linjc16/ctgov huggingface dataset:
Safety and Efficacy of BRM421 for Dry Eye Syndrome

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to compare the safety and efficacy of BRM421 Ophthalmic Solution to placebo for the treatment of the signs and symptoms of dry eye.

Detailed Description
-----------------
This is a multi-center, double-masked, randomized, vehicle-controlled, phase 2 study in approximately 150 subjects. (75 per treatment arm).

Official Title
-----------------
A Multi-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Safety and Efficacy of BRM421 Ophthalmic Solution in Subjects With Dry Eye Using a Controlled Adverse Environment (CAE®) Model

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

Intervention / Treatment
-----------------
* Drug: BRM421
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be at least 18 years of age; Provide written informed consent; Have a reported history of dry eye for at least 6 months prior to enrollment; Have a history of use of eye drops Exclusion Criteria: Have any clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters; Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1; Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study; Have used any eye drops within 2 hours of Visit 1; Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months; Be a woman of childbearing potential who is not using an acceptable means of birth control; acceptable methods of contraception

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: BRM421 Ophthalmic Solution<br>The active control with BRM421 solution | Drug: BRM421<br>* A topical solution of BRIM421 ophthalmic drops<br>|
| Placebo Comparator: Placebo<br>The vehicle solution | Drug: Placebo<br>* vehicle ophthalmic drops<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sign: Corneal fluorescein staining score |  | Up to 4 weeks | 
| Symptom: Ocular discomfort score |  | Up to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tear film break-up time |  | Up to 4 weeks | 
| Conjunctival Redness |  | Up to 4 weeks | 
| Ocular Surface Disease Index (OSDI)© |  | Up to 4 weeks |
Efficacy of Metoclopramide in Poor Ovarian Response IVF Patients

Study Overview
=================
Brief Summary
-----------------
Poor ovarian response population of ART are considered the biggest challenge for providers. Hitherto, no one protocol has been proven to be effect in this subgroup of IVF patients. Metoclopramide belongs to the antiemetic group, used for motion sickness and during early gestation for hyperemesis gravidarum. The mechanism of action is antagonisim to dopamine receptors. We hypothesize than by blocking dopamine receptors and decreasing the dopaminergic tone there is a possibility to increase the sensitivity of ovarian response to gonadotropins during controlled ovarian stimulation and result in increased oocyte retrival.

Official Title
-----------------
Efficacy of Metoclopramide in Poor Ovarian Response IVF Patients: a Randomised, Double-blind, Placebo-controlled Trial

Conditions
-----------------
Poor Responders in IVF

Intervention / Treatment
-----------------
* Drug: Metoclopramide
* Drug: Placebo Oral Tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Poor response according to Bologna criteria Exclusion Criteria: Allergy to metoclopramide Prolactinemia Women treated with dopamine agonists

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 54 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metoclopramide 10 mg BID<br> | Drug: Metoclopramide<br>* Metoclopramide 10 mg BID<br>|
| Placebo Comparator: Placebo 10 mg BID<br> | Drug: Placebo Oral Tablet<br>* Placebo 10 mg BID<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of oocytes | Number of oocytes | Approximately 5 weeks from first dose of study drug |
Action of Caffeinated and Decaffeinated Espresso on Autonomic Function

Study Overview
=================
Brief Summary
-----------------
More than 80% of the population in the USA consume coffee each day. However there not many studies on change of heart rate variability and placebo effects after consumption of coffee. In our study we aim to test the following hypotheses: Habitual caffeinated espresso coffee drinkers show an increase in blood pressure, heart rate variability and parasympathetic activity (high frequency band) of the heart. Non-habitual caffeinated espresso coffee drinkers show an increase of blood pressure. The heart rate variability and the parasympathetic activity of the heart will decrease. Caffeinated or decaffeinated espresso induces comparable changes in habitual or non-habitual coffee drinkers.

Official Title
-----------------
Short-term Autonomic Effects of Caffeinated and Decaffeinated Espresso in Young Healthy Individuals

Conditions
-----------------
Influence of Espresso on Heart Rate Variability

Intervention / Treatment
-----------------
* Other: hab cof with water
* Other: hab cof with dec espresso
* Other: hab cof with caf espresso
* Other: non-hab cof with water
* Other: non-hab cof with dec espresso
* Other: non-hab cof with caf espresso


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18- 50 years old, healthy Exclusion Criteria: Medication, obese(BMI > 30)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: H<br>habitual coffee drinkers | Other: hab cof with water<br>* habitual coffee drinker provided with water<br>Other: hab cof with dec espresso<br>* habitual coffee drinkers given decaffeinated espresso<br>Other: hab cof with caf espresso<br>* habitual coffee drinkers given caffeinated espresso<br>|
| Other: N<br>non-habitual coffee drinkers | Other: non-hab cof with water<br>* non-habitual coffee drinkers given water<br>Other: non-hab cof with dec espresso<br>* non-habitual coffee drinkers given decaffeinated espresso<br>Other: non-hab cof with caf espresso<br>* non-habitual coffee drinkers given caffeinated espresso<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate variability |  | 70 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood pressure |  | 70 min. |
Study of Genetic Differences in People With Depression

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify genes involved in depression. Specifically, the investigators will analyze some genes that may be related to whether or not a person responds to antidepressant medication. This project is part of basic scientific research to increase understanding of the role of genetic influences in psychological and mental processes involved in the response to treatment for depression.

Official Title
-----------------
Study of Genetic Differences in People With Depression

Conditions
-----------------
Depressive Disorder, Major

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of Unipolar Major Depression Control subjects must be healthy normal adults Exclusion Criteria: Subjects with mood symptoms that are not severe enough to qualify for MDD Subjects with any active medical illness that may be related to ongoing mood disorder Normal subjects must be free from: a psychiatric diagnosis, substance abuse, a history of seizure disorder, and any serious medical illness

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Depression, genetic, gene, antidepressant, research
The Effect of Acute Transcranial Bright Light on Anxiety Symptoms

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if transcranially administered bright light has acute effect on anxiety symptoms.

Detailed Description
-----------------
Subjects (n=30) with anxiety symptoms will be recruited into the study. To be included into the study, subjects have to get at least seven points in BAI(Becks Anxiety Inventory). At the beginning of the study subject will be randomly assigned to 12 minutes of acute transcranial bright light or placebo exposure group. Anxiety symptoms will be measured using Spielberger State-Trait Anxiety Inventory (STAI, form Y1)self-rating questionnaire just before and 10 and 110 minutes after the experiment.

Official Title
-----------------
The Effect of Acute Transcranial Bright Light on Anxiety Symptoms

Conditions
-----------------
Anxiety

Intervention / Treatment
-----------------
* Device: Transcranial bright light device
* Device: Transcranial sham device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject can read and understand the study protocol The written informed consent is obtained from subject Subject's BAI total score >= 7 Exclusion Criteria: Subject has a lifetime psychotic disorder Subject abuses substance or has a dependence Subject has had suicidal idealization during the past month Subject use psychotropic medications Subject has unstable somatic disease Subject has used bright-light therapy for the current episode Subject is pregnant Subject is a relative of a member of research team Subject has used transcranial light treatment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Transcranial bright light exposure<br>Transcranially administered bright light exposure for 12 minutes | Device: Transcranial bright light device<br> <br> * Other names: Valkee npt 1100;|
| Sham Comparator: Transcranial sham exposure<br>Transcranially administered sham exposure for 12 minutes | Device: Transcranial sham device<br> <br> * Other names: Valkee npt 1100;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in total score of STAI-Y1 | STAI-Y1 (Spielberger State-Trait Anxiety Inventory, form Y1) | just before exposure, 10 minutes and 110 minutes after the exposure |
Diagnosing Extremity Fractures and/or Dislocations Using Ultrasound Presenting to the Emergency Department

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the efficacy of ultrasound in diagnosing the presence or absence of extremity fractures or dislocations. Hypothesis: Can ultrasound be used as an accurate and effective method for determining the presence or absence of extremity fractures or dislocations? Is there a difference in amount of pain experienced prior to and after the ultrasound?

Detailed Description
-----------------
This prospective, multicenter cohort study. The sampling method will be a convenience sample of all adult patients presenting to the ED with symptoms concerning a fracture and/or dislocation of an extremity. Once a patient has been deemed an appropriate candidate for the study, written consent will be obtained from one of the Associate Investigators. Once consent has been obtained, a resident physician will perform the ultrasound examination on the affected extremity(s) and note their findings.

Official Title
-----------------
Diagnosing Extremity Fractures and/or Dislocations Using Ultrasound in Adult Patients Presenting to the Emergency Department

Conditions
-----------------
Fractures, Dislocations

Intervention / Treatment
-----------------
* Procedure: Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical suspicion of a fracture and/or dislocation of an extremity Age Greater than 18 years English speaking able to give consent Exclusion Criteria: Age less than 18 years, including emancipated minors Unstable patients with B/P below 90mmHg systolic Open, unstable, or suspected compound fracture Physician has reviewed X-Rays and made diagnosis before ultrasound could be done X-Rays will not be ordered Patient is pregnant Patient cannot give own consent English is not the patient's primary language

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Those with extremity fractures. | Procedure: Ultrasound<br>* use ultrasound to confirm diagnosis of extremity fractures<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Faster diagnosis and sooner definitive treatment for extremity fractures or dislocations. |  | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unnecessary evacuation in the pre hospital combat setting. |  | 2 hours |
Psychometric Study of Outcomes Instruments

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to develop a standardized, practical self-administered questionnaire to monitor young adult burn patients and to evaluate the effectiveness of burn management treatments with regard to improved function, physical appearance and other relevant outcomes.

Detailed Description
-----------------
Identifying young adult burned patients at risk for poor outcomes remains an underpublished field of study. The first step to identifying these patients is to review their responses to this burn specific young adult measure, that attempts to quantify aspects of quality of life. We are validating this questionnaire by now collecting information from non burned community based subjects and by having burned patients complete the questionnaire at 4 timepoints. Once we have recruited sufficient subjects we will finalize our testing of this questionnaire and publish the validity and reliability of the instrument. Our questionnaires will help us answer the question of how burn people differ from non burned person's reported quality of life. This will complete our array of burn specific outcomes questionnaires from infancy through young adulthood.

Official Title
-----------------
Psychometric Study of Outcomes Instruments

Conditions
-----------------
Burns, Trauma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All burn injured young adults with or without grafting All burned on or after their 17th birthday Between the ages of 19-30 English speaking Present for inpatient or outpatient treatment Exclusion Criteria: Non-burned skin conditions Non-English speaking Patients less than 19 years of age Patients over 30 years of age

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 30 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Burns, Trauma, Outcomes, Quality of Life
Risk of Cesarean Section in Primiparous Women Over 35 Years of Age.

Study Overview
=================
Brief Summary
-----------------
The investigators reviewed Saint Thomas Maternity Hospital's database during a 5 year period and compared two cohorts of patients (primiparous women over 35 years of age and primiparous woman between 20 and 34 years of age). The objective was to determine the risk of cesarean section and other perinatal complications between the groups.

Official Title
-----------------
Risk of Cesarean Section and Perinatal Complications in Primiparous Women Over 35 Years of Age. A Retrospective Cohort Study.

Conditions
-----------------
Pregnancy Complications

Intervention / Treatment
-----------------
* Procedure: Cesarean section
* Procedure: No cesarean section


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant Primiparous women. Birth after 22 weeks and neonatal weight > 501g. Exclusion Criteria: Multiparity. Birth before 22 weeks or neonatal weight < 500g.
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Over 35 years of age<br>Primiparous women over 35 years of age. | Procedure: Cesarean section<br>* Risk of cesarean section between the cohorts<br>Procedure: No cesarean section<br>* Vaginal birth rate between the cohorts<br>|
| Between 20-34 years of age<br>Primiparous women between 20 and 34 years of age. | Procedure: Cesarean section<br>* Risk of cesarean section between the cohorts<br>Procedure: No cesarean section<br>* Vaginal birth rate between the cohorts<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk of cesarean section | Rate of cesarean sections (birth by cesarean section), independent of the reason. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perinatal complications | Any combination of perinatal complications (Stillbirth, low apgar score) between groups. | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Older women (>35 years of age), Primipara, Cesarean section
A Registry for Patients With Multifocal Ground Glass Opacities (GGOs)

Study Overview
=================
Brief Summary
-----------------
The purpose of this registry study is to actively monitor people with GGOs and collect information about them, so that investigators can learn more about these lesions and about the risk of developing lung cancer in study participants whose GGOs are being monitored in the active surveillance program.

Official Title
-----------------
Thoracic Surgery Oncology Group (TSOG) Protocol: Registry Trial of Active Surveillance for Multifocal Ground Glass Opacities (GGOs)

Conditions
-----------------
Multiple Ground Glass Opacities (GGOs)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age greater than 18 years Have two or more GGOs on initial CT imaging GGOs must be measure ≤3.0 cm and ≥0.6 cm in the greatest dimension GGOs must be greater than half ground glass A biopsy is not necessary for inclusion in the trial. Biopsy of a GGO, even with a diagnosis of adenocarcinoma, does not necessarily preclude enrollment in this surveillance protocol. In other words, patients with a diagnosis of adenocarcinoma are still eligible, at the discretion of the clinician and/or investigator, if they meet the above criteria. Exclusion Criteria: Patients who are actively undergoing lung cancer treatment or have a history of lung cancer, except for cases of completely resected pathologic stage IA nonsmall cell lung cancer (NSCLC). Patients with stage IA NSCLC and multiple GGOs can enroll in this active surveillance protocol after complete resection of the NSCLC and confirmation of stage on final pathologic assessment. The presence of any solid lesion ≥0.6 cm suspicious for malignancy. Patients who are actively undergoing treatment for other malignancies

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- | --- |
| lung cancer-specific survival |  | 5 years |