linjc16/ctgov huggingface dataset:
3V- Improve Venous Access in Pediatric Anesthesia

Study Overview
=================
Brief Summary
-----------------
Our hypothesis is that a new medical device called Vein-Viewer Vision helps to see peripheral veins in children having forecasted difficult venous access and could facilitate the venous access.The main goal is to reduce the time necessary to get a venous access during the inhalation anesthesia induction.

Detailed Description
-----------------
Randomized study comparing the delay of peripheral access with or without using the device. Monosite study, including children undergoing surgery.

Official Title
-----------------
Difficult Venous Access in Pediatric Anesthesia: Evaluation of a New Medical Device in Multicenter Trial.

Conditions
-----------------
Cardiovascular Diseases

Intervention / Treatment
-----------------
* Device: Vein-Viewer Vision


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children aged less than 7 DIVA score ≥ 4 patient needing venous peripheral access for general anesthesia Exclusion Criteria: no social security opposition of the parent(s) to the participation of their child in the trial

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

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Vein-Viewer Vision<br>A medical device called Vein-Viewer Vision | Device: Vein-Viewer Vision<br>* A medical device called Vein-Viewer Vision<br>|
| No Intervention: no medical device<br>in the second arm, we use no medical device | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduce the time necessary to find the venous access during inhalation anesthesia induction |  | 1 day of anesthesia | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anesthesia, venous access
NAS-NRC Twin Registry

Study Overview
=================
Brief Summary
-----------------
To continue a registry of World War II veteran twins maintained by the National Academy of Sciences-National Research Council (NAS-NRC).

Detailed Description
-----------------
BACKGROUND: The registry of World War II veteran twins came into existence in the late 1960's through a search and link effort of state vital statistics records and Veterans Administration files through the Medical Follow-up Agency of NAS-NRC. Since that time, the registry has served as a data resource for investigators in a variety of scientific fields who want to study genetic and environmental aspects of various human characteristics. Because of the size and geographic coverage throughout the United States, the registry offers a method of recruiting sizeable numbers of twins for study even under geographic restrictions. Of special value to medical researchers is the built-in medical follow-up for morbidity and mortality through Veterans Administration insurance and benefits records. This allows researchers to gather baseline data which may be related prospectively to morbidity and mortality events. The NHLBI has made extensive use of the World War II veteran twin registry beginning in 1969, when the NHLBI Twin Study was initiated. At that time, NHLBI used the World War II veteran twin registry to recruit a group of 514 pairs of twins in five geographic areas to participate in a study which included a battery of questionnaires and a physical examination. Since that time, a second examination and third examination of the cohort have been completed and the registry has been used to maintain contact with the twins and provide surveillance for morbidity and mortality events of the participants in the study. DESIGN NARRATIVE: Maintenance of the existing registry continued as addresses of all members were updated annually as well as morbidity and mortality data through surveillance of Veterans Administration insurance and death benefit records or through the National Death Index. All morbid events and deaths were coded by ICD codes. Support activities were provided for the NHLBI Twin Study including providing death certificates for events occurring among the 1,028 twins participating in the study and mailed questionnaire follow-up. Although contract support ended in September, 1988, analyses of the survey and mortality data are continuing.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Coronary Disease, Myocardial Ischemia, Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria
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 |
| --- | --- | --- |
Granulocyte Transfusions in Hematological Patients With Febrile Neutropenia

Study Overview
=================
Brief Summary
-----------------
The investigators retrospectively evaluated the efficacy of granulocyte transfusions as adjunctive treatment for severe infections in neutropenic fever unresponsive to antimicrobial therapy in hematological patients.

Official Title
-----------------
Efficacy of Granulocyte Transfusions for the Treatment of Severe Infections in Hematological Patients With Febrile Neutropenia

Conditions
-----------------
Neutropenia, Fever, Bacterial Infection, Fungal Infection, Fever of Unknown Origin, Hematological Neoplasms, Sepsis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: fever; presence of absolute neutrophil count <0.5 x 10^9/L evidence of bacterial or fungal infections (including clinical signs of infection, positive cultures or biopsy, and radiological evidences) unresponsiveness to appropriate antimicrobial therapy for at least 48 hours Exclusion Criteria: none

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infection-related mortality | deaths due to infection occurred within 30 days after the last granulocyte transfusion | within 30 days after the last granulocyte transfusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
granulocyte transfusions
Patient Satisfaction in Stroke Patients

Study Overview
=================
Brief Summary
-----------------
The objective of this trial is to guarantee a follow-up of all stroke and transient ischemic attack (TIA) patients. With this follow-up assessment long term effects of therapy and prevention measures can be detected and monitored. It is part of quality assurance.

Detailed Description
-----------------
Primary efficacy endpoint: Number of patients who state that they received all the information they want about the causes and nature of their illness Key secondary endpoint(s): Compliance/adherence with discharge medication. Re-events. Degree of Disability. Activities of daily living. Mortality.

Official Title
-----------------
Berliner Schlaganfallregister - Nachbefragung Von Patienten Mit Schlaganfall

Conditions
-----------------
Stroke

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients eligible Exclusion Criteria: none

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary efficacy endpoint: Number of patients who state that they received all the information they want about the causes and nature of their illness. |  | September 2010 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance/adherence with discharge medication Activities of daily living |  | September 2010 | 
| Re-events |  | September 2010 | 
| Degree of Disability |  | September 2010 | 
| Mortality |  | September 2010 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stroke
MI-based PrEP Intervention

Study Overview
=================
Brief Summary
-----------------
Gay, bisexual and other men who have sex with men (MSM) are the group at highest risk of HIV infection in the United States. Pre-exposure prophylaxis (PrEP) has demonstrated high efficacy in preventing HIV infection among MSM. However, uptake in clinical settings has been slow for several reasons, including low awareness and education, low perceived HIV risk, concern for side-effects, and stigma associated with taking the medication. The purpose of the proposed study is to develop and evaluate a brief motivational interviewing (MI) intervention to promote PrEP uptake among MSM during the course of routine HIV screening at a public sexually transmitted disease (STD) clinic.

Official Title
-----------------
A Brief Motivational Interviewing-based Intervention to Improve HIV Pre-exposure Prophylaxis Uptake Among Men Who Have Sex With Men

Conditions
-----------------
PrEP Uptake

Intervention / Treatment
-----------------
* Behavioral: Motivational interviewing (MI)
* Other: Standard-of-care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older Assigned male at birth and currently identify as male Score at least 10 on the HIV Incident Risk Index for MSM HIV-negative based on results of antibody test English- or Spanish-speaking Have access to a working phone Have not taken PrEP Exclusion Criteria: Have previously taken PrEP Symptoms of acute HIV infection at baseline HIV positive A clinical contraindication to PrEP (e.g., renal dysfunction) Non-English or non-Spanish speaking

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br> | Behavioral: Motivational interviewing (MI)<br>* Brief MI intervention<br>|
| Active Comparator: Standard-of-care<br> | Other: Standard-of-care<br>* Standard-of-care education and counseling<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PrEP uptake |  | Three months |
Artificial Endometrial Preparation for Frozen Thawed Embryo Transfer Applying Either Endometrin or Utrogestan

Study Overview
=================
Brief Summary
-----------------
The transfer of frozen-thawed embryos can be performed in a natural ovulatory cycle or in a hormonally manipulated cycle with a comparable pregnancy rate of 15%-20% per ET. When a hormonally modulated ET cycle is scheduled,an artificial endometrial preparation is carried out using estrogen stimulation followed by a concomitant progesterone treatment. Two progestative drugs are currently used in conventional IVF treatment, Utrogetan and Endometrin. Although Endometrin has been be efficiently used to support the luteal phase after embryo transfer in IVF cycles, currently, there is no study that assess its efficacy for clinical use in frozen-thawed ET cycles. The present study aims to compare the outcome of frozen thawed ET cycles when either Endometrin or Utrogestan are used as the progestative substitution in an artificially prepared endometrium.

Official Title
-----------------
Artificial Endometrial Preparation for Frozen Thawed Embryo Transfer Applying Either Endometrin or Utrogestan - a Clinical Comparative Study

Conditions
-----------------
Frozen Thawed Embryo Transfer

Intervention / Treatment
-----------------
* Drug: Comparison between two different progesterone administration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing frozen thawed ET cycles Patient has at least two embryos suitable for transfer after thawing Age 18-35 years - Exclusion Criteria: Any known sensitivity to Endometrin or Utrogestan Endometrial thickness less than 7.5 mm after estrogen priming -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

| Intervention/Treatment |
| --- |
|Drug: Comparison between two different progesterone administration|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy rates |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lutheal hormonal profile |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endometrial preparation, Utrogestan, Endometrin
Study Evaluating Oral MOA-728 in Subjects on Methadone Therapy

Study Overview
=================
Brief Summary
-----------------
To evaluate the effects of single oral doses of MOA-728 compared to a positive control in subjects on methadone therapy.

Official Title
-----------------
A Randomized, Double-Blind, Triple-Dummy, 3-Period Crossover Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a New Formulation of MOA-728 in Subjects on Stable Methadone Maintenance

Conditions
-----------------
Methadone-maintenance Subjects

Intervention / Treatment
-----------------
* Drug: MOA-728


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: Healthy men or women, aged 18 to 65 years. History of methadone treatment for at least 1 month, at a dose >=30 and <=140 mg/day. Exclusion: History or active presence of clinically important medical disease. Allergy to opioids.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MOA-728|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterize the pharmacodynamics of single oral doses of MOA-728 compared to a positive control of MOA-728 administered intravenously in subjects on stable methadone maintenance. |  |  |
Effect of Moxifloxacin Versus Gatifloxacin on Corneal Epithelium Following Pterygium Excision

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether there is a difference in corneal epithelial healing rate and/or toxicity following pterygium excision, between eyes treated post-operatively by moxifloxacin(VIGAMOX)versus gatifloxacin (ZYMAR).

Official Title
-----------------
A Randomized Clinical Trial Comparing the Effect of Moxifloxacin Versus Gatifloxacin Following Pterygium Excision on Corneal Epithelial Healing and Epithelial Toxicity.

Conditions
-----------------
Primary Pterygium

Intervention / Treatment
-----------------
* Drug: Moxifloxacin ophthalmic solution 0.5% ; Gatifloxacin ophthalmic solution 0.3%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of primary pterygium with a clinical indication for surgery informed consent Exclusion Criteria: known allergic reaction to fluoroquinolones. secondary\recurrent pterygium or clinical suspected conjunctival tumor. eye surgery in the last 6 months. eye disorders: severe dry eye syndrome, ocular surface diseases, glaucoma, recurrent corneal erosions, chronic corneal diseases, after chemical burn. low compliance. pregnancy

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: Moxifloxacin<br>About 20 patients treated by Moxifloxacin ophthalmic solution 0.5% (Vigamox) 4 times a day (one drop each time) after pterygium excision with Mitomycin C application. | Drug: Moxifloxacin ophthalmic solution 0.5% ; Gatifloxacin ophthalmic solution 0.3%<br>* Each drug will be given 4 times a day, 1 drop each time to the operated eye, for 21 days.<br>|
| Active Comparator: Gatifloxacin<br>About 20 patients treated by Gatifloxacin ophthalmic solution 0.3% (Zymar) 4 times a day (one drop each time) after pterygium excision with Mitomycin C application. | Drug: Moxifloxacin ophthalmic solution 0.5% ; Gatifloxacin ophthalmic solution 0.3%<br>* Each drug will be given 4 times a day, 1 drop each time to the operated eye, for 21 days.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of corneal epithelial defect closure |  | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| toxicity findings: punctate keratitis, inferior conjunctival hyperemia, conjunctival papillary reaction |  | 12 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pterygium, gatifloxacin, moxifloxacin, corneal epithelial defect
Survey on Patient Satisfaction Rate for Mirena Use in Heavy Menstrual Bleeding

Study Overview
=================
Brief Summary
-----------------
The purposes of this study are: To evaluate patient satisfaction for efficacy and tolerability of heavy menstrual bleeding treatment by Mirena. To collect italian data for Mirena in clinical routine.

Official Title
-----------------
Levonorgestrel Releasing Intrauterine System (MIRENA) in Idiopathic Menorrhagia

Conditions
-----------------
Menorrhagia

Intervention / Treatment
-----------------
* Drug: Levonorgestrel (Mirena, BAY86-5028)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women diagnosed with Idiopathic Menorrhagia and Mirena inserted for a period no longer than three months according to the assessment of the investigator and according to the international and national guidelines. These women should also accept to be on contraception during the time period that they have Mirena in situ Body Mass Index = 18-30 Exclusion Criteria: One or more of the following disorders: Current or recurrent pelvic inflammatory disease; infection of the lower genital tract; postpartum endometritis; septic abortion during the past three months; cervicitis; cervical dysplasia; uterine or cervical malignancy; undiagnosed abnormal uterine bleeding; congenital or acquired abnormality of the uterus including fibroids if they distort the uterine cavity; conditions associated with increased susceptibility to infections; acute liver disease or liver tumor; known hypersensitivity to any of the constituents of the product Nulliparity Consumption of Iron, Antiprostaglandins, hormonal drugs and any medication that could effect bleeding should be stopped at least 3 months before the first visit and should not be used during the course of the study. History of diabetes mellitus, cardiovascular disease and thyroid abnormalities Anticoagulation therapy Cancer history including breast cancer

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 49 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 |
| --- | --- |
| Group 1<br> | Drug: Levonorgestrel (Mirena, BAY86-5028)<br>* Women using Mirena for intrauterine treatment of menorrhagia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The quality of life on the basis of the validated Health-Related Quality of Life questionnaire (HRQL SF-36) |  | at 12 months |