linjc16/ctgov huggingface dataset:
FOLFOXIRI Plus Cetuximab Versus FOLFOXIRI Plus Bevacizumab in Conversion Therapy of Right-sided Colon Cancer Liver Metastases

Study Overview
=================
Brief Summary
-----------------
To compare the efficacy of FOLFOXIRI plus Cetuximab and FOLFOXIRI plus Bevacuzumab in the conversion therapy of right-sided colon cancer liver metastases

Official Title
-----------------
FOLFOXIRI Plus Cetuximab Versus FOLFOXIRI Plus Bevacizumab in Conversion Therapy of Right-sided Colon Cancer Liver Metastases

Conditions
-----------------
Liver Metastasis Colon Cancer

Intervention / Treatment
-----------------
* Drug: Cetuximab
* Drug: Bevacizumab
* Drug: FOLFOXIRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ECOG perfomance 0-1 pathologically confirmed colorectal carcinoma, with RAS wild type inital unresectable liver metastases discussed by MDT prior no systemical therapy or exceed 6 months after the adjuvant chemotherapy of primary tumor surgery. without extraheptic metastatic lesions, except for locally controlled lung metastases (RFA or SBRT) adequate blood, liver and renal function expected survival longer than 6 months Exclusion Criteria: with bleeding risk interestinal obstruction or disease uncontrolled hypertension and severe heart disease previous severe thrombotic events central nervous system metastases accompanied with other malignant tumor

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FOLFOXIRI+C225<br> | Drug: Cetuximab<br>* one group plus cetuximab<br>Drug: FOLFOXIRI<br>* FOLFOXIRI<br>|
| Active Comparator: FOLFOXIRI+BEV<br> | Drug: Bevacizumab<br>* one group plus bevacizumab<br>Drug: FOLFOXIRI<br>* FOLFOXIRI<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | objective response rate | up to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| R0 resection rate of liver metastases | R0 resection rate of liver metastases | up to 8 weeks | 
| NED rate | percentage of patients who reach NED | up to 8 weeks | 
| OS | overal survival | up to 6 months | 
| PFS | progression free survival | up to 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bevacizumab, FOLFOXIRI, cetuximab
Ultrasonographic Diameter of Optic Nerve Sheath in Fluid Assessment in Severe Preeclamptic Patients

Study Overview
=================
Brief Summary
-----------------
Changes in the optic nerve sheath diameter detected by ultrasound are considered an important manifestation of increased intracranial pressure . The normal optic nerve sheath diameter measures up to 5.0 mm and an average optic nerve sheath diameter more than 5 mm is considered abnormal and elevated intracranial pressure should be suspected.Cerebral edema have been demonstrated in 71% to 100% of magnetic resonance imaging in preeclamptic patients and an increase in optic nerve sheath diameter has been described in preeclamptic females compared to healthy pregnant females Therefore, Increased optic nerve sheath diameter can indirectly reflect the state of intracranial edema that could be a part of generalized edema of preeclampsia and it could be a possible marker of generalized tissue edema and fluid overload in these patients.

Official Title
-----------------
Reliability of Utrasonographic Diameter of Optic Nerve Sheath in Assessment of Fluid Status in Severe Preeclamptic Patients

Conditions
-----------------
Severe Pre-eclampsia

Intervention / Treatment
-----------------
* Radiation: ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Systolic blood pressure of 160mm Hg or higher, or diastolic blood pressure of 110mm Hg or higher on 2 occasions at least 6 hours apart on bed rest. Proteinuria ≥5g in a 24 hour urine specimen or ≥3+ on 2 random urine samples collected at least 4 hours apart. patient acceptance Accepted mental state of the patients Exclusion Criteria: patient refusal to participate in the study chronic kidney disease chronic pulmonary disease chronic cardiac disease chronic hypertension previous ocular operation and diseases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: ultrasound|ultrasonographic assessment of optic nerve sheath diameter|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation between optic nerve sheath diameter and extravascular lung water | correlation between ultrasound assessment of optic nerve sheath diameter and extravascular lung water | up to 24 hours |
ONO-4538 Phase I Study in Patients With Solid Tumor

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to investigate the pharmacokinetics of ONO-4538 administered to Korean patients with advanced or recurrent solid tumors who are refractory or intolerant to standard therapy or for whom no appropriate treatment is available.

Official Title
-----------------
ONO-4538 Multicenter, Open-label, Uncontrolled, Phase I Study in Solid Tumor

Conditions
-----------------
Advanced Solid Tumors, Recurrent Solid Tumors

Intervention / Treatment
-----------------
* Drug: ONO-4538


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female ≥ 20 years of age Histologically or cytologically confirmed solid tumor Patients with advanced or recurrent solid tumors who are refractory or intolerant to standard therapy or for whom no appropriate treatment is available ECOG Performance Status is 0 to 1 Exclusion Criteria: Current or prior severe hypersensitivity to another antibody product Multiple primary cancers

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ONO-4538 1mg/kg<br>ONO-4538 water-soluble injection, 100 mg/vial, 1mg/kg, single dose | Drug: ONO-4538<br> <br> |
| Experimental: ONO-4538 3mg/kg<br>ONO-4538 water-soluble injection, 100 mg/vial, 3mg/kg, single dose | Drug: ONO-4538<br> <br> |
| Experimental: ONO-4538 10mg/kg<br>ONO-4538 water-soluble injection, 100 mg/vial, 10mg/kg, single dose | Drug: ONO-4538<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK outcome: Cmax of ONO-4538 |  | Approximately 3 weeks | 
| PK outcome: Tmax of ONO-4538 |  | Approximately 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety outcome: The number of subjects with overall adverse events |  | Approximately 3 weeks | 
| Safety outcome: The number of deaths |  | Approximately 3 weeks |
Acupressure for the Treatment of Raynaud's Phenomenon

Study Overview
=================
Brief Summary
-----------------
The use of acupressure will be compared to targeted Raynaud's education and will evaluate the' frequency, duration and pain of Raynaud's attacks.

Detailed Description
-----------------
Using a Raynaud's condition score, severity of tingling, numbness and pain of attacks, the number of attacks and patient and physician visual analog scale we will assess the effect of acupressure.

Official Title
-----------------
Acupressure in Raynaud's Phenomenon- A Pilot Study.

Conditions
-----------------
Primary Raynaud's Phenomeon

Intervention / Treatment
-----------------
* Other: Acupressure
* Other: Acupressure dilatation
* Behavioral: education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 18 years old Have Raynauds phenomenon, with at least 4 attacks in the last week on stable medications Willing to attend study visits Exclusion Criteria: smoker have a history of stroke, heart attack or irregular heart rhythm uncontrolled blood pressure physical or mental illness that would interfere with participating in the study

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Education<br>target education toward Raynaud's | Behavioral: education<br> <br> |
| Active Comparator: Acupressure<br>acupressure- dilatation | Other: Acupressure dilatation<br> <br> |
| Active Comparator: Acupressure relaxation<br>acupressure relaxation protocol | Other: Acupressure<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in number of Raynaud's attacks |  | 1-2 years |
Phase 1 Study of XAF5 Gel Applied to Skin of Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This is a study to assess the safety, tolerability, and pharmacokinetics of XAF5 Gel when applied to the skin of healthy volunteers.

Official Title
-----------------
A Randomized, Placebo-controlled, Double-blind, Multiple-ascending-dose Study to Assess the Safety and Tolerability of XAF5 Gel Applied to the Skin of Healthy Volunteers

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

Intervention / Treatment
-----------------
* Drug: XAF5, concentration A
* Drug: XAF5, concentration B
* Drug: XAF5, concentration C
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers Must understand and provide informed consent Skin upon which a reaction would be visible Body weight >= 70 kg Exclusion Criteria: Any active skin disease History of skin hypersensitivity Clinically significant abnormality on physical exam, ECG, or laboratory tests Positive test for HIV, Hepatitis B, or Hepatitis C

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: XAF5<br> | Drug: XAF5, concentration A<br> <br> Drug: XAF5, concentration B<br> <br> Drug: XAF5, concentration C<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

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
-----------------
volunteers
Invasive Hemodynamic Response to Transcatheter Edge-to-Edge Mitral Valve Repair

Study Overview
=================
Brief Summary
-----------------
Studying the effects of Trans-catheter Mitral Valve Repair (TMVr) on the hemodynamics and biomarkers in patients with severe mitral valve regurgitation.

Official Title
-----------------
Invasive Hemodynamic Response to Transcatheter Edge-to-Edge Mitral Valve Repair

Conditions
-----------------
Mitral Regurgitation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults (age ≥ 18 years) with severe, symptomatic primary mitral regurgitation identified by Doppler transthoracic echocardiogram Heart team (cardiologist and cardiac surgeon) agree that patient would be eligible for TMVR with Transcatheter edge to edge repair device. TMVR procedure will be performed in the cardiac catheterization laboratory for hemodynamic data recording Exclusion Criteria: Women who are pregnant or believe they could be pregnant

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 |
| --- | --- |
| Subjects undergoing TMVr<br>Subjects with severe, symptomatic primary mitral regurgitation (MR) scheduled to undergo a transcatheter mitral valve repair (TMVr) as standard of care will have intra-op baseline and post repair blood draws. Pre-procedure and post-procedure transthoracic echocardiograms (TTE) will assess the hemodynamic implications of the repair. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in stroke volume index | Change in stroke volume index 10 minutes post repair to baseline stroke volume index measurement (L/m^2) | Baseline, approximately 10 mins after valve repair | 
| Change in cardiac index | Change in cardiac index 10 minutes post repair to baseline cardiac index measurement (L/min/m^2) | Baseline, approximately 10 mins after valve repair |
Role of Intrapartum Ultrasound in Instrumental Delivery

Study Overview
=================
Brief Summary
-----------------
Investigators will perform a multicentric randomized controlled trial comparing the effect of transabdominal and transperineal ultrasound in pregnant women in the second stage of labor, in whom it was decided an operative delivery. Our objective is to evaluate the impact of intrapartal ultrasound measurements, as an auxiliary to clinical evaluation, in the efficacy of an instrumental delivery.

Official Title
-----------------
Role of Intrapartum Ultrasound in the Efficacy of an Instrumental Delivery

Conditions
-----------------
Obstetric Labor Complications

Intervention / Treatment
-----------------
* Other: Transabdominal and transperineal ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant women at term, in labor (≥ 37 weeks of gestation dated by a first trimester ultrasound live singleton pregnancy fetus in a cephalic presentation in the second stage of labor, after the decision to perform an instrumental delivery Exclusion Criteria: fetal malformations emergency situation

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>The study group will be constituted by pregnant women in whom the operative delivery will be preceded by a transabdominal and transperineal ultrasound to evaluate fetal head position and fetal head station, by means of determination of the 'angle of progression'. | Other: Transabdominal and transperineal ultrasound<br>* Transabdominal ultrasound, for determining fetal head position, is performed with the pregnant women in supine position after bladder emptying, with the transducer placed transversely on the suprapubic region of the maternal abdomen. For the sonographic determination of the fetal descent we will perform a transperineal ultrasound achieved by placing the ultrasound transducer on the perineum in a mid sagittal position between the labia below the pubic symphysis.<br>|
| No Intervention: Control group<br>The control group will be constituted by pregnant women in whom the operative delivery will be carried out based solely on clinical criteria, namely transvaginal digital examination. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal and neonatal morbidity | Severe postpartum hemorrhage, perineal trauma, prolonged hospital stay | 2 years | 
| Neonatal morbidity | low 5-minute Apgar score, umbilical artery metabolic acidosis, birth trauma and neonatal intensive care unit admission | 2 years |
Complementary and Alternative Medicine Use in Low-Income African American and Caucasian Adults With Asthma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify the types of and frequency of use of complementary and alternative medicine (CAM) strategies among low-income Caucasian and African American adults with persistent asthma. The overall goal is to collect data that will increase understanding of health beliefs and behaviors in people with low-income backgrounds so that studies can be created that may help modify and improve patients' symptoms of asthma.

Detailed Description
-----------------
The rates of asthma-related deaths and disease are disproportionately high among African Americans compared to Caucasians. Surveys indicate that middle- and upper-income Caucasians use more CAM than African Americans, but the therapies utilized are different. This study will determine how well people with persistent asthma adhere to their treatment and whether the type and frequency of use of CAM affects treatment adherence. Participants will begin this study by taking part in an interview about adherence to their current inhaled corticosteroids (ICS) regimen and their personal CAM use. After completing the interview, participant adherence to their ICS regimen will be monitored for 6 weeks. Depending on the type of ICS participants are taking, monitoring will be conducted either by participant self-reporting or electronic monitors that record the time and date of medication inhalation. Participant adherence will also be assessed at study completion.

Official Title
-----------------
The Role of Complementary and Alternative Medicine (CAM), Folk Care and Faith-Based Approaches in the Home Management of Persistent Asthma in Low-Income African American and Caucasian Adults

Conditions
-----------------
Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Physician-diagnosed asthma with episodes that last for long periods of time Medicaid recipients Self-identify as African American or Caucasian Daily use of inhaled corticosteroids Able to speak English Have mental capacity to understand and participate in the study Exclusion Criteria: Prisoners History of smoking at least ten packs of cigarettes per year Currently smoke more than one and a half packs of cigarettes per week

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 50 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
-----------------
Complementary Therapies
68Ga-PSMA-11 PET/CT in Patients With Various Types of Cancer

Study Overview
=================
Brief Summary
-----------------
To evaluate the potential usefulness of 68Ga-PSMA-11 positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions, efficacy assessment and recurrence monitoring in various types of cancer.

Detailed Description
-----------------
Subjects with various types of cancer underwent 68Ga-PSMA-11 PET/CT either for an initial assessment or for recurrence detection. Tumor uptake was quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 68Ga-PSMA-11 PET/CT were calculated.

Official Title
-----------------
68Ga-PSMA-11 PET/CT in Patients With Various Types of Cancer

Conditions
-----------------
Prostate Cancer, Positron-Emission Tomography

Intervention / Treatment
-----------------
* Drug: 68Ga-PSMA-11


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: (i) adult population (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled 68Ga-PSMA-11 PET/CT scan; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee. Exclusion Criteria: (i) patients with pregnancy; (ii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 68Ga-PSMA-11<br>Each subject receive a single intravenous injection of 68Ga-PSMA-11, and undergo PET/CT imaging within the specificed time. | Drug: 68Ga-PSMA-11<br>* Each subject receive a single intravenous injection of 68Ga-PSMA-11, and undergo PET/CT imaging within the specificed time.<br>* Other names: Diagnostic Test: PET/CT scan;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standardized uptake value (SUV) | Standardized uptake value (SUV) of 68Ga-PSMA-11 for each target lesion of subject or suspected primary tumor or/and metastasis. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic efficacy | The sensitivity, specificity and accuracy of 68Ga-PSMA-11 PET/CT were calculated. | 30 days |