linjc16/ctgov huggingface dataset:
Analysis of Hematoma Following Breast Surgery

Study Overview
=================
Brief Summary
-----------------
A retrospective review of patients who developed hematoma following breast surgery from 2003 to 2018 in a single institution was performed. The study investigated the value of closed-suction drains regarding the quantity and quality of fluid secretion for the prediction of subcutaneous hematoma in patients undergoing breast surgery procedures.

Official Title
-----------------
Retrospective Review of Patient Records for Analysis of Postoperative Bleeding Following Breast Surgery

Conditions
-----------------
Hematoma, Postoperative Bleeding

Intervention / Treatment
-----------------
* Diagnostic Test: Closed-suction drain fluid volume


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who developed hematoma requiring revision following bilateral breast surgery including augmentation mammoplasty, subcutaneous mastectomy and breast reduction. Exclusion Criteria: Patients who developed hematoma requiring revision following unilateral breast surgery. Breast surgery in absence of hematoma. Patients with known coagulation disorders.

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hematoma side<br>Drain secretion volume prior to revision surgery on the breast side affected by hematoma. | Diagnostic Test: Closed-suction drain fluid volume<br>* To evaluate the clinical value of postoperative drain fluid volume for detection of hematoma, an intra-individual comparison of drain secretion volumes between sides affected by hematoma and the uneventful contralateral breasts was performed.<br>|
| Non-hematoma side<br>Drain secretion volume prior to revision surgery on the breast side not affected by hematoma. | Diagnostic Test: Closed-suction drain fluid volume<br>* To evaluate the clinical value of postoperative drain fluid volume for detection of hematoma, an intra-individual comparison of drain secretion volumes between sides affected by hematoma and the uneventful contralateral breasts was performed.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drain fluid volume | The drain fluid volume in the breast affected by hematoma was compared to the non-hematoma side. | 24 hours postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast surgery, Closed-suction drains
Multicenter Clinical Study to Examine the Efficacy and Safety of Zarzenda in Patients With Hand Eczema

Study Overview
=================
Brief Summary
-----------------
To show efficacy of Zarzenda in the treatment of hand eczema

Detailed Description
-----------------
The objective of the study is to demonstrate efficacy and safety of Zarzenda (a medical device) in the management of hand eczema.

Official Title
-----------------
A Multicenter, Open Uncontrolled Clinical Study to Examine the Efficacy and Safety of Zarzenda in the Management of Hand Eczema

Conditions
-----------------
Hand Eczema

Intervention / Treatment
-----------------
* Device: Zarzenda


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mild to moderate hand eczema for at least 3 months At least 4 weeks have passed since use of systemic treatment for eczema At least 4 weeks have passed since any vaccination At least 1 week has passed since last topic treatment on hands with corticosteroids Agree to use adequate contraceptive method if of childbearing potential Willingness to avoid excessive exposure to sunlight and avoid skin irritants Exclusion Criteria: Pregnancy, breast feeding Severe excoriations on the hands Need for systemic treatment for atopic dermatitis Known sensitivity to Zarzenda and/or to extract of nut butyrospermum parkii (shea) Known immune deficiency Concomitant infection on hands

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 |
| --- | --- |
| Active Comparator: 1<br>Topically applied daily for 2 weeks | Device: Zarzenda<br>* Topically applied daily for 2 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hand eczema severity index (HECSI)at the end of study |  | End of study compared to baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator's Global Assessment |  | End of study compared to baseline | 
| Patients assessment of itch |  | End of study compared to baseline | 
| Hand surface area |  | End of study compared to baseline | 
| Clinical signs of hand eczema |  | End of study compared to baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Eczema, Medical device
Evaluation of SYSTANE Ultra Lubricant Eye Drops

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and efficacy of two artificial tears in dry eye patients.

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

Intervention / Treatment
-----------------
* Other: SYSTANE Ultra
* Other: Optive


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented diagnosis of dry eyes Must not have worn contact lenses for 1 week preceding enrollment Exclusion Criteria: Age related

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: SYSTANE Ultra<br>SYSTANE Ultra Lubricant Eye Drops | Other: SYSTANE Ultra<br>* SYSTANE Ultra Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days<br>|
| Active Comparator: OPTIVE<br>OPTIVE Lubricant Eye Drops | Other: Optive<br>* Optive Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tear Break-up Time | Tear breakup time is the time interval between a blink and the development of a dry spot in the tear film. Less than 10 seconds is abnormal. Dry spot is visible after fluorescein staining when viewed under a slit-lamp. | Day 0, Day 7, Day 14, Day 28, and Day 42 | 
| Conjunctival Staining | Conjunctival staining refers to the appearance of spots on the conjunctiva when dyed with lissamine green stain during an eye examination. Lissamine green temporarily stains the surface of the conjunctiva of the eye. An eye doctor looking at the eye's surface through a slit lamp observes the spots as green spots. Conjunctival staining grading scale is a 6 point scale, with 0 equals no staining (best case) and 6 equals maximum (worst) staining. | Day 0, Day 7, Day 14, Day 28, Day 42 | 
| Corneal Staining | Corneal staining refers to the appearance of corneal abrasions when dyed with fluorescein drops during an eye examination. Fluorescein temporarily stains the surface of the cornea of the eye. An eye doctor looking at the eye's surface through a slit lamp observes the abrasions as brightly-colored spots on an otherwise smooth cornea. Corneal staining grading scale is a 15 point scale, with 0 equals no staining (best case) and 15 equals maximum (worst) staining. | Day 0, Day 7, Day 14, Day 28, Day 42 |
The Effect of Dates and Castor Oil on the Initiation of Spontaneous Labor in Primigravida Parturients

Study Overview
=================
Brief Summary
-----------------
Finding a natural and efficient method to improve the chance of entering spontaneous labor beyond 39 weeks of gestation will address both the medical necessity and the will of many parturients to avoid medical interventions. In this study we aim to evaluate the effect of dates and castor oil on the initiation of spontaneous labor in primigravida parturients.

Official Title
-----------------
The Effect of Dates and Castor Oil on the Initiation of Spontaneous Labor in Primigravida Parturients- a Prospective Randomized Trial

Conditions
-----------------
Effect of Dates and Castor Oil on Spontaneous Labor

Intervention / Treatment
-----------------
* Dietary Supplement: Dates
* Dietary Supplement: Castor oil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women who come to the obstetrical emergency department for normal check up between 39+4 and 40+2 weeks of gestation Primipara Bishop cervical score below 5 Low risk pregnancy Singleton pregnancy Vertex presentation Women who haven't consumed dates over once a week in month prior the checkup and haven't consumed castor oil prior to enrollment. Exclusion Criteria: Any medical indication for labor induction Regular contractions Premature rupture of membranes Women who consumed dates over once a week in month prior the checkup or consumed castor oil prior to enrollment.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Date consumption<br>Consumption of 6 dates a day until 41 weeks of gestation | Dietary Supplement: Dates<br>* Consumption of 6 dates a days until 41 weeks of gestation<br>|
| Experimental: Castor oil consumption<br>One time consumption of 60 CC of Castor oil | Dietary Supplement: Castor oil<br>* One time consumption of 60 CC Castor oil<br>|
| No Intervention: Control Group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of spontaneous entry into labor | Rate of women who will enter labor spontaneously without intervention | 2 weeks after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cervical ripening- Bishop score | Change of cervical ripening status after intervention | 2 weeks after enrollment |
A Study of Letrozole in the Treatment of Endometrial Cancer

Study Overview
=================
Brief Summary
-----------------
Currently available treatments for endometrial cancer are associated with limited efficacy and significant toxicity. This study will assess the safety and efficacy of letrozole, an aromatase inhibitor, on endometrial cancer.

Official Title
-----------------
A PHASE II STUDY OF LETROZOLE IN PATIENTS WITH ADVANCED OR RECURRENT ENDOMETRIAL CANCER

Conditions
-----------------
Recurrent and Metastatic Endometrial Cancer

Intervention / Treatment
-----------------
* Drug: Letrozole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Postmenopausal women with recurrent or metastatic adeno- or adenosquamous carcinoma of the endometrium No adjuvant therapy Up to one prior hormonal (progestin) therapy for advanced/metastatic disease allowed No chemotherapy for recurrence (adjuvant permitted) Unidimensionally measurable disease Good Health status 0-2 (Eastern Cooperatitve Oncology Group) No prior tamoxifen or aromatase inhibitor therapy No other concurrent anti-cancer treatment No metastases in the central nervous system Exclusion criteria: Additional protocol-defined inclusion/exclusion criteria may apply

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rates (complete response, partial response, no change, progressive disease) measured by tumor marker assessments and radiologic imaging at week 12 then every 12 weeks x 1 year followed by every 16 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of clinical response, time to progression of the disease, correlation of tumor response with pretreatment ER/PR status, histological grade and aromatase levels |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Letrozole, Endometrial Cancer, Aromatase inhibitor
eUltra 10k - Biofreedom Ultra

Study Overview
=================
Brief Summary
-----------------
This registry captures data on BioFreedomTM Ultra CoCr DCS in standard clinical practice (real world population) and serves as Post Market Clinical Follow up (PMCF) as part of the Post-Market Surveillance.

Detailed Description
-----------------
Prospective, observational multi-center registry to be conducted at up to 150 interventional cardiology centers in up to 15 countries. Patients will be followed by telephone for 1 year after PCI for data collection. This registry captures data on BioFreedomTM Ultra CoCr DCS in standard clinical practice (real world population) and serves as Post-Market Surveillance. This registry will enroll up to 10000 patients in up to 150 investigative centers in Europe, South America, Middle East, Asia over a period of 5 years. Each patient be followed with phone (or clinic) visit at 12 months.

Official Title
-----------------
A Post-Market Registry of the BioFreedom Ultra CoCr Biolimus A9 Coated Coronary Stent System

Conditions
-----------------
Post Market Clinical Follow up (PMCF)

Intervention / Treatment
-----------------
* Device: Biofreedom Ultra


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: According to the current version of Instructions of Use (IFU) Patient is at least 18 years old Patient provides a signed informed consent Exclusion Criteria: According to current version of IFU Patients will be excluded as per Medical Device Regulation (MDR) (Article 65: Clinical investigations on minors and article 66: Clinical investigations on pregnant or breastfeeding women Patients will be excluded if they are under judicial protection, guardianship or curatorship or if they are deprived of their liberty by judicial or administrative decision

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

| Intervention/Treatment |
| --- |
|Device: Biofreedom Ultra|The BioFreedomTM Ultra CoCr DCS is a combination product consisting of two key components: the cobalt chromium stent platform coated abluminally with the active ingredient BA9TM (polymer and carrier free) and the delivery system.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target Lesion Failure (TLF) |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinically driven Target Lesion Revascularization (TLR) |  | 12 months | 
| Cardiovascular death (CD) |  | 12 months | 
| Target Vessel MI |  | 12 months | 
| Target Vessel Revascularization (TVR) |  | 12 months | 
| Stent thrombosis |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PMCF, Registry, Biofreedom Ultra, eUltra
Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Study Overview
=================
Brief Summary
-----------------
Study of the Safety and Efficacy of Adalimumab in Subjects with Moderate to Severe Chronic Plaque Psoriasis

Official Title
-----------------
Multicenter Extension Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Conditions
-----------------
Psoriasis

Intervention / Treatment
-----------------
* Drug: adalimumab
* Drug: adalimumab
* Drug: adalimumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject completed prior PS study Exclusion Criteria: Subject has other active skin diseases Multiple concomitant therapy restrictions and/or washouts (topicals, UV, other systemic PS therapies) Poorly controlled medical conditions History of neurologic symptoms suggestive of central nervous system (CNS) demyelinating disease History of cancer or lymphoproliferative disease History of active TB or listeriosis, or persistent chronic or active infections Known to have immune deficiency or is immunocompromised Clinically significant abnormal laboratory test results Erythrodermic psoriasis or generalized pustular psoriasis

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br> | Drug: adalimumab<br>* 40 mg eow through Week 12 followed by OL 40 mg eow through Week 48, permitted to escalate to weekly dosing upon relapse<br>* Other names: Humira;|
| Active Comparator: B<br> | Drug: adalimumab<br>* 40 mg weekly through Week 48 (OL Week 12 - 48)<br>* Other names: Humira;|
| Active Comparator: C<br> | Drug: adalimumab<br>* 80 mg W0, 40 mg eow through Week 12 followed by OL 40 mg eow through Week 48, permitted to escalate to weekly dosing upon relapse<br>* Other names: Humira;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psoriasis Area and Severity Index |  | Week 12 | 
| Adverse Events |  | Throughout Study Participation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psoriasis Area and Severity Index |  | Week 0, 4, 8, 12, 16, 20, 24, 32, 40 and 48 | 
| DLQI, SF-36, Zung Depression Self-Rating Scale, EQ-5D, VAS |  | Week 12, 24 and 48 | 
| Physician's Global Assessment |  | Week 12, 16, 20, 24, 32, 40 and 48 |
Single Nucleotide Polymorphisms (SNPs) Associated With Postherpetic Neuralgia

Study Overview
=================
Brief Summary
-----------------
Postherpetic neuralgia (PHN) is a common condition and affecting 5 to 30% of the herpes zoster patients. In some cases, the pain remained refractory after first and second line treatment for herpes zoster. This suggests that there may be genetic variants that make some patients susceptible to PHN. Using saliva samples from herpes zoster patients the investigators are going to analyze the relationship between single nucleotide polymorphisms (SNPs) in genes that are known to be involved in pain and PHN.

Official Title
-----------------
Association Between Some Candidate Single Nucleotide Polymorphisms and Postherpetic Neuralgia

Conditions
-----------------
Postherpetic Neuralgia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age more than 50 years Clinically defined herpes zoster patients Exclusion Criteria: Patients not able to provide informed consent

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- |
| PHN(+)<br>Patients who have persistent pain more than three months after the onset of herpes zoster. | |
| PHN(-)<br>Patients whose pain disappear within three months. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation between pain SNPs and PHN |  | At Enrollment |
Exercise Pulmonary Transit Time

Study Overview
=================
Brief Summary
-----------------
The study seeks to measure pulmonary transit time via contrast-echocardiography before and after exercise.

Detailed Description
-----------------
The ability to measure the amount of blood in the lungs using heart-ultrasound (echocardiography) can be useful to estimate how much fluid is in a patient's circulation, which can influence diagnosis and treatment of certain types of heart failure. In some patients, the amount of fluid is normal at rest, but can increase with activity and thus a diagnosis of heart failure can only be made after exercising. Currently, the amount of fluid is measured invasively. We have shown that echocardiography can measure the amount of fluid in the lung circulation at rest without the need for an invasive procedure. We now seek to find out if we can make a similar measurement after exercise. If successful, the need for catheter procedures may be reduced in certain types of heart failure.

Official Title
-----------------
Echocardiographic Assessment of Pulmonary Transit Time Following Exercise

Conditions
-----------------
Heart Failure, Diastolic

Intervention / Treatment
-----------------
* Diagnostic Test: contrast echocardiography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years old Able to give informed consent Exclusion Criteria: Known allergic reaction to Definity or Optison ultrasound contrast Pregnancy/Nursing - as assessed/disclosed by the participant

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: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: small pilot study to test technical feasibility
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Exercise<br>Everyone is in this arm | Diagnostic Test: contrast echocardiography<br>* giving echocardiographic contrast and taking echocardiographic images before and after exercise<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary Transit Time | interval required for the pulmonary blood volume to traverse the pulmonary circulation | 3-10 seconds |