linjc16/ctgov huggingface dataset:
Biomarkers in Bone Marrow Samples From Patients With Acute Promyelocytic Leukemia

Study Overview
=================
Brief Summary
-----------------
This research study is studying biomarkers in patients with acute promyelocytic leukemia. Studying samples of bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and about biomarkers related to cancer.

Detailed Description
-----------------
OBSERVATIONAL STUDY MODEL: Case-only TIME PERSPECTIVE: Retrospective BIOSPECIMEN RETENTION: Samples With DNA BIOSCPECIMEN DESCRIPTION: Bone marrow STUDY POPULATION DESCRIPTION: Primary Care Clinic SAMPLING METHOD: Non-Probability Sample PRIMARY OBJECTIVES: I. To measure WT1 and VEGF-1 expression in patients with acute promyelocytic leukemia. OUTLINE: This is a multicenter study. Patient mRNA samples from diagnosis are analyzed via quantitative PCR to measure WT1 and VEGF-1 expression.

Official Title
-----------------
Observational - WT-1's Role in Leukemogenesis

Conditions
-----------------
Adult Acute Myeloid Leukemia, Adult Acute Myeloid Leukemia With t(15;17)(q22;q12), Adult Acute Promyelocytic Leukemia (M3), Childhood Acute Promyelocytic Leukemia (M3)

Intervention / Treatment
-----------------
* Other: laboratory biomarker analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of acute promyelocytic leukemia [t(15;17) translocation] Not specified Not specified
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Basic science (correlative studies)<br>Patient mRNA samples from diagnosis are analyzed via quantitative PCR to measure WT1 and VEGF-1 expression. | Other: laboratory biomarker analysis<br>* Correlative studies<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WT1 and VEGF-1 expression |  | Baseline |
Liver Transplantation Results in Hepatocellular Carcinoma Patients With Immunosuppression Without Steroids

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to evaluate the safety and efficacy of a steroid-free immunosuppression protocol in Hepatocellular Carcinoma (HCC) patients.

Conditions
-----------------
Immunosuppression, Hepatocellular Carcinoma, Liver Transplantation, Post-operative Complications

Intervention / Treatment
-----------------
* Drug: solu medrol
* Drug: a steroid-free immunosuppression protocol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All liver transplantation patients with hepatocellular carcinoma in our center between Jan 2005 and Dec 2009 were potentially eligible for enrollment Exclusion Criteria: the recipient pass away within 3 month following up liver transplantation Inability to provide written informed consent prior to study entry acute rejection are treated only with steroids
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 |
| --- | --- |
| Active Comparator: a steroid immunosuppression protocol<br> | Drug: solu medrol<br>* total dose 20mg/kg, including first dose 10mg/kg, rest of drug given within one weeks after liver transplantation<br>|
| Active Comparator: a steroid-free immunosuppression protocol<br>without steroid | Drug: a steroid-free immunosuppression protocol<br>* receive immunosuppression with Basiliximab(20mg/day,twice following transplantation) and tacrolimus(0.06/kg/d,twice a day) without steroids.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient and graft survival | patient and graft survival include surviral rate and recurrence-free survival rate | Over 12-month after liver transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications | Postoperative complications include acute rejection, infection, metabolic complications and hepatitis B-virus recurrence. | Over 12-month after liver transplantation |
A Safety Study Of Pregabalin In Fibromyalgia

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety of pregabalin in patients with fibromyalgia.

Official Title
-----------------
A 12-Week, Open-Label, Safety Trial Of Pregabalin In Patients With Fibromyalgia

Conditions
-----------------
Fibromyalgia

Intervention / Treatment
-----------------
* Drug: pregabalin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must meet the ACR criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites. Patients must complete the double-blind study. Exclusion Criteria: Patients who experienced a serious adverse event during the previous fibromyalgia study, which was determined to be related to the study medication.

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety of pregabalin in patients with fibromyalgia |  |  |
A Study of AG-80308 in Dry Eye Patients

Study Overview
=================
Brief Summary
-----------------
This is a multicenter, double-masked, randomized, parallel-group study with topical AG-80308 eye drops in dry eye patients.

Official Title
-----------------
A Multicenter, Double-Masked, Phase 1b Study Evaluating the Safety, Tolerability, and Dose-Response of Topical AG-80308 in Patients With Dry Eye Disease

Conditions
-----------------
Dry Eye Disease

Intervention / Treatment
-----------------
* Drug: AG-80308


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, 18 years of age or older at the screening visit Diagnosis of dry eye disease in both eyes with or without meibomian gland disease Exclusion Criteria: Participation in any investigational study within 30 days prior to baseline or exposure to an investigational drug must be fully washed out (at least 5 half-lives) Any ocular infection or inflammation within 30 days prior to the screening visit Corneal disorder or abnormalities other than dry eye disease that impact normal spreading of the tear film (except superficial punctate keratitis) History of chronic ocular allergy, systemic lupus erythematosus, rheumatoid arthritis, corneal ulcer/erosions, uveitis or dry eye due to Stevens Johnson syndrome, irradiation, alkali burns, cicatricial pemphigoid or vitamin A deficiency. Use of contact lenses in either eye within 14 days of screening visit or planned use during the study Use of the dry eye and/or meibomian gland disease medications/procedures within 2 to 8 weeks prior to the screening visit

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 |
| --- | --- |
| Experimental: Group 1<br>One drop of 0.001% AG-80308, two times daily to both eyes for 3 months | Drug: AG-80308<br>* AG-80308 Eye Drop Solution<br>* Other names: AGN-232411;|
| Experimental: Group 2<br>One drop of 0.03% AG-80308, two times daily to both eyes for 3 months | Drug: AG-80308<br>* AG-80308 Eye Drop Solution<br>* Other names: AGN-232411;|
| Experimental: Group 3<br>One drop of 0.1% AG-80308, two times daily to both eyes for 3 months | Drug: AG-80308<br>* AG-80308 Eye Drop Solution<br>* Other names: AGN-232411;|
| Experimental: Group 4<br>One drop of 0.03% AG-80308, new formulation, two times daily to both eyes for 3 months | Drug: AG-80308<br>* AG-80308 Eye Drop Solution<br>* Other names: AGN-232411;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of adverse events (AEs) and serious AEs (SAEs) |  | Screening to 3 months |
A Study to Evaluate the Impact of Maintaining Hemoglobin Levels in Anemic Patients With Carcinoma of the Cervix

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the feasibility, safety and short term effects on health related quality of life, of maintaining hemoglobin from 120 to 130 g/L versus from 100 to 110 g/L, with red cell concentrate (RCC) transfusion, in women having chemo-radiation for cancer of the cervix.

Official Title
-----------------
A Phase III Study to Evaluate the Impact of Maintaining Haemoglobin Levels Above 120g/L Verses Above 100g/L in Anaemic Patients With Carcinoma of the Cervix Receiving Concurrent Cisplatin and Radiation Therapy

Conditions
-----------------
Cervical Cancer, Anemia

Intervention / Treatment
-----------------
* Procedure: Blood transfusion
* Procedure: Blood transfusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previously untreated cervix cancer FIGO stage IB2, II, IIIB, IVA Suitable for treatment with radical intent using concurrent cisplatin and pelvic radiation Exclusion Criteria: Hemoglobin level above 125g/L Lower one-third vaginal involvement Para-aortic lymphadenopathy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Maintain hemoglobin level above 120 g/L<br>Hemoglobin level from 120 g/L to 130 g/L | Procedure: Blood transfusion<br>* Blood transfusion to maintain hemoglobin level above 120 g/L<br>|
| Active Comparator: Maintain hemoglobin level above 100 g/L<br>Hemoglobin level from 100 g/L to 110 g/L | Procedure: Blood transfusion<br>* Blood transfusion to maintain hemoglobin level above 100 g/L<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The impact of maintaining hemoglobin levels above 120 g/L versus above 100 g/L |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Haemoglobin
Clinical Outcomes of Patients With Deferred Revascularization Based on FFR and iFR Negative Coronary Artery Lesions.

Study Overview
=================
Brief Summary
-----------------
The objective is to assess long-term clinical outcomes of patients in whom intervention of coronary lesions was deferred due to negative fractional flow reserve (FFR) and negative Instantaneous wave-free ratio (iFR) in a real-world patient population and to identify factors associated with deferred target lesion failure.

Detailed Description
-----------------
Fractional flow Reserve (FFR) evaluates functional significance of stenosis in intermediate coronary lesions. Instantaneous wave-free ratio (iFR) is considered noninferior to FFR and does not require adenosine administration. This study was done to assess long-term clinical outcomes and factors associated with target vessel revascularization (TVR) in patients with deferred revascularization based on negative FFR and iFR. Retrospective analysis of medical records of 345 patients with deferred revascularization at a tertiary care hospital , from January 2012 to January 2020 will be done.

Official Title
-----------------
Clinical Outcomes of Patients With Deferred Revascularization Based on Fractional Flow Reserve (FFR) and Instantaneous Wave-free Ratio (iFR) Negative Coronary Artery Lesions in Pakistani Population

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Diagnostic Test: Fractional flow reserve, instantaneous wave-free Ratio


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who had intermediate to severe coronary lesions on coronary angiogram. Patients who had negative FFR >0.80 or iFR >0.89 and did not undergo immediate or planned revascularization on basis of negative physiologic assessment. Exclusion Criteria: Patients younger than 18 years of age or those having positive FFR/iFR values irrespective of revascularization status were excluded. Similarly, those who were lost to follow up and could not be traced via telephonic or were also excluded.
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Fractional flow reserve, instantaneous wave-free Ratio|Clinical outcomes observed for patients with moderate coronary lesions in whom coronary revascularization was deferred due to a negative physiologic study.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac death | Number of participants who died due to sudden cardiac arrest, sudden death due to acute MI and death due to heart failure or cardiogenic shock | 29 months | 
| Non-fatal myocardial infarction | Number of patients suffering from Myocardial infarction but did not die. | 29 months | 
| Target vessel revascularization. | Repeat PCI or bypass graft placement for a stenosis in another part of the vessel treated at the index PCI | 29 months |
Validation Study for an Unobtrusive Online Sleep Measurement System

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine the precision of an unobtrusive sleep measurement system. The system measures a force sensor signal under the mattress and analyzes sleep quality. The system measures: time in bed, sleep stages, sleep fragmentation, heart rate, respiration rate, sleep related breathing disorders, and limb movements.

Official Title
-----------------
Validation Study for an Unobtrusive Online Sleep Measurement System

Conditions
-----------------
Apnea, Restless Legs Syndrome, Sleep Fragmentation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-80 Finnish-speaking

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 20 volunteers<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Precision of sleep measurement | The volunteers are measured for seven consecutive days. The precision of the sleep measurements output by the ubobtrusive sleep monitoring system is evaluated by comparing the measurements to polysomnography and actigraphy reference measurements. | 7 days |
Verification of Prediction Algorithm

Study Overview
=================
Brief Summary
-----------------
Prospective observational clinical study to verify an algorithm used to predict cardiopulmonary events in patients presenting to the emergency department.

Detailed Description
-----------------
A novel algorithm for determining risk of acute cardiac complications, including cardiac arrest, for patients presenting to the ED has recently been reported. Unlike prior risk stratification tools that relied on basic vital sign data, this algorithm utilizes advanced computing of ECG data to solve the risk classification problem. Data will be collected on patients presenting to the emergency department with a primary complaint that is determined to be cardiopulmonary of origin by a clinician. Verification of the results of the previous studies using this algorithm in a more diverse patient cohorts is required. As such, the proposed study will investigate the accuracy of the algorithm.

Official Title
-----------------
Verification of a Prediction Algorithm for Cardiopulmonary Patients Admitted to the Emergency Department (ED) (VPAC)

Conditions
-----------------
Shortness of Breath Episode, Tachycardia, Bradycardia, Difficulty Breathing

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older Admission to emergency department requiring immediate medical attention due to presumed cardiac or pulmonary cause(s) and considered 2nd or 3rd tier priority in triage system. Exclusion Criteria: Pregnant or suspected pregnancy Significant trauma Do Not Resuscitate order Known as Ward of the State

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 |
| --- | --- | --- |
| Occurrence of a cardiopulmonary event |  | Within 72 hours of presentation to ED | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Cardiopulmonary Events in a single subject |  | Within 72 hours of presentation to ED | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cariopulmonary, cardiac arrest
LH Response to GnRH Test in Prepubescent Girls Under 6 Years

Study Overview
=================
Brief Summary
-----------------
The project aims to establish the normal LH and FSH response to a standardized GnRH dose in healthy girls below 6 years of age, and compares the normal GnRH response to the GnRH response in girls with early puberty development. The novel data may help to determine whether the girl is in early puberty or not. Healthy girls under 6 years of age attending routine examinations including an i.v. line for other causes are included in this study. Our examinations also include bone age determination, Tanner stage determination, and anthropometric measures (height and weight). 10 healthy girls in each of the following age groups: 7-12 months, 12-24 months, 24-36 months, 36-48 months, 48-60 months and 60-72 months are included.

Detailed Description
-----------------
Please refer to the brief summary which covers the study aim, methods and outcome measures.

Official Title
-----------------
LH Response to GnRH Test in Prepubescent Girls Under 6 Years

Conditions
-----------------
Precocious Puberty

Intervention / Treatment
-----------------
* Drug: GnRH agonist


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Endocrinologically healthy girls in the age from 7 months to 6 years Obtained oral and written informed consent from participants parents Exclusion Criteria: Anamnestic, clinical or laboratory findings that indicate that the subject is suffering from other diseases (eg poorly controlled asthma) or is in a condition which might affect the subject's ability to complete the study or which is likely to affect the parameters under investigation. Current medical treatment apart from prophylactic antibiotics or weak analgesics. GFR <50 ml/min/1,73m2 or if absence of previous GFR study: serum creatinine above normal upper age-specific normal range. Clinical signs of precocious puberty

Ages Eligible for Study
-----------------
Minimum Age: 7 Months
Maximum Age: 6 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GnRH intervention<br>All participating subjects are assigned to receive an intravenous GnRH agonist injection. | Drug: GnRH agonist<br>* 100 µg/m2 body surface max 100 µg i.v.<br>* Other names: LHRH agonist;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LH response |  | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FSH response |  | 30 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Precocious puberty, GnRH-test