linjc16/ctgov huggingface dataset:
Sleep Disturbance in Pregnant Women in Upper Egypt

Study Overview
=================
Brief Summary
-----------------
Pregnant women are associated with hormonal, anatomic and mechanical changes that Change sleep patterns and quality of sleep. Several Investigators have reported Associations between sleep disturbances and hypertension, Coronary artery disease, Diabetes, and depression. Most of these associations have been established in the association with sleep disturbances

Official Title
-----------------
Sleep Disturbance in Pregnant Women in Upper Egypt

Conditions
-----------------
Sleep Disturbance

Intervention / Treatment
-----------------
* Device: Polysomnography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All viable third trimester pregnancy Exclusion Criteria: Intrauterine fetal death Any History of neurological, mental disorder. Any previous diagnosed sleep disturbances breathing disorder before pregnancy. Any patient with respiratory infection in the pregnancy.
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant group<br>pregnant women in the third trimester of pregnancy | Device: Polysomnography<br>* Polysomnography, also called a sleep study, is a test used to diagnose sleep disorders. Polysomnography records your brain waves, the oxygen level in your blood, heart rate and breathing, as well as eye and leg movements during the study<br>|
| Non-pregnant group<br>middle aged women | Device: Polysomnography<br>* Polysomnography, also called a sleep study, is a test used to diagnose sleep disorders. Polysomnography records your brain waves, the oxygen level in your blood, heart rate and breathing, as well as eye and leg movements during the study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of women with sleep disturbances among overall included women | diagnosis of sleep disturbances will depend on STOP and STOP-Bang questionnaires | 30 minutes |
Hybrid Capture 2 Human Papiloma Virus (HPV) High-Risk Anal DNA Test

Study Overview
=================
Brief Summary
-----------------
This is a study to determine if HC2 HPV testing in the anal canal can detect high-risk HPV and whether this aids in identifying individuals are risk for anal cancer or precancerous lesions.

Official Title
-----------------
Collection of Anal Specimens for Assessment of Anal Cancer Using the HC2 High-Risk DNA Test (QIAGEN)

Conditions
-----------------
Anal Canal HPV Infection Diagnosis, Anal Dysplasia Diagnosis, Anal Cancer

Intervention / Treatment
-----------------
* Device: HC2 collection kit with a swab or brush


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male or female 18 years of age or older screened for anal dysplasia, including MSM and women - Exclusion Criteria: subject has had a previous treatment for anal cancer. subjects that have used enemas or other foreign substances, in the anal canal or anal sex within 24 hours of collection. subjects that have bleeding disorders or use anticoagulation treatments. -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: swab and brush or swab and swab<br>we will determine which collection method is superior | Device: HC2 collection kit with a swab or brush<br>* We will sample the anal canal for cells with either a swab and swab or swab and brush to determine which is superior<br>* Other names: Qiagen HC2 HPV High-Risk DNA Test;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HC2 can accurately test for oncogenic HPV in anal specimens | Determination that HC2 testing in the anal canal can be performed | in approximately 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of cytology with HC2 | To determine if HC2 improves the sensitivity and specificity of anal cytology | in approximately 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anal HPV, Anal Dysplasia, Ana Cancer
Dose Estimation for Studies of Acute Respiratory Effects

Study Overview
=================
Brief Summary
-----------------
To modify and expand an existing pharmacokinetic model for nasal dose as well as to develop a new model to estimate tracheobronchial dose of an active agent for each subject in a study of acute respiratory health effects.

Detailed Description
-----------------
BACKGROUND: Epidemiologic analysis of acute, reversible respiratory health effects is uncommonly performed, yet these are important health outcomes because acute responses by the respiratory defense system appear to represent one end of the continuum toward progressive, chronic and potentially disabling physiologic changes. Repeatable epidemiologic studies of dose-response relationships necessitate accurate measures of 'dose'. However, in occupational and environmental settings, exposure to a toxin is seldom found at identical concentrations and/or particle sizes among persons with the same activity patterns. In addition, air concentration does not account for factors such as clearance or metabolism which may alter the biologically effective tissue dose. These factors cause the target tissue dose of the toxin to vary greatly despite exposure to similar air concentrations. DESIGN NARRATIVE: The results of these toxicokinetic models were individual measures of tissue dose used in a 2-stage epidemiologic analysis which placed special emphasis on the definition of individual dose-response curves for exposure to an irritant dust, sodium borate, and the reversible effects of peak expiratory flow and irritant symptoms. A primary advantage of the two stage epidemiologic approach was that it permitted particular attention to be focused on the factors which determined the sensitivity (threshold) and reactivity (slope) for an individual. The use of tissue dose estimates were also compared to simple exposure measurements in the epidemiologic analysis to evaluate the efficacy of using dosimetric methods in epidemiologic studies. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Lung Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 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 |
| --- | --- | --- |
Prospective Registry and Biobank for Long-term Observational Studies in Adult Patients With Pulmonary Hypertension

Study Overview
=================
Brief Summary
-----------------
Prospective registry and biobank for long-term observational studies in adult patients with pulmonary hypertension

Detailed Description
-----------------
In a prospective registry prevalent and incident patients diagnosed with group 1 to 5 pulmonary hypertension will be enrolled. In an integrated biobank body fluid samples will be collected at enrollment and sequentially during treatment with targeted drugs for pulmonary hypertension.

Official Title
-----------------
Prospective Registry and Biobank for Long-term Observational Studies in Adult Patients With Pulmonary Hypertension

Conditions
-----------------
Pulmonary Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of pulmonary hypertension group 1 to 5 Ability to give informed consent Exclusion Criteria: - Withdrawal of informed consent

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 |
| --- | --- | --- |
| Transplant-free survival |  | Up to 20 years of follow-up after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk score (averaging low, intermediate and high risk categories) as proposed by the 2015 European Society of Cardiology (ESC)/European Respiratory Society (ERS) guidelines for pulmonary hypertension |  | Up to 20 years of follow-up after enrollment | 
| Registry to Evaluate Early And Long-term PAH Disease Management (REVEAL) 2.0 risk score |  | Up to 20 years of follow-up after enrollment |
Total Knee Arthroplasty: Relation Between Patient Satisfaction and Implant Geometry

Study Overview
=================
Brief Summary
-----------------
A RCT (randomized controlled trial) comparing 3 different TKA (total knee arthroplasty) implant designs and investigating the relation between patient satisfaction and the implant geometry.

Official Title
-----------------
Total Knee Arthroplasty: Relation Between Patient Satisfaction and Implant Geometry

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Device: Total Knee Arthroplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients of all ages, scheduled for TKA Primary osteoarthritis of the knee joint post traumatic arthritis rheumatoid arthritis Exclusion Criteria: previous TKA in same joint evidence of neuromuscular or neurosensory deficiency immunologic suppression
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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Implant design 1<br>Journey II, BCS, Smith&Nephew | Device: Total Knee Arthroplasty<br> <br> * Other names: Unity, Corin;|
| Active Comparator: Implant design 2<br>Persona, Zimmer | Device: Total Knee Arthroplasty<br> <br> * Other names: Unity, Corin;|
| Active Comparator: Implant design 3<br>Unity, Corin | Device: Total Knee Arthroplasty<br> <br> * Other names: Unity, Corin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction | Determining patient specific factors by use of validated questionnaires | Preop | 
| Patient Satisfaction | Determining patient specific factors by use of validated questionnaires | 3 months postoperative | 
| Patient Satisfaction | Determining patient specific factors by use of validated questionnaires | 6 months postoperative | 
| Patient Satisfaction | Determining patient specific factors by use of validated questionnaires | 1 year postoperative | 
| Patient Satisfaction | Determining patient specific factors by use of validated questionnaires | 2 years postoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Total Knee Arthroplasty, Patient Satisfaction, PROMs, Implant Design
ZIAGEN® Post-marketing Surveillance

Study Overview
=================
Brief Summary
-----------------
An open label, multi-centre, non-interventional post-marketing surveillance (PMS) to monitor the safety and efficacy of ZIAGEN® administered in Korean patients according to the prescribing information.

Detailed Description
-----------------
This study will collect clinical data, mainly focused on safety, in Korean population as per the requirement of KFDA for market authorization. ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship.

Official Title
-----------------
An Open Label, Multi-centre, Non-interventional Post-marketing Surveillance (PMS) to Monitor the Safety and Efficacy of ZIAGEN® Administered in Korean Patients According to the Prescribing Information

Conditions
-----------------
Infection, Human Immunodeficiency Virus I

Intervention / Treatment
-----------------
* Drug: ZIAGEN®


Participation Criteria
=================
Eligibility Criteria
-----------------
All subjects must satisfy the following criteria. Subject who is treated in combination with other antiretroviral agents for the treatment of HIV infection. Subject who is considered to follow this post marketing surveillance protocol by the investigator. Subject who is treated with ZIAGEN® according to the prescribing information. As considering the characteristic of observational post marketing surveillance, the exclusion criteria is not strict. All investigators should prescribe ZIAGEN® according to the prescribing information which approved in Korea. Subjects with hypersensitivity to ZIAGEN® or ingredients Subjects with moderate or severe hepatic impairment Subject with end-stage renal disease
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ZIAGEN®<br>Patients administrated ZIAGEN® at the site | Drug: ZIAGEN®<br>* Basically there is no treatment allocation. Subjects who would be administrated ZIAGEN® at their physician's discretion will be enrolled. Dosage regimen will be recommended according to the prescribing information. Subjects will be enrolled consecutively.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of adverse event after ZIAGEN® administration |  | 12month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of serious adverse event after ZIAGEN® administration |  | 12month | 
| efficacy after ZIAGEN® administration |  | 12month | 
| Occurrence of unexpected adverse drug reaction after ZIAGEN® administration |  | 12 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Abacavir, post-marketing surveillance
MRI-based Biomarkers for Predicting Punctate White Matter Lesions in Neonates

Study Overview
=================
Brief Summary
-----------------
As a common white matter (WM) disease in preterm neonates, punctate white matter lesion (PWML) frequently leads to the abnormalities of brain development (e.g. the motor, visual and auditory disorders), even to cerebral palsy (CP) and amblyopia during childhood. However, it is lack of certain methods in identifying the prognosis of PWML. Through using various advanced MRI techniques, neuro-behavioral and visual assessments, a multicenter longitudinal study would be conducted to follow-up the PWML neonates with varying spatial-position and degree lesions. Through tracking the variations in WM microstructures from neonate period to childhood (2 years old and 3 years old), this study aims to explore (1) the potential relations between varying PWMLs and motor and visual disorders (2) the relations between WM MRI-metrics and neurodevelopmental assessment results, and thus determine the early biomarkers to identify CP and amblyopia.

Official Title
-----------------
MRI-based Biomarkers for the Prognosis Judgement of Punctate White Matter Lesions in Neonates: a Longitudinal Multicenter Study

Conditions
-----------------
Brain Diseases, Amblyopia, Brain Damage, Chronic, Cerebral Palsy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -(1) Age: 1-28 days (2) PWML (3) High quality MRI scan Exclusion Criteria: -(1) Congenital malformations, infections, metabolic disorders, intraventricular hemorrhage (2) Neonates of mothers with gestational diabetes, hypertension, hypoglycemia and history of alcohol

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 28 Days

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control Group<br>Neonates with no evidence of brain lesions on conventional MRI. | |
| Patients Group<br>Neonates with PWML diagnosed by conventional MRI. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebral Palsy | The enrolled subjects who will be diagnosed as cerebral palsy by clinical examination at age 2. | At age 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amblyopia or movement disorder | The enrolled subjects who will be diagnosed as amblyopia or movement disorder by clinical examination at age 3. | At age 3 |
Efficacy and Safety of Vildagliptin as add-on Therapy to Insulin in Patients With Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
To assess the efficacy and safety of vildagliptin add-on therapy to reduce HbA1c in patients with T2DM inadequately controlled by insulin, with or without concurrent metformin therapy.

Official Title
-----------------
A 24-week, Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Vildagliptin 50mg Bid as an add-on Therapy to Insulin, With or Without Metformin, in Patients With Type 2 Diabetes Mellitus.

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed diagnosis of T2DM On a stable dose of insulin as defined by the protocol On a stable does of metformin (if applicable) as defined by the protocol Age 18 to 80 years HbA1c of 7.5 to 11.0% Body Mass Index (BMI) 22 to 40 kg/m2 Exclusion Criteria: Type 1 diabetes Short-acting or rapid-acting insulin Pregnancy or lactation Evidence of serious diabetic complications Evidence of serious cardiovascular complications Laboratory value abnormalities as defined by the protocol Other protocol-defined inclusion/exclusion criteria may apply

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vildagliptin<br> | Drug: Vildagliptin<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c reduction |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c reduction in subpopulation treated with insulin and with metformin |  | 24 weeks | 
| HbA1c reduction in subpopulation treated with insulin and without metformin |  | 24 weeks | 
| Reduction in FPG (overall and subpopulations) |  | 24 weeks | 
| Responder rates (overall and subpopulations) |  | 24 weeks | 
| Incidence of hypoglycemia and severe hypoglycemia (overall and subpopulations) |  | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Add-on to insulin
Myomectomy During CS: A Retrospective Cohort Study

Study Overview
=================
Brief Summary
-----------------
To evaluate the value of myomectomy during delivery by cesarean section (CS) in pregnant women with uterine fibroids.

Official Title
-----------------
Myomectomy During Cesarean Section: A Retrospective Cohort Study

Conditions
-----------------
Cesarean Section, Uterine Fibroid

Intervention / Treatment
-----------------
* Procedure: Myomectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women who underwent elective CS with presence of uterine fibroid during the index pregnancy documented antenatal and at surgery Exclusion Criteria: Antepartum hemorrhage Blood diseases or bleeding tendencies. Medical conditions complicating pregnancy. Performed another surgical procedure at CS other than myomectomy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 41 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 |
| --- | --- |
| CS with myomectomy<br>Women having uterine myoma with pregnancy and subjected to myomectomy during delivery by CS | Procedure: Myomectomy<br>* Surgical removal of uterine fibroid<br>|
| CS without myomectomy<br>Women having uterine myoma with pregnancy and delivered by CS without myomectomy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Deficit in hemoglobin level | Preoperative hemoglobin minus postoperative hemoglobin level (in gm/dl) | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time | Time to complete the procedure | 3 hours | 
| Postoperative hospital stay period | Time from the end of operation to discharge from hospital | 7 days |