linjc16/ctgov huggingface dataset:
Detection of Meconium in Amniotic Fluid in Post Term Pregnancies

Study Overview
=================
Brief Summary
-----------------
Meconium constitutes the bowel contents of the fetus and is normally expelled only after birth. However, it may be secreted into the amniotic fluid of 20% of all fetuses. Meconium Stained Amniotic Fluid had been recognized from ancient times as an obstetric hazard which complicates delivery and is associated with increased newborn morbidity and mortality. At present there is no viable diagnostic test for Meconium prior to the onset of labor and the rupture of membranes. The system developed for the detection of Meconium, based on recognizing a characteristic fluoroscopic spectral pattern emitted by Meconium under light excitation at a specific wavelength. The diagnostic test being developed does not require penetration into the amniotic sac and is safe, painless and simple to perform.

Official Title
-----------------
Detection of Meconium in Amniotic Fluid in Post Term Pregnancies

Conditions
-----------------
Meconium

Intervention / Treatment
-----------------
* Other: amniometer model po1


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 37-42 weeks regnancy without rupture of membranes Exclusion Criteria: none
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| volunteers<br> | Other: amniometer model po1<br>* The detection of Meconium, is based on recognizing a characteristic fluoroscopic spectral pattern emitted by Meconium under light excitation at a specific wavelength. The diagnostic test does not require penetration into the amniotic sac and is safe, painless and simple to perform.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the capability for diagnosing Meconium stained Amniotic Fluid prior to a cervical ripening procedure in women, using the Amniometer device |  | prior to breakage of water | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
amniotic fluid, post term pregnancies
Comparison of Two Laser Therapy Methods for PDR

Study Overview
=================
Brief Summary
-----------------
Proliferative diabetic retinopathy (PDR) is treated with conventional pan retinal photocoagulation (PRP) which can improve the visual prognosis in this complication significantly. However , the treatment may also resulting adverse effects such as blurring of central vision, visual field constriction and disturbance in dark adaptation and contrast vision. Extended targeted retinal coagulation (TRP) to the ischemic areas may cause regression of the neovascularization while minimizing some of the risks and complication associated of treatment of PDR with these two methods.

Official Title
-----------------
Comparison Between Result and Side Effects of Treatment of Prolifrative Diabetic Retinopaty by Conventional and Extended Targeted Pan Retinal Photocoagolation

Conditions
-----------------
Proiriftrative Diabetic Retinopathy

Intervention / Treatment
-----------------
* Procedure: conventional prp
* Procedure: targeted prp


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with PDR condidate for photocoagulation teraphy Pupil with dilatasion≥6mm without privious treatment with anti VEGF drugs 3months before study without privious vitroretinal sugery without privoius lasertraphy Exclusion Criteria: To have NVI cricteria with increase of inraocular pressure to have cataract or vitrus leakage which prevent lasertraphy pupil smaller that 6mm traditional retinal detachment privious treatment with anti VEGF drugs 3months before study privious PRP patient unable to get wide field FAG
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: conventional prp<br> | Procedure: conventional prp<br>* pan retinal photocoagulation<br>|
| Active Comparator: targeted PRP<br> | Procedure: targeted prp<br>* 1200-1600 spot in far periphery retin, anterior equator<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| no leakage in widefield fluorescin angiography |  | 3 months after lasertraphy |
Temporal Trends of COronary Artery Disease and PEripheral Artery Disease (COPE) in Korea

Study Overview
=================
Brief Summary
-----------------
Cardiovascular disease (CVD) is caused by atherosclerosis of the artery and is classified into coronary artery disease, cerebrovascular disease, and peripheral arterial disease, depending on the location of the artery and the target organs. However, since CVD share a similar pathophysiology and the probability of incidence of other CVD in CVD patients is very high. It is thought that CVD incidence and mortality can be reduced by predicting the degree of incidence of other CVD in CVD patients. The aim of this study is to investigate the incidence and mortality of other CVD diseases in CVD patients.

Official Title
-----------------
Temporal Trends in the Incidence, Treatment Patterns, and Outcomes of COronary Artery Disease and PEripheral Artery Disease (COPE) in Korea

Conditions
-----------------
Coronary Artery Disease, Peripheral Artery Disease, Cardiovascular Diseases

Intervention / Treatment
-----------------
* Other: Observational study, no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Koreans who diagnosed with coronary artery disease between 2009 and 2018 Koreans who diagnosed with peripheral artery disease between 2009 and 2018 Koreans who diagnosed with cerebrovascular disease between 2009 and 2018 more than 18 years old Exclusion Criteria: less than 18 years old

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Observational study, no intervention|Observational study, no intervention|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of coronary artery disease, cerebrovascular disease, peripheral arterial disease | Among all Koreans, percentage (%) of patients with a history of being diagnosed with CVD and underwent in-hospital treatment | Up to 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1-year mortality | The percentage (%) of any CVD related mortality | Up to 1 year |
Pharmacogenetics Of Vinorelbine In Malignant Pleural Mesothelioma Patients

Study Overview
=================
Brief Summary
-----------------
This is a multicenter retrospective analysis .The aim of the present study is to investigate the molecular predictors of vinorelbine response in tumor samples of a series of MPM patients and evaluate the possible impact on clinical outcome. Sample size: around 150 patients based on the availability of tumor size

Detailed Description
-----------------
Vinorelbine has recently become an alternative option for palliation in selected pemetrexed-pretreated patients with malignant pleural mesothelioma (MPM). However, nowadays there are no definitive data about vinorelbine predictors of response in MPM patients. The identification of molecular predictors of effective therapy is important for maximizing therapeutic efficacy and minimizing useless treatment in cancer patients. In oncology a pharmacogenetic approach to customize the chemotherapy treatment according to individual as well as tumour genetic characteristics represents a modern and intriguing challenge. Recent studies have suggested that the expression levels of class III β-tubulin (TUBB3) or BRCA1, are related to a survival benefit from vinorelbine chemotherapy among patients with advanced solid malignancies, especially non-small cell lung cancer. There are no data about the predictive factors to vinorelbine in MPM patients. The identification of molecular predictors of effective therapy may allow in the future the development of better therapies.

Official Title
-----------------
Pharmacogenetics of Vinorelbine in Malignant Pleural Mesothelioma Patient

Conditions
-----------------
Malignant Pleural Mesothelioma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: MPM patients treated with vinorelbine in the ≥ second line setting will be retrospectively analyzed Patients will be selected based on the availability of tumor tissue Exclusion Criteria: NA
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| no treatment<br>no treatment | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expression of TUBB3 and BRCA1 in MPM tumor tissue by immunohistochemistry and RT-PCR. |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association of expression of TUBB3 and BRCA1 with clinical outcome (response, survival) . |  | 2 months |
Intraoperative Hyaluronic Acid Gel Injection for Improvement of Scar Quality Following Reduction Mammaplasty

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the efficacy of hyaluronic acid gel injections compared to saline injections in improving scar quality in patients undergoing breast reduction surgery. Hyaluronic acid has been implicated in scarless fetal healing, and the investigators therefore hypothesize that injections of hyaluronic acid gel into breast reduction incisions will improve their appearance compared to injections of saline.

Official Title
-----------------
Intraoperative Hyaluronic Acid Gel Injection for Improvement of Scar Quality Following Reduction Mammaplasty: a Phase III Double-blinded, Single-centred, Randomized Controlled Study

Conditions
-----------------
Cicatrix

Intervention / Treatment
-----------------
* Device: Hyaluronic acid gel
* Device: Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adequate organ function (BUN < 4.0 mmol/L; serum creatinine < 120 micromol/L; Hgb > 100 g/L; WBC > 4,000/mm3 and < 12,000/mm3; platelets > 100,000/mm3) age 18 years or older, with a minimum life expectancy of 2 years current non-smoker American Society of Anaesthesiology score of 1 or 2 ability to provide informed consent Exclusion Criteria: previous history of breast surgery; known allergy to polyglactin, poliglecaprone, or injectable hyaluronic acid gel (Restylane or Prevelle) history of current or recent (<2 months) immunosuppression documented hypersensitivity to streptococcal products acute or chronic skin diseases such as folliculitis or psoriasis history of bleeding dyscrasia or active anticoagulation (INR>2.0) pregnancy or active breast-feeding any additional surgical procedures performed in the same surgical session in the same anatomical region personal or family history of susceptibility to keloid or hypertrophic scar formation Fitzpatrick skin type 5 or 6.

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

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hyaluronic acid gel<br> | Device: Hyaluronic acid gel<br>* Hyaluronic acid gel (20 mg/mL), 0.9 mL, intradermal over 2 cm area, once<br>* Other names: Hyaluronate;|
| Active Comparator: Saline<br> | Device: Saline<br>* Normal saline, 0.9 mL, intradermal over 2 cm area, once<br>* Other names: Normal saline;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rasch analysis-modified Objective Scar Assessment Score (OSAS) value |  | 12 months post-operatively |
Utility of Restrata With Split Thickness Skin Graft to Reconstruct the Forearm Donor Site

Study Overview
=================
Brief Summary
-----------------
Understand association between use of Restrata (Acera Surgical Inc., St. Louis, MO) in forearm flap reconstruction with donor site healing and function

Official Title
-----------------
Utility of Restrata With Split Thickness Skin Graft to Reconstruct the Forearm Donor Site

Conditions
-----------------
Wound Heal

Intervention / Treatment
-----------------
* Device: Restrata


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients age 19 or greater that will undergo radial forearm free flap or ulnar free flap. Photo documentation of wound bed at two weeks and four weeks must be obtainable either by physician or patient. Exclusion Criteria: Active systemic immunosuppression (active use of high-dose steroids (≥40mg prednisone daily or equivalent) or other immunosuppressive medications OR medical conditions causing immunosuppression, i.e. human immunodeficiency virus etc). Diabetes mellitus with most recent Hemoglobin A1c ≥10.0 within 30 days prior to surgery. Morbid obesity (BMI >40). Inability to maintain wrist immobilization for full planned period. Severe malnutrition (prealbumin levels <10 mg per dL within 30 days prior to surgery OR BMI <15 (very severely underweight). Other conditions felt to significantly impair wound healing per surgeon discretion.

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Restrata with a split-thickness skin graft<br> | Device: Restrata<br>* Restrata is a sterile, single use device intended for use in local management of wounds<br>|
| No Intervention: Split-thickness skin graft alone<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tendon Exposure | Percentage of participants with tendon exposure | 4 weeks post-operatively | 
| Surface Area of Split-thickness Skin Graft Incorporation | Percentage of surface area of split-thickness skin graft incorporation | 4 weeks post-operatively |
Study Evaluating Single Doses of BLI-489 in Healthy Japanese Male Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and tolerability of single doses of BLI-489 administered intravenously in healthy Japanese male subjects, and how the drug is absorbed and eliminated.

Official Title
-----------------
Ascending Single Dose Study of the Safety, Tolerability, and Pharmacokinetics of BLI-489 Administered Intravenously to Healthy Japanese Male Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: BLI-489
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men, aged 20 to 50 years of age inclusive at screening. Body mass index (BMI) in the range of 17.6 to 26.4 kg/m2 and body weight ≥45 kg. Healthy as determined by the investigator on the basis of the screening evaluations. Nonsmoker of smoker of fewer than 10 cigarettes per day as determined by history. Exclusion Criteria: Presence of history of any disorder that may prevent the successful completion of the study. History of drug abuse within 1 year.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>BLI-489 | Drug: BLI-489<br> <br> |
| Placebo Comparator: 2<br>Placebo | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety as measured by the number of adverse events and serious adverse events. Tolerability will be assessed based upon the occurrence of dose limiting toxicities. |  | 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics as evaluated by drug concentrations in the blood and urine. |  | 4 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy Subjects
Correlation Between Glycated Hemoglobin and Mean Plasma Glucose in Hemodialysis Patients

Study Overview
=================
Brief Summary
-----------------
The investigators are studying the correlation between Hba1c and the mean plasma glucose in diabetic hemodialysis patients.We are reviewing if HbA1c is a good clinical tool to assess glycemic control over a 3 months duration in hemodialysis patients

Detailed Description
-----------------
The Hb turnover in hemodialysis population is higher than the general population leading to a general believe that HbA1c tend to underestimate mean plasma glucose. The investigators are trying to define the correlation between mean plasma glucose and HbA1c in the hemodialysis population and trying to study the factors that could affect this correlation (dose of erythropoetin, ret count..) We are trying to see if HbA1c is a better tool to assess glycemic control over 1 month than glycemic control over 3 month. This clinicaly will translate in obtaining HbA1c more frequently in hemodialysis patients to assess their glycemic control.

Official Title
-----------------
Correlation Between Glycated Hemoglobin and Mean Plasma Glucose in Hemodialysis Patients.

Conditions
-----------------
ESRD

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age>18 Hemodialysis and diabetic Lab data are available for more than 6 months Exclusion Criteria: Lab data not available

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 |
| --- | --- |
| diabetic hemodialysis<br>all patient diabetic and on hemodialysis were involved if they are on hemodialysis for more than 3 months | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure levels of plasma blood glucose and HbA1c |  | 6 month intervals | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure ferritin, erythropoetin dose, reticulocytes count |  | 6 month intervals | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
glycated hemoglobin, mean plasma glucose
Novel Pulmonary Function Measures for Diagnosis of Bronchiolitis Obliterans Syndrome Following Hematopoietic Stem-Cell Transplantation in Children

Study Overview
=================
Brief Summary
-----------------
In this study, we will study 129Xe-MRI and LCI as tools for diagnosis of BOS in pediatric patients who have received Hematopoietic Stem Cell Transplantation (HSCT) and have been identified as eligible for this study. Participants will be required to have vital signs collected, complete breathing tests and complete an MRI. The MRI will require participants to perform breath holds in the MRI scanner with xenon gas while being coached by a research assistant.

Official Title
-----------------
Novel Pulmonary Function Measures for Diagnosis of Bronchiolitis Obliterans Syndrome Following Hematopoietic Stem-Cell Transplantation in Children

Conditions
-----------------
Bronchiolitis Obliterans Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female participants aged 6 -17.9 years old. Received HSCT treatment at least 6 months prior to enrollment in study. Participants should have an FEV1%pred value greater than 40%. Participant understands the study procedures and is willing to participate in the study as indicated by signature on the informed consent or assent. Participant must be able to perform a breath hold for 16s. Participant meets MRI screening criteria Exclusion Criteria: Participant has had a cold or respiratory infection in the last four weeks. Participant requires supplemental oxygen or has a daytime room air oxygen saturation ≤ 95%. Participant is unable to perform spirometry or plethysmography maneuvers. Participant is pregnant or lactating.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum 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 |
| --- | --- |
| Group 1<br>Participants who meet the screening criteria for the development of bronchiolitis obliterans syndrome (BOS) according to the NIH criteria | |
| Group 2<br>Participants who may or may not have abnormal spirometry; however they do not fulfill the NIH criteria for the development of BOS | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of MRI | Perform xenon MRI, in participants with and without a diagnosis of BOS as defined by NIH criteria. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation | Correlate MRI with conventional breathing tests | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lung, Stem cell transplantation, Xenon MRI