linjc16/ctgov huggingface dataset:
Quality of Life After Cervical Ripening

Study Overview
=================
Brief Summary
-----------------
Women's experience of childbirth differs with type of labor, mode of delivery and parity. Induction of labor (IOL) is associated with lower satisfaction of women than spontaneous labor. A Nigerian study of 252 women with induced labor, irrespective of parity and device used for IOL and a French cohort study of 3042 women with IOL have been published. Theses latter identified several determinants of maternal dissatisfaction. However, no published study has reported the assessment of quality of life of women at long term after cervical ripening according to the device required for cervical ripening. The aim of this study is to characterize the quality of life of women after cervical ripening according to parity and device required, and to assess possible factors associated with this quality of life at long-term after delivery.

Official Title
-----------------
Quality of Life 3 Months After Cervical Ripening

Conditions
-----------------
Delivery

Intervention / Treatment
-----------------
* Other: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Woman who experienced at least one method of cervical ripening in our hospital Exclusion Criteria: - Patient's refusal

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Women with cervical ripening in the context of artificial labor induction<br> | Other: Questionnaire<br>* EQ5D-5L questionnaire self-reported 3 months after delivery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EuroQol 5 Dimension Score | Quality of life from the EuroQol 5 Dimension questionnaire For each of the dimensions, there are 5 levels coded from 1 to 5. A one-digit number is obtained for each dimension. By combining the 5 dimensions, a 5-digit number is obtained, ranging from 11111 to 55555, representing the health status of the respondent. The code 11111 indicates a person with no problems on the 5 dimensions. | 3 months after delivery |
A Comparison of Fellow Eyes Undergoing LASIK or PRK With a Wavefront-guided Excimer Laser Versus a Wavefront-optimized Excimer Laser

Study Overview
=================
Brief Summary
-----------------
Subjects with myopia, hyperopia and astigmatism are being randomized to be treated in one eye with a wavefront-guided excimer laser and their fellow eye treated with a wavefront-optimized excimer laser.

Detailed Description
-----------------
Subjects with myopia, hyperopia and astigmatism are being randomized by ocular dominance to be treated with either PRK or LASIK. One eye will be treated with a wavefront-guided excimer laser and the fellow eye will be treated with a wavefront optimized excimer laser.

Official Title
-----------------
A Prospective Randomized Comparison of Fellow Eyes Undergoing LASIK or PRK With a Wavefront-guided Excimer Laser Versus a Wavefront-optimized Excimer Laser

Conditions
-----------------
Hyperopia, Myopia, Astigmatism

Intervention / Treatment
-----------------
* Procedure: LASIK and PRK


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects age 21 and older. Subjects with nearsightedness, farsightedness and/or astigmatism. Exclusion Criteria:Autoimmune diseases. Children. Women pregnant or nursing. Ectatic corneal disease. Previous ocular surgery.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Wavefront guided LASIK/PRK<br>Wavefront-guided LASIK/PRK | Procedure: LASIK and PRK<br>* Wavefront-guided versus wavefront-optimized LASIK or PRK.<br>* Other names: Wavefront-optimized;|
| Active Comparator: Wavefront optimized LASIK/PRK<br>Wavefornt optimized LASIK/PRK | Procedure: LASIK and PRK<br>* Wavefront-guided versus wavefront-optimized LASIK or PRK.<br>* Other names: Wavefront-optimized;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in best spectacle corrected visual acuity. |  | One year | 
| Changes in 25 and 5% low contrast visual acuity. |  | One year | 
| Improvement in uncorrected visual acuity |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in higher order aberrations. |  | One year | 
| Topographic changes. |  | One year | 
| Quality of vision changes. |  | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PRK, Myopia, Hyperopia, Astigmatism, LASIK
The Value of Placental Vascularization and Placental Volume in Pregnancy in APLS

Study Overview
=================
Brief Summary
-----------------
Antiphospholipid antibodies are autoantibodies directed against phospholipid-binding proteins. Among these groups of antibodies, lupus anticoagulant (LA) and anticardiolipin antibodies (aCL)

Detailed Description
-----------------
APLS can be primary when no evidence of autoimmune disease is found, or secondary to autoimmune processes like systemic lupus erythematous (SLE) in a 40% of the cases.

Official Title
-----------------
TheValue of Placental Vascularization Indices and Placental Volume in Pregnancies With Antiphospholipid Syndrome for Prediction of Neonatal Outcome

Conditions
-----------------
Antiphospholipid Syndrome in Pregnancy

Intervention / Treatment
-----------------
* Diagnostic Test: Ultrasound with Doppler and 3D technology


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Singleton pregnancy. Gestational age of 34-37 weeks. Pregnant women with antiphospholipid syndrome Exclusion Criteria: Twin or multiple pregnancies. Congenital fetal anomalies. Gestational age of less than 34. Gestational age of more than 37. Women with placental or umbilical artery anomalies. Antepartum hemorrhage (placental abruption, placenta previa and vasa previa). Posterior placenta. History of rupture of membrane. Patient refusal or fall outs.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| antiphospholipid group<br>pregnant ladies in the third trimester who have antiphospholipid syndrome | Diagnostic Test: Ultrasound with Doppler and 3D technology<br>* ultrasound will be made to pregnant females in 3rd trimester with doppler and 3D technology<br>|
| control group<br>pregnant ladies in the third trimester who have no medical disorders with pregnancy | Diagnostic Test: Ultrasound with Doppler and 3D technology<br>* ultrasound will be made to pregnant females in 3rd trimester with doppler and 3D technology<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of participants who will have impaired placental doppler indices |  | within 2 months |
Respiratory Syncytial Virus Infection in Neonatal Intensive Care Units Throughout Turkey: Prospective Multicenter Study (TurkNICU-RSV Trial)

Study Overview
=================
Brief Summary
-----------------
The principle purpose of this multicenter trial is to determine the definition, timing and the percentage of nosocomial RSV epidemics throughout Turkey. In addition, secondary purpose of the trial is to determine the prevention strategies of further spread of Respiratory Syncytial Virus (RSV) in the neonatal intensive care unit (NICU).

Official Title
-----------------
Management of Hospitalized Respiratory Syncytial Virus (RSV) Infected Patients in the Neonatal Intensive Care Unit (NICU) and Control of Epidemics; TurkNICU-RSV Study: A Multicentric, Prospective Trial

Conditions
-----------------
Respiratory Syncytial Virus Infections, Infections, Epidemics

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed RSV infection with either RSV-strip test or polymerase chain reaction (PCR). Admission to the NICU or hospitalized in the NICU between 1 October 2013 and 01 April 2014. Exclusion Criteria: Refused informed consent

Ages Eligible for Study
-----------------
Minimum Age: 5 Days
Maximum Age: 90 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 |
| --- | --- |
| Hospitalized Respiratory Syncytial Virus Infected Newborns<br>All admitted newborns to the neonatal intensive care unit (NICU) will be enrolled in the study | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalized Respiratory Syncytial Virus infected Newborn in the Neonatal Intensive Care Units, and its relation with possible epidemics. |  | Patients will be followed during hospitalization, with expected average of 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | mortality related to RSV infection and epidemics | Patients will be followed during hospitalization, with expected average of 3 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Respiratory Syncytial Virus Infections, Epidemics, Neonatal Intensive Care Unit, Newborn infants
Intraoperative Imaging of a PET Positive Lymph Node(s) Using 18FDG and a Dual-Mode, Hand-Held Intraoperative Imager

Study Overview
=================
Brief Summary
-----------------
This study is a prospective collection of data utilizing the Imaging Beta Probe (IBP) in patients with positron emission tomography (PET) positive disease. A pilot clinical study involving 5 patients will be conducted using the IBP. The sterilized IBP will be used intraoperatively in surgical wounds for localization of tumor sites and detecting completeness of excision vs. positive margins. The outcome of each of these studies will be documented and used to demonstrate clinical benefits of the new probe. The investigators will correlate the images from the probe of the Fludeoxyglucose (18FDG) positive tissue, both in-vivo and ex-vivo after dissection, with the previously performed PET scan and with the routine pathology results obtained on the surgical specimens.The experimental imaging modality studied in this protocol will be compared to clinically utilized modalities of ultrasound and PET/ CT. Localization between imaging modalities will be compared with respect to: detection and side of localization.

Official Title
-----------------
Intraoperative Imaging of a PET Positive Lymph Node(s) Using 18FDG and a Dual-Mode, Hand-Held Intraoperative Imager

Conditions
-----------------
Head and Neck Neoplasms

Intervention / Treatment
-----------------
* Device: Imaging Beta Probe (IBP)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women, 18- to 90-years old. Positive for PET positive disease in the neck. Exclusion Criteria: Pregnant women (all women of child bearing potential will have undergone pregnancy testing as standard of care) Nursing or lactating women

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Use of IntraOperative Imaging Probe<br>The sterilized (Imaging Beta Probe) IBP will be used intraoperatively in surgical wounds for localization of tumor sites and detecting completeness of excision vs. positive margins. | Device: Imaging Beta Probe (IBP)<br>* Using IBP for imaging of PET positive lymph nodes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of PET positive disease | Localization between imaging modalities will be compared with respect to: detection (y/n) and side of localization (r/l). | Day 1 |
Study Evaluation the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction for 10 Weeks

Study Overview
=================
Brief Summary
-----------------
The aim of this international study was to determine if 10 weeks of flexible-dose vardenafil therapy demonstrates superior efficacy compared to the dummy drug (placebo) in Erectile dysfunction subjects of a broad etiology when dosed 8 (+/-2) hours prior to sexual intercourse. In addition it should have been determined, if subjects with ED from a broad etiology can tolerate 10 weeks of flexible-dose vardenafil therapy when dosed 8(+/-2) hours prior to sexual intercourse.

Official Title
-----------------
A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Duration of Efficacy and Safety of Vardenafil Administered for 10 Weeks in a Flexible-Dose Regimen Compared to Placebo in Subjects With Erectile Dysfunction

Conditions
-----------------
Erectile Dysfunction

Intervention / Treatment
-----------------
* Drug: Levitra (Vardenafil, BAY38-9456)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men >/= 18 years of age, with 6 months or longer diagnosis of ED as defined by NIH Consensus statement, History of unresponsiveness to sildenafil Stable sexual relationship for > 6 month. Exclusion Criteria: Primary hypoactive sexual desire History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month Nitrate therapy.

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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Levitra (Vardenafil, BAY38-9456)<br>* 5mg, 10mg or 20mg taken 8 hours before sexual intercourse<br>|
| Placebo Comparator: Arm 2<br> | Drug: Placebo<br>* matching placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Per-patient success rates based on Sexual Encounter Profile, Question 3 |  | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Per-subject success rates based on Sexual Encounter Profile, Question 2 |  | 10 weeks | 
| International Index of Erectile Function- Erectile Function domain score |  | 10 weeks | 
| Global Assessment Question (GAQ) |  | 10 weeks | 
| Safety and tolerability |  | 10 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Erectile Dysfunction, Vardenafil
Schistosoma Haematobium Infections and Praziquantel

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the impact of praziquantel for the treatment of Schistosoma haematobium infection among schoolchildren in Al Salamania in Central Sudan.

Detailed Description
-----------------
A longitudinal study will be conducted to evaluate the impact of praziquantel for the treatment of Schistosoma haematobium infection among schoolchildren in Al Salamania in Central Sudan. A cohort of schoolchildren (6-15 years of age) was investigated before and 1 year after treatment with a single dose of praziquantel 40mg/kg.

Official Title
-----------------
Schistosoma Haematobium Infections Among Schoolchildren in Central Sudan One Year After Treatment With Praziquantel

Conditions
-----------------
Schistosomiasis

Intervention / Treatment
-----------------
* Drug: praziquantel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: School children Exclusion Criteria: Taking praziquantel

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

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Praziguantel<br>tablet single dose | Drug: praziquantel<br>* praziquantel 40 mg/kg oral tablets<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cure rate | The reduction of the prevalence and intensity of S.haematobium infection following a single dose of praziquantel40mg/kg | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction in the intensity of infection by | will a single dose of PZQ significantly reduced intensity of infection of S. haematobium infection 1 year after treatment | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schistosoma haematobium, schoolchildren, Central Sudan, Praziquantel
Study to Evaluate Long-Term Tolerability and Safety of Oral Prucalopride in Chronic Constipation

Study Overview
=================
Brief Summary
-----------------
Objectives: Evaluation of the clinical long-term safety, tolerability, patient satisfaction, pharmacokinetics and pattern of use of oral prucalopride tablets given in doses up to 4 mg once daily to patients with chronic constipation

Official Title
-----------------
A Study to Evaluate the Long-Term Tolerability and Safety of Oral Prucalopride Administered to Patients With Chronic Constipation

Conditions
-----------------
Chronic Constipation

Intervention / Treatment
-----------------
* Drug: Prucalopride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or non-pregnant, non-breast-feeding female outpatients of at least 18 years of age Patient had completed the entire treatment period of the PRU-INT-6 study or the PRU-INT-12 study . Exclusion Criteria: Patients with impaired renal function Patients with clinically significant abnormalities of haematology, urinalysis, or blood chemistry. Females of child-bearing potential without adequate contraceptive protection during the study.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Prucalopride|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
The Clinical Difference Between the Nonfatal Patients and the Fatal Patients With Severe COVID-19

Study Overview
=================
Brief Summary
-----------------
To investigate the difference of the difference between the nonfatal Coronavirus Disease 2019 (COVID-19) Patients and the fatal Patients .The cross sectional study was undertaken to compare the clinical information (laboratory and radiologic characteristics)of nonfatal participants and fatal cases. The investigators wish figure out the clinical character of the fatal participants. The result may help the physician to find the fatal patients with COVID-19 more easily. The fatal patients with COVID-19 could be treated early.

Official Title
-----------------
The Clinical Difference Between the Nonfatal Coronavirus Disease 2019 (COVID-19) Patients and the Fatal Cases With Severe COVID-19

Conditions
-----------------
Coronavirus Disease 2019, Character of the Severe Patients

Intervention / Treatment
-----------------
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patients with Coronavirus Disease 2019 Positive result on real-time reverse-transcriptase-polymerase-chain-reaction Positive result on chest computed tomography Exclusion Criteria: No

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 100 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 |
| --- | --- |
| the nonsevere Coronavirus Disease 2019 Patients<br> | Other: no intervention<br>* no intervention<br>|
| the severe Coronavirus Disease 2019 Patients<br> | Other: no intervention<br>* no intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lymphocyte cell | the counting of Lymphocyte(counts/L) | 2 month | 
| d-dimer | d-dimer（mg/L） | 2 month | 
| PLT | the counting of Platelets（(counts/L)） | 2 month | 
| CRP | the level of C-reactive protein (mg/uL) | 2 month | 
| LDH | lactate dehydrogenase ( U/L) | 2 month | 
| CK | creatine kinase (U/L) | 2 month | 
| PT | prothrombin time(second) | 2 month | 
| ALT | alanine aminotransferase(U/L) | 2 month | 
| AST | aspartate aminotransferase(U/L) | 2 month | 
| NK cell | natural killer cell(counts/L) | 2 month | 
| PCT | procalcitonin（ng/ml） | 2 month | 
| IL-6 | interleukin-6(mg/L) | 2 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the clinical difference of radiologic characteristics between the fatal patients with COVID -19 and the non fatal cases | CT scan feature | 2 months |