linjc16/ctgov huggingface dataset:
Visual Function After Implantation of Bilateral AcrySof ReSTOR Aspheric +3

Study Overview
=================
Brief Summary
-----------------
A prospective evaluation of the visual parameters in a series of patients bilaterally implanted with AcrySof ReSTOR +3 Intraocular Lens (IOL).

Official Title
-----------------
Visual Function After Implantation of Bilateral AcrySof ReSTOR Aspheric +3

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Device: ReSTOR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with cataracts Exclusion Criteria: Pre-existing conditions that could skew the results or are contraindications for the ReSTOR intraocular lens; <1 diopter astigmatism by keratometry readings.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ReSTOR Aspheric +3<br>Enrolled subjects receive implantation of ReSTOR +3 intraocular lenses (IOLs) for replacement of cataract in the natural lens of the eye. The patients were to be implanted bilaterally (in both eyes). | Device: ReSTOR<br>* Enrolled subjects receive implantation of ReSTOR +3 intraocular lenses (IOLs) for replacement of cataract in the natural lens of the eye. The patients were to be implanted bilaterally (in both eyes).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uncorrected Visual Acuity (UCVA) | Uncorrected Visual Acuity (UCVA) measured by means of logMAR at various distances (40 centimeters (cm), 50 cm, 60 cm, 70 cm, and 4 meters (m)). Visual Acuity (VA) is measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution. A lower logMAR value indicates better visual acuity. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ReSTOR Aspheric +3 IOL
Positive Pressure Ventilation Through a Laryngeal Mask Airway in Pediatrics

Study Overview
=================
Brief Summary
-----------------
The investigators aimed to investigate effects of intubation and laryngeal mask airway usage in pediatrics during laparoscopic inguinal hernia repair.

Detailed Description
-----------------
Considering blood gas analysis, end tidal carbon dioxide measurements and airway changes, the investigators aimed to investigate effects of intubation and laryngeal mask airway usage in pediatrics during laparoscopic inguinal hernia repair in this study.

Official Title
-----------------
Can Positive Pressure Ventilation be Provided Through a Laryngeal Mask Airway in Pediatrics During Laparoscopic Inguinal Hernia Repair?

Conditions
-----------------
Pediatric, Anesthesia

Intervention / Treatment
-----------------
* Device: Orotracheally intubation
* Device: Laryngeal Mask Airway


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologists physical status I, being scheduled to undergo laparoscopic inguinal hernia. Exclusion Criteria: Patients, who did not want to participate, patients with severe airway deformities, patients having increased gastroesophageal regurgitation risk, reactive airway hiatal hernia, peripheric vascular disease, mental retardation, neuropsychiatric illness or an lung infection during the last 6 weeks.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 8 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: Parallel Assignment
Interventional Model Description: All pediatric patients, who were scheduled to undergo laparoscopic surgery
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Orotracheally Intubation<br>Intervention:orotracheally intubation | Device: Orotracheally intubation<br>* Interventions used for airway safety and ventilation during surgical procedures<br>|
| Active Comparator: Laryngeal Mask Airway<br>Intervention: Laryngeal Mask Airway | Device: Laryngeal Mask Airway<br>* Interventions used for airway safety and ventilation during surgical procedures<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| end tidal carbon dioxide | A parameter measured during positive pressure ventilation | up to 200 minutes |
Chest Shielding in Premature Infants During Phototherapy

Study Overview
=================
Brief Summary
-----------------
This is a feasibility study where Infants will be randomized to either chest shielding with aluminum foil or chest shielding without aluminum foil while undergoing phototherapy for premature infants. The primary outcome is patent ductus arteriosus.

Official Title
-----------------
Effect of Chest Shielding on the Incidence of Patent Ductus Arteriosus in Premature Infants Undergoing Phototherapy

Conditions
-----------------
Patent Ductus Arteriosus in Premature Infants

Intervention / Treatment
-----------------
* Device: Chest shield with aluminum foil (CALF)
* Device: SHIELD


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: less or equal to 29 weeks or 1000g at birth Admitted to the NICU (Neonatal intensive care unit) within 24 hours after birth English speaking parents Exclusion Criteria: Congenital abnormalities Chromosomal disorders Cyanotic heart defects Nitric oxide Prophylactic phototherapy Unlikely to survive beyond 72 hours according to the attending neonatologist Do not require phototherapy

Ages Eligible for Study
-----------------
Minimum Age: 23 Weeks
Maximum Age: 33 Weeks

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CALF<br>Chest shield with aluminum foil | Device: Chest shield with aluminum foil (CALF)<br> <br> |
| Sham Comparator: SHIELD<br>Chest shield without aluminum foil | Device: SHIELD<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of symptomatic Patent ductus arteriosus |  | During first 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary Nitric oxide level |  | During first 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PDA, Jaundice, Phototherapy
Analysis on AEFI Surveillance Data for Live Attenuated Varicella Vaccine

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to observe the occurrence of adverse events of live attenuated varicella vaccine.

Conditions
-----------------
Varicocele

Intervention / Treatment
-----------------
* Biological: live attenuated varicella vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The registered permanent residence or resident place are local (reside more than 3 months); Participant preventive inoculation of varicella vaccine in 2014-2015; Adverse reactions occurred and should be reported in the AEFI monitoring system. Exclusion Criteria: Subjects with a known allergy to any ingredient of the vaccine, and with any allergy history to any vaccine; Subjects with any acute diseases, severe chronic diseases, acute bout of chronic diseases, and catching cold and fever; Subjects with uncontrolled seizures and other progressive neurological diseases, with a history of Guillain-Barré syndrome.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 15 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: live attenuated varicella vaccine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of adverse reactions |  | 1 year after the first and second doses | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vaccine Safety
Genetic Markers of Patients With History of Pulmonary Embolism Post Total Joint Arthroplasty

Study Overview
=================
Brief Summary
-----------------
This study seeks to uncover potential genetic determinants of pulmonary embolism (PE). Our translational goal is to ultimately identify certain genetic markers that will allow us to stratify patients in terms of their PE risk post total knee or total hip arthroplasty. The clinical implications for this study would allow for better patient care by lowering the risk of post-operative bleeding while still preventing symptomatic PEs and deep vein thromboses (DVTs). We look to sample patients who have a history of PE after undergoing total knee or total hip arthroplasty. We will sample these patients' blood DNA for a set of DNA genetic markers. To do so, we will utilize the Taqman assay, which is a PCR-based 5'-nuclease allelic discrimination assay to determine single nucleotide polymorphism (SNP) genotypes at specified loci. The region flanking the SNP is amplified using two allele-specific fluorescent probes, allowing for the detection of each allele in a single tube. Using this assay, there is no post-PCR processing because the probes are included in the PCR reaction (Hui). Using this approach, we will measure the frequency of genetic mutations in patients who have developed a PE after a total joint arthroplasty. This data would then be used to perform a prospective study to determine a subset of genetic markers that can definitively be used to risk stratify patients.

Official Title
-----------------
Risk Stratification Using Genetic Markers of Patients With a History of Pulmonary Embolism Post Total Hip or Total Knee Arthroplasty

Conditions
-----------------
Pulmonary Embolism

Intervention / Treatment
-----------------
* Genetic: Blood sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with a history of Pulmonary Embolism and Total Hip Arthroplasty or Total Knee Arthroplasty, between the ages of 18 and 70 years Exclusion Criteria:

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: Blood sample|5 mL of blood withdrawn from patients with history of pulmonary embolism post total hip arthroplasty or total joint arthroplasty|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of Genetic Mutations | identify the frequency of genetic mutations in patients who have developed a PE after a total joint or total hip arthroplasty | 6 weeks Post Total Hip Arthroplasty or Post Total Knee Arthroplasty |
Trabectedin and Irinotecan for Refractory Pediatric Sarcomas

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate patients with refractory childhood sarcomas, who have been treated with a combination therapy of trabectedin and irinotecan (within compassionate use), to determine, if this is a promising treatment option with acceptable toxicity and if the results warrant a prospective study.

Official Title
-----------------
Trabectedin and Irinotecan in Pediatric Refractory Sarcomas

Conditions
-----------------
Recurrent Childhood Soft Tissue Sarcoma, Recurrent Ewing Sarcoma, Recurrent Rhabdomyosarcoma

Intervention / Treatment
-----------------
* Drug: Combined chemotherapy with trabectedin followed by irinotecan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adolescents and young adults (age10 - 40 yoa) with refractory sarcoma, for which there are presently no further treatment options in EURO-Ewing/ EURAMOS/CWS (i.e. ≥ second relapse in ES, resistance to surgery in osteosarcoma, relapsed rhabdomyosarcoma) and have been treated with a combined chemotherapy of trabectedin and irinotecan (described in intervention) existing matched control in existing study databases have started of treatment within three months of last progress Key Exclusion Criteria: Patients newly diagnosed or in first relapse.

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Combined chemotherapy with trabectedin followed by irinotecan|Day 1: Trabectedin 1,1 - 1,5 mg/m²/day i.v. Day 3-5 and 10-12: Irinotecan 30- 90 mg/m²/day p.o. or i.v.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity during therapy | WHO toxicity grading | As long as patient is undergoing therapy/ 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Assessment of quality of life at the day before starting the next cycle and at months 3, 6, 9 and 12 after start of treatment, using adapted Karnofsky Score. | 12 months | 
| Assessment of therapeutic effect | Read out after every two cycles (functional imaging, PET-MRT/PET-CT), evaluation according to RECIST. | 12 months | 
| Assessment of time to treatment failure | Read out after every two cycles (functional imaging, PET-MRT/PET-CT), evaluation according to RECIST. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pediatric sarcomas, Ewing sarcoma, rhabdomyosarcoma, soft tissue sarcoma
Oral Paracetamol Premedication Effect on Maternal Pain in Amniocentesis

Study Overview
=================
Brief Summary
-----------------
This randomized controlled trial, compares perioperative and postoperative pain score by using visual analog scale in pregnant women undergoing amniocentesis. The experimental group will be given oral paracetamol premedication whereas the controlled group will be given oral placebo premedication.

Detailed Description
-----------------
Perioperative and postoperative amniocentesis are often painful which cause concerns to those who has to undergo amniocentesis. Anxiety is one of the factor that may prolong operative time, resulting in an increase risk of complication from the procedure. Furthermore, pregnant women, in order to relief the pain, might require others drugs, which has both maternal and fetal side effect. So In conclusion, this study aims to compare efficacy of oral paracetamol premedication and oral placebo premedication by using visual analog scale to evaluate pain.

Official Title
-----------------
Oral Paracetamol Premedication Effect on Maternal Pain in Amniocentesis: A Randomized Double Blind Placebo-controlled Trial

Conditions
-----------------
Amniocentesis

Intervention / Treatment
-----------------
* Drug: Paracetamol
* Drug: Placebo Oral Tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Singleton pregnant women undergo amniocentesis for the first time at Rajavithi Hospital in 2016-2017 Exclusion Criteria: Pregnant women with psychiatric disorder Contraindicated to paracetamol Pregnant women undergoing amniocentesis due to fetal anomaly Take oral paracetamol or other analgesics within 24-48 hrs before operation Deny to participate the research
Sexes Eligible for Study
-----------------
Female

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

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: Comparator1: Paracetamol 650 mg (325 mg/tablet) oral<br>Drug: Paracetamol Comparison pain score between paracetamol and placebo | Drug: Paracetamol<br> <br> |
| Placebo Comparator: Comparator 2: Placebo oral<br>Drug: placebo Comparison pain score between paracetamol and placebo | Drug: Placebo Oral Tablet<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Different in pain score on visual analog scale in amniocentesis between controlled group (placebo) and experimental group (paracetamol). |  | 1 yrs |
Efficacy and Safety of TJ-100 in the Treatment of Chronic Constipation

Study Overview
=================
Brief Summary
-----------------
TJ-100, a Japanese herbal medicine, is clinically effective in postoperative ileus. So it may activate bowel movement. This study will test the efficacy and safety of TJ-100 in the treatment of patients with chronic constipation.

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

Intervention / Treatment
-----------------
* Drug: TJ-100


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chronic constipation defined as less than 3 spontaneous bowel movement frequencies per week had symptoms of abdominal bloating or discomfort Exclusion Criteria: mechanical bowel obstruction clinically systemic disease-induced constipation pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 89 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

| Intervention/Treatment |
| --- |
|Drug: TJ-100|TJ-100 2.5g three times per day for 6 weeks|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bowel movement frequency, rescue medication use, symptom assessments, bowel gas volume measurement, adverse events |  | baseline (4 weeks) | 
| Bowel movement frequency, rescue medication use, symptom assessments, bowel gas volume measurement, adverse events |  | 6 weeks | 
| Bowel movement frequency, rescue medication use, symptom assessments, bowel gas volume measurement, adverse events |  | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
constipation
A Safety, Tolerability and Pharmacokinetic Study of ABT-102 in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of three different strengths of an investigational product dosed twice a day over 7 days in healthy subjects.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study of the Safety, Tolerability and Pharmacokinetics of ABT-102 in Healthy Subjects

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: ABT-102
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and Females with a condition of general good health. Must be willing to participate in all study-related procedures. Exclusion Criteria: History of significant sensitivity to any drug. Allergy to soy lecithin, soybeans, soybean oil, or other soybean derivatives. A requirement for medications, vitamins and/or herbal supplements during the study. Pregnant or breast-feeding. History of drug or alcohol abuse. Positive Hepatitis or HIV test. History of certain medical conditions or any uncontrolled medical illness. History of certain gastrointestinal surgeries that may interfere with gastrointestinal motility, PH or absorption. Current participation in another clinical study or receipt of investigational drug within the past 6 weeks.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>ABT-102 Tablets, 4 mg BID | Drug: ABT-102<br>* BID tablets, 7 days of treatment<br>|
| Active Comparator: 2<br>ABT-102 Tablets BID, escalating dose | Drug: ABT-102<br>* BID tablets, 7 days of treatment<br>|
| Active Comparator: 3<br>ABT-102 Tablets BID, escalating dose | Drug: ABT-102<br>* BID tablets, 7 days of treatment<br>|
| Placebo Comparator: 4<br>Placebo Tablets, BID | Drug: Placebo<br>* BID tablets, 7 days of treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the safety and tolerability of ABT-102 vs placebo in healthy adults. |  | 10 days | 
| To determine the plasma concentrations and pharmacokinetic parameters of multiple does of ABT-102 vs. placebo in healthy adults. |  | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exploratory analyses of Quantitive Thermosensory Testing (Warm Detection Threshold, Cold Detection Threshold, Warm Pain Threshold) done at peripheral and oral sites, will be done for ABT-102 and placebo treated subjects. |  | 10 days |