linjc16/ctgov huggingface dataset:
Role of Acetylcysteine in Creatinine Clearance

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the exact role of Acetylcysteine (Mucomyst) in altering creatinine clearance. Prior studies have shown the protective effects of Acetylcysteine on contrast-induced renal dysfunction. In these studies, Acetylcysteine lowered the incidence of serum creatinine elevation after administration of radiographic contrast agents. Not only was the increase in serum creatinine prevented, the studies also demonstrated a significant increase in creatinine clearance after administration of the agent. These prior studies did not evaluate if the increase in creatinine clearance was indeed from a protective benefit of Acetylcysteine in preserving the GFR versus simply increasing the proximal tubular creatinine secretion without actually affecting the GFR. We propose an experiment to help support our hypothesis that Acetylcysteine increases creatinine clearance via an increase in proximal tubular secretion of creatinine.

Conditions
-----------------
Creatinine Clearance

Intervention / Treatment
-----------------
* Drug: Acetylcysteine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Between the ages of 18 and 79 years In good general health Able to provide informed consent Exclusion Criteria: Allergy to acetylcysteine or cimetidine, Age less than 18 years or greater than 79 years of age, Women of childbearing age and not able to use adequate contraception, or 4. Anyone currently on any medication that interferes with tubular secretion of creatinine such as trimethoprim-sulfamethoxazole (Bactrim).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 79 Years

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

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

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

Design Details

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


Arms and Interventions

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

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
-----------------
Creatinine clearance, Acetylcysteine
Study Of The Effects Of SB 480848 (Darapladib) On The Electrical Conduction Of The Heart

Study Overview
=================
Brief Summary
-----------------
This is a study to assess the effects of darapladib on the cardiac conduction of the heart as compared to placebo and moxifloxacin. This a four period crossover design with each period lasting about 10 days. There will be a 7 to 10 day wash out in between each period.

Official Title
-----------------
A Study to Evaluate the Effect of Repeat Oral Doses of Darapladib on Cardiac Conduction as Compared to Placebo and a Single Oral Dose of Moxifloxacin

Conditions
-----------------
Atherosclerosis

Intervention / Treatment
-----------------
* Drug: Darapladib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Body weight greater than 50 kg (110 lbs) and a body mass index between 19 and 30 Signed and dated written informed consent prior to admission to the study Subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions Exclusion Criteria: cardiac abnormalities history of asthma or severe allergic reactions history of alcohol or drug abuse use of prescription or non-prescription drugs or vitamins or herbal supplements history of cholecystectomy or biliary tract disease pregnant or nursing women history of allergy to the study drugs

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in QTc interval as compared to placebo and moxifloxacin |  | throughout the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ECG parameters as compared to placebo and moxifloxacin |  | throughout the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
darapladib, moxifloxacin, QT study
Tamoxifen Pharmacokinetics and CYP2D6 Polymorphisms in Asian Women With Hormone Receptor Positive Breast Cancer

Study Overview
=================
Brief Summary
-----------------
We hypothesized that subjects with CYP2D6*10 alleles may have a lower steady state levels of endoxifen due to reduced conversion of tamoxifen to endoxifen. Primary objectives: To determine the steady state pharmacokinetics of tamoxifen and its metabolites To test the effects of genetic polymorphisms of CYP2D6 on plasma concentration of tamoxifen and its metabolites in hormone receptor positive women who are taking tamoxifen as adjuvant treatment for breast cancer.

Official Title
-----------------
Tamoxifen Pharmacokinetics and CYP2D6 Polymorphisms in Asian Women With Hormone Receptor Positive Breast Cancer

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent. At least 18 years of age. On tamoxifen for at least 3 months for adjuvant therapy. On a stable diet for past 1 week before blood sampling. Compliant with tamoxifen medication. Completed adjuvant chemotherapy and/or adjuvant radiation therapy. Exclusion Criteria: • Patients should not be on the list of medications for the last 1 week before accrual to the study

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the steady state pharmacokinetics of tamoxifen and its metabolites |  |  | 
| To test the effects of genetic polymorphisms of CYP2D6 on plasma concentration of tamoxifen and its metabolites in hormone receptor positive women who are taking tamoxifen as adjuvant treatment for breast cancer. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hormone Receptor Positive Breast Cancer
A Randomised Open Controlled Parallel Group Study Comparing Norspan and Tramadol

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy and safety of Norspan versus Tiperol Retard among OA patients who are sub-optimally treated with current analgesic. Those patients may benefit from treatment with a long lasting analgesic.

Official Title
-----------------
A Randomised Open Controlled Parallel Group Multicenter Study to Evaluate the Efficacy and Safety of Norspan Versus Tiparol Retard in Subjects With Chronic Moderate to Severe OA Pain of the Hip and/or Knee.

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Drug: Transdermal delivery system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: OA diagnosis BS11 greater than or equal to 4 at base line Not adequately pain relieved with 4,000 mg paracetamol daily Exclusion Criteria: Treated with high potent opioids for their OA pain Treated with a regular dose for greater than one week of Tramadol, Codeine or dextropropoxifene during the last three months Other chronic conditions requiring frequent analgesic therapy

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

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

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

| Intervention/Treatment |
| --- |
|Drug: Transdermal delivery system|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Box Scale 11 pain scores for pain on average during the last week then mean change from base line to completion. BS11 is recorded daily by the patients in a diary. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rescue medication recorded daily by patients. Sleep disturbance and quality of sleep. Patients global assessment of pain relief, investigators global assessment of pain relief, patients preference, WOMAC OA index, EuroQoL EQ-5D. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoarthritis, Norspan versus Tramadol, Randomised, Efficacy and safety, OA pain of the hip and/or knee
Haemorrhages and Thromboembolic Venous Disease of the Postpartum

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the frequencey and the determinants of postpartum major complications (hemorrhage and thrombosis) up to 3 months after delivery in the maternity hospitals of Finistère (Bretagne - France)

Detailed Description
-----------------
This is an analytical observational prospective multicenter cohort study , conducted on all the maternity hospitals in Finistère (Bretagne - France), with a biological collection. This protocol allows to study all women at risk of PPH (Postpartum Hemorrhage) and postpartum venous thromboembolic disease, including maternity level 1-3 without case selection. The prospective nature of the study should provide a more detailed analysis of exposures in this particular population of women (risk factors related to the field, childbirth, the postpartum events ...). The events of interest were PPH and venous thromboembolic disease.

Official Title
-----------------
Hémorragies et Maladie Veineuse Thromboembolique du Post-partum : Epidémiologie, Etudes Des déterminants Cliniques et Biologiques

Conditions
-----------------
Postpartum Hemorrhage, Venous Thromboembolism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any woman giving birth and supported in one of Gynaecology Obstetrics services of a maternity Finistere. Women ≥ 16 at the time of the collection of non-opposition. For minor patients: understanding the patient and at least one parent. All births ≥ 15 weeks gestation. Exclusion Criteria: Home Birth Expressed opposition to participation in this study. Childbirth under X. Parent (s) uninformed of the pregnancy of their child.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

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

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 |
| --- | --- | --- |
| Postpartum Hemorrhage | Volume of blood loss up to 48 hours after delivery and / or weight compresses collected at delivery, and / or diagnosis of the clinician | 2 days | 
| Symptomatic thromboembolic events |  | 3 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postpartum Hemorrhage, Venous Thromboembolism, Pregnancy
C-reactive Protein and Endothelial Dysfunction in Women With Glucose Intolerance

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to determine whether markers of vascular inflammation (such as c-reactive protein) can predict endothelial dysfunction (as measured by flow-mediated dilation) in postmenopausal women with glucose intolerance compared to normal controls.

Official Title
-----------------
C-reactive Protein and Endothelial Dysfunction in Women With Glucose Intolerance

Conditions
-----------------
Glucose Intolerance

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy postmenopausal women ages 40-65 Exclusion Criteria: smokers diabetes requiring medication

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 65 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>postmenopausal women with glucose intolerance (either pre-diabetes or diet-controlled diabetes) | |
| 2<br>postmenopausal women with normal glucose tolerance | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| c-reactive protein |  | performed after screening evaluation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| flow-mediated dilation of brachial artery |  | performed twice after screening visit | 
| sex steroids |  | performed after screening visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
c-reactive protein, endothelial dysfunction, glucose intolerance
Circadian Variation of Cardiac Troponin

Study Overview
=================
Brief Summary
-----------------
Acute myocardial infarction (AMI) is defined by an increase and/or decrease in the concentration of cardiac troponin, with at least one value above the 99th percentile value of the reference population together with evidence of ischemia. An objective tool to determine the magnitude of the cardiac troponin change is the use of reference change values (RCV). The basis for this tool is that, for a change to be significant, the difference in serial results must be greater than the inherent variation in two test results. The inherent variation of a laboratory test result is composed of analytical and within-subject biological variation. An important requirement to use RCVs is that the concentrations of cardiac troponins fluctuate randomly around a homeostatic set point in cardio-healthy individuals. Verification of this important condition has never been performed, and violation of this condition would preclude the use of RCV's in clinical practice.

Conditions
-----------------
Healthy Individuals

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals with no evidence of active cardiovascular disease Exclusion Criteria: History of acute myocardial infarction in the last year

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiac troponins |  | measured every hour, total time 25h (08:30 day 1, till 09:30 day 2) |
Pharmacokinetics (PK), Pharmacodynamics (PD) and Safety Study of MT-1303 in Subjects With Crohn's Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate PK, PD and safety of a single oral dose of MT-1303 in subjects with Crohn's disease.

Detailed Description
-----------------
This is a Phase I, open-label, non-randomised, multicenter single-dose study to evaluate PK, PD, and safety of a single oral dose of MT-1303 in subjects with moderate to severe active Crohn's disease (ileal and ileo-colonic type).

Official Title
-----------------
A Phase I, Open-label Study to Evaluate PK, PD, and Safety of a Single Oral Dose of MT-1303 in Subjects With Moderate to Severe Crohn's Disease

Conditions
-----------------
Crohn's Disease

Intervention / Treatment
-----------------
* Drug: MT-1303


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who were diagnosed as Crohn's disease Subjects who were confirmed as ileal or ileo-colonic type by image inspection. Disease severity determined as either moderate or severe Exclusion Criteria: Present or past history of gastrointestinal surgery which may have impact on drug absorption Subjects with stenosis or fistula in small intestine or colon

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MT-1303<br> | Drug: MT-1303<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentration of MT-1303 |  | 15 time points up to 29 days | 
| Plasma concentration of MT-1303 metabolite |  | 15 time points up to 29 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in lymphocyte count after MT-1303 administration |  | 16 time points up to 29 days | 
| Type of adverse events |  | 29 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Crohn's disease
Prospective Analysis of the Effect of Widowhood on CVD

Study Overview
=================
Brief Summary
-----------------
To determine the effect of widowhood on cardiovascular disease.

Detailed Description
-----------------
BACKGROUND: Widowed persons have been found to have higher mortality rates than married persons in both cross-sectional and longitudinal studies. In many of these studies, excess mortality has been attributed to deaths from cardiovascular disease. Despite these consistent findings, the lack of detailed data collected prior to widowhood has hampered our ability to understand the mechanisms to explain this effect. Furthermore, an understanding of the mechanisms underlying this effect might help elucidate the apparent gender differences in mortality following widowhood. DESIGN NARRATIVE: The study took advantage of the data collected as part of the Framingham Study to investigate the effect of widowhood on cardiovascular disease. The Framingham dataset has extensive clinical data related to cardiovascular disease, as well as to health behaviors. These longitudinal data provided the opportunity to prospectively characterize the health of widows prior to and following the loss of a spouse in much greater detail than previously possible. The analyses used a prospective design in which those men and women who had a spouse die during the course of the study (N=626) were compared to men and women who remained married (N=2044). These analyses also provided the opportunity to examine reasons for the beneficial effect found of remarriage. The study addressed the following questions: 1. Can the increased risk of mortality from cardiovascular disease often found following widowhood be explained by pre-widowhood health status? 2. Can increased mortality following widowhood be explained by changes in health behaviors related to cardiovascular disease risk. 3. What pre-widowhood risk factors place the widowed at greater risk for cardiovascular disease morbidity and/or mortality following the death of a spouse? 4. Can pre-widowhood risk factors or post-widowhood behavior change account for gender differences in mortality following widowhood? 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

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

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

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

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 |
| --- | --- | --- |
Adhesion Formation Following Laparoscopic and Open Colorectal Surgery

Study Overview
=================
Brief Summary
-----------------
To ascertain whether there are fewer adhesions (internal scars) formed following laparoscopic (key-hole) surgery for colorectal diseases than traditional open surgery.

Official Title
-----------------
Adhesion Formation Following Laparoscopic and Open Colorectal Surgery

Conditions
-----------------
Adhesions

Intervention / Treatment
-----------------
* Procedure: Laparoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previous elective colonic or rectal resection Having a further operative intervention at which time a laparoscopy can be performed Exclusion Criteria: Children <18 Further surgery not relating to the primary colorectal surgery

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br>Patients who have had previous open colorectal surgery and are referred for a further operative procedure, at which time a second-look laparoscopy can be performed. | Procedure: Laparoscopy<br>* A second-look laparoscopy, in patients who require further surgery (for example a liver resection or closure of ileostomy).<br>|
| B<br>Patients who have had a previous laparoscopic colorectal procedure and are having a second-look procedure | Procedure: Laparoscopy<br>* A second-look laparoscopy, in patients who require further surgery (for example a liver resection or closure of ileostomy).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colorectal disease, Adhesions, Laparoscopy, Colorectal surgery