linjc16/ctgov huggingface dataset:
Ophthalmic Artery Resistance Index After Peribulbar Block in the Presence of Epinephrine

Study Overview
=================
Brief Summary
-----------------
Evaluate ophthalmic artery flow by echo-Doppler before and after peribulbar block with lidocaine in presence or absence of epinephrine.

Detailed Description
-----------------
There are controversies regarding the ophthalmic artery (OA) flow after peribulbar block with the addition of epinephrine. Therefore, we aimed to evaluate OA flow by echo-Doppler before and after peribulbar block with lidocaine in presence or absence of epinephrine. Fifty-six patients that were eligible for cataract phacoemulsification surgery were selected. Patients were divided into two groups: group 1 - Peribulbar block with lidocaine and 1/200.000 epinephrine; group 2 - Peribulbar block with lidocaine in the absence of epinephrine. The resistance index (RI) of OA was evaluated using echo-Doppler before and 10 min after the peribulbar block.

Official Title
-----------------
Ophthalmic Artery Resistance Index After Peribulbar Block in the Presence of Epinephrine

Conditions
-----------------
Ophthalmic Artery, Peribulbar Block

Intervention / Treatment
-----------------
* Drug: Epinephrine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologists (ASA) I, II or III physical status classification Cataract surgery Exclusion Criteria: glaucoma diabetic retinopathy previous eye surgery in the same eye ocular trauma allergic to any protocol medication uncooperative patients or cognitive difficulties axial eye diameter of less than 21.0 mm or greater than 25.5 mm.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 85 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Group 1: Peribulbar anesthesia with 2% lidocaine with epinephrine 1/200,000. Group 2: Peribulbar anesthesia with 2% lidocaine without epinephrine.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lidocaine with epinephrine<br>Peribulbar anesthesia with lidocaine and epinephrine | Drug: Epinephrine<br> <br> |
| No Intervention: Lidocaine without epinephrine<br>Peribulbar anesthesia with lidocaine | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Artery resistance index of ophthalmic artery | The resistance index (RI) of OA was evaluated using echo-Doppler before and 10 minutes after the peribulbar block. | Change on resistance index 10 minutes after peribulbar anesthesia | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ocular flow, cataract surgery, peribulbar block, ocular Doppler
Early-Phase Schizophrenia: Practice-based Research to Improve Outcomes

Study Overview
=================
Brief Summary
-----------------
The goal if the project is to develop a learning health network devoted to the treatment of first episode psychosis.

Detailed Description
-----------------
The RAISE ETP study, designed and conducted by our group, signaled that a Coordinated Specialty Care (CSC) model could be feasibly delivered in community mental health clinics in multiple states and was effective. Since then, with the support of SAMSHA block grants to states, there are CSC programs across the nation. The goal of this project is to develop a learning health system with sites providing CSC treatment of first-episode psychosis (FEP). Sites are drawn from five states: Connecticut, Florida, Michigan, Oklahoma and South Carolina. They vary in populations served, levels of funding available and research experience. All are committed to advancing the development of CSC using a health learning system model, to implementing a practical assessment strategy to enhance outcome assessment and to conducting research to improve outcomes that will be meaningful to the full range of stakeholders.

Official Title
-----------------
Early-Phase Schizophrenia: Practice-based Research to Improve Outcomes

Conditions
-----------------
First Episode Psychosis

Intervention / Treatment
-----------------
* Other: Coordinated Specialty Care (CSC)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Enrolled in CSC program Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 40 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Coordinated Specialty Care (CSC)|CSC is an integrated and team-based treatment model for first episode psychosis elements include psychotherapy, supported employment and education, family education and support, and pharmacotherapy.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Enrolled participants | Number of enrolled participants into the learning health system | 5 years of the project |
Examine Maximum Tolerated Dose and Pharmacokinetic and Pharmacodynamic Profile

Study Overview
=================
Brief Summary
-----------------
Open label, single dose and phase I study. The primary objective: To determine the maximum tolerated dose in Single dose The secondary objective: to evaluate the toxicity in administration to determine desirable dosing amount for phase II to evaluate tumor response in progressive solid cancer patients to evaluate pharmacokinetic/ pharmacodynamic profile.

Detailed Description
-----------------
Number of Subjects: 28 36, dose escalation (2 6 subject of each step) Adverse Events will be coded to preferred therm and body system using the CTCAE

Official Title
-----------------
Phase I Study of CG200745 to Examine the Maximum Tolerate Dose, Pharmacokinetic and Pharmacodynamic Profiles, and Safety Among Patients With Progressive Solid Cancer

Conditions
-----------------
Solid Tumour

Intervention / Treatment
-----------------
* Drug: CG200745


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: from 20 years old to 69 years old diagnosed with progressive solid cancer In spite of standard chemotherapies, the efficacy of the treatment or life extension cannot be expected. Evaluated 0-1 of ECOG Expected life duration is within 3 months Exclusion Criteria: Major surgery except tumor-removal surgery received within 2 weeks of screening. history of CNS metasis hyper-sensitivy of study drug pregancy or lactating administered other HDAC inhibitor within 4 weeks of screening

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 69 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: Single Arm for CG200745<br>any progrossive solid cancer | Drug: CG200745<br>* Multiple administration (IV) over the cycles untile MTD/LTD<br>* Other names: No specific generic name yet;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the maximum tolerated dose in Single dose |  | On 22 days after administration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Solid Tumour
Music During ESWL for Entire Treatment

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate if music listening relieves pain and discomfort during Extracorporeal Shock-Waves Lithotripsy (ESWL).

Detailed Description
-----------------
Patients undergoing ESWL and interested in music listening are randomly divided in two groups: patients in group A listen to music during the ESWL treatment, patients in group B do not. At the end of the treatment patients are asked to fill in a questionnaire. They are asked if they were pleased to have had the opportunity to listen to music during ESWL, if they would like to listen to music again in case of further treatments, if they consider music helpful in relieving pain and discomfort during ESWL. Patients are also asked to mark their level of pain during each part of the treatment on a visual analogue scale (VAS) for pain.

Official Title
-----------------
Music Listening to Decrease Pain and Discomfort During Extracorporeal Shock Wave Lithotripsy (ESWL)

Conditions
-----------------
Urolithiasis

Intervention / Treatment
-----------------
* Other: Music


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients undergoing ESWL and interested in music listening Exclusion Criteria: Contraindication to ESWL No interest in music listening Age < 18 and > 80

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Music during ESWL<br>Patients listen to music during ESWL | Other: Music<br>* Music listening during ESWL<br>|
| No Intervention: ESWL without music<br>Patients don't listen to music during ESWL | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in VAS score | Visual analogue scale (VAS) - 0 to 10, higher values, worse pain | 10 mins after SWL treatment completed | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in Soundwave voltage (kV) | change in Soundwave voltage (kV) | 10 mins after SWL treatment completed | 
| change in analgesic request | change in analgesic request | 10 mins after SWL treatment completed | 
| change in requested interruptions | change in requested interruptions | 10 mins after SWL treatment completed | 
| change in Soundwave number | change in Soundwave number | 10 mins after SWL treatment completed | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Urolithiasis, Kidney Calculi, Lithotripsy, Pain Management, Music
Abarelix Versus Goserelin Plus Bicalutamide in Patients With Advanced or Metastatic Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
To compare the safety of efficacy of abarelix versus goserelin plus bicalutamide in patients with advanced or metastatic prostate cancer.

Detailed Description
-----------------
Inclusion Criteria Males over 18 with documented advanced or metastatic prostate cancer Outcome measures Comparative castration rates one week after starting therapy Degree of testosterone surge in the first month of treatment. Maintenance of medical castration during one year of therapy. Comparison of the treatments on QTc prolongation

Official Title
-----------------
Phase III Study of the Comparison of Abarelix Versus Goserelin Plus Bicalutamide in Patients With Advanced or Metastatic Prostate Cancer. A One Year Randomised, Open Label, Multi-Centre Phase III Trial.

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

Intervention / Treatment
-----------------
* Drug: Abarelix
* Drug: Goserelin plus Bicalutamide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically proven prostate cancer and not previously treated with hormones Evidance of advanced disease or metastases Life expentancy of at least 3 months Normal serum testosterone levels Written informed consent Exclusion Criteria: Previous endocrine or cytoxic theapy for prostate cancer Known tumour complication of prostate cancer which owuld require immediate treatment Another malignancy other than basal cell cancer History of significant drug hypersensitivity to either LHRH agonists or GnRH antagonists. Congenital or acquired coagulation disorders contraindicating intramuscular injections Pagets disease of the bone QTcB > 450 msec at Day - 14

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

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

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

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: 1 Abarelix<br>Investigative drug | Drug: Abarelix<br>* 100 mg by Intramuscular injection on days; 1, 15 and 29 and monthly thereafter<br>* Other names: Plenaxis;|
| Active Comparator: 2 Goserelin plus bicalutamide<br>Standard therapy | Drug: Goserelin plus Bicalutamide<br>* Goserelin - 3.6 mg by monthly subcutaneous injection Biaclutamide 50 mg orally daily for first three months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early castration rates |  | One week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maintenance of medical castration |  | 48 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostate cancer, Advanced, Metastatic
Hypodontia and Ovarian Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this project is to examine whether the risk of developing ovarian cancer is increased in Danish women with congenital missing teeth as a result of their failure to develop (hypodontia). Should this prove to be the case, these women could be offered regular clinical controls and prophylactic removal of their ovaries when menopause enters and the ovaries are no longer functional (producing hormones). If there is a connection between congenital hypodontia and the development of different types of cancer, the investigators will perform a genetic screening in families with increased risk of cancer and hypodontia for changes in relevant genes, based on the current literature. The investigators hereby search for new genes, which in a changed form leads to an increased risk of cancer and thereby enables us to perform genetic screening in risk families.

Official Title
-----------------
Hypodontia and Ovarian Cancer - the Connection Between Dental Agenesis and Epithelial Cancers, Especially Ovarian Cancer.

Conditions
-----------------
Ovarian Cancer, Hypodontia, Breast Cancer, Colon Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: confirmed suspicion of ovarian cancer. Exclusion Criteria: suspicion of ovarian cancer disproved.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ovarian Cancer<br>Women treated for ovarian cancer at the departments of obstetrics and gynecology, Aarhus University Hospital and Rigshospitalet, Copenhagen. Expected recruitment: 200 | |
| Control patients<br>Women referred to the departments of obstetrics and gynecology in Aarhus University Hospital and Rigshospitalet, Copenhagen on benign indication. Expected recruitment: 200. | |
| HBOC/HNPCC<br>Patients registered in the large Danish Register of HBOC( hereditary breast and ovarian cancer) and HNPCC (hereditary nonpolyposis colorectal cancer). Expected recruitment: 200. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence rates of hypodontia in women with ovarian cancer |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genetic causes for hypodontia and ovarian cancer |  | two years | 
| Prevalence rates of hypodontia in patients with a known risk for epithelial cancer |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
screening, genetic, cancer
A Trial of Echinacea in Children

Study Overview
=================
Brief Summary
-----------------
This is a randomized trial to determine if echinacea is effective in shortening the length and/or lessening the severity of colds in children 2 through 11 years old.

Detailed Description
-----------------
Upper respiratory tract infections (URI's) are a significant health burden in childhood. URI's are a major reason for visits to health care providers, and up to 35 percent of young children at any given time are taking some over-the-counter cold medication. Unfortunately, data suggest that most of these medications have limited effectiveness. Alternative medical therapies are growing in popularity; in a recent survey of parents of children being seen by pediatricians in Seattle, Washington, 24.2 percent indicated that their child had been seen by an alternative medicine health care provider, and 53.3 percent received therapies for the treatment of URI's in children. The proposed study is a randomized, double blind, placebo controlled trial of Echinacea for the treatment of URI's in children 2-11 years old. The aims of the project are: to determine if Echinacea shortens the duration and/or lessens the severity of URI's, if children receiving Echinacea for treatment of URI's have a reduced rate of secondary bacterial infections, and to determine if the use of Echinacea in patients 2-11 years old is associated with any significant side effects. A two-year study of 600 children is planned. Not only will the results of this study determine if Echinacea, the most popular medicinal herb sold in the United States, is an effective therapy for URI's in children, the study will provide a design framework for further assessment on the efficacy of other complementary and alternative medicines in children.

Official Title
-----------------
A Randomized Controlled Trial of Echinacea in Children

Conditions
-----------------
Common Cold

Intervention / Treatment
-----------------
* Drug: Echinacea


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parent available to observe child during the night Parent peaks and reads English Exclusion Criteria: History of asthma or allergic rhinitis History of auto-immune disease History of chronic lung disease Allergy to sunflower species

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 11 Years

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
FeNO and Cytokines in Respiratory Syncytial Virus (RSV) and Non RSV Bronchiolitis in Relation to Future Asthma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine Fractional exhaled Nitric-Oxide (FeNO)levels and blood cytokines during acute bronchiolitis, and to seek for correlation between these markers and future development of asthma.

Official Title
-----------------
FeNO and Cytokines in RSV and Non RSV Bronchiolitis in Relation to Future Asthma

Conditions
-----------------
Acute Bronchiolitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: First episode of shortness of breath Children in ages 2 weeks to 2 years Exclusion Criteria: Any chronic disease Congenital anomalies

Ages Eligible for Study
-----------------
Minimum Age: 2 Weeks
Maximum Age: 2 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 |
| --- | --- |
| RSV<br>Infant with acute bronchiolitis due to RSV | |
| Co- Infection<br>Infant with acute bronchiolitis due to RSV and other respiratory virus | |
| Other<br>Infant with acute bronchiolitis due to non-RSV respiratory virus | |
| Unknown<br>Infant with acute bronchiolitis with negative PCR results for respiratory viruses | |
| Control<br>Healthy infants | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician diagnosed asthma | Modification of The International Study of Asthma and Allergies in Childhood (ISAAC) questionnaires | At the age of 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fractional exhaled Nitric Oxide (FENO) level | FeNO level measured by a rapid-response chemiluminescence analyzer (Eco Physics CLD88 NO analyzer, EcoMedics AG,Switzerland). | During acute bronchiolitis, after 2 and 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bronchiolitis, FeNO, Asthma, wheezing, RSV
Identification and Treatment of Men With BPH in the Primary Care Setting

Study Overview
=================
Brief Summary
-----------------
Male patients between the ages of 18 to 100 years of age who entered the Mid Michigan Health Center were administered a patient demographic questionnaire, a Lower Urinary Tract Symptom (LUTS) questionnaire, and the Men's Sexual Health Questionnaire (MSHQ) without exception. The purpose of this study was to better identify symptoms of benign prostatic hyperplasia (BPH) with the intent to prescribe better and more helpful treatment options for patients demonstrating these symptoms.

Official Title
-----------------
A Proactive Approach to the Identification and Treatment of Men With BPH Inthe Primary Care Setting

Conditions
-----------------
No Conditions for This Study. All Male Patients 18 Years of Age or Older Were Administered the LUTS, MSHQ, and Patient Demographics Questionnaire

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All male patients between the ages of 18 to 100 years Exclusion Criteria: -

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

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

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 |
| --- | --- | --- |