linjc16/ctgov huggingface dataset:
Long-Term Use Of Pegaptanib In Patients For Subfoveal Choroidal Neovascularization Secondary To Age-Related Macular Degeneration

Study Overview
=================
Brief Summary
-----------------
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3) factors considered to affect the safety and/or efficacy of this drug.

Detailed Description
-----------------
All the patients whom an investigator prescribes the first Macugen® should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Official Title
-----------------
Special Investigation For Long-term Use Of Macugen (Regulatory Post Marketing Commitment Plan).

Conditions
-----------------
Macular Degeneration

Intervention / Treatment
-----------------
* Drug: Pegaptanib sodium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients need to be administered Macugen® in order to be enrolled in the surveillance. Exclusion Criteria: Patients not administered Macugen®.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pegaptanib sodium<br>Patients administered Pegaptanib sodium. | Drug: Pegaptanib sodium<br>* Macugen Intravitreous Injection Kit 0.3mg depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. Pegaptanib sodium is administered intravitreously once every 6 weeks at a dose level of 0.3 mg (on an oligonucleotide of pegaptanib basis ).<br>* Other names: Macugen;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Factors considered to affect the safety and/or efficacy of this drug. |  | 2 years | 
| The incidence of adverse drug reactions in this surveillance. |  | 2 years | 
| Adverse drug reaction not expected from the LPD (unknown adverse drug reaction). |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Subfoveal choroidal neovascularization secondary to age-related macular degeneration
Retrospective Chart Review to Assess Outcomes in Subjects That Received MAGNIFUSE® in the Posterolateral Lumbar Spine

Study Overview
=================
Brief Summary
-----------------
The purpose of this chart review is to assess outcomes in subjects that received MAGNIFUSE in the posterolateral lumbar spine at 1 or 2 continuous levels from L1-S1.

Official Title
-----------------
A Retrospective Review of Charts to Assess Outcomes in Subjects That Received MAGNIFUSE® DBM in the Posterolateral Lumbar Spine

Conditions
-----------------
Subjects Received MAGNIFUSE in Posterolateral Lumbar Spine

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A subject's medical record must contain the following for the subject to be included: Posterolateral surgical procedure using MAGNlFUSE with local autograft and/or iliac crest bone graft at one or two continuous lumbar levels from L1-S1. Radiographs available for fusion assessment by clinician at 12 and/or 24 month post-surgery visits. Subject must be at least 18 years old at the time of index procedure. Exclusion Criteria: The subject data will be excluded from this study if the medical record indicates: Additional surgical treatment adjacent to the initial lumbar levels treated per Inclusion Criterion 1. Infection at index level(s) at time of surgery. Extant tumor (evident at any level), spinal metastasis, or spinal tumor at the time of surgery. Pregnant at time of surgery. Surgery is due to trauma (e.g., motor vehicle accident or high impact fall). Use of growth factors or growth peptide (BMP2, BMP7, or iFactor) in the index-level fusion surgery. Procedure is a revision surgery for previously failed fusion at the surgery index level(s). Subjects with body mass index > 40 at the time of surgery.
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 |
| --- | --- | --- |
| Fusion status at 12 or 24 months | Fusion status will be assessed using the Lenke posterior fusion criteria below: Grade I: Solid trabeculated transverse process and facet fusions bilaterally. Grade II: Thick fusion mass on one side, and difficult to visualize on the other side. Grade III: Suspected lucency or defect in the fusion mass. Grade IV: Definite resorption of graft with fatigue of instrumentation. | 12 or 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Back pain and leg pain measured by visual analog scale (VAS) |  | 12 or 24 months | 
| Pain and Disability status measured by Oswestry Disability Index (ODI) |  | 12 or 24 months | 
| Quality of life measured by EQ-5D |  | 12 or 24 months |
A Volunteer Study to Collect Imaging Data for the Development of the ntelligentUltrasound Anatomy Guide

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine if machine learning can be used to automatically highlight key anatomy on the ultrasound image to help anaesthetists perform ultrasound-guided regional anaesthesia.

Detailed Description
-----------------
The study will involve adult volunteers who are willing to be scanned by a trained sonographer to collect ultrasound video data for the following categories: Adductor canal Popliteal fossa Fascia Iliaca Rectus sheath Axillary ESP PECS Interscalene Each volunteer will be scanned to collect data for every category in the list. Where applicable, both sides of the body will be scanned. The videos will be segmented by hand to identify the relevant anatomical regions for each category. The primary objective for this study is to provide the range of data required to develop robust models in conjunction with additional data from patients undergoing a Peripheral Nerve Block procedure that are able to produce the desired segmentation on the unseen validation images. The models will be scored using the standard Mean intersection over Union pixel-level metric for semantic segmentation.

Official Title
-----------------
A Volunteer Study to Collect Imaging Data for the Development of the ntelligentUltrasound Anatomy Guide

Conditions
-----------------
Ultrasound Imaging of Anatomical Structures

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, at least 18 years of age; Willing to undergo ultrasound scanning and provide ultrasound video data for the following categories: Adductor canal Popliteal fossa Fascia Iliaca Rectus sheath Axillary ESP PECS Interscalene Able to comprehend and sign the Informed Consent prior to enrolment in the study. Exclusion Criteria: Aged <18 years of age; Unwilling or unable to provide informed consent.

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 |
| --- | --- | --- |
| Model development | Models with a Mean intersection over Union score of 0.95 or better for each region in each category. | 6 months |
Prevalence of Mullerian Anomalies in Infertile Women

Study Overview
=================
Brief Summary
-----------------
Mullerian anomalies are congenital structural anomalies in the uterus . Its prevalence is not uncommon .

Detailed Description
-----------------
PCO is very common in gynecological practice Women with mullerian anomalies should be properly evaluated for other gynecological and urological problems

Official Title
-----------------
Prevalence of Mullerian Anomalies and PCO in Egyptian Women

Conditions
-----------------
Mullerian Anomaly of Uterus

Intervention / Treatment
-----------------
* Diagnostic Test: 3D ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: females with age between 20-42 years with primary infertility Exclusion Criteria: females with age above 42 years or below 20 years females with secondary infertility

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: 3D ultrasound|3D ultrasound will be done to females complaining from primary infertility with mullerian anomalies|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the number of participants who will prove to have PCO | diagnosis of PCO by US and by FSH and LH levels | within 4 weeks |
Hypoglycemia at Initiation of Pump Therapy in Children With Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if patients have more hypoglycemic episodes the first 3 days following pump start compared to their usual number of hypoglycemias with our actual pump initiation protocol.

Official Title
-----------------
Evaluation of the Frequency of Hypoglycemia at Initiation of Insulin Pump Therapy in Children With Type 1 Diabetes

Conditions
-----------------
Type 1 Diabetes

Intervention / Treatment
-----------------
* Other: Observation of hypoglycemias frequency 3 days before and after pump initiation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with type 1 diabetes with follow-up at the CHU Sainte-Justine Patient about to start insulin pump therapy at the CHU Sainte-Justine Last HbA1c between 7.2 and 9.7% Informed and signed consent Exclusion Criteria: Type 1 diabetes diagnosed less than 1 year ago WITH total daily dose of insulin < 0.5U/kg/day Home of the patient at more than 50km of the CHU Sainte-Justine Refusal to consent

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients starting pump therapy<br> | Other: Observation of hypoglycemias frequency 3 days before and after pump initiation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of hypoglycemias | Frequency of hypoglycemias defined as blood sugars < 4.0mmol/l | 6 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of hyperglycemias | Frequency of hyperglycemias defined as blood sugars > 17.0mmol/L | 6 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypoglycemias, Insulin pump, Children
Cognitive and Functional Status and Dialysis Outcomes in Older Hemodialysis Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to estimate how quickly cognitive status and functional status in older patients on hemodialysis declines.

Detailed Description
-----------------
Dialysis outcome measures, which predict morbidity and mortality of younger patients on renal replacement therapy, such as dialysis clearance, do not correlate with survival of the elderly patients on hemodialysis. Survival of older patients on hemodialysis is significantly worse when compared to that of the younger patients. Conditions commonly affecting older adults, such as functional decline, cognitive impairment, depression and declining quality of life have not been well studied in hemodialysis population. There may be an important relationship between these measurements and outcomes in older dialysis patients. Institution of appropriate age-specific interventions could result in improved health status and mortality of older patients on hemodialysis. Our broad objective is to better understand global functioning of the elderly dialysis patients and its possible impact on dialysis outcomes in attempt to improve health care of the older patients receiving hemodialysis.

Official Title
-----------------
Cognitive and Functional Status and Dialysis Outcomes in Older Hemodialysis Patients

Conditions
-----------------
Dementia, Cognition, End-stage Renal Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Prevalent and incident hemodialysis patients over the age of 60, receiving hemodialysis treatments at the University of Chicago outpatient dialysis program. Exclusion Criteria: Patients 59 and younger, and patients with the following medical conditions: malignancies currently requiring chemotherapy or radiation therapy, severe heart failure (NYHA class IV), known HIV infection, or currently active hepatic encephalopathy.

Ages Eligible for Study
-----------------
Minimum Age: 60 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dementia,, Cognitive Disorders,, Hemodialysis
Is it Possible to Replace Fentanyl in Anesthesia for Minor Procedures?

Study Overview
=================
Brief Summary
-----------------
To compare between fentanyl group and ketamine lidocaine group for induction of anesthesia as regards hemodynamics and smooth intubation.

Detailed Description
-----------------
Two groups each with 60 patients Group I anesthesia initiated by propofol, fentanyl and cisatracurium. Group II anesthesia initiated by ketamine, lidocaine, propofol and cisatracurium.

Official Title
-----------------
Is it Possible to Replace Fentanyl by Non Narcotic Medication for Induction and Maintenance of Anesthesia in Minor Procedures?

Conditions
-----------------
Anesthesia

Intervention / Treatment
-----------------
* Drug: Ketamine
* Drug: Propofol
* Drug: Fentanyl
* Drug: Cisatracurium
* Drug: Lidocaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I and II between Age between 18-55 years Undergoing minor surgical procedure less than an hour. Exclusion Criteria: Patients with hypertension Patients with Ischemic heart diseases Patients with chronic renal or liver diseases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fentanyl<br>Administered propofol and fentanyl for induction. | Drug: Propofol<br>* propofol<br>Drug: Fentanyl<br>* fentanyl<br>Drug: Cisatracurium<br>* cisatracurium<br>|
| Active Comparator: Ketamine and lidocaine<br>Administered propofol, ketamine and lidocaine for induction. | Drug: Ketamine<br>* ketamine<br>Drug: Propofol<br>* propofol<br>Drug: Cisatracurium<br>* cisatracurium<br>Drug: Lidocaine<br>* lidocaine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intubation with less hemodynamic changes | changes in blood pressure with intubation | 15 minutes after induction of anesthesia. | 
| Smooth Maintenance of anesthesia | changes in blood pressure during anesthesia | anesthesia time | 
| less postoperative pain killers | amount of pain killers used and timing | 24 hours postoperative | 
| Intubation with less hemodynamic changes | changes in pulse rate during anesthesia | Anesthesia time | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fentanyl, lidocaine, ketamine, induction of anesthesia, intubation
Evaluating the Effects of Tasimelteon vs. Placebo in Delayed Sleep-Wake Phase Disorder (DSWPD)

Study Overview
=================
Brief Summary
-----------------
This is a multicenter, double-blind, randomized study to evaluate the efficacy and safety of a daily single oral dose of tasimelteon and matching placebo in male and female participants with DSWPD.

Official Title
-----------------
A Multicenter, Double-blind, Randomized Study to Evaluate the Effects of Tasimelteon vs. Placebo in Participants With Delayed Sleep-Wake Phase Disorder (DSWPD)

Conditions
-----------------
Sleep Wake Disorders, Sleep Disorders, Circadian Rhythm, Chronobiology Disorders

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ability and acceptance to provide written informed consent. A confirmed clinical diagnosis of Delayed Sleep-Wake Phase Disorder (DSWPD). Men or women between 18 - 75 years, inclusive. Body Mass Index (BMI) of ≥ 18 and ≤ 35 kg/m^2. Exclusion Criteria: History of psychiatric disorders within 12 months. Major surgery, trauma, illness, general anesthesia, or immobility for 3 or more days within the last 30 days. Pregnancy, recent pregnancy (within 6 weeks), or women who are breastfeeding. A positive test for substances of abuse.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Tasimelteon<br> | Drug: Tasimelteon<br>* oral capsule<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* oral capsule<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Sleep Onset over the treatment period, as measured by sleep diary. |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in nighttime objective sleep-wake parameters such as sleep time, as measured by actigraphy. |  | 28 days | 
| Change in nighttime subjective sleep-wake parameters such as sleep time, as measured by sleep diary. |  | 28 days | 
| Assessment of safety and tolerability of daily single dose of tasimelteon, as measured by spontaneous reporting of adverse events (AEs). |  | 28 days |
Oral Contraceptive (OC) Progestin Dose and Breast Proliferation

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to gain a better understanding of the changes that may occur in the breast when a woman uses an oral contraceptive (birth control pill). Some research indicates that women who use birth control pills with lower amounts of progestin (a hormone in the birth control pill) may have lower breast cell growth than women who use birth control pills with a higher amount of progestin; this research will examine that in detail.

Official Title
-----------------
Evaluating the Effect of Oral Contraceptive Progestin Dose on Breast Epithelial Cell Proliferation

Conditions
-----------------
Oral Contraceptive

Intervention / Treatment
-----------------
* Drug: Oral Contraceptive: Ortho-Novum® 1/35
* Drug: Oral Contraceptive: Ovcon Fe®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-34. Premenopausal. Currently taking or want to start oral contraceptives for contraception Non-smoker. Competent to give informed consent (as judged by the investigator). Provided written informed consent. Willingness to refrain from smoking and consumption of grapefruit or grapefruit juice during the study (grapefruit interferes with metabolism of exogenously administered OCs). Exclusion Criteria:1. Abnormal breast examination. History or current therapeutic or prophylactic use of anticoagulants. Known bleeding disorder or history of unexplained bleeding or bruising. History of breast cancer or previous diagnostic breast biopsy. Known allergy to local anesthetic. Currently pregnant or pregnant within the previous 6 months. Having any standard contra-indication to being prescribed OCs.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 34 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ortho-Novum® 1/35<br>Ortho-Novum® 1/35 is an oral contraceptive that contains more progestin. | Drug: Oral Contraceptive: Ortho-Novum® 1/35<br> <br> |
| Active Comparator: Ovcon Fe®<br>Ovcon Fe® is an oral contraceptive that contains less progestin. | Drug: Oral Contraceptive: Ovcon Fe®<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breast Cell Proliferation Levels Between the Two Oral Contraceptive Dose Groups | Percent of cells expressing staining for Ki67 will be examined in breast epithelial cells | 32 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oral Contraceptives, Breast Tissue