linjc16/ctgov huggingface dataset:
Evaluation of the Emergency Imaging Strategy for the Diagnostic Management of Renal Colic

Study Overview
=================
Brief Summary
-----------------
Emergency imaging is necessary for the diagnostic management of renal colic in the emergency department. Ultrasound is rapidly available and non-irradiating, allowing to look for a stone and a pyelocalic dilatation. But it is less sensitive when the stone is ureteral. CT has a sensitivity of 96% and a specificity of 100%. The latest French recommendations date from 2008, recommending ultrasound and an unprepared abdomen in cases of uncomplicated renal colic. For the European Society of Radiology, ultrasound should be the first-line examination. The place of a systematic CT scan as first-line examination for the diagnosis of renal colic in the emergency department is therefore still under discussion. An evaluation of practice will make it possible to assess the imaging strategy applied in an emergency department.

Official Title
-----------------
Evaluation of the Emergency Imaging Strategy for the Diagnostic Management of Renal Colic

Conditions
-----------------
Renal Colic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Major subject (≥18 years) Subject who was managed in the NHC emergency department from July 01, 2018 to June 30, 2019 with a final diagnosis of renal colic diagnostic Subject who has not expressed opposition, after information, to the reuse of their data for the purpose of this research Exclusion criteria: Subject who has expressed opposition to participating in the study Subject under guardianship or curatorship Subject under legal protection

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 |
| --- | --- | --- |
| Retrospective study of the practices of management of renal colic in the emergency room concerning the imaging strategy |  | Files analysed retrospectively from from July 01, 2018 to June 30, 2019 will be examined | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Renal Colic, Nephritic Colic, Pyelocalic dilatation
Electromyography Evaluation of the Impacts of Different Insoles in the Activity Patterns of the Lower Limb Muscles

Study Overview
=================
Brief Summary
-----------------
The main objective of this research is to demonstrate that the use of insoles of different hardness in motorcycle riders may cause variations in the electromyographic activity of the lower limb muscles during the race. This study is a cross-over quasi-experimental study. Nine motorcycle riders were recruited. Electromyographic activity of the lower limb muscles is recorded under different insole types.

Official Title
-----------------
Electromyography Evaluation of the Impacts of Different Insoles in the Activity Patterns of the Lower Limb Muscles: A Cross-over Quasi-experimental Study

Conditions
-----------------
Electromyography, Muscles, Foot Orthoses

Intervention / Treatment
-----------------
* Other: Foot insoles


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects Motorcycle riders Exclusion Criteria: Musculoskeletal conditions Neurological alterations Systemic diseases.

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 50 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: Foot orthoses<br>Different foot orthoses | Other: Foot insoles<br>* Different foot insoles of different hardness<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Superficial electromyography peak measured as percentage | Superficial electromyography activity peak of the vastus lateralis muscle | Change from Baseline superficial electromyography peak at 5 minutes |
A Non Interventional Study With Paclitaxel Onkovis (Paclitaxel) Utilized for the Treatment of Cancer

Study Overview
=================
Brief Summary
-----------------
The main purpose of this observational study with Paclitaxel is to determine the number of treatment cycles and the quantity of Paclitaxel onkovis needed therefore under the special circumstance of ambulant chemotherapy. onkovis aims an economical utilization of the chemotherapeutics.The provision with adapted packaging sizes as to decrease the excess quantity to be discarded follows also this objective. Secondary objectives are the survey of the side effects of Paclitaxel onkovis in comparison to Docetaxel. To this purpose, data regarding co medications and adverse events are also collected.

Official Title
-----------------
Open, Multicenter Observational Study of Paclitaxel Utilized in Mono- or Combination Therapy for the Treatment of Breast Cancer, Non-small Cell Lung Cancer and Ovarial Cancer.

Conditions
-----------------
Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Indication for Paclitaxel according to the SmPC and treating physician Exclusion Criteria: according to the Paclitaxel SmPC
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| carcinoma, Paclitaxel onkovis (Paclitaxel)<br>treatment in mono- or combination therapy with Paclitaxel of breast-, non-small cell lung- and ovarial cancer. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the quantity of Paclitaxel onkovis needed pro treatment cycle | Determine the quantity of Paclitaxel onkovis needed pro treatment cycle | the time the participants will be followed depends on the number of treatment cycles; that means the time frame may extend up to 24 weeks (8 cycles). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse events during and after treatment in comparison to Docetaxel onkovis | The number and kind of adverse events during and after the intra-venous application of Paclitaxel will be assessed, documented and compared to those of Docetaxel. | up to 24 weeks (8 cycles) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
carcinoma, breast cancer, non-small cell lung cancer, ovarial cancer, ambulant chemotherapy, treatment cycles, Paclitaxel, Paclitaxel onkovis, Quantity of Paclitaxel, Packaging Sizes
A Study to Evaluate Intramuscular ASP7374

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate safety and immunogenicity of intramuscular ASP7374 in adults ≥61 years of age.

Official Title
-----------------
Phase 3 Study of ASP7374 -Open-label Study of Intramuscular ASP7374 in Adults ≥61 Years of Age-

Conditions
-----------------
Influenza, Vaccine

Intervention / Treatment
-----------------
* Biological: ASP7374


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy or medically stable, as judged on the basis of history and concurrent diseases. Subject understands procedure of the protocol and is willing to comply with the protocol. Written informed consent has been obtained. Exclusion Criteria: Scheduled to receive another vaccine during the study. Received influenza HA vaccine within 180 days prior to screening. Received or scheduled to receive a live vaccine within 28 days prior to vaccination with the study vaccine, and received or scheduled to receive an inactivated vaccine or a toxoid within 7 days prior to vaccination with the study vaccine. Diagnosis of immune deficit in the past, has a family member (within the third degree of kinship) with a diagnosis of congenital immunodeficiency syndrome. Received one of the following medications or treatment prior to vaccination with the study vaccine: Interferon formulation, Drugs which affect the immune system, corticosteroids, G-CSF, M-CSF, Human immunoglobulin products, Blood products, Blood transfusion History of anaphylactic shock or an allergic reaction such as generalized eruption due to food or drug (including vaccines) allergies, fever ≥39.0°C within 2 days after the previous vaccination (influenza vaccine and others) History of seizures, except for febrile seizures in childhood

Ages Eligible for Study
-----------------
Minimum Age: 61 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ASP7374 group<br> | Biological: ASP7374<br>* intramuscular<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hemagglutination inhibition (HI) antibody titer | evaluated for A/H1N1, A/H3N2, and B | Day 1 and Day 29 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neutralizing antibody titer | evaluated for A/H1N1, A/H3N2, and B | Day 1 and Day 29 | 
| Local and systemic reactions associated with the vaccination |  | Day 1 through Day 8 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ASP7374, Prevention of seasonal influenza
Establishment of Drug-induced Liver Injury Databases and Application of Circulating microRNA(miRNA)

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to establish drug-induced liver injury databases in China, make criteria for Chinese drug-induced liver injury patients and evaluate the application of certain circulating miRNA in diagnosis or treatment of drug-induced liver injury.

Detailed Description
-----------------
Firstly, this study collects some retrospective data. Analyse these data and establish certain unique diagnostic criteria for Chinese. Then collect prospective data and validate the criteria. Otherwise,collect blood sample or other sample of the patients and study certain miRNA in diagnosis or treatment of drug-induced liver injury.

Official Title
-----------------
Establishment of Drug-induced Liver Injury Databases and Application of Circulating miRNA

Conditions
-----------------
Drug-induced Liver Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females between the age of 18 to 70 years Women in child-bearing period taking some contraception measures Patients with onset of acute liver injury attributed to antituberculosis drugs or antineoplastic drugs, Roussel Uclaf Causality Assessment Method（RUCAM ） score≥6 Written informed consent can be obtained, some patients agree with liver biopsy Exclusion Criteria: Viral hepatitis Alcoholic liver disease or non-alcoholic liver disease Wilson's disease or other inherited metabolic liver diseases Auto-immune liver diseases Any dysfunction of liver Malnutrition Chronic diseases such as HIV,severe heart diseases, severe brain diseases or chronic kidney diseases Patients who can not complete follow-ups on time

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| histological features of drug-induced liver injury obtained by liver biopsy | Liver biopsy is the main method | within six months of the DILI onset date | 
| clinical features of drug-induced liver injury assessed by serum parameters of liver function | serum parameters of liver function is the focus | participants will be followed for the duration of hospital stay, an expected average of 3 weeks |
Study to Evaluate Long-Term Safety, Tolerability, and Satisfaction With Prucalopride in Chronic Constipation

Study Overview
=================
Brief Summary
-----------------
Objectives: To evaluate the clinical long-term safety and the tolerability, patient satisfaction, pharmacokinetics and use of pattern of prucalopride given in doses up to 4 mg per day to patients with chronic constipation (CC).

Official Title
-----------------
A Study to Evaluate the Long-Term Tolerability, Safety, Patient Satisfaction, Pharmacokinetics, and Use Patterns of Oral Prucalopride Tablets in Patients With Chronic Constipation

Conditions
-----------------
Chronic Constipation

Intervention / Treatment
-----------------
* Drug: Prucalopride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and non-pregnant, non breast-feeding female outpatients at least 18 years of age. Patient completed the entire treatment period of one of the following studies: PRU-USA-3, PRU-USA-11, PRU-USA-13, PRU-USA-21, PRU-USA-25, PRU-USA-27 or PRU-USA-28, or Patient participated in the re-treatment study PRU-USA-28 and did not qualify for Treatment period II after both washout periods. Exclusion Criteria: Patient with impaired renal function Patient with clinically significant abnormalities of haematology, urinalysis, or blood chemistry. Female of childbearing potential without adequate contraceptive protection during the study. Patient who used an investigation drug other than prucalopride in the 30 days preceding 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Prucalopride|1 mg tablets, free dosing regiment with max. of 4 tablets o.d., treatment duration: up to 24 months|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: adverse events, lab tests, vital signs, ECGs |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: PAC-QOL self-administered questionnaire, Patient's pattern of use of prucalopride |  | 24 months | 
| Pharmacokinetics: Prucalopride plasmaconcentrations |  | 24 months |
Malnutrition Clinical Characteristics Validation Study

Study Overview
=================
Brief Summary
-----------------
Malnutrition (under-nutrition) occurs in approximately 30% of hospitalized adults worldwide and results in poor outcomes. However there is no universal method for diagnosing malnutrition. A group of experts created a set of 6 characteristics to identify malnutrition. The goal of this project is to determine whether these characteristics are the best indicators to identify malnutrition or if there are other factors that may better identify malnutrition. Because there is no gold standard definition for malnutrition, the investigators will compare the characteristics against outcomes such as length of stay, hospital readmission and death. Outcomes are also influenced by disease state, therefore, information on what brought the patient to the hospital and what happened to them in the hospital will be collected that allows the investigators to separate the effect of malnutrition from disease. The hypothesis for this study is that the malnutrition clinical characteristics and diagnosis criteria, as presented by the experts, are valid and reliable principles for the diagnosis of adult under-nutrition.

Official Title
-----------------
Malnutrition Clinical Characteristics Validation Study

Conditions
-----------------
Malnutrition

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient on inpatient dietitian consult list Able to speak English to answer questions Ability to provide informed consent (or provided by family member) Expected remaining admission time > 24 hours (determined by no mention of pending discharge in physicians notes) Age ≥ 18 years Exclusion Criteria: Seen previously by Registered Dietitian during current admission Patient on hospice or palliative care, in a psychiatric, maternity, pediatric or day surgery area, or in dedicated trauma or burn unit. Life expectancy <7 days per physician note or Registered Dietitian (RD) judgment Participated in the study during a previous admission

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 |
| --- | --- | --- |
| Number of participants diagnosed with and without malnutrition using the MCC. |  | 30-days post-discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day readmission rate among study participants |  | Within 90 days after data collection is complete |
A Phase 1 Study to Examine the Pharmacodynamics of Different AZD1722 Formulations

Study Overview
=================
Brief Summary
-----------------
The study is designed to evaluate safety, tolerability, pharmacodynamics and pharmacokinetics of different formulations of AZD1722 in healthy male and female subjects taking Omeprazole.

Official Title
-----------------
A Phase 1, Single-Center, Randomized, 3-Way Cross-Over, Open Label Study to Evaluate the Pharmacodynamics of Different Formulations of AZD1722 in Healthy Volunteers Taking Omeprazole

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

Intervention / Treatment
-----------------
* Drug: AZD1722
* Drug: Omeprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy man or woman Body mass index between 18 and 29.9 kg/m2 Exclusion Criteria: Diagnosis or treatment of any clinically symptomatic biochemical or structural abnormality of the gastrointestinal (GI) tract Any surgery on the small intestine or colon, excluding appendectomy or cholecystectomy or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs Clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematologic, metabolic, endocrine, neurologic, psychiatric disease, or any condition that may interfere with the subject successfully completing the trial or that would present a safety risk

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AZD1722 HCl Capsule<br>15 mg bid AZD1722 HCl and 20 mg bid Omeprazole | Drug: AZD1722<br> <br> * Other names: RDX5791;Drug: Omeprazole<br> <br> |
| Experimental: AZD1722 HCl Tablet<br>15 mg bid AZD1722 HCl and 20 mg bid Omeprazole | Drug: AZD1722<br> <br> * Other names: RDX5791;Drug: Omeprazole<br> <br> |
| Experimental: AZD1722 Free-base Tablet<br>15 mg bid AZD1722 and 20 mg bid Omeprazole | Drug: AZD1722<br> <br> * Other names: RDX5791;Drug: Omeprazole<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with adverse events | Measurement of safety laboratories, ECGs, vitals signs and physical exams | 8 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sodium levels in stool and urine | Pharmacodynamic activity | 8 days | 
| Plasma drug concentration to calculate AUC | Pharmacokinetics | 8 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Volunteers