follow-up on a broad basis of ICD recipients and to determine their treatment satisfaction with ICD therapy in a randomised, prospective trial.

Official Title
-----------------
Treatment Satisfaction With Remote Monitoring in Implantable Cardioverter Defibrillator Recipients

Conditions
-----------------
Improvement of Treatment Satisfaction

Intervention / Treatment
-----------------
* Device: Home-Monitoring
* Device: Follow-up by Home-Monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ICD indication according to current national or international guidelines Patient available for follow-up during study period Exclusion Criteria: Clinically unstable medical conditions that require regular outpatient clinic follow-up
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 |
| --- | --- |
| Active Comparator: ICD traditional follow-up<br>ICD with traditional follow-up in the outpatient clinic | Device: Home-Monitoring<br>* Home-Monitoring<br>Device: Follow-up by Home-Monitoring<br>* Follow-up by Home-Monitoring<br>|
| Active Comparator: Home-Monitoring<br>Home-Monitoring | Device: Home-Monitoring<br>* Home-Monitoring<br>Device: Follow-up by Home-Monitoring<br>* Follow-up by Home-Monitoring<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment satisfaction with ICD therapy and follow-up |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of healthcare consultations |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ICD, Home-Monitoring, Quality of life
Neural Mechanisms of Decision Making in Hoarding Disorder

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to understand the neural mechanisms of decision making in hoarding disorder.

Detailed Description
-----------------
Hoarding disorder is a common and disabling disorder that represents a significant public health problem. This study aims to build on current research on decision making by examining these processes in hoarding disorder.

Official Title
-----------------
Neural Mechanisms of Decision Making in Hoarding Disorder

Conditions
-----------------
Hoarding Disorder

Intervention / Treatment
-----------------
* Device: MRI with fMRI frequency


Participation Criteria
=================
Eligibility Criteria
-----------------
Identify inclusion criteria. Inclusion criteria for participants diagnosed with HD: ages 18-70 primary diagnosis of hoarding disorder sufficient severity of hoarding symptoms stable on psychotropic medications for 1 month prior to study enrollment capacity to provide informed consent ability to tolerate clinical study procedures Inclusion criteria for healthy control participants: ages 18-70 capacity to provide informed consent Identify exclusion criteria. Exclusion criteria for participants with HD: psychiatric or medical conditions that make participation unsafe pregnant or nursing females concurrent use of any medications that might increase the risk of participation (e.g. drug interactions) presence of metallic device or dental braces Exclusion criteria for healthy control participants: any current or lifetime psychiatric diagnosis current or past use of psychotropic medication pregnant or nursing females major medical or neurological problem presence of metallic device or dental braces

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Hoarding Disorder<br>Adults diagnosed with Hoarding Disorder | Device: MRI with fMRI frequency<br>* Functional magnetic resonance imaging or fMRI measures brain activity by detecting changes in blood flow. Participants will do cognitive tasks during fMRI.<br>|
| Healthy Controls<br>Adults without mental illness | Device: MRI with fMRI frequency<br>* Functional magnetic resonance imaging or fMRI measures brain activity by detecting changes in blood flow. Participants will do cognitive tasks during fMRI.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BOLD signal | BOLD signal derived from fMRI | up to 90 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hoarding Disorder
Association Between the Prevalence of Cardiovascular Risk Factors and New Use of Testosterone

Study Overview
=================
Brief Summary
-----------------
We will investigate if testosterone is preferentially given to patients at higher risk of cardiovascular events. If this is the case, then observational studies may be prone to selection bias resulting in overestimation of the cardiovascular risk associated with testosterone when compared to a healthier population not taking testosterone

Official Title
-----------------
Association Between the Prevalence of Cardiovascular Risk Factors and New Use of Testosterone

Conditions
-----------------
Hypogonadism

Intervention / Treatment
-----------------
* Drug: Testosterone Product


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - All male individuals in the source population with a first testosterone use during the study period will be included as cases. The date of the GP consultation associated with the first testosterone prescription will be designated as the index day. Exclusion Criteria: - Patients of less than 18 years on the index day, with less than 2-year contribution to the CPRD-HES link before the index day, or with use of testosterone before the study period will be excluded from the group of cases.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Case group: Testosterone Product<br>Male subjects prescribed testosterone in UK | Drug: Testosterone Product<br>* Men used testosterone product following prescription<br>|
| Control group<br>Matched male subjects not prescribed testosterone in the UK | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimation of the association between cardiovascular risk factors and initiation of testosterone therapy |  | Retrospectively from 01 January 2001 to 31 March 2016 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Risk factors predicting the initiation of testosterone use
Study of T Cell Phenotype Activation Pathway in Human Alcoholic Liver Disease

Study Overview
=================
Brief Summary
-----------------
Alcoholic liver disease is characterized by circulating T cell activation and liver T cell infiltration but their phenotype is poorly studied. The aim of the study is to test the hypothesis that the (CD4+ T cell secreting Interleukin-17) Th17 pathway is involved in alcoholic liver disease.

Detailed Description
-----------------
Consecutive patients undergoing transjugular liver biopsies for alcoholic liver disease or hepatitis C virus infection will be included in the study to measure plasma cytokines levels, peripheral blood mononuclear cells cytokine release and liver T cell infiltrates.

Official Title
-----------------
Study of T Cell Phenotype Activation Pathway in Human Alcoholic Liver Disease

Conditions
-----------------
Alcoholic Liver Disease, Chronic Hepatitis C Virus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Alcohol excess intake and suspected liver disease Alcohol excess intake and clinical liver cirrhosis chronic hepatitis C virus infection and suspected liver disease chronic hepatitis C virus infection and clinical liver cirrhosis Exclusion Criteria: bacterial or fungal infection immunosuppressive treatment other causes of liver disease

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>alcoholic liver disease | |
| 2<br>chronic hepatitis C virus infection | |

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
-----------------
liver, alcohol, lymphocyte