linjc16/ctgov huggingface dataset:
Effect of Itopride, on Symptoms of Functional Dyspepsia, Such as Indigestion, Bloating, Inability to Finish a Meal

Study Overview
=================
Brief Summary
-----------------
Itopride is a new compound that is already marketed in Japan and in some countries of Eastern Europe under the name of Ganaton. It is used to treat symptoms of functional dyspepsia. Patients suffering from this condition have difficulties digesting food. They feel full after eating a few bites; they feel bloated and their stomachs hurt. The goal of this study is to see if itopride helps to relieve the symptoms of functional dyspepsia.

Detailed Description
-----------------
The study lasts approximately 10 weeks. Patients may either receive the real itopride, or a sugar pill called placebo. They have equal chances of receiving either treatment. After having completed this study, patients may be eligible to continue treatment for a longer period. At that point, all patients receive itopride. Patients need to come to the clinic for evaluations 4 times during the trial. Various evaluations are done at these visits, such as a physical exam, lab tests, evaluation of the heart condition, and questionnaires need to be completed by the patient to see if the drug helps them in relieving their symptoms.

Official Title
-----------------
A Multicentre, Randomized, Double-Blind Placebo-Controlled Study of the Efficacy and Safety of Itopride HCl in Patients Suffering From Functional Dyspepsia

Conditions
-----------------
Dyspepsia

Intervention / Treatment
-----------------
* Drug: Itopride Hydrochloride
* Drug: itopride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients suffering from functional dyspepsia according to Rome II criteria 18-65 years old Absence of, or infrequent heartburn (one episode per week or less) Helicobacter pylori (H. pylori) negative Normal upper endoscopy

Ages Eligible for Study
-----------------
Minimum Age: 18 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Itopride Hydrochloride|100 mg tid|
|Drug: itopride|100 mg three times daily|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom relief |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of symptom relief on quality of life |  |  | 
| Safety |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Functional dyspepsia, Abdominal Symptom relief, Fullness, Bloating, Indigestion
A Retrospective Analysis to Evaluate Long Term Outcomes of SCC Patients Previously Treated With Alpha DaRT

Study Overview
=================
Brief Summary
-----------------
Evaluation of long-term efficacy outcomes of patients previously treated with the Alpha DaRT seeds for management of their malignancy following initial response.

Detailed Description
-----------------
Medical records of patients that previously underwent the Alpha DaRT treatment will be reviewed by an authorized staff member. Evaluation of long-term outcomes of patients previously treated with the Alpha DaRT seeds for management of their malignancy following initial response. These outcomes include: Safety - assessment of late onset of Alpha DaRT related AE in patients treated with the Alpha DaRT seeds Efficacy - assessment of local recurrence rates in patients who achieved initial complete response (CR) following the Alpha DaRT treatment assessment of duration of response in patients who achieved initial CR following the Alpha DaRT treatment assessment of survival status in patients treated with the Alpha DaRT seeds

Official Title
-----------------
A Retrospective Analysis to Evaluate Long Term Outcomes of Squamous Cell Carcinoma Patients Previously Treated With Alpha Diffusing Alpha-emitters Radiation Therapy

Conditions
-----------------
Squamous Cell Carcinoma, DaRT Treated Patients

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients previously treated with the Alpha DaRT seeds for management of either skin or oral cavity SCC Available information in medical charts and records (electronic or paper) Exclusion Criteria: None.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 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 |
| --- | --- | --- |
| Progression Free Survival (PFS) | Time from DaRT insertion to disease progression (according to RECIST V1.1) or death, whichever occurs first | Up to 60 months following DaRT insertion | 
| Adverse Events (AE) | Assessment of late onset of Alpha DaRT related AE | Up to 60 months following DaRT insertion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Response | Time from partial or complete response to the first disease progression according to RECIST V1.1 | Up to 60 months following DaRT insertion | 
| Overall Survival (OS) | Time from DaRT insertion to death | Up to 60 months following DaRT insertion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Squamous Cell Carcinoma, Alpha Radiation
Screening CEDM in Intermediate and High-Risk Patient Populations

Study Overview
=================
Brief Summary
-----------------
This research study is being done to determine if Contrast Enhanced Digital Mammography (CEDM) can improve breast cancer detection and can be used as an additional screening method to the standard mammographic screening.

Official Title
-----------------
Screening Contrast Enhanced Mammography (CEDM) in Intermediate and High-Risk Patient Populations

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

Intervention / Treatment
-----------------
* Device: Contrast Enhanced Digital Mammography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women aged 35 and had a negative routine mammogram within 6 months. Qualifies as intermediate or high-risk (>15% lifetime risk of breast cancer as defined by IBIS version 8). Exclusion Criteria: Known breast cancer Previously had negative MBI or MRI within 12 months of study Pregnant or lactating Contraindication to intravenous iodinated contrast Unable to understand or sign informed consent Self-reported signs or symptoms of breast cancer

Ages Eligible for Study
-----------------
Minimum Age: 35 Years

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

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

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

Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Interventional Model Description: Patients are prospectively assigned to the CEDM /screening intervention which may lead to additional screening or biopsy based on the study schema.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intermediate or high-risk breast cancer subjects<br>Subjects with a negative mammogram who are intermediate or high-risk for breast cancer will get supplemental screening with contrast enhanced digital mammography (CEDM) | Device: Contrast Enhanced Digital Mammography<br>* High-resolution, low-energy, full-field digital mammography (FFDM) image and contrast-enhanced image<br>* Other names: CEDM;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breast Cancer | Number of subjects diagnosed with breast cancer | 3 years |
Platelets Induced Vasodilation, in Vitro and in Vivo Study

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to show the implication of platelets in vasodilation using in vivo and in vitro analysis and to compare the effects of placebo, aspirin and Clopidogrel in this interaction platelets/vessels. The effects of 7 days of each treatment will be compared in healthy subjects and patients with arteriopathy.

Official Title
-----------------
Platelets Induced Vasodilation, in Vitro and in Vivo Study in Patients With Arteriopathy and Healthy Subjects.

Conditions
-----------------
Peripheral Arterial Disease

Intervention / Treatment
-----------------
* Drug: placebo, aspirine, clopidogrel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inclusion criteria healthy subjects Man or Woman 18 years Agreement signed French health insurance Able to understand the study Biological haemostatic test normal Vascular Doppler of lower limbs normal Pressure index > 1 in both lower limbs Inclusion criteria healthy subjects Man or Woman 18 years Agreement signed French health insurance Able to understand the study Biological haemostatic test normal Lower limbs arteriopathy (clinical, pressure index, Doppler) Exclusion Criteria: Unable to sign agreement Subjects protected by low Participation to other study Changes of treatment within the 15 days before inclusion Chronic treatment with Clopidogrel or drugs against inflammation Severe respiratory, cardiac, kidney, hepatic insufficiency Haemostatic troubles Diabetic neuropathy Neurologic desease (Parkinson…..) Hypertension Symptomatic stomach ulcer Anaemia Hb<11g/l Pregnant women or breast feeding

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: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: placebo, aspirine, clopidogrel|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In vivo vasodilation induced by low intensity current |  |  | 
| In vitro study of platelets function |  |  | 
| In vitro vasodilation induced by platelets in isolated rat's vessels |  |  |
Efficacy and Safety of Vildagliptin in Subjects With Impaired Glucose Tolerance

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to placebo in lowering post-meal blood glucose levels in people with pre-diabetes who have high blood sugar levels after meals.

Official Title
-----------------
Efficacy and Safety of Vildagliptin in Subjects With Impaired Glucose Tolerance

Conditions
-----------------
Prediabetic State

Intervention / Treatment
-----------------
* Drug: vildagliptin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Blood glucose criteria must be met Body mass index (BMI) in the range 23-45 Exclusion Criteria: Diagnosis of diabetes Serious cardiovascular events within the past 6 months Use of insulin or any oral antidiabetic agent Other protocol-defined exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in area under the 0-2 hour prandial glucose curve at 12 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event profile after 12 weeks of treatment |  |  | 
| Change in ratio for postprandial insulin AUC and postprandial glucose AUC (0-2 hours) after 12 weeks of treatment |  |  | 
| Change in HOMA B at 12 weeks |  |  | 
| Change in fasting insulin at 12 weeks |  |  | 
| Change in fasting proinsulin/insulin ratio at 12 weeks |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IGT, Pre-diabetes, vildagliptin
A Comparison of Patch vs. Pill Estrogen Therapy on Testosterone Levels and Thyroid Tests in Menopausal Women

Study Overview
=================
Brief Summary
-----------------
This study compares the effects of 12 weeks of treatment with transdermal versus oral estrogen therapy on testsoterone levels and thyroid tests in healthy, naturally menopausal women.

Official Title
-----------------
A Comparison of Transdermal vs. Oral Estrogen Replacement Therapy on Androgen Levels and Thyroid Function in Naturally Menopausal Women

Conditions
-----------------
Menopause

Intervention / Treatment
-----------------
* Drug: Premarin® (oral) vs. Alora® (transdermal)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Naturally menopausal women Aged 42-70 years Currently using combination estrogen-progestin replacement therapy Exclusion Criteria: Women with contraindications to HRT use, including:Unexplained vaginal bleeding, liver disease, breast or endometrial cancer, venous thromboembolic events Thyroid disease Adrenal disease

Ages Eligible for Study
-----------------
Minimum Age: 42 Years
Maximum Age: 70 Years

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

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence A<br>Oral ERT then transdermal ERT | Drug: Premarin® (oral) vs. Alora® (transdermal)<br> <br> |
| Experimental: Sequence B<br>Transdermal ERT then oral ERT | Drug: Premarin® (oral) vs. Alora® (transdermal)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the effects of a 12-week course of oral CEE to a 12-week course of transdermal estradiol on free testosterone concentrations in menopausal women. |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the effects of oral versus transdermal ERT on thyroid binding globulin concentrations and tests of thyroid function. |  | 12 weeks | 
| Compare the effects of oral versus transdermal ERT on cortisol binding globulin and total and free cortisol concentrations. |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Menopause, Testosterone, Androgens, Sex Hormone Binding Globulin, Thyroid function, Cortisol
HKT-500 in Adult Patients With Shoulder Pain

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to determine the efficacy of HKT-500 in subjects with acute shoulder pain

Detailed Description
-----------------
Randomized, double-blind, placebo-controlled, multicenter study in men and women 18 years of age or greater who have acute shoulder pain requiring analgesic treatment daily for at least 2 weeks.

Official Title
-----------------
Protocol HKT-500-US08: A Randomized, Multicenter, Double-blind, Placebo-controlled, Two-week Study to Assess the Efficacy and Safety of HKT-500 in Subjects With Acute Shoulder Pain

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: HKT-500 Ketoprofen Topical Patch
* Other: Placebo Patch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subject has unilateral acute shoulder pain. Exclusion Criteria: The subject is a women of childbearing potential who has a positive urine pregnancy test, or who is lactating, or who is not surgically sterile (by tubal ligation or hysterectomy), or at least 2 years postmenopausal, and has not practiced an acceptable form of birth control (defined as the use of an intrauterine device with spermicide, a barrier method with spermicide, condoms with spermicide, subdermal implant, oral contraceptives, or abstinence) for at least 2 months prior to Visit 1.

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A,1 HKT-500 Ketoprofen Topical Patch<br>A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Two-Week Study to Assess the Efficacy and Safety of HKT-500 in Subjects with Acute Shoulder Pain | Drug: HKT-500 Ketoprofen Topical Patch<br>* HKT-500 Ketoprofen Topical Patch<br>* Other names: Ketoprofen Topical Patch;|
| Placebo Comparator: A,2 Placebo Patch<br>Treatment with placebo patch | Other: Placebo Patch<br>* Treatment with Placebo Patch<br>* Other names: Sham treatment;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Assessment |  | 2 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Assessment |  | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Shoulder pain, Pain, Ketoprofen, Topical Patch
RAAS Inhibitor Drugs in Dialysis Patients

Study Overview
=================
Brief Summary
-----------------
Hypertensive haemodialysis patients are at high risk for cardiovascular events. This study was undertaken to ascertain whether the upstream of aliskirne, a direct renin inhibitor improves mortality and cardiovascular outcomes in these high-risk population.

Official Title
-----------------
Upstream Use of Aliskiren in Hypertensive Haemodialysis Patients: Effects on Cardiovascular Outcomes

Conditions
-----------------
Hypertension, End Stage Renal Disease

Intervention / Treatment
-----------------
* Drug: aliskiren


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chronic kidney disease stage 5 undergoing maintenance haemodialysis for a minimum of 3 months existing arterial hypertension or history of arterial hypertension or resting blood pressure ≥140/90 mmHg or antihypertensive medication man and female 18 years and older. Exclusion Criteria: recent myocardial infarction (less than 3 months) atrial fibrillation/atrial flutter hypotension with systolic blood pressure of <90 mmHg high-grade aortic stenosis left ventricular ejection fration <50% known allergy to aliskiren severe disorders of liver function

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aliskiren<br> | Drug: aliskiren<br>* 150 mg once a day per 2 week with forced uptitration to 300 mg once a day, if tolerated<br>|
| Placebo Comparator: Placebo<br> | Drug: aliskiren<br>* 150 mg once a day per 2 week with forced uptitration to 300 mg once a day, if tolerated<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to first clinical event (among mortality from any cause, cardiac event including myocardial infarction, need for coronary angioplasty or coronary bypass surgery, ischaemic stroke, new-onset heart failure, new-onset atrial fibrillation) |  | 30 months |
Infections With Enterobacteria Producing Carbapenemases at the University Hospitals of Strasbourg

Study Overview
=================
Brief Summary
-----------------
Infections with enterobacteria producing carbapenemases at the University Hospitals of Strasbourg - descriptive epidemiology and risk factors for infection in the event of colonization There is a worrying situation of an increase in the number of patients colonized with carbapenemase-producing Enterobacteriaceae (CPE) at HUS. 7 to 15% of patients colonized with EPC would develop an infection with EPC. The cohorts published mainly concern patients hospitalized in intensive care. The associated mortality reported in the literature is high (> 25%) and greater than that associated with infection with the same bacterium sensitive to carbapenems.

Official Title
-----------------
Infections With Enterobacteria Producing Carbapenemases at the University Hospitals of Strasbourg - Descriptive Epidemiology and Risk Factors for Infection in the Event of Colonization

Conditions
-----------------
Nfections, Enterobacterial

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Major subject (≥18 years old) Subject hospitalized at HUS between 01/01/2011 and 07/31/2021 Clinical sample or rectal screening smear finding an enterobacterium producing a carbapenemase (EPC) Subject not having expressed their opposition to participating in the study Exclusion criteria: Subject having expressed opposition to participating in the study Subject under guardianship or guardianship Subject under safeguard of justice

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retrospective study of Enterobacteriaceae infections producing carbapenemases |  | Files analysed retrospectively from January 01, 2011 to July 31, 2021 will be examined] | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nfections, Enterobacterial, carbapenemases, producers of a carbapenemase