linjc16/ctgov huggingface dataset:
A Study to Investigate the Effect of MT-8554 on the Pharmacokinetics of Simvastatin and Rosuvastatin in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the effect of MT-8554 on the pharmacokinetics of simvastatin and rosuvastatin in healthy subjects.

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: MT-8554
* Drug: rosuvastatin
* Drug: simvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy and free from clinically significant illness or disease Male Caucasian subjects aged 18 to 55 A body weight of ≥60 kg Exclusion Criteria: Participation in more than three clinical studies involving administration of an Investigational Medicinal Product in the previous year, or any study within 12 weeks. Clinically significant endocrine, thyroid, hepatic, respiratory, gastro-intestinal, renal, cardiovascular disease, or history of any significant psychiatric/psychotic illness disorder. Clinically relevant abnormal medical history, physical findings or laboratory values

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MT-8554, rosuvastatin and simvastatin<br>Subjects will be administered a single dose of rosuvastatin followed on Day 4 by a single dose of simvastatin. MT-8554 will be administered from Days 6 to 12 with co-administration of rosuvastatin and simvastatin on Days 9 and 12, respectively. | Drug: MT-8554<br> <br> Drug: rosuvastatin<br> <br> Drug: simvastatin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration-time curve (AUC) of rosuvastatin alone and in the presence of MT-8554. |  | 72 hours post dose | 
| Cmax of rosuvastatin alone and in the presence of MT-8554. |  | 72 hours post dose | 
| AUC of simvastatin/simvastatin acid alone and in the presence of MT-8554. |  | 24 hours post dose | 
| Cmax of simvastatin/simvastatin acid alone and in the presence of MT-8554. |  | 24 hours post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability as measured by vital signs |  | Up to Day 16 | 
| Safety and Tolerability as measured by number of participants with adverse events |  | Up to Day 16 |
The Efficacy of Oral Versus Intravenous Hypertonic Saline Administration in Runners With Exercise-Associated Hyponatremia

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to 1) evaluate incidence and primary cause of exercise-associated Hyponatremia (EAH) in race finishers participating in the Western States 100-mile Endurance Run, 2) determine if the ingestion of oral hypertonic saline (high salt) is as effective as intravenous administration of hypertonic saline to elevate below-normal blood salt concentrations (EAH) at the end of the Western States Endurance Run, and 3) determine if oral and intravenous hypertonic saline solutions are equally as effective at reversing mild (without altered mental status) symptoms associated with EAH.

Official Title
-----------------
Incidence and Cause of Hyponatremia in Endurance Runners, Also to Determine if Oral Hypertonic Saline is as Efficacious as Intravenous Hypertonic Saline in the Correction of Below Normal Blood Sodium Concentrations in Runners With Hyponatremia Without Neurological Symptoms

Conditions
-----------------
Exercise-associated Hyponatremia

Intervention / Treatment
-----------------
* Other: Intravenous hypertonic Saline
* Other: Oral hypertonic saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: consenting Western States 100 race finisher hyponatremic Exclusion Criteria: altered mental status

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intravenous hypertonic saline<br> | Other: Intravenous hypertonic Saline<br>* Intravenous 100mL bolus of 3% saline<br>|
| Experimental: Oral hypertonic saline<br> | Other: Oral hypertonic saline<br>* Oral 100mL bolus of 3% saline<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood sodium concentration post administration of oral or IV hypertonic saline. |  | 1 hour post administration of hypertonic saline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Exercise-associated hyponatremia, Randomized treatment trial, Endurance runners
VENOUS: A Translational Study of Enterococcal Bacteremia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assemble a multicenter prospective cohort of patients with enterococcal bloodstream infections (BSIs) to provide data on outcomes of patients with enterococcal BSIs for sample size calculations for future trials, as well as to characterize enterococcal isolates causing BSIs in order to comprehensively dissect the molecular epidemiology of infecting organisms for future studies.

Official Title
-----------------
VENOUS: A Translational Study of Enterococcal Bacteremia

Conditions
-----------------
Enterococcal Bacteremia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospitalized patient ≥1 positive blood culture with Enterococcus spp. (VRE or VSE) during hospitalization bacterial isolate(s) is/are available for further characterization Repeat blood culture(s) within 7 days from the first positive culture Exclusion Criteria: Cultures obtained from patients not admitted to the hospital Isolate(s) not available for further studies.

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 |
| --- | --- |
| Patients with enterococcal bloodstream infections<br>Adult patients (≥ 18 years of age) with ≥ 1 positive blood cultures with Enterococcus during hospitalization and who have repeat blood culture(s) within 7 days from the first positive culture will be included. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause, in-hospital mortality | Death by any cause while patient is in the hospital | 30 days or until hospital discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with microbiological outcome | Eradication defined as a negative follow-up blood culture > 4 days after index blood culture | 7 days after first documented positive blood culture | 
| Number of participants with recurrence of bacteremia | Positive blood culture with the same organism within the following 14 days after the documented eradication of bacteremia | 14 days after the documented eradication of bacteremia | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
entercoccal bloodstream infection, vancomycin-resistant enterococci, vancomycin-susceptible enterococci
Establish a Vegetable Signature Database From Human Metabolomics Responses

Study Overview
=================
Brief Summary
-----------------
Vegetable is well known to prevent chronic disease,however, the mechanism of its nutrients and non-nutrients still remains to be discovered.We design a feeding study which provides plant foods to subjects one by another and monitoring metabolomic changes up to 7 hours.The goal of this study is to establish a protocol for documenting metabolomics response to plant foods and try to characterize plant foods in terms of their anti-hypertension potentials with metabolomic profiling information.

Official Title
-----------------
Establish a Vegetable Signature Database From Human Metabolomics Responses

Conditions
-----------------
Human Metabolomic Responses to Plant Foods, Blood Pressure

Intervention / Treatment
-----------------
* Other: Low phytochemical diet(LPD), high phytochemical diet(HPD)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age :18-60 years Body Mass Index :18.5-30(kg/m2) Non-smoking,alcohol abusing,and other bad hobbies Exclusion Criteria: With regular drug intake e.g. anti-hypertensive or antidiabetes drug or history of immune, hepatic and metabolic disease or other unsuitable disorders e.g. cancer. unwilling to stop regular food supplement e.g. vitamins, herb cannot cooperate with designed diet History of urinary tract infection or antibiotic use within the previous 3 month

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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

| Intervention/Treatment |
| --- |
|Other: Low phytochemical diet(LPD), high phytochemical diet(HPD)|LPD is a basal diet which low in soy,vegetable and fruit and other plant food to approach low phytochemical. HPD is the diet which add two serving test vegetable in the lunch of LPD.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood pressure | fasting, before lunch,and every 1 hr after lunch | one day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| metabolomic profile of serum and urine | serum sample will be measure fasting ,before lunch,and every 1 hr after lunch;urine sample will be measure fasting ,before lunch(0hr),0-2 hr,2-4hr 4-7hr after lunch | one day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
metabolomics, nutri-metabolomics, plant food, blood pressure
Evaluation of Satisfaction in Patients Receiving PegIntron Pen/Rebetol for Hepatitis C (Study P04067)

Study Overview
=================
Brief Summary
-----------------
The current gold standard for treatment of chronic hepatitis C (CHC) patients is with pegylated interferon plus ribavirin. Drug administration accuracy and ease of use will definitely determine treatment effectiveness. This is the idea behind the development and usage of the PegPen. The goal of this study is to determine the satisfaction grade with this novel device.

Detailed Description
-----------------
Enrollment of patients will occur in a sequential order of treatment initiation.

Official Title
-----------------
Evaluation of Satisfaction in Patients Receiving PegIntron Pen/Rebetol for Hepatitis C

Conditions
-----------------
Hepatitis C, Chronic

Intervention / Treatment
-----------------
* Biological: Peginterferon alfa-2b (SCH 54031)
* Drug: Ribavirin (SCH 18908)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients with hepatitis C Exclusion Criteria: According to the products' labeling.

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 |
| --- | --- |
| Patients with chronic hepatitis C<br>Adult patients with chronic hepatitis C treated with PegIntron pen/Rebetol. | Biological: Peginterferon alfa-2b (SCH 54031)<br>* Peginterferon alfa-2b will be administered according to the products' labeling.<br>* Other names: PegPen;Drug: Ribavirin (SCH 18908)<br>* Ribavirin will be administered according to the products' labeling.<br>* Other names: Rebetol;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the Satisfaction of the PegPen (PegIntron Preparation and Injection Easiness) Using a Patient Questionnaire Answered at 1 Month and 3 Months | Patient satisfaction for each item on the questionnaires was rated on a scale from 0 (not satisfied) to 7 (very satisfied). | The patient was instructed to answer and return by mail the first self-questionnaire after 1 month of treatment and the second one after 3 months of treatment. |
Dosage of Tacrolimus Metabolites in Blood and Bile for Prediction of Its Side Effects in Liver Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate if concentration of tacrolimus metabolites is increased in patients presenting tacrolimus (TAC) side effects.

Detailed Description
-----------------
The study will evaluate whether the blood concentration of TAC metabolites (13-O-desmethyl-tacrolimus, 15-O-desmethyl-tacrolimus and 31-O-desmethyl-tacrolimus), measured between Day1 and Day5 of its introduction, is increased in patients with TAC toxicity. A blood test will be performed daily from Day1 to Day5 for the measurement of TAC concentration and TAC metabolites concentration.

Official Title
-----------------
Dosage of Tacrolimus Metabolites in Blood and Bile for Prediction of Its Side Effects in Liver Transplant Recipients

Conditions
-----------------
Blood Concentration of Tacrolimus Metabolites

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients (> 18 years) of both sexes, Candidates for liver transplantation or retransplantation, whatever the etiology and severity of the underlying disease, Not having expressed their opposition to participation in the study Exclusion Criteria: Associated transplantation of another organ Contraindications to TAC administration Delayed introduction of TAC (beyond the 5th postoperative day) whatever the cause.

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 |
| --- | --- | --- |
| Comparison of blood concentration of TAC metabolites between patients presenting TAC related side effects or not. |  | Day 5 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tacrolimus, metabolites, liver transplantation
Single Center Experience Over a Decade in Living Donor Liver Transplantation for Egyptian Patients With Hepatocellular Carcinoma: Stretching the Limits

Study Overview
=================
Brief Summary
-----------------
Within community with high incidence of HCC, stretching the limits could be justified based on tumor characters and its biological behavior

Detailed Description
-----------------
590 Egyptian patients underwent LDLT; of them, 172 (32%) patients were transplanted for HCC. Twenty six cases (15.1%) were excluded due to early postoperative mortality (n=22) or due to non HCC related mortality (n=4). One hundred forty six patients were retrospectively reviewed to determine prognostic factors for recurrence.

Official Title
-----------------
Single Center Experience Over a Decade in Living Donor Liver Transplantation for Egyptian Patients With Hepatocellular Carcinoma: Stretching the Limits

Conditions
-----------------
Recurrence of HCC After LDLT

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Egyptien Patients with HCC Patients within Milan Criteria Patients beyond Milan criteria are selected on a case by case basis until 2005. From 2005 , patients beyond Milan criteria are subjected to down staging protocol and then reassessed (pre transplantation local ablative therapy either with RFA or TACE according to the size and the site of the lesion and we wait for 12 weeks after ablation ,only those with well ablated lesions, decreased AFP and no denovo lesions were transplanted). Exclusion Criteria: • Evidence of macro vascular invasion by CT portography and/or US duplex. Metastatic HCC General contraindications for LT (ongoing sepsis, other major co morbidities,…). Early postoperative mortality (first1 month). Post transplant mortality during the period of follow up due to any cause other than recurrent HCC (e.g. sepsis, rejection, cardiological or cerebrovascular complications…)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 62 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 |
| --- | --- | --- |
| Recurrence of Hepatocellular carcinoma after LDLT |  | at least 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
LDLT,HCC, Microvascular invasion
The Effect of Lower Back Massage on Perceived Labor Pain

Study Overview
=================
Brief Summary
-----------------
The aim of the study was to assesment the change in pain scores with lower back massage, a non-pharmacological method, on perceived labor pain in the early active phase of the first stage of labor.

Official Title
-----------------
Angle Labor Pain Questionnaire Turkish Version: Validity and Reliability Study and Evaluation of Efficacy With a Non-pharmacological Method

Conditions
-----------------
Labor Pain

Intervention / Treatment
-----------------
* Procedure: lower back massage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The study group consisted of pregnant women who were at 37-40 weeks of pregnancy, had cervical dilatation of 4-6 cm, had a single, live, and vertex fetus, had an uncomplicated pregnancy, had no contraction anomalies, could communicate in Turkish planned for a vaginal delivery. Exclusion Criteria: with cognitive dysfunction using narcotic analgesics or sedative drugs had any contraindications for applying a back massage

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 49 Years

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

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

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: Intervention<br>pregnant women undergoing lower back massage | Procedure: lower back massage<br>* Lower back massage performance: In the study, Linda Kimber's massage protocol was used. First, the researcher ensured that the patient was holding the bed, squatting, or bent over on the bed, which is suitable for the massage, between two contractions. The pregnant woman was instructed to breathe deeply and exhale audibly when her contractions began. Gloves were worn during the massage and liquid Vaseline, which does not contain any active substance, was used to provide lubricity. The circular hip massage was applied at the beginning of the contraction, and lower lateral area and sacral pressure massage was applied towards the end of the contraction as per the massage protocol, and simultaneously with the inhaling sound of the pregnant woman<br>|
| No Intervention: control group<br>pregnant women given routine care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assessment of change in pain scores with lower back massage | Lower back massage is a non-pharmacological method to reduce perceived labor pain. | Change in perceived labor pain scores in an average of 30 minutes (During the lower back massage application) |