linjc16/ctgov huggingface dataset:
Study Describing the Hypertensive Population Treated With Telmisartan and Conditions of Use by Medical Practitioners and Patients

Study Overview
=================
Brief Summary
-----------------
Primary objective: to characterize hypertensive patients treated for at least 1 month with Telmisartan (alone or in combination with other drugs) in order to define the beneficiary population (those actually receiving the treatment). Secondary objectives: to describe the patients' blood pressure values (when self-monitored) and satisfaction with the treatment (ease of use, efficacy, safety) on the basis of a patient self-questionnaire, filled out 4 weeks after consultation. to compare the characteristics of the beneficiary population to those of the initial target population defined in the SPC (summary of product characteristics) for Telmisartan

Official Title
-----------------
Pharmaco-epidemiological Study Describing the Hypertensive Population Treated With Telmisartan and Conditions of Use by Medical Practitioners and Patients

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Telmisartan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hypertensive patients treated with Telmisartan for at least one month, consulting a medical practitioner (for whatever reason) Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 94 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 |
| --- | --- |
| Hypertensive patients<br> | Drug: Telmisartan<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characteristics of hypertensive patients | Questionnaire to determine the beneficiary population | Baseline, after 1 month of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in blood pressure | Self-monitored by patient | Up to 1 month | 
| Evaluation of patients satisfaction with treatment | Based on a patient 6-point self-questionnaire | Up to 1 month |
Progesterone Induced Blocking Factor Expression Levels in Endometrial Cancer Cells.

Study Overview
=================
Brief Summary
-----------------
Immune system suppression effect of Progesterone Induced Blocking Factor(PIBF), it could be questionable whether tumor cells express PIBF for escape of immune system. There are some studies in the literature that evaluate PIBF expression of different malign cells (e.g. glioblastoma multiforme as a malign central nerve system, leukemia, astrocytoma as a primary brain tumor, lung cancer and chorionic carcinoma). According to previous studies PIBF has been used as an anti-tumor immune suppressor by tumor cells. There is no data about the PIBF expression of endometrial tumor cells. Therefore, the investigators aim to determine the PIBF expression levels in the endometrial cancer cells.

Detailed Description
-----------------
This retrospective controlled study will be conducted at both Obstetrics and Gynecology clinics and Pathology clinics of Kayseri Training and Research Hospital. This study will be conducted with the use of formalin fixed paraffin embedded tissue blocks immunohistochemically to determine the PIBF expression levels in the samples. There are three groups in this study; endometrial cancer, endometrial hyperplasia and normal endometrium and each of the groups contained 20 paraffin embedded blocks provided form the Pathology clinic of Kayseri Training and Research Hospital archives.

Official Title
-----------------
Determining Levels of Expression of Progesterone-Induced Blocking Factor in Endometrial Cancer Cells.

Conditions
-----------------
Progesterone Induced Blocking Factor in Endometrial Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosed endometrial cancer diagnosed endometrial hyperplasia Exclusion Criteria: diagnosed cancer except endometrial cancer

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 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 |
| --- | --- |
| study group1<br>20 paraffin embedded blocks which was diagnosed endometrial cancer | |
| control group<br>20 paraffin embedded blocks of healthy women | |
| study group2<br>20 paraffin embedded blocks which was diagnosed endometrial hyperplasia | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunohistochemically Levels of PIBF in Endometrial Cancer Cells |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Progesterone Induced Blocking Factor, Endometrial Cancer
Bile Duct Injuries During Laparoscopic Cholecystectomies: An 11-year Population-based Study

Study Overview
=================
Brief Summary
-----------------
The aim of this retrospective study is to review the annual incidence, management, and outcomes of bile duct injuries (BDI) during laparoscopic cholecystectomy (LC) in a population-based cohort during 2008-2018 in Estonia.

Detailed Description
-----------------
The aim of this retrospective study is to review the annual incidence, management, and outcomes of bile duct injuries (BDI) during laparoscopic cholecystectomy (LC) in a population-based cohort during 2008-2018 in Estonia. Background Data: Iatrogenic bile duct injuries (BDI) following laparoscopic cholecystectomy (LC) result in major morbidity and incidental mortality. There is a lack of unselected population-based cross-sectional studies on the incidence, management, and outcomes of BDI. We hypothesised that due to improved imaging capabilities and collective laparoscopic experience, the BDI incidence will decrease over the study period and compare favourably with contemporary literature. After IRB approval, all cholecystectomies performed at national public healthcare facilities between 2008 and 2018 were retrospectively reviewed. BDIs were classified according to the Strasberg classification. We hypothesized that due to improved imaging capabilities and collective laparoscopic experience the BDI incidence will decrease over the study period and compare favourably to contemporary literature.

Official Title
-----------------
Bile Duct Injuries During Laparoscopic Cholecystectomies: An 11-year Population-based Study

Conditions
-----------------
Bile Duct Injury

Intervention / Treatment
-----------------
* Procedure: Management of bile duct injury


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients with BDI during laparoscopic cholecystectomy (LC) Exclusion Criteria: The sole exclusion criterion in the case selection was cholecystectomy performed primarily using the open method

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 bile duct injuries during laparoscopic cholecystectomy<br>The data concerning 241 patients´ BDI emergence, severity, management, and outcomes was analyzed | Procedure: Management of bile duct injury<br>* There are different options for BDI management, we analyzed their utilization and results<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of bile duct injuries | We aimed to review the annual incidence of bile duct injuries in a population-based cohort in Estonia. | During the years 2008-2018 |
Open Label Trial to Assess Iressa in Prostate Cancer Patients

Study Overview
=================
Brief Summary
-----------------
A study to assess the activity of Iressa in patients who's prostate cancer has recurred, and who have rising PSA levels

Official Title
-----------------
Phase II, Open-Label Trial to Assess the Activity of ZD1839 (IRESSA TM) in Patients With Recurrent Prostate Cancer Who Have Rising Serum PSA Levels Despite Serum Testosterone < 50mg/dl

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: Gefitinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Prostate cancer diagnosis no evidence of metastasis Age 18 or older Exclusion Criteria: Prior chemotherapy for recurrent prostate cancer Radiotherapy completed within 28 days of starting the study Incomplete healing from prior cancer or other major 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?
-----------------

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Gefitinib|Iressa|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Prostate Specific Antigen |  | Monthly | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of PSA decline |  | Monthly | 
| Safety variables |  | Monthly | 
| Time to Progression |  | Every 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Iressa, Gefitinib, Prostate Cancer, PSA
Study of Axillary Skin Temperature as a Marker of Ovulation

Study Overview
=================
Brief Summary
-----------------
Infertility is the most common reason women (aged 20-45yrs)see their GP, affecting 1 in 7 couples. Measuring basal body temperature is a technique that has been used since the 1930's to attempt to predict ovulation. Current NICE guidelines don't recommend the use of BBT charts to predict ovulation, as it has not been established to reliably confirm ovulation. The DuoFertility sensor a CE marked Class la device provides a continuous accurate measure of axilla temperature whilst worn under the arm. The investigators plan to compare the temperature measurements of the DuoFertility sensor with the gold standard transvaginal ultrasound scan obtained during 10 infertile women's menstrual cycles, up to 10 cycles per women. The investigators aim to investigate if continuous axillary skin temperature measurement obtained from the DuoFertility sensor, provides comparable results for identifying the occurrence of ovulation as the gold standard transvaginal ultrasound scan.

Official Title
-----------------
Pilot Study of Measuring Axillary Skin Temperature, Using DuoFertility, as a Marker of Ovulation in 10 Women of Childbearing Age

Conditions
-----------------
Infertility

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant is willing and able to give informed consent for participation Females aged 18 to 44 years. Referred with infertility to the Reproductive Medicine Clinic, Rosie Hospital Have a body mass index (BMI) above 19 and below 29 Regular menstrual cycles, i.e. no greater than 7 days difference between the shortest and longest cycle in the last 6 months Minimum menstrual cycle 21 days Maximum menstrual cycle 35 days Willing to wear a DuoFertility sensor continuously for 8 to 10 menstrual cycles; Willing to attend Rosie Hospital up to 5 times per cycle for TVS and blood tests Willing to perform twice daily LH urine tests at home from day 8 of cycle till positive Normal pelvic ultrasound and blood results obtained during screening tests Exclusion Criteria: Aged younger than 18 years, or older than 44 years Have a BMI less than 18 or greater than 29 Any diagnosed systemic illnesses, including but not restricted to thyroid disease, diabetes or inflammatory diseases Polycystic ovary disease Endometriosis or other pelvic pathology (including proven tubal disease) Taking steroids, including oral contraceptives or anti inflammatory drugs

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 44 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 |
| --- | --- | --- |
Impact of Grafts and Endografts for Abdominal Aneurysms on Arterial Stiffness.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate by non-invasive methods the change in central hemodynamics and arterial stiffness produced by grafts and endografts after abdominal aortic aneurysm repair. Our main goal is to measure the changes in: Augmentation index, central blood pressure, pulse wave analysis, pulse wave velocity.

Detailed Description
-----------------
The measures will be done before the procedure and after them. We will use the device called: SphygmocoR (Atcor Medical, Sydney, Australia).

Official Title
-----------------
Impact of Aortic Grafts After Open and Endovascular Repair in Central Hemodynamics and Arterial Stiffness Measured by Non-invasive Methods in Patients With Abdominal Aortic Aneurysms.

Conditions
-----------------
Aortic Aneurysm, Abdominal

Intervention / Treatment
-----------------
* Other: non-invasive methods


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with diagnosis of abdominal aortic aneurysm requiring repair (open or endovascular) based on guidelines criteria for management. Exclusion Criteria: Patients who don´t want to enter in the study. Patients who don´t want to sign the informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 90 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 |
| --- | --- |
| Open-graft group<br>Patients treated for abdominal aortic aneurysm with open graft will be measured for central hemodynamics and arterial stiffness by non-invasive methods. | Other: non-invasive methods<br>* To measure central hemodynamics and arterial stiffness by non-invasive methods using SphygmocoR (Atcor Medical, Sydney, Australia) before and after the procedure.<br>|
| Endograft group<br>Patients treated for abdominal aortic aneurysm with endograft will be measured for central hemodynamics and arterial stiffness by non-invasive methods. | Other: non-invasive methods<br>* To measure central hemodynamics and arterial stiffness by non-invasive methods using SphygmocoR (Atcor Medical, Sydney, Australia) before and after the procedure.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aix@75 | Augmentation Index corrected to 75 bpm | Before surgery | 
| AIx@75 | Augmentation Index corrected to 75 bpm | 2 months after Surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central Blood Pressure |  | before surgery | 
| Carotid Radial Pulse Wave Velocity |  | before surgery | 
| Carotid Radial Pulse Wave Velocity |  | 2 months after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
arterial stiffness, central hemodynamics
Assessment of the Efficacy of FOSFOMYCIN in Patients With Bacterial Infection

Study Overview
=================
Brief Summary
-----------------
This project aims to assess the clinical and microbiological efficacy of fosfomycin(FOM) in patients with bacterial infection. Primary objective: • To assess clinical and microbiological efficacy of FOM in patients with bacterial infection. Secondary objectives: To determine the rate and severity of unexpected adverse events. To determine the mean duration of therapy with FOM in patients with bacterial infection. Study design: Multi-center, non-interventional study

Detailed Description
-----------------
Please note that InfectoPharm Arzneimittel und Consilium GmbH has taken over sponsor responsibilities for all German sites of this clinical trial with Jannuary 2016 from J&P MEDICAL RESEARCH LTD.

Official Title
-----------------
Assessment of the Efficacy of FOSFOMYCIN in Patients With Bacterial Infection

Conditions
-----------------
Bacterial Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with bacterial infection receiving FOM for clinical purposes will be included into the analysis. Exclusion Criteria: -
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Bacterial Infection<br>All Patients with bacterial infection receiving fosfomycin may be included | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Pharmacokinetics of Sildenafil Following Administration of an Chewable Tablet of Sildenafil Relative to Viagra® Conventional Oral Tablet in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This is a single dose open-label comparative pharmacokinetic study to assess the pharmacokinetic characteristics of sildenafil between HIP0908 (chewable tablet) and Viagra (tablet) in healthy male subjects.

Conditions
-----------------
Erectile Dysfunction

Intervention / Treatment
-----------------
* Drug: HIP0908
* Drug: viagra


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age between 20 and 45 weight : over 55kg and 18.5 < BMI, 25.0 have to give their consent to participating clinical trial by oneself Exclusion Criteria: has a medical history of hypersensitivity to drug including PDE5 inhibitor and QTc > 430ms or uncontrolled arrhythmia

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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 |
| --- | --- |
| Active Comparator: viagra,anti-erectile dysfunction agent<br> | Drug: viagra<br>* single dose, cross over<br>|
| Experimental: HIP0908<br> | Drug: HIP0908<br>* SINGLE DOSE , CROSS OVER<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC and Cmax of sildenafil |  | Pre-dose (0h), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 hr post-dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anti erectile dysfunction agent
The Safety of a High-Dose, Rapid Infusion of Iron Sucrose

Study Overview
=================
Brief Summary
-----------------
Iron sucrose infusion is an iron replacement used to treat iron deficiency anemia (not enough iron in the body to make hemoglobin). Iron is a mineral that the body needs to produce hemoglobin, which carries oxygen in the blood. When the body does not get enough iron, it cannot produce enough hemoglobin and you become anemic. The research study is looking at the side effects of using a higher dose and faster rate of iron sucrose infusion than what is used in standard of care. The purpose of this study is to see if infusion with 500 mg of iron sucrose over a one hour time period can be done safely. If this can be done safely, it may reduce the total number of infusions required and the time for each infusion. This may be less costly and less burdensome to patients.

Official Title
-----------------
The Safety of a High-Dose, Rapid Infusion of Iron Sucrose in a Non-Dialysis Dependent Population

Conditions
-----------------
Iron Deficiency

Intervention / Treatment
-----------------
* Drug: Iron sucrose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient requiring iron infusion Exclusion Criteria: Patients will be excluded from enrollment if they are under the age of 18, unable to give signed consent, are pregnant, have end-stage renal disease, are on hemodialysis (HD), or have a history of clinically significant adverse reactions to iron sucrose.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Dose, Rapid Infusion Iron Sucrose<br>Patients will receive an infusion of 500 mg of iron sucrose over one hour and will be monitored for four hours. | Drug: Iron sucrose<br>* Iron sucrose will be infused at dose of 500 mg over a one hour period<br>* Other names: Venofer;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of adverse events in the study population attributed to drug administration. |  | 4 hours |