linjc16/ctgov huggingface dataset:
URINARY VEGF Levels in GBM Patients on Radiation Treatment Protocol

Study Overview
=================
Brief Summary
-----------------
Study of the urinary vascular endothelial growth factor (VEGF) levels in patients with glioblastoma, receiving standard therapy. Hypothesis: that urinary VEGF levels can serve as a predictor of treatment response and survival.

Detailed Description
-----------------
Measurement of urinary VEGF levels pre treatment,immediately after treatment, and 1 month after treatment

Official Title
-----------------
Urinary VEGF and MMP Levels in Patients Receiving Radiation Therapy for Glioblastoma Multiforme: Prospective Determination of a Predictive Value for Recurrence

Conditions
-----------------
Glioblastoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient must be enrolled on an RTOG GBM study that prescribes 6000 cGy of radiation therapy. Patient must meet the eligibility requirements for the RTOG treatment study. (If the patient is deemed retrospectively ineligible for the RTOG treatment study, the patient will likewise be ineligible for this study.) Patient must sign a study-specific informed consent for RTOG 0611 prior to study entry. Exclusion Criteria: Patient not able to receive 6000 cGy of radiation therapy.

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

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

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

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GBM, glioblastoma, urine, VEGF, radiation, Patients must be enrolled to an RTOG GBM study that prescribes 6000 cGy of radiation therapy.
Trial of Autologous Mesenchymal Stem Cells in Patients With Multiple System Atrophy

Study Overview
=================
Brief Summary
-----------------
This study is based on positive results in open label trial of mesenchymal stem cells therapy in patients with Multiple System Atrophy (MSA).

Official Title
-----------------
A Double-blind Placebo-controlled Randomized Clinical Trial of Autologous Mesenchymal Stem Cells in Patients With Multiple System Atrophy

Conditions
-----------------
Multiple System Atrophy

Intervention / Treatment
-----------------
* Biological: autologous mesenchymal stem cells
* Biological: normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 75 Years Old or Less Multiple System Atrophy Voluntary Participants Exclusion Criteria: Doubted dementia (MMSE < 24) Severe febrile condition Serum SGOT/SGPT three times above Malignant mass

Ages Eligible for Study
-----------------
Maximum Age: 75 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 |
| --- | --- |
| Placebo Comparator: normal saline<br> | Biological: normal saline<br>* saline<br>|
| Experimental: autologous mesenchymal stem cells<br> | Biological: autologous mesenchymal stem cells<br>* 4*107 stem cell (100ml) Intra arterial infusion/ one time, then 4*107 stem cell(100ml)Intravenous infusion 3 times/monthly -> Total four times<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scores on unified MSA rating scale | The statistical difference between scores before and after autologous mesenchymal stem cells treatment of unified MSA rating scale will be measured every month and every year using paired t-test. | one month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
voluntary participants, 75 years old or less
Mindfulness Meditation Format Pilot Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess feasibility of an internet and individual format of mindfulness meditation in people with posttraumatic stress disorder (PTSD) and depression symptoms

Detailed Description
-----------------
Internet and individual formats of mindfulness meditation have not been previously evaluated. In order establish feasibility of such formats a pilot study is need. The current study will randomize up to 20 people with PTSD and depression symptoms and evaluate changes in PTSD and depression symptoms from before to after the internet and individual mindfulness meditation interventions.

Official Title
-----------------
Mindfulness Meditation Format Pilot Study

Conditions
-----------------
Depression, Posttraumatic Stress Disorder

Intervention / Treatment
-----------------
* Behavioral: Internet Mindfulness Meditation
* Behavioral: Individual Mindfulness Meditation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Good general health Age 25-65 Access to internet PTSD symptoms (score >14 on PTSD screen) Depression symptoms (endorsement of one question on depression screen) Stable on medications six weeks prior to the study Willing to be stable on medications during study Exclusion Criteria: Significant potentially life-limiting acute medical illness Risk for suicide >2 drinks/day of alcohol and street drug use besides marijuana Current daily meditation practice

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 65 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: Internet Mindfulness Meditation<br> | Behavioral: Internet Mindfulness Meditation<br>* one hour session each week for six weeks<br>|
| Experimental: Individual Mindfulness Meditation<br> | Behavioral: Individual Mindfulness Meditation<br>* one hour session each week for six weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Posttraumatic Stress Disorder Checklist | The Posttraumatic Stress Disorder Checklist will be administered immediately before their first intervention session and within one week of their last intervention session. The primary outcome is the change in score on this instrument from baseline to week 7. | Change from baseline to week 7. | 
| Beck Depression Inventory | The Beck Depression Inventory will be administered immediately before their first intervention session and within one week of their last intervention session. The primary outcome is the change in score on this instrument from baseline to week 7. | Change from Baseline to Week 7 |
Early Breast Feeding and Glucose Levels in High Risk Newborns

Study Overview
=================
Brief Summary
-----------------
Early breast feeding has shown to be important to mother-infant bonding and is associated with longer duration of breast feeding. However, little data is available regarding its contribution to glucose levels in the newborn infants. Newborns that are at risk to develop hypoglycemia may benefit from early breast feeding if this appears to prevent post-partum hypoglycemia.

Detailed Description
-----------------
Mothers will be encouraged to breast feed early after delivery (at the delivery room). Data of high risk babies for developing post partum hypoglycemia (Infants of diabetic mothers, infants of hypertensive mothers, infants with birth weight more than 4 Kg or less than 2.5 Kg and infants with meconium stained amniotic fluid)will be recorded including maternal breast feeding times and quality of feeding. Glucose levels shall be routinely monitored and recorded at the neonatal department. A comparison of all data will be made between those newborns that breast feed after labor and those who were not.

Official Title
-----------------
Does Early Breast Feeding Prevents Neonatal Hypoglycemia in High Risk Newborns

Conditions
-----------------
Neonatal Hypoglycemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newborns to diabetic mothers Newborns to hypertensive mothers Newborns with birth weight greater than 4 Kg or less than 2.5 Kg Newborns with meconium stained amniotic fluid Exclusion Criteria: Newborns with major congenital malformation Preterm babies Newborns with post-birth distress

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| normal neonatal glucose levels |  | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoglycemia prevention |  | 2 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
early breast feeding, hypoglycemia, newborn
An In-vitro Real-time System Based on Tissue Smears to Identify Malignancy During Hysteroscopic Procedure

Study Overview
=================
Brief Summary
-----------------
The aim of the current study is to develop a near real-time system using infrared spectroscopy, that will evaluate the histological specimen that was removed from the uterine cavity during the hysteroscopy.

Official Title
-----------------
A Development of an In-vitro Real-time System Based on Tissue Smears to Identify Malignancy During Hysteroscopic Procedure Using FTIR-ATR Spectroscopy

Conditions
-----------------
Uterine Cervical Neoplasm, Uterine Neoplasms

Intervention / Treatment
-----------------
* Procedure: Hysteroscopy
* Device: Infrared Spectroscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing hysteroscopy Exclusion Criteria: Pregnancy

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

Sexes Eligible for Study
-----------------
Female

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 |
| --- | --- |
| Other: Women undergoing hysteroscopy<br>Women presenting with abnormal bleeding, abnormal cervical or uterine findings who have consented to undergo hysteroscopy | Procedure: Hysteroscopy<br>* Diagnostic procedure<br>Device: Infrared Spectroscopy<br>* This device uses spectral absorption of the tissue taken during hysteroscopy to determine immediate diagnosis of malignancy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of infrared spectroscopy with routine histopathology | Tissue smears that have undergone infrared spectroscopy during hysteroscopy will have a different spectral absorption than healthy tissue, thus indicating malignancy. These results will be compared to the results of routine histopathology to determine accuracy of spectroscopy to indicate malignancy. | 3 years |
Integrated Coronary Multicenter Imaging Registry - Extended

Study Overview
=================
Brief Summary
-----------------
The coronary images of invasive angiography and optical coherence tomography (or Coronary CT angiography) with FFR(Fractional Flow Reserve) values of the intermediate lesions (50-70% stenosis) will be prospectively registered.

Official Title
-----------------
Integrated Coronary Multicenter Imaging Registry - Extended

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Other: OCT, coronary angiography, FFR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who underwent coronary CT angiography because of chest pain Patients who need OCT or FFR evaluation because of intermediate lesions according to invasive angiography (diameter stenosis of 50-70%) Age: 20-80 yrs Patients who consent and fully understand the protocol Patients who consent the clinical follow-up Patients who can be followed-up Exclusion Criteria: Patients who had contrast allergy Patients who had unstable blood pressure needing the vasopressors Patients who had severe left ventricular function (left ventricular ejection fraction<30%) Chronic kidney disease who had Cr level of greater than 2.0 mg/dl Patients whose expected survival is less than 12 months Patients who had a severe valvular disease

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 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 |
| --- | --- |
| Patients with intermediate lesions<br>Imaging cohort will be performed invasive angiography and optical coherence tomography (or Coronary CT angiography) with FFR(Fractional Flow Reserve) values of the intermediate lesions (50-70% stenosis) | Other: OCT, coronary angiography, FFR<br>* Coronary images by OCT and angiography and FFR values will be registered.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of computed FFR derived by coronary images and real FFR values | FFR values computed by OCT/CT/invasive coronary angiography will be compared by real invasive FFR values | at registration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event (Death, acute myocardial infarction) | Death and occurrence of myocardial infarction during follow-up period will be assessed. | 2 years after registration |
Effects of Lubiprostone on Gastric Function in Patients With Chronic Idiopathic Constipation

Study Overview
=================
Brief Summary
-----------------
This prospective study is designed to evaluate how lubiprostone may affect gastric motor and sensory function.

Official Title
-----------------
Effects of Lubiprostone on Gastric Sensory and Motor Function in Patients With Chronic Idiopathic Constipation

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

Intervention / Treatment
-----------------
* Drug: lubiprostone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chronic idiopathic constipation Exclusion Criteria: medications that slow gastrointestinal (GI) motility prior surgery to the GI tract

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>24 micrograms of lubiprostone twice daily for one week. | Drug: lubiprostone<br>* 24 micrograms twice daily for 1 week<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric Emptying | gastric emptying was measured before and after 7 days of treatment.at set times (2 and 4 hours post eating a radio-labeled meal) | Day 1 and Day 7 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
constipation, chronic idiopathic constipation, no prior history of surgery to the colon, not on any type of medication that could alter gastrointestinal motility or transit
Curcumin Bioavailability in Glioblastoma Patients

Study Overview
=================
Brief Summary
-----------------
Measuring the bioavailability of orally administered curcumin in the tumors of glioblastoma patients.

Official Title
-----------------
Measurement of Intratumoral Concentration of the Nontoxic Natural Compound Curcumin in Glioblastoma Patients

Conditions
-----------------
Patient Harboring Glioblastoma That Will Undergo Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients harboring Glioblastoma Patient will undergo surgery Exclusion Criteria: BMI > 30 Liver and Kidney Function so compromised that medication is prescribed

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of Curcumin in Glioblastoma | At the time of surgery | At Tumor resection |
Solana™ Trichomonas Assay Field Study

Study Overview
=================
Brief Summary
-----------------
The Solana® Trichomonas Assay is an in vitro qualitative nucleic acid amplification test for the detection of Trichomonas vaginalis to aid in the diagnosis of trichomoniasis using the Helicase-Dependent Amplification (HDA) technology and the Solana instrument.

Detailed Description
-----------------
This study is to establish the clinical performance of the Solana® Trichomonas Assay for the detection of Trichomonas vaginalis in vaginal swabs and urine samples as compared to a combined reference method of direct wet mount microscopy and a FDA-cleared device.

Official Title
-----------------
Solana™ Trichomonas Assay Field Study

Conditions
-----------------
Trichomonas Vaginalis

Intervention / Treatment
-----------------
* Device: Solana Trichomonas Assay Testing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female subjects will be recruited from the general population as they present to the clinical facility. Subjects will be categorized by the clinician as either asymptomatic or symptomatic for Trichomonas vaginalis infection. Symptoms in women can include: Greenish-yellow, frothy vaginal discharge with a strong odor Painful urination Vaginal itching and irritation Discomfort during intercourse Lower abdominal pain (rare) Exclusion Criteria: The study is limited to females. Male subjects are not accepted. At clinical sites informed consent, unable to understand and consent to participation; for minors this includes parent or legal guardian.
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Symptomatic<br>Subjects will be categorized by the clinician as symptomatic for Trichomonas vaginalis infection. | Device: Solana Trichomonas Assay Testing<br>* Specimen collection of urine and/or vaginal swabs for testing<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trichomonas Test Result | Testing results will be received by testing site for current FDA cleared tests | 2 days |
Trimodality Therapy for Malignant Pleural Mesothelioma

Study Overview
=================
Brief Summary
-----------------
The role of surgical resection in the management of Malignant Pleural Mesothelioma (MPM) is still controversial. The selection criterion to perform either Extrapleural Pneumonectomy (EPP) or Pleurectomy/Decortication (P/D) is dependent not only on the cardio-pulmonary status of the patient, tumor stage and intraoperative findings but also on surgeons' decision and philosophy. There are no established guidelines. Radical Pleurectomy (RP) competes against EPP as surgical therapy modality. Both surgical approaches are cytoreductive treatment options. The aim is to remove all gross disease and to achieve macroscopic complete resection. Originally P/D was a palliative option for controlling pleural effusion. But lung-sparing surgery for MPM seems to be an alternative to patients unsuitable or unwilling to undergo EPP in a multimodality therapy concept. Most studies evaluating multimodality therapies for MPM are based on retrospective analyses and their interpretation is difficult because of inhomogeneous patient groups studied. The aim of our study was to analyze the feasibility and results of RP as surgical therapy modality in a standardized trimodality therapy concept.

Official Title
-----------------
Trimodality Therapy for Malignant Pleural Mesothelioma: Radical Pleurectomy, Followed by Adjuvant Chemotherapy With Cisplatin/Pemetrexed and Radiotherapy

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed diagnosis of MPM (all subtypes) Clinical T1-3, N0-2, M0 disease. No prior treatment for MPM. Adequate renal and liver function Adequate cardio-pulmonary reserves Exclusion Criteria: Patients with unresectable disease Patients with an active infection that require systemic treatments Patients with a concurrent active malignancy. Patients with serious medical illness.

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the overall 5-year survival rate. |  | 5-years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Morbidity | 3 months | 
| Number of Participants with treatment related deaths as a Measure of Safety and Tolerability | Mortality | 3 months | 
| Recurrence | Occurence of tumor recurrence | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Radical Pleurectomy, Pleurectomy/decortication, Cisplatin, Pemetrexed, Radiation