linjc16/ctgov huggingface dataset:
Open-Label Study to Evaluate the Effect of Rifaximin on Midazolam in Normal Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to determine if rifaximin, administered daily has an effect on the cytochrome P450 (CYP) isoenzyme 3A4, by examining any changes in the pharmacokinetics of midazolam (a CYP3A4 substrate), when co-administered.

Detailed Description
-----------------
This is a single-site, single-arm, open-label, drug-interaction study that examines the effect of rifaximin (RFX), 550 mg 3 times daily (TID; 1650 mg/day), on orally administered (PO) midazolam (MDZ) 2 mg (administered as a 2 mg dose in 1 mL of midazolam HCL Syrup; 2 mg/mL) when dosed for 7 and 14 consecutive days, respectively.

Official Title
-----------------
A Phase 1, Single Arm, Open-Label Study to Evaluate the Effect of Rifaximin 550 MG Tablets TID on the Pharmacokinetics of Orally Administered Midazolam in Healthy Male and Female Volunteers

Conditions
-----------------
Pharmacokinetic

Intervention / Treatment
-----------------
* Drug: rifaximin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is medically normal Patient has normal laboratory values Patient has the ability to understand the requirements of the study Exclusion Criteria: HIV Hepatitis B Hepatitis C History of renal, hepatic, endocrine, oncological, gastrointestinal or cardiovascular disease. History of epilepsy, asthma, diabetes, psychosis, glaucoma or severe head injury.

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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>open-label rifaximin 550 mg TID | Drug: rifaximin<br>* 550 mg TID<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Individual midazolam and rifaximin plasma concentrations and pharmacokinetic parameters will be summarized. |  | 21 to 38 days (including a 21 day screening period) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall safety assessments will include the incidence, intensity, and type of adverse events, and clinically significant changes in the patient's physical examination, vital signs and laboratory results. |  | 21 tyo 38 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rifaximin, midazolam, pharmacokinetics
Evaluating Clinical Outcomes of Treatment Effectiveness for Children and Adults With ADHD

Study Overview
=================
Brief Summary
-----------------
To evaluate clinical effectiveness of medication treatment for ADHD. It is hypothesized that the effectiveness is lower than efficacy outcomes measured in clinical trials

Detailed Description
-----------------
This is a prospective, long-term, observational study of routine clinical care. The study measurements will be integrated into the clinical assessment and follow-up procedures of the outpatient services under the Provincial ADHD Program. The study is designed for systematic follow-up of children and adolescents, diagnosed with ADHD irrespective of comorbidity or whether they elect to receive medication treatment. Evaluations occur every 6 months for 24 months. The population to be examined is children and adolescents with a diagnosis of ADHD, aged 6 to 18 inclusive (at baseline), referred to the Provincial ADHD Program for clinical assessment. No studies have been conducted that have evaluated the outcome of core ADHD symptoms in a clinic setting. Metaanalysis of clinical trials of medication treatment for ADHD have suggested an effect size of approximately 0.8. Because of the heterogeneity of the clinic sample, a much lower effect size can be anticipated. Two hundred patients will be enrolled in this study with primary measure of effectiveness being change in ADHD symptoms.

Official Title
-----------------
Evaluating Clinical Outcomes of Treatment Effectiveness for Children and Adolescents With ADHD: An Observational, Long-Term Follow-up Study of Routine Clinical Care

Conditions
-----------------
Attention-Deficit/Hyperactivity Disorder (ADHD)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meet DSM-IV criteria for ADHD Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 18 Years

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

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

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
-----------------
ADHD Effectiveness
Role of Dietary Fatty Acids in Fatty Liver and Insulin Resistance

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate whether substituting saturated fats with polyunsaturated fats reduces fatty liver and improves insulin action and other metabolic variables in abdominally obese subjects

Detailed Description
-----------------
Specific goals: Investigate if substituting saturated fats with polyunsaturated fats reduces steatosis and improves hepatic and/or peripheral insulin action in abdominally obese subjects with type 2 diabetes Investigate if changes of lipogenic enzymes in response to dietary fat intervention are associated with changes in hepatic/peripheral insulin sensitivity or liver fat content Investigate potential mechanism of the effects of dietary fatty acids; e.g. gene expression and lipogenic enzyme activity

Official Title
-----------------
Role of Dietary Fatty Acids in Fatty Liver and Insulin Resistance: a Randomized Controlled Study

Conditions
-----------------
Obesity, Diabetes, Insulin Resistance, Fatty Liver

Intervention / Treatment
-----------------
* Other: PUFA Diet
* Other: SFA diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: abdominal obese subjects with or without type 2 diabetes sagittal abdominal diameter >25cm Exclusion Criteria: insulin treatment history of serious cardiovascular events morbid obesity claustrophobia (relative criterion)

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PUFA diet<br>Diet high in polyunsaturated (rich in linoleic acid, omega-6) fat (15 E%) | Other: PUFA Diet<br>* Diet high in polyunsaturated (rich in linoleic acid, omega-6) fat (15 E%).<br>|
| Active Comparator: SFA diet<br>Diet high in saturated fat (15 E%) | Other: SFA diet<br>* Diet high in saturated fat (15E%)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hepatic steatosis by MRT |  | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin resistance by oral glucose tolerance test |  | 10 weeks | 
| Changes in adipose tissue gene expression and lipogenic enzyme activity |  | 10 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity, Diabetes, Insulin resistance, Fatty liver, NAFLD, Steatosis, Dietary fatty acids
A Trial To Study The Effect Of Lamivudine In Adult Patients Who Suffer From Chronic Hepatitis B Alone

Study Overview
=================
Brief Summary
-----------------
The efficacy of lamivudine in Hepatitis Be Antigen (HBeAg) positive Asian patients of chronic hepatitis has been well established.The evidence in HBeAg negative patients is limited. Limited sustained response was observed post-treatment following a one year treatment period. Whether these results can be applied to patients in Iran is uncertain. This study is therefore intended to further assess the efficacy profile after two years of open treatment in the adult Iranian population.

Official Title
-----------------
AN OPEN STUDY OF LAMIVUDINE TREATMENT IN ADULT HBeAg NEGATIVE (Presumed Pre-core Mutant) CHRONIC HEPATITIS B PATIENTS IN IRAN.

Conditions
-----------------
CHRONIC HEPATITIS B

Intervention / Treatment
-----------------
* Drug: LAMIVUDINE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed active liver disease due to Hepatitis B virus. Patients must have adequate blood & liver functions. Female patients of child-bearing potential must be non pregnant and willing to abstain from intercourse from 2 weeks prior to administration of the first dose of study medication until 28 days after the final dose of study medication or be willing to consistently and correctly use an acceptable method of birth control. Patients who have serious concurrent illnesses other than hepatitis B like cancer, severe heart disease, uncontrolled diabetes mellitus or AIDS will not be eligible. Exclusion Criteria: Persons allergic to lamivudine or suffering from hepatitis C, D or E infection or taking alcohol will not be eligible.

Ages Eligible for Study
-----------------
Minimum Age: 15 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: LAMIVUDINE|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete virologic response at Month 24 which is normalisation of alanine aminotransferase (ALT) and disappearance of HBV DNA by NAXCOR(brand name of a virus assay kit) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Partial response, histological improvement (at 24 months). Sustained complete response, sustained partial response at 30 months. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HBeAg, HBV, CHRONIC HEPATITIS, lamivudine
Novel Device for Reducing Catheter-Related Infections

Study Overview
=================
Brief Summary
-----------------
This study is a pilot study of the safety, tolerability and efficacy of an investigational central venous catheter device used in conjunction with a standard central venous catheter. The hypothesis is that utilization of a catheter device incorporating cyanoacrylate will reduce catheter colonization by bacteria, and may decrease the rate of catheter-related bloodstream infections.

Official Title
-----------------
Exploring the Use of a Novel Device for Reducing Catheter-Related Bloodstream Infections

Conditions
-----------------
Intensive Care

Intervention / Treatment
-----------------
* Device: silicone catheter boot


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Admission in the ICU at time of catheter insertion Indication for central venous catheter placement De novo catheter insertion in the subclavian or internal jugular veins Exclusion Criteria: Anticipated catheter duration < 72 hours Planned guidewire exchange Documented bacteremia within 48 hours prior to catheter placement Extensive skin breakdown near the site of potential catheter placement Emergent line placement Screening labs with ANC < 500 or platelets < 50K Hypersensitivity to cyanoacrylates or formaldehyde Prior enrollment in 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Device and standard catheter | Device: silicone catheter boot<br>* silicone device using Dermabond<br>|
| No Intervention: 2<br>Standard catheter | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Catheter site inspection |  | Baseline, Daily |
Efficacy of HUMIRA in Subjects With Active Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to assess the efficacy of adalimumab in subjects with rheumatoid arthritis focusing on subject-reported outcomes and early response to treatment

Official Title
-----------------
Humira Efficacy Response Optimization Study in Subjects With Active Rheumatoid Arthritis (HERO)

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: adalimumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject was age 18 or older and in good health (Investigator discretion) with a recent stable medical history. Subject, based on assessment of investigator, meets the definition of active RA Exclusion Criteria: Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study Female subject who is pregnant or breast-feeding or considering becoming pregnant

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: adalimumab|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient reported outcomes, clinical response indicators. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject reported assessments of disease activity, physician reported assessments of disease activity, safety parameters, clinical response indicators. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adalimumab, rheumatoid arthritis
Composix Kugel Mesh Recall Leaves Unresolved Problems of Patient Management

Study Overview
=================
Brief Summary
-----------------
From its introduction in 2000 until its US recall in December 2005, the Composix Kugel Mesh was implanted in an estimated 350,000 patients worldwide. The purpose of the study is to evaluate retrospectively the complications related to this mesh that occurred in our patients between 2003 and 2005, since new complications continue to be diagnosed, although the investigators discontinued the use of the mesh.

Detailed Description
-----------------
From 2003 to 2005(2006) we implanted Komposix Kugel Meshes in 21 Patients with incisional ventral hernias. With the recall of January 2006 (in Germany), we stopped the implantation of this mesh and continued to monitor the patients with follow up and phone interviews. Late complications still continue to occur, mainly as a consequence of the product defect identified 7 years ago.

Official Title
-----------------
The 2005 Composix Kugel Mesh Recall Leaves Unresolved Problems of Patient Management: Taking Stock After 5-year Follow up

Conditions
-----------------
Incisional Hernia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 Incisional hernia Exclusion Criteria: Younger than 18 years Peritonitis Intestinal fistula

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 |
| --- | --- | --- |
| Early postoperative complications | Assessment of postoperative complications (wound complication, mesh infection, seroma) | 6 months postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term postoperative complications | Chronic pain, chronic and recurrent mesh infection, mesh bulging, incisional hernia and intestinal fistula | 6 months to 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Incisional hernia, Mesh, Surgery, Composix Kugel, IPOM technique
Utility of the History and Physical Exam in the Emergency Department

Study Overview
=================
Brief Summary
-----------------
The study is trying to prove that the history and physical exam (H&P) in the emergency department is the most important tool in exam of patients. The investigator is attempting to correlate the time of the H&P of residents and attendings to the accuracy of diagnosis.

Detailed Description
-----------------
The purpose of the study is to examine the utility of the history and physical exam in the emergency room towards obtaining a diagnosis. The goal of this observational study is to correlate physician level of experience and time spent on history and physical exam, to the correct diagnosis. The aim of this study is: To draw a connection between time and accuracy of the history and physical exam. To draw a connection between time and level of experience as a physician based on post-graduate level. To assess the number of laboratory and radiographic studies and the post-graduate level. To assess the relevance of the labs and radiographs ordered. (Relevance is defined as something that changes plan of care.) Time is a critical component of the ED physician. Our study will analyse if modern medicine has created a more laboratory/image based need to ascertain a diagnosis or if history and physical examination alone can predict the ultimate diagnosis.

Official Title
-----------------
Utility of the History and Physical Exam in the Emergency Department

Conditions
-----------------
Abdominal Pain, Back Pain, Dyspnea, Headache, Weakness

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Anyone over the age of 18 with a generalized complaints able to provide consent Exclusion Criteria: Anyone under 18 yrs and anyone with a very specific, system based complaint.

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 |
| --- | --- | --- |
Trans Health: Evaluation of Markers of Cardio-metabolic Health and Well-being in Transgender Youth

Study Overview
=================
Brief Summary
-----------------
This study plans to learn more about puberty blockers and cross (testosterone and estradiol). There is not much known about how these medications affect hormone levels, heart health and overall general health in young transgender individuals.

Detailed Description
-----------------
This study plans to learn more about puberty blockers and cross (testosterone and estradiol). There is not much known about how these medications affect hormone levels, heart health and overall general health in young transgender individuals.

Official Title
-----------------
Trans Health: Evaluation of Markers of Cardio-metabolic Health and Well-being in Transgender Youth

Conditions
-----------------
Transgendered Persons

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Followed in Endocrinology Clinic or Adolescent Medicine Clinic at Children's Hospital Colorado Between age 9 and 21 years (inclusive) Identifies as transgender Has been on pubertal blockade or cross-sex hormones for at least three months. Exclusion Criteria: Known diabetes Presence of significant medical or psychiatric comorbidities Using hormones not prescribed by a physician

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 21 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 |
| --- | --- | --- |
| Reproductive hormone concentrations in transgender youth on cross-sex hormones and/or puberty blockers and compared to age-, natal sex- and body mass index (BMI)-matched controls. |  | at enrollment | 
| Markers of cardiometabolic risk in transgender youth on cross-sex hormones and/or puberty blockers and compared to age-, natal sex- and BMI-matched controls |  | at enrollment | 
| Body composition as measured by Dual-energy X-ray absorptiometry (DEXA) in transgender youth compared to age- and BMI-matched controls of both sexes. |  | at enrollment | 
| Data on quality of life as measured by the Pediatric Quality of Life Inventory (PedsQL) compared to published norms |  | at enrollment |