linjc16/ctgov huggingface dataset:
Safety/Efficacy Study of Drospirenone/Estradiol to Treat Postmenopausal Chinese Women With Vasomotor Symptoms.

Study Overview
=================
Brief Summary
-----------------
The study evaluates in Chinese post-menopausal women the combination of drospirenone 2 mg and estradiol 1 mg for the treatment of climacteric symptoms, such as hot flushes (vasomotor symptoms) and uro-genital complaints.

Detailed Description
-----------------
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer HealthCare AG, Germany. Bayer HealthCare AG, Germany is the sponsor of the trial.

Official Title
-----------------
A Double-blind, Randomized, Placebo-controlled, Multicenter Study Investigating the Efficacy and Tolerability of Angeliq® (Drospirenone 2mg and Estradiol 1mg) in Postmenopausal Chinese Women With Vasomotor Symptoms Over Four 28-day Treatment Cycles.

Conditions
-----------------
Vasomotor Symptoms

Intervention / Treatment
-----------------
* Drug: Estradiol/DRSP (Angeliq, BAY86-4891)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chinese postmenopausal women with moderate to severe vasomotor symptoms Exclusion Criteria: History of steroid hormone dependent malignant disease Known or suspected malignant or premalignant disease Current or history of severe heart, liver, renal, psychiatric disease Hyperlipemia

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1<br> | Drug: Estradiol/DRSP (Angeliq, BAY86-4891)<br>* Drospirenone (DRSP) 2mg and Estradiol 1mg. One cycle consists of 28 days. One tablet daily for 28 days given for a total of 4 cycles. Oral administration.<br>|
| Placebo Comparator: Arm 2<br> | Drug: Placebo<br>* Same administration.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of hot flushes |  | From baseline to week 16 | 
| Change in intensity of hot flushes |  | From baseline to week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in other climacteric symptoms |  | From baseline to week 16 | 
| Vaginal Bleeding pattern |  | From baseline to week 16 | 
| Global clinical impression |  | From baseline to week 16 |
Trial on Metoclopramide and Ketoprofen in Acute Migraine of Childhood

Study Overview
=================
Brief Summary
-----------------
This is a Randomized double blind trial with the aim to estimate the effectiveness of 3 therapeutic regimes per os on migraine pain: metoclopramide 0,15 mg/kg + placebo metoclopramide 0,15 mg/Kg + ketoprofen 1 mg/kg ketoprofen 1 mg/Kg + placebo Intensity of pain will be measured with linear 1-10 scale or analogic McGrath type scale every 20 min. The main objective is the evaluation of healing times from pain in the 3 groups

Official Title
-----------------
Randomized Controlled Trial on the Effectiveness of Metoclopramide Alone or in Combination With Ketoprofen in Acute Migraine of Child

Conditions
-----------------
Migraine

Intervention / Treatment
-----------------
* Drug: metoclopramide
* Drug: placebo
* Drug: ketoprofen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children 6-17 years old with migraine presenting in emergency room Exclusion Criteria: Informed consensus not obtained Occurring migraine still treated Hemiplegic migraine

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 17 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 |
| --- | --- |
| Experimental: 1<br>metoclopramide 0,15 mg/kg and Ketoprofen 1 mg/Kg per os in single dose | Drug: metoclopramide<br>* metoclopramide 0,15 mg/kg<br>Drug: ketoprofen<br>* ketoprofen 1 mg/Kg<br>|
| Active Comparator: 2<br>metoclopramide 0,15 mg/Kg + placebo per os | Drug: metoclopramide<br>* metoclopramide 0,15 mg/kg<br>Drug: placebo<br>* placebo per os<br>|
| Active Comparator: 3<br>ketoprofen 1 mg/Kg and placebo in single dose | Drug: placebo<br>* placebo per os<br>Drug: ketoprofen<br>* ketoprofen 1 mg/Kg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluation of healing times from pain in the 3 groups |  | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparison of percentage of healing from acute migraine and of relapses of pain in the three arms of trial |  | 2 and 24 hours respectively | 
| need of a rescue drug for lack of effect in every arms of the trial |  | 2 hours and 24 hours for relapses | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
migraine, metoclopramide, ketoprofen, child
Case Management Study to Reduce Health Care Utilization for Frequent Hospital Care Users

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify persons with high risk of frequent hospital admissions and by counselling by one in depth interview followed by frequent telephone contacts improve their quality of life and reduce their healthcare utilization.

Detailed Description
-----------------
Participants are identified by administrative data and a model predicting high risk of future healthcare utilization. Participants are invited to the study by mail. After informed consent participants are randomized to either active treatment or control 3:1. Active patients have an in depth interview with a specially trained nurse. Further counselling by telephone weekly for 6-9 months. Quality of Life is measured by SF-36 every 3 months for one year both in active participants and in controls.

Official Title
-----------------
Randomised Case Management Study to Reduce Health Care Utilization for Frequent Hospital Care Users

Conditions
-----------------
Quality of Life

Intervention / Treatment
-----------------
* Behavioral: Interview followed by frequent telephone support


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient > 18 years Recent history of contact with hospital Anticipated sustained high visit frequency Exclusion Criteria: Dementia (ICD10: F00-F03 or F051) Psychoses (ICD10: F20-F29) Drug abuse (ICD10: F10-F19) Metastases (ICD10: C77-C80) Hearing impairment or language difficulties Life expectancy < 1 year No telephone

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active patient support<br>Interview followed by frequent telephone support Questionnaire every 3 months | Behavioral: Interview followed by frequent telephone support<br>* Interview followed by telephone support<br>|
| No Intervention: Controls<br>Questionnaire every 3 months | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life reported by the participants with use of Short Form 36 |  | Questionaire Short Form-36 Every 3 months for one year | 
| Health Care Utilization - Admissions to and days in hospital | The use of different health care systems will be recorded | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Quality of Life, Health Care Utilization
Rhythm Disturbances After Ventricular Septal Defects

Study Overview
=================
Brief Summary
-----------------
We would like to conduct a retrospective chart review examining the incidence of surgical heart block in children treated in the Cardiac Service Line at Children's Healthcare of Atlanta. We would like to look at the last 30 surgical heart block cases seen at Children's Healthcare of Atlanta. We will collect the following information on each patient: Patient Date of Birth Date of the surgical procedure Weight of the patient at the time of surgery Concomitant Diagnoses Need for permanent pacemaker Outcome of pacing (i.e. pacing successful) We hope to look at each data element in order to determine potential risks factors for surgical heart block. By identifying the risk factors, the investigator hopes to establish a training program regarding surgical avoidance of certain areas of the heart (if possible) and education regarding pacemaker follow-up. Each patient will be given a unique study number. The patient's name, social security number, medical record number or initials will not be used in our research database.

Official Title
-----------------
Rhythm Disturbances After Ventricular Septal Defects

Conditions
-----------------
Heart Block After Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with heart block after surgery - Exclusion Criteria: -
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
arrhythmia, pediatrics, cardiac
Prevalence of Advanced Fibrosis in Patients Living With HIV

Study Overview
=================
Brief Summary
-----------------
Monocentric, cross-sectional study to define the prevalence of advanced fibrosis in an HIV infected outpatient population. Follow-up over 10 years to assess clinical relevance.

Detailed Description
-----------------
Globally a shift in the spectrum of diseases has occurred. While in earlier year's infectious (communicable) disease were the main contributors to morbidity and mortality, today non-communicable diseases (NCD) exhibit a dramatic increase and have reached epidemic proportions, even in developing countries. Diabetes, cardiovascular disease, and cancer are the most frequent NCDs and the underlying risk factors including Insulin resistance, dyslipidemia and obesity have been increasing over the last decades. The current study explores the prevalence of advanced fibrosis in an HIV-infected outpatient study population.

Official Title
-----------------
Cross-sectional Study on the Prevalence of Fatty Liver and Metabolic Risk Factors in an HIV-infected Population

Conditions
-----------------
Fatty Liver Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: informed consent age >18 Exclusion Criteria: pregnancy disease with expectation of life under 12 months

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 |
| --- | --- | --- |
| Prevalence of significant hepatic fibrosis | Significant hepatic fibrosis defined as greater or equal to >8,2 kPa meassured by transient elastography using a Fibroscan | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of hepatic steatosis | Hepatic steatosis defined as greater or equal to 275 db/m measured by controlled attenuation parameter (CAP) using a Fibroscan | 1 year | 
| Incidence of events of interest (clinical outcome) | Over the 10 year follow-up time, (1) overall mortality, (2) the incidence of AIDS-associated and defining diseases (according to the CDC classification) and (3) metabolic morbidity including incidence of cardiovascular disease (CVD), type 2 diabetes, hyperlipidemia, renal function impairment, arterial hypertension (according to the International Diabetes Federation Task Force on Epidemiology) and (4) liver related-morbidity (according to the EASL; https://easl.eu/wp-content/uploads/2018/10/Non-invasive-English-report.pdf) | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non-invasive Diagnostics
A Study of the Clinicopathologic Behaviour of the Different Types of Unsafe Chronic Otitis Media

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to study the clinicopathologic behaviour of the 3 dangerous types of chronic otitis media that are prone for complications. In which type are the complications more common? Which type gives rise to more hearing loss? How does the disease process in the 3 types evolve? should the 3 types of otitis media be managed differently?

Detailed Description
-----------------
Design: prospective cross sectional study setting: tertiary referral medical college hospital No of groups: 3 group 1: primary acquired atticoantral disease group 2: secondary acquired atticoantral disease group 3: mixed atticoantral disease Interventions: Diagnostic nasal endoscopy Eustachian tube function tests Pure tone audiometry biopsy of middle ear mucosa culture and sensitivity of ear discharge

Official Title
-----------------
A Cross Sectional Study of Clinicopathologic Behaviour of Primary, Secondary and Mixed Types of Atticoantral Chronic Otitis Media

Conditions
-----------------
Chronic Otitis Media, Cholesteatoma

Intervention / Treatment
-----------------
* Behavioral: biopsy, audiometry, ET function test, ear swab culture, DNE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:1. Atticoantral chronic otitis media 2. complicated unsafe otitis media 3. Otitis media with cholesteatoma, polyp, granulation tissue 4. Ear with retraction pockets leading to attic - Exclusion Criteria: tubotympanic otitis media alone otitis media with effusion Acute otitis media -

Ages Eligible for Study
-----------------
Minimum Age: 8 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: biopsy, audiometry, ET function test, ear swab culture, DNE|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
-----------------
retraction pockets ear, unsafe otitis media, otitis media complications
Preoperative Alignment of Total Knee Replacement

Study Overview
=================
Brief Summary
-----------------
The hypothesis of this study is that total knee alignment will be improved by preoperative planning from CT scans and the production of custom instruments compared to the use of standard instruments.

Detailed Description
-----------------
Patients will be randomized to have either customized knee instruments or standard generic instrumentation for primary total knee replacement. Postoperative CT scan will be used to determine alignment of each group.

Official Title
-----------------
Alignment of Total Knee Components Using Standard or Custom Instrumentation

Conditions
-----------------
Knee Arthritis

Intervention / Treatment
-----------------
* Procedure: trumatch group
* Procedure: control group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:patients undergoing primary total knee replacement - Exclusion Criteria:patients who have hardware involving the hip, knee or ankle -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: control group<br>control group will have standard instrumentation of their knee replacement | Procedure: control group<br>* these patients will have standard instrumentation used for for knee replacement<br>* Other names: Depuy knee instruments;|
| Experimental: trumatch group<br>the trumatch patient will have custom instruments made from preop CT scans | Procedure: trumatch group<br>* these patient will have CT based customized knee instruments used for surgery<br>* Other names: trumatch CPI;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alignment of Knee - Measured Mechanical Axis From CT Data | the mean knee mechanical axis was determined from 3D CT data - negative value designates varus alignment | postoperatively - CT done within 1 week of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical Time | the difference between the average surgical time will be determined and compared with 95% CI | intraoperative surgical time | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
alignment
Enzastaurin For Breast Cancer Patients Who Previously Received an Anthracycline and a Taxane Chemotherapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effectiveness of enzastaurin in the treatment of patients with metastatic breast cancer.

Official Title
-----------------
A Phase II Study of Oral Enzastaurin in Patients With Metastatic Breast Cancer Previously Treated With an Anthracycline and a Taxane-Containing Regimen

Conditions
-----------------
Breast Neoplasms

Intervention / Treatment
-----------------
* Drug: Enzastaurin Hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of metastatic breast cancer or recurrent breast cancer where surgery can not be done for curative intent Have received prior therapy with an anthracycline (class of drugs) and a taxane (class of drugs). Tumors must not be positive for HER2, but if positive, the treatment plan should not include further treatment with the drug Herceptin. Disease that can be definitely measured on Cat Scans or other radiological tests. May have received high dose chemotherapy for autologous stem cell support greater than or equal to 6 months of starting this study. Exclusion Criteria: More than 2 chemotherapy regimens for metastatic or locally recurrent disease. Have brain cancer from breast cancer Pregnant or breastfeeding Have an inability to swallow tablets Within 6 months have had a serious heart condition

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Enzastaurin Hydrochloride|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the effects of enzastaurin in the treatment of patients with breast cancer by measuring its ability to reduce the size of the tumor or prevent further increases in tumor size. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the length of time that enzastaurin is able to effect control of the disease. |  |  | 
| To evaluate the side effects of enzastaurin in patients with breast cancer |  |  | 
| To determine whether changes in laboratory tests of patients treated with enzastaurin is associated with the response of their tumors to the drug. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast Cancer, Cancer of the Breast