linjc16/ctgov huggingface dataset:
A Study to Evaluate [18F]-FDG PET (Fluorodeoxyglucose-positron) in Patients With Pancreatic Cancer (MK-0000-144)

Study Overview
=================
Brief Summary
-----------------
This study will determine whether [18F]-fluorodeoxyglucose-positron emission tomography (FDG-PET) can be used to screen for the activity of novel pancreatic cancer treatments.

Official Title
-----------------
A Multicenter Trial to Evaluate 18F-FDG Uptake by PET in Patients With Advanced Pancreatic Adenocarcinoma as an Early Indicator of Drug Activity

Conditions
-----------------
Advanced Pancreatic Adenocarcinoma

Intervention / Treatment
-----------------
* Procedure: Comparator: [18F]-FDG PET/CT and Volumetric CT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has a diagnosis of Stage IV pancreatic adenocarcinoma with distant metastases Patient is scheduled to receive standard chemotherapy containing gemcitabine Patient has not received prior systemic therapy for advanced pancreatic adenocarcinoma Patient must be available for periodic blood sampling, study-related assessments, and management at the treating institution Exclusion Criteria: Patient has had open abdominal surgery within 6 weeks of the screening visit Patient has had radiotherapy to the thorax, abdomen, or pelvis within 6 months of the screening visit Patient has an active infection, inflammation, or unresolved bowel obstruction Patient has poorly controlled diabetes

Ages Eligible for Study
-----------------
Minimum Age: 35 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>[18F]-FDG-PET/CT (Computed Tomography) Imaging | Procedure: Comparator: [18F]-FDG PET/CT and Volumetric CT<br>* Patients will receive gemcitabine-based therapy as prescribed by their treating physician. FDG-PET/CT scans will be performed at baseline following enrollment, and after 3 and 6-7 weeks of therapy. Volumetric CT scans will be performed at baseline following enrollment, and after 3 and 6-7 weeks of therapy.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association of changes in FDG uptake with overall survival (OS) |  | Week 3 and at least 7 months after the last patient is treated | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association of metabolic response with OS |  | Baseline, Week 3, and at least 7 months after the last patient is treated | 
| Correlation between FDG standardized uptake values (SUV) at Week 3 and Week 6-7 |  | Week 3 and Week 6-7 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Advanced pancreatic adenocarcinoma
Factors Associated With Postoperative Strabismus After Floor Fracture Repair

Study Overview
=================
Brief Summary
-----------------
In patients suffered from floor fractures, there are 21.9% complaining about diplopia before fracture repair surgery and 20.8% after operation. Even after 6 months, there still are 16.4% had similar conditions. Investigators are planned to find predicting factors to prevent such conditions from happening.

Official Title
-----------------
Factors Associated With Postoperative Strabismus After Floor Fracture Repair

Conditions
-----------------
Orbital Fractures, Strabismus

Intervention / Treatment
-----------------
* Procedure: Floor repair surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients suffering from floor fractures in Tri-Service General Hospital in past 10 years. Exclusion Criteria: Prior ocular surgeries Multiple facial trauma or facial bone fractures
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- With strabismus<br>Study group with strabismus happening after floor fracture repair | Procedure: Floor repair surgery<br> <br> |
| Group 2- Without strabismus<br>No strabismus happening after floor fracture repair | Procedure: Floor repair surgery<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Strabismus happening | Number of participants suffered from strabismus happening at 6 months after operation and their characteristics. | 6 months after orbital floor fracture repair surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Orbital fractures, Strabismus, Predicting factors, orbital floor fractures
Early NCPAP Before Surfactant Treatment in Very Preterm Infants With RDS

Study Overview
=================
Brief Summary
-----------------
We hypothesis a period of early NCPAP before surfactant treatment is effective for treating RDS and preventing BPD in very premature infants.

Conditions
-----------------
Nasal Continuous Positive Airway Pressure,, Preterm Infants,, Surfactant Treatment,, Respiratory Distress Syndrome,, Bronchopulmonary Dysplasia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All enrolled infants were able to breathe at 5 min of age, had evidence of respiratory distress, unable to receive surfactant therapy, and were administrated with early NCPAP as the initial treatment Exclusion Criteria: Exclusion criteria were endotracheal intubation for resuscitation or insufficient respiratory drive, died in the first 24 hours after birth, known genetic disorders, potentially life-threatening conditions unrelated to prematurity, and premature rupture of membranes (PROM) for >3 weeks.

Ages Eligible for Study
-----------------
Minimum Age: 30 Minutes
Maximum Age: 2 Hours

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| <2h group<br> | |
| 2-4h group<br> | |
| >4h group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| death or bronchopulmonary dysplasia |  | 24 hours after birth |
The Effect of Dexmedetomidine in the Management of Pain After Uterine Artery Embolization

Study Overview
=================
Brief Summary
-----------------
The investigators examined the effect of dexmedetomidine in the management of pain after uterine artery embolization.

Detailed Description
-----------------
Leiomyoma are the most common female reproductive tract tumors. Uterine artery embolization(UAE) is a minimally invasive treatment alternative to hysterectomy and myomectomy. However, post-procedural pain control after UAE remains a major problem. Therefore, the aim of study is to evaluate the efficacy of dexmedetomidine in pain control after UAE.

Conditions
-----------------
Pain Control

Intervention / Treatment
-----------------
* Drug: Dexmedetomidine
* Drug: Normal saline 0.9%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age ≥ 20, ASA class I and II Exclusion Criteria: bradycardia (< 45 bpm) heart block liver failure renal failure uncontrolled hypertension body mass index ≥ 30 kg/m2

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br> | Drug: Normal saline 0.9%<br>* Normal saline 100mL(guess as 2㎍/mL):the infusion of 0.2㎍/kg/hr is started at 30 minutes before the procedure and the infusion dose is raised to 0.4㎍/kg/hr after completion of procedure<br>|
| Active Comparator: Dexmedetomidine<br> | Drug: Dexmedetomidine<br>* Dexmedetomidine(Dexmedetomidine 2 mL and normal saline 98 mL mixed -> 2㎍/mL) : the infusion of 0.2㎍/kg/hr is started at 30 minutes before the procedure and the infusion dose is raised to 0.4㎍/kg/hr after completion of procedure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fentanyl consumption by patient-controlled analgesia |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects |  | 24 hours |
The Effect of Rosuvastatin in Diabetic Polyneuropathy: A Phase IIa Randomized Double-blind Placebo-controlled Study

Study Overview
=================
Brief Summary
-----------------
To evaluate the impact of oral rosuvastatin in diabetic polyneuropathy, and the role of lipid peroxidation and nerve growth factor.

Official Title
-----------------
Phase IIa Randomized Double-blind Placebo-controlled Study to Evaluate the Effect of Rosuvastatin in Diabetic Polyneuropathy

Conditions
-----------------
Diabetic Polyneuropathy

Intervention / Treatment
-----------------
* Drug: Rosuvastatin
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with type 2 diabetes mellitus Glycated hemoglobin <12.0% Signing of informed consent Presence of an abnormality of nerve conduction study Symptoms and signs of diabetic polyneuropathy Exclusion Criteria: Pregnancy and lactation Foot ulcers Treatment with statins Antioxidant drug and/or supplements one month previous to enrolment Inability to mobilize Renal and/or hepatic failure

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 80 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rosuvastatin<br>20 mg daily of oral rosuvastatin | Drug: Rosuvastatin<br>* 20 mg daily of oral rosuvastatin for 12 weeks<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 100 mg of oral placebo with identical appearance, form and size than rosuvastatin, one tablet daily for 12 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stage of diabetic polyneuropathy |  | 12 weeks | 
| Severity of diabetic polyneuropathy | Severity according nerve conduction studies | 12 weeks | 
| Nerve conduction studies |  | 12 weeks | 
| Neuropathy symptoms and impairment scores |  | 12 weeks | 
| Lipid peroxidation |  | 12 weeks | 
| Nerve growth factor |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rosuvastatin, Diabetic polyneuropathy, Nerve conduction, Oxidative stress, Nerve growth factor
Genetics and Epigenetics of Graves' Orbitopathy

Study Overview
=================
Brief Summary
-----------------
Graves' orbitopathy (GO) is an autoimmune disease persisting when immunosuppression is achieved. Orbital fibroblasts from GO patients display peculiar phenotypes even if not exposed to autoimmunity, possibly reflecting genetic or epigenetic mechanisms, to be investigated here. Primary cultures of orbital fibroblasts from GO and control patients will be established. Cell proliferation, release of hyaluronic acid (HA) and HA synthases (HAS) will be measured. Next Generation Sequencing and gene expression analysis of the whole genome will be performed, as well as global DNA methylation assay.

Detailed Description
-----------------
The investigators will establish primary cultures of orbital fibroblasts from orbital adipose tissue samples taken from six GO patients who underwent orbital decompressive surgery. Normal orbital tissue samples will be collected from six patients undergoing eye surgery for unrelated reasons. Cell proliferation and HA will be measured using commercial assays DNA and RNA will be extracted. HAS-1, HAS-2 and HAS-3 will be measured were assessed by Real Time-PCR Next Generation Sequencing, Gene expression analysis and DNA methylation assays will be performed

Official Title
-----------------
Genetics and Epigenetics of Graves' Orbitopathy

Conditions
-----------------
Graves Ophthalmopathy

Intervention / Treatment
-----------------
* Other: No Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Graves' Orbitopathy Informed consent Exclusion Criteria: -Lack of informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Graves' Orbitopathy<br>Graves' Orbitopathy patients who undergoing orbital decompressive surgery | Other: No Intervention<br>* Not applicable to these subjects. There is no study-related intervention<br>|
| Control Patients<br>Patients undergoing eye surgery for unrelated reasons | Other: No Intervention<br>* Not applicable to these subjects. There is no study-related intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gene expression | Gene expression in patients vs controls | Baseline |
Effect of Maternal BMI on Measurement of Cervical Length

Study Overview
=================
Brief Summary
-----------------
All consecutive pregnant patients in 2nd or 3rd trimester will be asked to participate. Cervical length will be assessed in all patients, once abdominally and then vaginally (that would serve as golden standard). Correlation would be assessed between accuracy of measurement to BMI

Detailed Description
-----------------
This study will include pregnant women in either 2nd or 3rd trimester of pregnancy. All consecutive pregnant patients in 2nd or 3rd trimester who will attend our unit for routine ultrasound exam will be asked to participate. Cervical length will be assessed in all patients, once abdominally and then vaginally (that would serve as golden standard). Correlation would be assessed between accuracy of measurement to BMI. Accuracy would be defind as the delta of cervical length between abdominal and vaginal routs. BMI would be calculated prior to the ultrasound exam (by weighing and measuring all patients).

Official Title
-----------------
Effect of Maternal BMI on Accuracy of Measurement of Cervical Length During the 3rd Trimester of Pregnancy

Conditions
-----------------
PREGNANCY

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All pregnant women in 2nd or 3rd trimester who attend routine ultrasound exam Exclusion Criteria: Known shore cervix PPROM

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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 |
| --- | --- | --- |
| Accuracy of cervical length according to BMI | the golden standard for cervical length measurement is vaginal scan. Our outcome measure will be the accuracy of cervical length measurement - measured abdominally, according to BMI. I other words - was there a difference between measurement by vaginal probe and abdominal probe and whether this difference correlates with BMI | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational age at delivery according to cervical length | Gestational age at delivery according to cervical length | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cervical length, BMI
Treatment of Acetaminophen Toxicity With N-acetylcysteine

Study Overview
=================
Brief Summary
-----------------
Retrospective chart review of patients who received N-acetylcysteine for APAP toxicity to assess length of oral vs IV treatment and overall healthcare costs.

Official Title
-----------------
Treatment of Acetaminophen Toxicity With Intravenous vs Oral N-acetylcysteine: A Retrospective Review

Conditions
-----------------
Acetaminophen Toxicity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Admitted to CHMCA between June 1, 2004 to May 31, 2008 with a qualifying ICD-9 diagnosis code for the following APAP overdose situations; poisoning, accidental, suicide attempt, therapeutic use, assault, and undetermined (965.4, E850.4, E950.0, E935.4, E962.0, E980.0) Serum APAP concentrations ≥ 150 g/mL at 4 hours or a serum concentration above the possible hepatotoxic line on the Rumack-Matthew's nomogram if obtained > 4 hours post ingestion Between the ages of 0-21 years Exclusion Criteria: Serum APAP concentrations are not actually documented Patient did not receive oral or IV NAC treatment Patient has a preexisting liver disease such as cirrhosis or hepatitis C Patient > 21 years of age
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Patients receiving oral NAC treatment | |
| 2<br>Patients receiving IV NAC treatment | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of oral vs IV NAC treatment in hours |  | From admission to discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall healthcare costs associated with IV vs Oral NAC treatment |  | From admission to discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acetaminophen toxicity, n-acetylcysteine, liver toxicity
Androgenetic Alopecia in Fabry Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess whether patients with the classic form of Fabry disease have significantly less androgenic alopecia (male pattern baldness).

Detailed Description
-----------------
Objectives: To test the hypothesis that adult males with classic form of Fabry disease have a significantly lower incidence of androgenic alopecia than matched controls. Study Population: 120 patients aged 20-64 with Fabry disease that have GLA mutations or alpha-galactosidase A activity associated with no residual enzyme activity and non-Fabry male controls of the same age range and the same number of non-Fabry controls. Design: This is a cross-sectional study comparing the prevalence of androgenic alopecia in two groups of subjects. Outcome Measures: The levels of the outcome will be no androgenic alopecia and frontal only androgenetic alopecia opposed to vertex only and frontal and vertex androgenetic alopecia.

Official Title
-----------------
Androgenetic Alopecia in Fabry Disease

Conditions
-----------------
Fabry Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male patients with Fabry disease age 20-64 years old. Healthy male controls age 20-64 years old GLA gene mutations associated with the classic form of Fabry disease or having alpha-galactosidase A activity that is essentially zero Patients who freely agree to participate in this study and understand the nature, risks and benefits of this study and give their written informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with the classic form<br> | |
| Fabry disease and healthy controls<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| No and frontal only androgenetic alopecia | No and frontal only androgenetic alopecia opposed to vertex only and frontal and vertex androgenetic alopecia. | 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vertex only and frontal and vertex androgenetic alopecia. | No and frontal only androgenetic alopecia opposed to vertex only and frontal and vertex androgenetic alopecia. | 1 Year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fabry disease, Male pattern baldness, Alopecia, GLA gene mutation, Alpha-galactosidase A