linjc16/ctgov huggingface dataset:
Photoacoustic Imaging (PAI) of Suspicious Breast Cancers - A Clinical Feasibility Study

Study Overview
=================
Brief Summary
-----------------
After locating the suspicious lesion/mass with standard of care mammography and/or ultrasound, a photoacoustic scan will be performed in the breast where the lesion is located. After the PA scan a biopsy will be performed, if clinically indicated (based on the mammogram and ultrasound only).

Official Title
-----------------
Pilot Photoacoustic Imaging (PAI) of Suspicious Breast Cancers - A Clinical Feasibility Study

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

Intervention / Treatment
-----------------
* Procedure: Photoacoustic Imaging (PAI)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have a breast lesion/mass found at physical examination, mammography or ultrasound (US), that has not been surgically resected Patients may have any of the following characteristics: Taking hormones (e.g., contraceptives, hormone replacement therapy, post-cancer Tamoxifen) Breast implants Previous breast biopsy Previous breast surgery Previous breast cancer High risk of breast cancer (e.g., breast cancer susceptibility gene (BRCA) mutations, other gynecologic cancer) Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: Patients who have had primary surgical excision of the suspicious finding Pregnant or lactating women

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

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

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

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: Photo Acoustic Imaging<br>An exploratory, single armed, pilot study designed to evaluate the feasibility of Photo Acoustic Imaging (PAI) in a clinical setting. | Procedure: Photoacoustic Imaging (PAI)<br>* Standard of Care<br>* Other names: Hand held photoacoustic probe;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The lesion visibility on PAI, described using a five-level scale: 1. Not visible 2. Barely visible 3. Fair (or moderately visible) 4. Visible 5. Clearly visible. |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measures of hypoxia in the lesion |  | 6 months |
Evaluation of Marginal Bone Loss After Immediate Implant Placement in Esthetic Zone Without Xenograft.

Study Overview
=================
Brief Summary
-----------------
Marginal bone loss in immediate implant placement in upper esthetic zone by comparing between non grafting in immediate implant placement with xenograft placement in other side. the study is to assess the marginal bone loss in the two techniques and compare results between them.

Detailed Description
-----------------
Marginal bone loss in immediate implant placement in upper esthetic zone by comparing between non grafting in immediate implant placement with xenograft placement in other side. the study is to assess the marginal bone loss in the two techniques and compare results between them after follow up period of 4 months.

Official Title
-----------------
Evaluation of Marginal Bone Loss After Immediate Implant Placement in Maxillary Esthetic Zone With and Without Xenograft.

Conditions
-----------------
Bone Loss

Intervention / Treatment
-----------------
* Procedure: xenograft placement .


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients with badly broken teeth in upper esthetic zone indicated for extraction presence of at least 4 mm of bone beyond root apex Exclusion Criteria: presence of fenestrations or dehiscences of the residual bony walls after extraction heavy smokers more than 20 cigarettes per day. systemic diseases that may affect normal healing. psychiatric problems.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Marginal bone loss without grafting.<br>immediate implant placement in upper esthetic zone. | |
| Active Comparator: marginal bone loss with xenograft.<br>xenograft placement (Geistlich Bio-Oss) in immediate implant placement in upper esthetic zone between the residual labial bone and implant surface. | Procedure: xenograft placement .<br>* immediate implant placement in upper esthetic zone with xenograft placement between residual labial bone and implant surface.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| marginal bone loss | Evaluation of marginal bone loss after Immediate implant placement in maxillary esthetic zone with and without xenograft | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient satisfaction | measure patient satisfaction by patient satisfaction chart. | 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
immediate implant, upper esthetic zone, marginal bone loss
Regional Differences In Indication for Ventral Hernia Repair

Study Overview
=================
Brief Summary
-----------------
The aim of the present study is to investigate whether there are differences in indication for ventral hernia repair and surgical approach among hernia surgeons from different geographical regions of Denmark.

Detailed Description
-----------------
30 outpatient consultation will be taped and distributed among hernia surgeons in different regions of Denmark. The surgeon will then be asked to answer a questionnaire regarding the treatment and surgical technique.

Official Title
-----------------
Regional Differences In Indication for Ventral Hernia Repair

Conditions
-----------------
Ventral Hernia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients referred to Køge Hospital Surg. Department with ventral hernia in December 2014

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 |
| --- | --- | --- |
| Differences in indication for ventral hernia repair | Number of patients offered a ventral hernia repair after primary consultation by different hernia specialists. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in choice of surgical technique between surgeons | Which surgical approach does different surgeons offer patients with a ventral hernia | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Indication, Differences
Safety Study of DuoTrav APS in Patients With Open-Angle Glaucoma or Ocular Hypertension

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to describe the long-term safety of a fixed combination product containing an alternative preservative, dosed once daily for 12 months, in patients with open-angle glaucoma or ocular hypertension.

Official Title
-----------------
A Twelve-Month Open-Label Safety Study of Polyquaternium-Preserved DuoTrav APS Dosed Once Daily in Patients With Open-Angle Glaucoma or Ocular Hypertension

Conditions
-----------------
Open-angle Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: Travoprost/Timolol Maleate Fixed Combination solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Willing and able to sign an informed consent document. Open-angle glaucoma or ocular hypertension who would benefit from a fixed combination medication, in the opinion of the investigator. Stable treatment of an IOP-lowering medication. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Pregnant, breastfeeding, or not using adequate birth control. Best-corrected visual acuity (BCVA) worse than 55 ETDRS letters. Other protocol-defined exclusion criteria may apply.

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: DuoTrav APS<br>Travoprost/Timolol Maleate Fixed Combination solution, 1 drop in the study eye(s) once daily, at 9 AM, for 12 months | Drug: Travoprost/Timolol Maleate Fixed Combination solution<br> <br> * Other names: DuoTrav (POLYQUAD-preserved);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events (AEs) |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
open-angle glaucoma, ocular hypertension, pseudoexfoliation, pigment dispersion
Evaluation of Screening Methods for Treatment of Meibomian Gland Dysfunction

Study Overview
=================
Brief Summary
-----------------
The objective is to evaluate the feasibility of using additional screening methods to optimize effectiveness outcomes with the LipiFlow System for application of heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye, and chalazia. The screening methods include diagnostic expression of the meibomian glands and interferometry assessment of the tear film.

Official Title
-----------------
Pilot Study for Evaluation of LipiFlow Screening Methods

Conditions
-----------------
Chalazion, Dry Eye Syndromes

Intervention / Treatment
-----------------
* Device: LipiFlow System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meibomian gland dysfunction Dry Eye symptoms Exclusion Criteria: Ocular surgery, ocular injury or ocular Herpes infection within past 3 months Active ocular infection Active ocular inflammation or recurrent inflammation within past 3 months Moderate to severe allergic conjunctivitis Severe eyelid inflammation Eyelid abnormalities that affect lid function Ocular surface abnormalities that may compromise corneal integrity Systemic disease conditions or medications that cause dry eye Use of other treatments for meibomian gland dysfunction or dry eye Pregnant or nursing women Participation in another ophthalmic clinical trial within past 30 days

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: LipiFlow Treatment<br>Treatment with LipiFlow device | Device: LipiFlow System<br>* In-office treatment for meibomian gland dysfunction<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association Between Screening Methods (Meibomian Gland Expression) and Treatment Effectiveness Outcomes (Total Meibomian Gland Score) | Analysis of association between Baseline Meibomian Gland Expression Score and Total Meibomian Gland Score at 4 Weeks. Success was defined by demonstration of a statistically significant (p<0.05) association between the screening method and outcome. Meibomian gland expression sum scores range from 0 to 60 with a higher score reflecting less meibomian gland dysfunction. Total meibomian gland scores range from 0 to 45 with a higher score reflecting less meibomian gland dysfunction. | Baseline and 4 Weeks |
Evaluation of Knowledge and Practice About Prostate Cancer in Male Employees

Study Overview
=================
Brief Summary
-----------------
Analyze, through an online questionnaire, the knowledge and practice about the prevention and detection of prostate cancer in male employees of a pharmaceutical company.

Detailed Description
-----------------
In Brazil, there are still few published and current studies that explore man's attention and awareness of health. Historically, women attend medical appointments and perform routine tests more frequently than men. For this is very important Analyze, through an online questionnaire, the knowledge and practice about the prevention and detection of prostate cancer in male employees of Libbs Farmacêutica (a pharmaceutical company in Brazil).

Official Title
-----------------
Evaluation of Knowledge and Practice About Prostate Cancer in Male Employees of Libbs Pharmaceuticals

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

Intervention / Treatment
-----------------
* Behavioral: questionare online application


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male individuals included in the Libbs workforce; Age 18 years or older; Subjects who agree to participate in the study after reading and signing the Informed Consent Form. Exclusion Criteria: There is no exclusion criteria

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group I<br>All volunteer male employees of Libbs Pharmaceuticals residing in all Brazilian regions will participate in this research.An online questionnaire will be applied to assess research subjects understanding of prostate cancer and health habits. | Behavioral: questionare online application<br>* questionare online application<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Knowledge and Practice About Prostate Cancer e Healthy Habits | Assess the subjects knowledge and practice in relation to educational campaigns aimed at prostate cancer.All the information wil be collected using a questionnaire previously approved by the ethics committee. | 1 month |
A Clinical Study Assessing the Potential of Piboserod for the Treatment of Heart Failure

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether piboserod, a serotonin-4 receptor antagonist, is effective for the treatment of patients with congestive heart failure.

Detailed Description
-----------------
Despite intensive research for decades, mortality and morbidity in chronic heart failure remains quite high. There is an obvious need for new drugs, especially drugs which may have a different mode of action than the existing ones on the market. The purpose of this trial is to evaluate whether a new drug candidate, piboserod, has beneficial biological effects in stable outpatients with symptomatic heart failure receiving evidence based treatment for heart failure and to assess safety and tolerability of this treatment.

Official Title
-----------------
A Proof of Biological Efficacy Study Assessing the Potential of Piboserod, a Specific 5-HT4 Antagonist, for the Treatment of Symptomatic Congestive Heart Failure on Top of Usual Evidence Based Pharmacological Treatment

Conditions
-----------------
Congestive Heart Failure

Intervention / Treatment
-----------------
* Drug: Piboserod


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of CHF (NYHA class II-IV) Locally determined LVEF < 0.35 (by CMR, echocardiography, LV angiography, or radionuclide cardioangiography) Stable sinus rhythm Stable evidence based pharmacological treatment for CHF. Exclusion Criteria: Unstable patients hospitalised within last 2 weeks Baseline prolongation of QTc interval Atrial fibrillation at randomisation MI or re-vascularisation last 3 months Stroke last 3 months.

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to end-of-therapy in Left Ventricular Ejection Fraction, as measured using CMR imaging |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in LV systolic and diastolic volume (and/or diameter) by CMR |  | 6 months | 
| Change in NYHA functional class |  | 6 months | 
| Change in various biomarkers for heart failure |  | 6 months | 
| Change in QoL-scores |  | 6 months | 
| Change in 6-minute walk distance |  | 6 months |
Acute Comfort and Haze Profile of FID 114657

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to describe the acute comfort and haze profile of FID 114657 in dry eye patients.

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

Intervention / Treatment
-----------------
* Other: FID 114657 ORB Preserved Ocular Emulsion
* Other: Soothe XP Lubricant Eye Drops


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

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: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FID 114657<br>FID 114657 | Other: FID 114657 ORB Preserved Ocular Emulsion<br>* 1 drop OU<br>|
| Active Comparator: Soothe XP Lubricant Eye Drops<br>Soothe XP Lubricant Eye Drops | Other: Soothe XP Lubricant Eye Drops<br>* 1 drop OU<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drop comfort upon instillation |  | Upon instillation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dry eye, artificial tears
Investigation of Psychophysiological Correlation of Aggression and Response to Aversive Stimuli

Study Overview
=================
Brief Summary
-----------------
This study investigates the psychophysiological correlations of aggression and response to aversive stimuli in a population of 133 children clinically diagnosed with conduct disorder (CD) and/or attention-deficit/hyperactivity disorder (ADHD). Data was gathered about participants' level of aggression through the Reactive-Proactive Aggression Questionnaire (RPQ). The stimuli that were presented to the participants included 1) a loud sound, 2) threatening photographs from the International Affective Picture System (IAPS), and 3) the Trier Social Stress Task (TSST). Participants' psychophysiological features of heart rate and galvanic skin conductance were measured and analyzed in relation to their RPQ scores and clinical diagnosis.

Official Title
-----------------
Investigation of Psychophysiological Correlation of Aggression and Response to Aversive Stimuli

Conditions
-----------------
Conduct Disorder, ADHD, Oppositional Defiant Disorder

Intervention / Treatment
-----------------
* Other: No intervention was administered for the purpose of this study.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects between ages 7 and 16 years Subjects who fulfil all criteria for a DSM-IV diagnosis of ADHD, conduct disorder, or oppositional defiant disorder Subjects with willingness to participate in a randomized, double-blind controlled trial Subjects with complete written, informed parental consent and child assent Subjects with IQ of 70 or more Exclusion Criteria: Subjects who have IQ in the below 70 Subjects who are younger than 7 years old or older than 16 years old Those without written parental consent Those with brain pathology such as serious head injury, epilepsy, etc.

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 16 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No intervention was administered for the purpose of this study.|No intervention was administered for the purpose of this study. Observations were carried out for all participants.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Rate | For Trier Social Stress Task | 7 minutes | 
| Skin Conductance Response | For loud sound | 4 minutes | 
| Skin Conductance Response | For threatening photograph | 4 minutes |