linjc16/ctgov huggingface dataset:
The Effect of Bevacizumab (Avastin) on Pterygium

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether local injection of bevacizumab might halt and or cause regression of pterygium growth. This may enable earlier treatment and prevention of pterygium growth into the patient's line of sight thereby limiting the need for surgery and improving quality of life for patients with pterygia.

Official Title
-----------------
The Effect of Bevacizumab (Avastin) on Pterygium

Conditions
-----------------
Pterygium

Intervention / Treatment
-----------------
* Drug: local injection of bevacizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 19 years of age and older Diagnosis of pterygia healthy enough to make scheduled follow-up visits Exclusion Criteria: Women of childbearing potential and males who plan to father a child during their participation in the study will be excluded from the study.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bevacizumab<br>Bevacizumab injection: 0.1ml, 6 monthly doses plus baseline and 1 week post baseline | Drug: local injection of bevacizumab<br>* Upon enrollment into the study: - initial injection of bevacizumab, a 1 week post-injection visit,and monthly visits thereafter for a total of 6 months. At the 1-month and 3-month visit post-injection visit, an additional bevacizumab injection will be offered if pterygium regression has not occurred. All injections of bevacizumab will consist of injecting 0.1mL of a 2.5mg/0.1mL concentration of bevacizumab into the head of the pterygium.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Area the Pterygium Enlarged or Regressed as Measured From the Limbus Before and After Subconjunctival Bevacizumab Injection. | Growth of the pterygium was defined as an increase in the area of the pterygium as measured from the limbus toward the visual axis. This would be a positive change value indicating progression Regression of the pterygium was defined as a decrease in the area of the pterygium length measured from the limbus toward the visual axis. This would be negative change value indicating regression. | Baseline and 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Having Surgical Removal of Pterygium. | The number of patients having surgical removal of pterygium within 12 months. | 12 months |
A Study to Assess Safety, Tolerability and PK of AZD2171 and Chemotherapy on Patients With Solid Tumors

Study Overview
=================
Brief Summary
-----------------
A multicentre, 2-part study to assess the safety and tolerability of once daily oral doses of AZD2171 when administered with various anticancer regimens (part A) and to confirm the tolerability of its combination with FOLFOX (part B).

Official Title
-----------------
A Phase 1, Open Label Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD2171 and Selected Chemotherapy Regimens When Given in Combination to Patients With Advanced Solid Tumors

Conditions
-----------------
Advanced Solid Tumor

Intervention / Treatment
-----------------
* Drug: AZD2171
* Drug: FOLFOX
* Drug: Pemetrexed
* Drug: Irinotecan (administered with & without Cetuximab)
* Drug: Docetaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histologically confirmed metastatic cancer that is not amenable to surgery or radiation therapy with curative intent measurable lesion by CT or other techniques according to RECIST Exclusion Criteria: Inadequate bone marrow reserve history of poorly controlled hypertension

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: AZD2171|oral tablet once daily|
|Drug: FOLFOX|intravenous infusion|
|Drug: Pemetrexed|intravenous infusion|
|Drug: Irinotecan (administered with & without Cetuximab)|intravenous injection|
|Drug: Docetaxel|intravenous infusion|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the safety and tolerability of once daily oral doses of AZD2171 when given in combination with one of these anticancer regimens; FOLFOX, Pemetrexed, Irinotecan, Docetaxel |  | After 5 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Examine the PK interaction of AZD2171 with one of the 4 different chemotherapeutic regimens. Make a preliminary evaluation of clinical response as measured by objective response rate. |  | Assessed at each visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
advanced solid tumors, AZD2171, Phase I
A Data Collection Study for Patients With Adenocarcinoma Treated With the MyVaccx Immunotherapy Regimen.

Study Overview
=================
Brief Summary
-----------------
A retrospective and prospective data collection study on 27 consecutive subjects with adenocarcinoma who were treated using the MyVaccx system by Dr. Gary Onik. Retrospective data were collected on the treatment with the immunotherapy system and prospective data will be collected as they are prospectively monitored through their normal standard of care for their original cancer.

Official Title
-----------------
A Retrospective and Prospective Study of a New Immunotherapy Regimen (MyVaccx) for Patients With Adenocarcinoma.

Conditions
-----------------
Adenocarcinoma

Intervention / Treatment
-----------------
* Drug: Immunotherapeutic Agents
* Device: Ablation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Treatment with the MyVaccx System Greater than 18 years of age Signature of the informed consent Exclusion Criteria: 2 subjects treated with the MyVaccx System with known visceral disease

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| Adenocarcinoma treated with MyVaccx<br>MyVaccx combines tumor ablation and immunotherapeutic agents for treatment of late stage cancer disease.. | Drug: Immunotherapeutic Agents<br>* Antigen exposure immediately followed by in situ injection of combination of immunotherapeutic agents<br>* Other names: Yervoy, Keytruda, Leukine;Device: Ablation<br>* Antigen exposure immediately followed by in situ injection of combination of immunotherapeutic agents<br>* Other names: Cryo and radio frequency (RF) ablation;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MyVaccx immunotherapy treatment impact on late stage cancer disease | Time to death after the start of treatment | From date of treatment until the date of death from any cause up to 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MyVaccx immunotherapy treatment impact on late stage cancer disease | Complete and partial response to treatment based on the iRESIST criteria | Time to progression after a complete or partial response up to 60 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prostate cancer, lung cancer, pancreatic cancer, colorectal cancer, bladder cancer
Evaluation of the ECOM™ Monitor for Continuous and Non-invasive Measure of the Cardiac Output in Cardiac Surgery Patients

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to estimate the reliability of the determination of the cardiac output measured by the ECOM™ device. This study will be performed with the latest version of the software which should give better results than those published previously. Two techniques of measure of the cardiac output will be compared: the reference measure by trans-esophageal echography and the bioimpedance used by the ECOM™. monitor.

Conditions
-----------------
Cardiac Surgery

Intervention / Treatment
-----------------
* Device: ECOM™.
* Device: Trans-esophageal echography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over18 years Needed cardiac surgery, Needed a monitoring by transesophageal ultrasound , Benefiting from a social security scheme Having given their written consent. Exclusion Criteria: Pregnant or breast-feeding women, Allergy to polyvinylchloride (PVC), The patients for whom a difficulty of ventilation with a mask or intubation is envisaged, Contraindication to transesophageal ultrasound, a steady cardiac arrhythmia, a flight or an aortic shrinkage.

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cardiac Surgery<br> | Device: ECOM™.<br> <br> Device: Trans-esophageal echography<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac output |  | 4 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiac output
XLIF® vs. MAS®TLIF for the Treatment of Symptomatic Lumbar Degenerative Spondylolisthesis With or Without Central Stenosis.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine differences in the XLIF and TLIF procedures with respect to perioperative variables in adult patients with low-grade symptomatic spondylolisthesis.

Detailed Description
-----------------
The study is a prospective multi-center randomized evaluation of clinical and radiographic outcomes of two commonly used lumbar interbody fusion procedures (XLIF and TLIF) in adult patients with low-grade symptomatic spondylolisthesis. The study seeks to identify differences between the procedures with respect to perioperative variables.

Official Title
-----------------
A Prospective Multi-Center Randomized Evaluation of the Clinical and Radiographic Outcomes of XLIF® Compared With MAS® TLIF for the Treatment of Symptomatic Lumbar Degenerative Spondylolisthesis With or Without Central Stenosis

Conditions
-----------------
Spondylolisthesis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Male and female patients who are at least 18 years of age; - Patients who present with symptomatic Grade I or II degenerative spondylolisthesis at 1 or 2 contiguous lumbar levels between L1 and L5 and are surgical candidates for interbody lumbar fusion surgery; symptoms should include radiculopathy and/or neurogenic claudication with or without back pain; - Patients who have been unresponsive to at least 6 months of conservative treatments or exhibit progressive neurological symptoms in the face of conservative treatment; - Patients who understand the conditions of enrollment and are willing to sign an informed consent to participate in the study. Exclusion Criteria: - Patients with lumbar pathologies requiring treatment at more than 2 levels; - Patients who have had previous lumbar fusion surgery; - Patients with lytic spondylolisthesis or a defect of the pars interarticularis; - Patients with radiographic confirmation of Grade IV facet joint disease or degeneration; - Patients with non-contained or extruded herniated nucleus pulposus

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 |
| --- | --- |
| XLIF<br>This group will have the XLIF procedure done. | |
| MAS TLIF<br>This group will have the MAS TLIF procedure done. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The average improvement in clinical function (ODI) at 24 months compared with baseline, for each procedure. |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The average improvement in pain (VAS) at 24 months compared with baseline, for each procedure. |  | 24 months |
Reliability of Ultrasound Assisted Epidural Analgesia in Obese and Normal Weight Parturients

Study Overview
=================
Brief Summary
-----------------
This study wants to investigate if ultrasound assisted epidural catheter insertion for labor analgesia is easier and safer to the standard epidural technique.

Detailed Description
-----------------
This study has four specific aims: to evaluate congruity between palpatory technique and ultrasound lumbar evaluation to identify the correct spinal space; to compare between ultrasound evaluation and needle measure of skin-epidural space depth; to compare between longitudinal and transverse ultrasound epidural space depth in obese and normal parturients; to check the reduction of complications and failure rates of epidural analgesia with ultrasound assistance.

Official Title
-----------------
Reliability of Ultrasound Assisted Epidural Analgesia in Obese and Normal Weight Parturients

Conditions
-----------------
Pregnancy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all women who request epidural analgesia for labor Exclusion Criteria: all women who present contraindication for epidural analgesia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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 |
| --- | --- |
| normal subjects<br>parturients admitted to the labor ward who request epidural analgesia with BMI < 30 | |
| obese subjects<br>parturients admitted to the labor ward who request epidural analgesia with BMI > 30 | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The congruity between palpatory technique and ultrasound lumbar evaluation | The congruity between palpatory technique and ultrasound lumbar evaluation to identify the correct spinal space performing epidural analgesia | participants will be followed for the duration of hospital stay, an expected average of 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Longitudinal and transverse ultrasound epidural space depth in obese and normal parturients | Longitudinal and transverse ultrasound epidural space depth in obese and normal parturients will be measured and compared to the needle depth | participants will be followed for the duration of hospital stay, an expected average of 3 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
epidural analgesia, ultrasound, labor analgesia, labor
Lamellar Body Counts on Gastric Aspirate in Healthy Term Newborns

Study Overview
=================
Brief Summary
-----------------
The aim of this study to determine the reference ranges of LBC on gastric aspirate in healthy term newborns.

Detailed Description
-----------------
Lamellar bodies represent the storage form of lung surfactant. Surfactant is produced in alveolar type II cells and transported to the alveolar surface as lamellar bodies. Lamellar bodies are present in the amniotic fluid and also gastric aspirate.It has become a preferred test for determine fetal lung maturity, because of the rapid, inexpensive, easily accessible and easily applicable method.

Official Title
-----------------
Reference Ranges of Lamellar Body Counts on Gastric Aspirate in Healthy Term Newborns

Conditions
-----------------
Infant, Newborn, Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: infants born at ≥ 37 weeks of gestation and birth weight ≥ 2500 g Exclusion Criteria: intubated immediately after birth, infants with respiratory distress, infants with gestational pathology that can influence fetal lung maturity (cases with premature rupture of membranes, preeclampsia/eclampsia, gestational diabetes, oligohydramnios/polyhidramnios or antenatal steroid use), infants with major congenital or chromosomal abnormalities and lack of parental consent, therapeutic infusion was given in the amniotic cavity or if gastric aspirate contaminated by meconium, pus or blood.

Ages Eligible for Study
-----------------
Minimum Age: 10 Minutes
Maximum Age: 30 Minutes

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| observational<br>healthy newborns | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| normal levels of lamellar body counts on gastric aspirate in healthy term newborns. |  | 2 months |
NADPH Oxidase Polymorphisms in Obstructive Sleep Apnea Syndrome (OSAS)

Study Overview
=================
Brief Summary
-----------------
Obstructive Sleep Apnea (OSA) is associated with increased oxidative stress. The major sources of Reactive Oxygen Species (ROS) in the vasculature are the NADPH oxidases. Several polymorphisms related to NADPH oxidase expression or NADPH oxidase activity has been identified. The investigators are going to compare the distribution of the allelic frequencies of A-930G and C242T polymorphisms and their possible relationship with the levels of 8-isoprostanes as a marker of oxidative stress in patients with OSA and in a control group without OSA.

Detailed Description
-----------------
DESIGN: CASE-CONTROL STUDY METHODS: We are going to determine the A-930G and C242T p22phox genotypes in patients with OSA and healthy subjects recruited from sleep unit of Son Dureta University Hospital, (Palma de Mallorca, Spain). 8-Isoprostane is going to be measured as an oxidative stress marker with an 8-isoprostane EIA kit (Cayman Chemicals Company, USA) in plasma samples.

Official Title
-----------------
NADPH Oxidase p22phox Polymorphisms and Oxidative Stress in Patients With Obstructive Sleep Apnea

Conditions
-----------------
Sleep Apnea Syndrome, Oxidative Stress, Single Nucleotide Polymorphism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:Polyysomnografic study with Apnoea/Hypoapnoea Index higher to 10 in patients and lower in controls. Exclusion Criteria: chronic obstructive pulmonary disease, liver cirrhosis, thyroid dysfunction, rheumatoid arthritis, chronic renal failure and/or psychiatric disorders.

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NADPH oxidase
The Efficacy and Safety of Topical Valproic Acid in Preventing Hair Loss

Study Overview
=================
Brief Summary
-----------------
Beta-catenin, the transducer of Wnt signaling, is critical in development, growth, and regeneration of hair. In the absence of Wnt signals, cytoplasmic β-catenin is maintained at low level through regulation by GSK-3, multifunctional serine/threonin kinase. After phosphorylation by GSK-3, β-catenin is ubiquitinated and degraded in cytoplasm. Therefore, inhibition of GSK-3 is able to increase β-catenin in nucleus and would be able to induce growth of hair. Valproic acid (VPA) is an anticonvulsant and mood-stabilizing drug used for decades and is known to inhibit the GSK-3β. However, the effect of VPA on hairs has not been studied yet.

Official Title
-----------------
The Efficacy and Safety of Topical Valproic Acid in Preventing Hair Loss

Conditions
-----------------
Androgenetic Alopecia, Male Pattern Baldness

Intervention / Treatment
-----------------
* Drug: Valproic Acid
* Drug: Control placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age: 19 years   45 years subjects with AGA (Hamilton&Norwood grad III IV) subjects who are able to be followed for next 24 weeks. Exclusion Criteria: subjects with severe medical problems including cardiovascular diseases, renal problems, and chronic metabolic disease subjects with AGA treated with surgical methods (hair TPL) subjects who has ever applied minoxidil in recent 3 months or has taken finasteride or dutasteride in recent 6 months. subjects who took medicine which can affect the hair growth subjects with alopecia other than AGA

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 45 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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sodium valproate<br>spray 7.2% of sodium valproate on scalp twice a day (morning and evening) for 24 weeks | Drug: Valproic Acid<br>* spray 7.2% of sodium valproate on scalp twice a day (morning and evening) for 24 weeks<br>|
| Placebo Comparator: Control<br>spray vehicle without sodium valproate on scalp twice a day (morning and evening) for 24 weeks | Drug: Control placebo<br>* spray vehicle without sodium valproate on scalp twice a day (morning and evening) for 24 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| linear hair growth rate | the average growth rate of hair shaft for 3 days | 24th week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| final hair density | total count of hair in a 1cm-diametered circle | 24th week |