linjc16/ctgov huggingface dataset:
Three-dimensional Cleft Lip and Palate Morphology Prior to One-stage Cleft Repair

Study Overview
=================
Brief Summary
-----------------
This is a prospective observational cohort study of consecutive patients with cleft lip and palate deformity undergoing cleft repair at the Institute of Mother and Child in Warsaw. Cleft morphology will be captured with photo and intraoral camera before routine surgery at around 8 months. Furthermore, wound healing at 3 months postoperative will be assessed.

Official Title
-----------------
Collaborative, Comparative Study on Three-dimensional Cleft Lip and Palate Morphology Prior to One-stage Cleft Repair (Warsaw/Basel)

Conditions
-----------------
Cleft Lip and Palate, Cleft Palate, Craniofacial Deformity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with orofacial cleft, who undergo routine cleft repair Exclusion Criteria: missing datasets no signed consent for research

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 15 Months

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 |
| --- | --- | --- |
| True Cleft Area in mm2 of Newborns With Cleft Lip and Palate at 8 Month of Age | True cleft area in mm2 will be measured at 8 month of age in newborns with cleft lip and palate. | Capture of the cleft morphology with photo and intraoral camera before routine surgery at around 8 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cleft Width and Height in mm of Newborns With Cleft Lip and Palate at 8 Month of Age | Measurement of the width and height in mm of the cleft measured at 8 months of age. | Capture of the cleft morphology with photo and intraoral camera before routine surgery at around 8 months. | 
| Wound Healing (fistula yes or no) 3 Months After One-Stage Cleft Repair | Assessment of wound healing by fistula formation at 3 months postoperative | At 3 months postoperative | 
| Correlation of Cleft Width in mm and Wound Healing after One-Stage Cleft Repair | Evaluation of the correlation between cleft width in mm and wound healing | At surgery and at 3 months postoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cleft Lip and Palate, Presurgical Orthopedics, Cleft Morphology, Palatal Plate
Phase I Study PK Study With OXP005 and Naprosyn

Study Overview
=================
Brief Summary
-----------------
The Sponsor is developing a new form of naproxen (the study drug, OXP005), for the potential treatment of rheumatic and painful conditions. The study will compare the study drug to an already marketed formulation of prescription strength naproxen (Naprosyn® the reference product) by looking at how a single dose of the drug is taken up by the body. The safety and tolerability of the drug will also be assessed.

Official Title
-----------------
Study to Assess the Comparative Bioavailability and Pharmacokinetics of Naproxen From OXP005 Tablets (Test) And Naprosyn® Tablets (Reference) in Normal, Healthy, Adult Subjects

Conditions
-----------------
Pharmacokinetics

Intervention / Treatment
-----------------
* Drug: OXP005
* Drug: Naprosyn®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male subjects and non-pregnant, non breast feeding healthy female subjects aged 18 to 55 years Body mass index 18.0 to 30.0 kg/m2 Exclusion Criteria: History of or current significant diseases or conditions including any disease or condition affecting the haematopoietic, cardiovascular, renal, hepatic, endocrine, pulmonary, central nervous, immunological, dermatological, gastrointestinal or any other body system

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OXP005<br> | Drug: OXP005<br> <br> * Other names: Naproxen;|
| Active Comparator: Naproxen<br> | Drug: Naprosyn®<br> <br> * Other names: Naproxen;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparative bioavailability of naproxen as measured by Tmax, Cmax, AUC, half-life |  | Day 1 & Day 8 single dose crossover |
Outcome Assessment in Patients Treated With Hyperbaric Oxygen Using OxyVu Tissue Oxygenation Monitoring System

Study Overview
=================
Brief Summary
-----------------
The objective is to define patient eligibility for hyperbaric oxygen therapy and to evaluate wound healing progression using a new hyperspectral imaging technology.

Detailed Description
-----------------
The purpose of this clinical study is to define patient eligibility for hyperbaric oxygen therapy (HBOT) and to evaluate wound healing progression during HBOT using a new hyperspectral imaging technology (OxyVu).

Official Title
-----------------
Outcome Assessment in Patients Treated With Hyperbaric Oxygen Using OxyVu Tissue Oxygenation Monitoring System

Conditions
-----------------
Wounds

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: 18 - 85 years of age Patients with wounds that meet the criteria for hyperbaric oxygen therapy (e.g. problem wound, diabetic foot ulcer, necrotizing soft tissue infections) Compromised Flap or Grafts. Exclusion criteria: Patients with poor cardiac output (EF < 20%) Patients with severe obstructive pulmonary disease who don't qualify for HBOT Patients with untreated asthma who don't qualify for HBOT Patients utilizing supplemental oxygen and those on ventilators Patients on life support medications (pressors)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- | --- |
| OxyVu measurements will be compared to transcutaneous oxygen measurements pre and post HBOT |  | Days 1, 7, 14, 21, 4wks, and 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hyperspectral imaging, tissue oxygenation, wounds, wound healing, prevention, hyperbaric
STELLAR-Rosuvastatin vs. Atorvastatin, Pravastatin, Simvastatin Across Dose Ranges

Study Overview
=================
Brief Summary
-----------------
To compare the efficacy of various doses of rosuvastatin with atorvastatin, pravastatin & simvastatin in reducing levels of low density lipoprotein cholesterol in subjects with hypercholesterolaemia.

Official Title
-----------------
A 6 Week Open Label, Dose Comparison Study to Evaluate the Safety and Efficacy of Rosuvastatin Versus Atorvastatin, Pravastatin, and Simvastatin in Subjects With Hypercholesterolemia.

Conditions
-----------------
Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: Rosuvastatin
* Drug: Atorvastatin
* Drug: Pravastatin
* Drug: Simvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Discontinuation of all previous lipid lowering therapy. Fasting LDL-c levels of between 160mg/dl - 250 mg/dl at Visits 2 & 3 for subjects not on lipid lowering therapy at Visit 1. Other lipid parameters as specified in the protocol. Exclusion Criteria: The use of lipid lowering drugs or dietary supplements after Visit 1. Active arterial disease eg Unstable angina, or recent arterial surgery Abnormal laboratory parameters as defined in the protocol.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Rosuvastatin | Drug: Rosuvastatin<br> <br> * Other names: Crestor;|
| Active Comparator: 2<br>Atorvastatin | Drug: Atorvastatin<br> <br> * Other names: Lipitor;|
| Active Comparator: 3<br>Pravastatin | Drug: Pravastatin<br> <br> * Other names: Lipostat;|
| Active Comparator: 4<br>Simvastatin | Drug: Simvastatin<br> <br> * Other names: Zocor;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage change in low density lipoprotein cholesterol. |  | 4 & 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage change in other lipid parameters as defined by the protocol |  | 6 weeks | 
| Safety evaluation |  | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cholesterol, hypercholesterolemia, low density lipoproteins
Longitudinal Outcomes in Hepatic Resection

Study Overview
=================
Brief Summary
-----------------
This observational registry of patients undergoing liver surgery collects patients both retrospectively and prospectively. Patients undergoing liver resection for any non-transplant indication will be evaluated for clinical outcomes (such as surgical complications, survival, and disease progression) based on clinical and patient factors (like indication, age, and other treatments for the disease).

Official Title
-----------------
Longitudinal Outcomes in Hepatic Resection

Conditions
-----------------
Liver Diseases, Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients requiring liver resection Exclusion Criteria: Patients under the age of 18 years Patients undergoing liver transplant

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients undergoing hepatectomy<br>Patients undergoing hepatectomy, or liver resection, for a non-transplant indication. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival |  | 10 years | 
| Surgical-site infection |  | 3 months | 
| Postoperative bleeding |  | 3 months | 
| Blood clot |  | 3 months | 
| Use of other therapy | e.g., antibiotics in liver abscess, chemotherapy in liver cancer | 5 years | 
| Operative time |  | 1 day | 
| Intraoperative blood loss |  | 1 day | 
| Number of segments resected | If applicable | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatectomy
Assessment Of Safety Of UK-390,957

Study Overview
=================
Brief Summary
-----------------
To determine whether UK-390,957 is a safe treatment for premature ejaculation.

Official Title
-----------------
A Phase 2 Multi-Center, Open Label Long-Term Extension Trial To Assess The Safety Of Oral Uk-390,957 Administered As Required In Adult Men With Premature Ejaculation

Conditions
-----------------
Ejaculation

Intervention / Treatment
-----------------
* Drug: UK-390,957


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects will have completed one of the phase 2 trials (A3871022/ A3871027/ A3871029) and will have met the diagnostic criteria for premature ejaculation as defined by DSM-IV Exclusion Criteria: No drug related serious adverse events

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: UK-390,957|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of safety |  |  |
A Phase IIIB Study to Compare the Efficacy and Safety of Concomitant Treatment in Patients With COPD

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of the concomitant treatment of formoterol fumarate with tiotropium bromide compared to treatment with tiotropium bromide alone.

Official Title
-----------------
A 6-Week Double-Blind, Parallel-Group, Active-Controlled Trial to Compare the Efficacy and Safety of Concomitant Treatment of Formoterol Fumarate Inhalation Solution 20 Mcg Twice Daily and Tiotropium 18 Mcg Once Daily to Tiotropium 18 Mcg Once Daily Alone in the Treatment of Patients With Chronic Obstructive Pulmonary Disease

Conditions
-----------------
COPD

Intervention / Treatment
-----------------
* Drug: Formoterol Fumarate
* Drug: Tiotropium Bromide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Medical diagnosis of COPD Current or prior history of cigarette smoking Exclusion Criteria: Medical diagnosis of asthma Significant condition or disease other than COPD

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Formoterol Fumarate|nan|
|Drug: Tiotropium Bromide|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of lung Function |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in lung function, vital signs; physical examinations; clinical laboratory assessments; adverse event reporting; patient questionnaires |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, Formoterol, Tiotropium
Clinical Assessment of a Multifocal Contact Lens for People Who Use Reading Glasses Only

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to evaluate the use of multifocal contact lenses in people who use reading glasses only.

Official Title
-----------------
Clinical Assessment of a New Multifocal Contact Lens With Emmetropic Presbyopes

Conditions
-----------------
Presbyopia

Intervention / Treatment
-----------------
* Device: Lotrafilcon B multifocal contact lens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Is between 40 and 48 years of age (inclusive). Has read and signed the Informed Consent. Is willing and able to follow instructions and maintain the appointment schedule. Wears reading spectacles for close work. Other protocol-defined inclusion/exclusion criteria may apply. Exclusion Criteria: Eye injury or surgery within twelve weeks of enrollment. Evidence of systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of accessory solutions. Currently enrolled in a clinical trial. Has worn contact lenses previously. Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 48 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: Lotrafilcon B multifocal<br>Lotrafilcon B multifocal contact lenses worn bilaterally for 3 weeks on a daily wear basis | Device: Lotrafilcon B multifocal contact lens<br>* Commercially marketed, silicone hydrogel, multifocal, soft contact lenses FDA-approved for up to 4 weeks recommended replacement schedule and up to 6 nights of extended (overnight) wear.<br>* Other names: AIR OPTIX® AQUA MULTIFOCAL;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Convenience With Contact Lenses | Overall convenience with contact lenses, as interpreted by the participant and reported on a questionnaire as a single, retrospective evaluation of 3 weeks of wear time. Overall convenience is measured on a 4-point scale: 1=very satisfied; 2=satisfied; 3=dissatisfied; 4=very dissatisfied. Results were reported as a percentage of participants who responded, very satisfied or satisfied. | 3 weeks of wear |
Genotype-phenotype Correlation of SLC26A4 in CI Patients With EVA

Study Overview
=================
Brief Summary
-----------------
To explore the genotype-phenotype correlation of SLC26A4 mutations in cochlear-implanted patients with enlarged vestibular aqueduct.

Detailed Description
-----------------
Enlarged vestibular aqueduct (EVA) is one of the most common forms of inner ear malformation that cause sensorineural hearing loss (SNHL). Some patients with EVA present delayed, fluctuating, and progressive hearing loss, while the others are with congenital or sudden hearing loss. Cochlear implants (CI) have been widely used in patients with severe-profound SNHL. However, it is difficult to define the optimal timing of CI operations for patients with EVA. Mutations in SLC26A4 are known to be responsible for EVA. This study is to explore the genotype-phenotype correlation of SLC26A4 mutations in cochlear-implanted patients with EVA.

Official Title
-----------------
A Genotype-phenotype Correlation of SLC26A4 Mutations in Cochlear-implanted Patients With Enlarged Vestibular Aqueduct

Conditions
-----------------
Sensorineural Hearing Loss, Enlarged Vestibular Aqueduct

Intervention / Treatment
-----------------
* Procedure: Cochlear implantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Bilateral severe-to-profound sensorineural hearing loss who received cochlear implantation. Bilateral or unilateral enlarged vestibular aqueduct (EVA) with or without Mondini malformation (IP-II) on temporal bone computed tomography (CT) and/or magnetic resonance imaging (MRI). Exclusion Criteria: Hearing loss that is associated with symptoms which meet the criteria of already known syndromes. With other type of inner ear malformation.

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 18 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Cochlear implantation|Cochlear implantation|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cochlear implant age | Age of cochlear implantation. | Immediately after cochlear implantation | 
| Duration of hearing loss | Time between found of hearing loss and cochlear implantation. | Immediately after cochlear implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type of initial hearing loss | Prelingual or postlingual; Hearing aid can or cannot benefit | On the 1 day of recruitment. | 
| Type of hearing loss progression | Initial profound, sudden, or fluctuating hearing loss. | Immediately after cochlear implantation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
enlarged vestibular aqueduct, SLC26A4, cochlear implant
Intraorbital Dermoid/Epidermoid Cyst

Study Overview
=================
Brief Summary
-----------------
Intraorbital epidermoid and dermoid cyst (DC) has been reported in the literature rarely. The current study evaluates clinicopathologic, radiologic, and management of intraorbital DC cases over ten years.

Official Title
-----------------
Atypical Intraorbital Dermoid and Epidermoid Cyst: A Single Institution Cross-sectional Retrospective Study

Conditions
-----------------
Dermoid Cyst of Orbit

Intervention / Treatment
-----------------
* Other: clinical and radiologic manifestations of rare presentations of Dermoid cyst


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Those who had an excision biopsy with histology indicative of dermoid/epidermoid cyst Exclusion Criteria: Other cystic lesions
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: clinical and radiologic manifestations of rare presentations of Dermoid cyst|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histopathology report | cyst pathology | Ten years | 
| Magnetic Resonance Imaging report | The cyst features | Ten years | 
| Surgery technique | Managing the cyst | Ten years |