linjc16/ctgov huggingface dataset:
The Global Angelman Syndrome Registry

Study Overview
=================
Brief Summary
-----------------
The Global Angelman Syndrome Registry is an online patient organisation driven registry to collect information about the natural history of children and adults with Angelman Syndrome. The registry will facilitate 1) recruitment for clinical trials into therapies and interventions to benefit participants with Angelman Syndrome and their families, and 2) advancement of research and best standards of care for Angelman Syndrome. The registry is currently available in English, Spanish, Traditional Chinese and Italian.

Official Title
-----------------
The Global Angelman Syndrome Registry

Conditions
-----------------
Angelman Syndrome

Intervention / Treatment
-----------------
* Other: Observational study only


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Angelman Syndrome Exclusion Criteria: -
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Individuals with Angelman Syndrome<br>Individuals from birth to adulthood with Angelman Syndrome | Other: Observational study only<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gather longitudinal data on individuals living with Angelman Syndrome | Parent/ caregiver reporting on diagnosis, clinical status, and patient-reported outcomes of individual living with Angelman Syndrome. This will be achieved by inviting parents/ caregivers with additional questionnaire like modules, and tracking changes in their responses over time. | 70 years (lifespan) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Angelman Syndrome, Registries, Observational study only
Bimatoprost Versus Travoprost at Cairo University

Study Overview
=================
Brief Summary
-----------------
Bimatoprost has been shown to provide effective IOP lowering in patients of all races. Conversely, travoprost has been shown to be more effective in black patients than in Caucasians in some studies. However, Noecker et al 2004 compared bimatoprost with travoprost in African-Americans with glaucoma or OHT, and found that bimatoprost was more likely than travoprost to achieve target pressure at 3 months. These racial differences in efficacy of these medications warrant further investigations. The investigators study aim to compare the IOP-lowering efficacies of bimatoprost and travoprost in an Egyptian population with primary open-angle glaucoma (OAG) or ocular hypertension (OHT).

Official Title
-----------------
Bimatoprost Versus Travoprost in an Egyptian Population: A Hospital-Based Prospective Randomized Study.

Conditions
-----------------
Glaucoma, Ocular Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Glaucoma and Ocular Hypertension Exclusion Criteria: Any ocular disease or medication that may raise the intraocular pressure.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 72 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Bimatoprost versus Travoprost<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of intraocular pressure lowering of bimatoprost versus travoprost. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of development of complications. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glaucoma and Ocular Hypertension
A New Measure of Egg Consumption and the Effect of Social Marketing Eggs

Study Overview
=================
Brief Summary
-----------------
About 1600 children 6 to 24 months old will be enrolled from 8 egg hubs. 4 hubs will be receive social marketing campaign to raise awareness about the benefits of eggs while the other 4 will not receive social marketing campaign. Children will provide a urine sample for analysis of metabolites to correlate with egg consumption.

Official Title
-----------------
A Two-Phase Study to Investigate Novel Biomarkers of Egg Consumption and Social Marketing Effectiveness of Egg Hubs for Malawian Infants

Conditions
-----------------
Nutritional Stunting

Intervention / Treatment
-----------------
* Other: Social Marketing Campaign


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Health children between 6 and 24 months of age Exclusion Criteria: acute malnutrition congenital abnormalities chronic debilitation disease such as heart disease, cerebral palsy, or HIV infection

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 24 Months

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Social Marketing Campaign<br>Select egg hubs will receive social marketing campaign which aims to raise awareness about the benefits of eggs - 'why eggs': increasing the value of eggs from a consumer perspective and encourage consumption of eggs by children (<5yrs) and pregnant/lactating women. | Other: Social Marketing Campaign<br>* aims to raise awareness about the benefits of eggs - 'why eggs': increasing the value of eggs from a consumer perspective and encourage consumption of eggs by children (<5yrs) and pregnant/lactating women<br>|
| No Intervention: No Social Marketing Campaign<br>Other egg hugs will not receive social marketing campaign. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of egg consumed daily | As determined by urinary metabolite concentrations. The specific metabolites will be identified in the course of the study. | 12 Months |
Transdermal Testosterone Gel/Effect on Erection Quality as Measured by DIR

Study Overview
=================
Brief Summary
-----------------
Low testosterone may be responsible for soft erections in men. The purpose of our study is to see whether the daily application of a testosterone gel to raise testosterone levels will also increase the hardness of a man's erection.

Official Title
-----------------
Phase I Study of Transdermal Testosterone Gel and Its Effect on Erection Quality as Measured by a Digital Inflection Rigidometer (DIR)

Conditions
-----------------
Hypogonadism

Intervention / Treatment
-----------------
* Drug: AndroGel (Transdermal Testosterone Gel)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Testosterone <350 ng/dL, 21-59 years of age, BMI <30 Exclusion Criteria: Those with carcinoma of the breast or known or suspected carcinoma of the prostate or with known hypersensitivity to any of the ingredients in AndroGel. Men will be excluded if they have unstable angina, hypertension, diabetes, heart failure, or coronary artery disease. Men will agree to discontinue use of current testosterone replacement, as well as Viagra or any other PDE5 inhibitors for 30 days.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 59 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: AndroGel (Transdermal Testosterone Gel)|nan|

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
-----------------
hypogonadism, low testosterone level, gonadal deficiency
Safety of Percutaneous Tracheostomy in Clopidogrel and Selective Serotonin Reuptake Inhibitors

Study Overview
=================
Brief Summary
-----------------
Safety of Percutaneous Tracheostomy in Clopidogrel and Selective Serotonin Reuptake Inhibitors

Detailed Description
-----------------
We propose a retrospective review of our experience with bleeding complication in the presence of antiplatelet and SSRI therapy and compare the complications with those who were not on antiplatelet agents or SSRI.

Official Title
-----------------
Safety of Percutaneous Tracheostomy in Clopidogrel and Selective Serotonin Reuptake Inhibitors

Conditions
-----------------
Tracheostomy Complication

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: on antiplatelet therapy or selective serotonin reuptake inhibitors(SSRI) Exclusion Criteria: N/A

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- | --- |
| a retrospective review of our experience with bleeding complication in the presence of antiplatelet and SSRI therapy and compare the complications with those who were not on antiplatelet agents or SSRI |  | 24 months |
Fiber-Optic Confocal Microscopy of the Urinary Tract Histopathology

Study Overview
=================
Brief Summary
-----------------
The goal of the study is to develop a novel approach to obtain real time optical biopsy of urinary tract pathology (e.g., bladder tumors) during urinary tract endoscopy using a novel fibered confocal microscope.

Official Title
-----------------
Fiber-Optic Confocal Microscopy of the Urinary Tract Histopathology

Conditions
-----------------
Bladder Cancer

Intervention / Treatment
-----------------
* Device: Fibered confocal microscope


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:Research subjects with suspected urinary tract pathology (e.g., bladder tumors) who are scheduled to undergo cystoscopy with possible excisional biopsy (e.g. transurethral resection of bladder tumor) in the operating room.&#xA; Exclusion Criteria:History of hypersensitivity to fluorescein; active urinary tract infection; pregnant; currently breast feeding;
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Fibered confocal microscope|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Reliability and Validation of 3-D Electromagnetic Tracking During Pelvic Floor Muscle (PFM) Activation - a Pilot Study

Study Overview
=================
Brief Summary
-----------------
Now a days the ultrasound is seen as a valid and reliable measurement tool to test the Pelvic Floor Muscle (PFM) movement (Sherburn, Murphy, Carroll, Allen, & Galea, 2005). The hypothesis is that the electromagnetic tracking system, TrakSTARTM, can measure the PFM movement in an equal or even more precise way. The TrakSTARTM will have the advantage to be used in measuring functional movements. In this Master thesis the hypothesis is to show a good reliability by trampoline jumping (physical activity).

Detailed Description
-----------------
There will be two measurements. One measurement of MVIC and quick flicks will be done in a standing and supine position with 3 repetitions. The TrakSTARTM, Ultrasound, surface EMG and Accelerometer will measure the PFM movements and activation simultaneously. The Ultrasound is measured from one tester (to guaranty a high intratester reliability) (Sherburn et al., 2005). TrakSTARTM, surface EMG and Accelerometer will measure 3 Trampoline jumps. The measurements will be done once during one hour. The women will insert the vaginal probe by themselves and stay dressed during the measurement procedure. The measurements will be done in a standardized way. All the arrangements are made to ensure the hygiene requirements.

Official Title
-----------------
Reliability and Validation of 3-D Electromagnetic Tracking During Pelvic Floor Muscle (PFM) Activation - a Pilot Study

Conditions
-----------------
Pelvic Floor Dyssynergia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women aged between 18 and 35 years anamnestically healthy nulliparous and a BMI between 18 and 30 Exclusion Criteria: latex and nickel allergy anamnestically current pregnancy menstruation urogenital operations anal operations vaginal infections

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 20 healthy women<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the way in x-y coordinates for the pelvic floor mouvement measured by the ultrasonography and TrakSTAR | the mouvement of the pelvic floor is measured similtanous by the ultrasound and the TrakSTAR | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EMG | EMG will measure the contraction of the plevic floor | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pelvic floor, ultrasonography
Prospective Data Collection on Cementless Oxford Partial Knee

Study Overview
=================
Brief Summary
-----------------
Prospective data collection on clinical and radiographic outcomes of Cementless oxford Partial Knee.

Detailed Description
-----------------
Prospective radiographic and clinical data collection on outcomes of Cementless oxford Partial Knee. Screened radiographs are taken postoperatively and after 12 months. Oxford Knee Scores, SF12 Health Questionnaires and American Knee Society Radiographic Assessment are taken at 12 month follow-up.

Official Title
-----------------
Prospective Clinical Evaluation of the Cementless Oxford Partial Knee

Conditions
-----------------
Arthroplasty, Replacement, Knee

Intervention / Treatment
-----------------
* Device: Cementless Oxford Partial Knee


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing primary knee arthroplasty Patients with one of the following primary diagnoses in the medial compartment of the knee: Osteoarthritis, Avascular necrosis Exclusion criteria: Inability to co-operate with and complete the study. Inadequate fixation of cementless components. If either before or after randomization the surgeon feels that cementless fixation is inadequate, cemented components should be inserted.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Cementless Oxford Partial Knee|Cementless Oxford Partial Knee Replacement|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| American Knee Society Score | The Knee Score consists of points given for pain, range of motion, and stability in both the coronal and sagittal planes, with deductions for fixed deformity, and extensor lag. The Function Score consists of points given for the ability to walk on level surfaces, and the ability to ascend and descend stairs, with deductions for the use of external supporting devices. | 1 yr | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic Assessment | x-ray evaluation | 1yr | 
| Oxford Knee Score | Oxford Knee Score: Assess the impact that knee pain has on an individual's daily life. The survey consists of 12 self reported questions, where a higher score corresponds with a better outcome. | 1 yr | 
| Short Form 12 | Short Form 12: Multipurpose short form generic general health measure. The questionnaire looks at physical and mental scores for patients. | 1 yr | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
knee replacement
Cell Based Non Invasive Prenatal Testing as an Alternative to Chorionic Villus Sampling Following Preimplantation Genetic Testing

Study Overview
=================
Brief Summary
-----------------
The study aims to investigate whether cell-based non-invasive prenatal testing (cbNIPT) can be used as an alternative to invasive chorionic villus sampling (CVS) in patients who achieve pregnancy following preimplantation genetic testing for monogenic disorders (PGT-M).

Official Title
-----------------
Evaluation of Cell-based Non-invasive Prenatal Testing as an Alternative to Chorionic Villus Sampling as a Tool to Confirm the Pregnancy With an Unaffected Fetus Following Preimplantation Genetic Testing

Conditions
-----------------
Prenatal Diagnoses, Preimplantation Genetic Diagnosis

Intervention / Treatment
-----------------
* Procedure: Cell-based non-invasive prenatal testing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Achieved pregnancy following preimplantation genetic testing Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>This arm has blood collected either at the time of CVS. | Procedure: Cell-based non-invasive prenatal testing<br>* Blood sampling.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Agreement between cbNIPT and CVS (The gold standard) | How do the cbNIPT results compare to the results of the genetic test following CVS | Immidiately after the results from cbNIPT and CVS has been obtained | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of fetal cell isolation | How large a fraction of the potential fetal cells isolated is verified by genetic testing to be of fetal origin. | Immidiately after genetic testing of the isolated fetal cells | 
| Effectiveness of testing the genetic variant of interest | How often does the test on a fetal cell yield a result that allows determination of the mutational status of the embryo with respect to the genetic variant of interest. | Immidiately after genetic testing of the isolated fetal cells |
Dose Ranging Study of the GLP-1 Agonist AVE0010 in Metformin-Treated Subjects With Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
To evaluate the dose-response relationship of AVE0010 administered once daily and twice daily with chronic dosing in metformin-treated subjects with type 2 diabetes

Official Title
-----------------
A 13-week Multinational, Randomized, Double-Blind, Placebo-Controlled, Dose-Response Trial Assessing the Safety, Tolerability and Efficacy of AVE0010 in Metformin-Treated Subjects With Type 2 Diabetes Mellitus

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Drug: LIXISENATIDE (AVE0010)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males, females, age 30, - 75 years, type 2 diabetes mellitus, treated with metformin ≥1.0 g/day, at a stable dose for at least 3 months, BMI 25 - 40 kg/m2, HbA1C ≥7.0% and <9.0%. Exclusion Criteria: Type 1 diabetes, pregnancy, lactation, women of childbearing potential, treatment with other antidiabetic agents than metformin, history of metabolic acidosis, hemoglobinopathy or hemolytic anemia, clinically significant medical abnormalities.

Ages Eligible for Study
-----------------
Minimum Age: 30 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: LIXISENATIDE (AVE0010)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c levels at baseline and endpoint (at 13 weeks). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fructosamine, fasting plasma glucose, fasting serum insulin, proinsulin, C-peptide, glucagon. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 diabetes