linjc16/ctgov huggingface dataset:
Characterizing Breast Cancer With 18F-FES PET/CT

Study Overview
=================
Brief Summary
-----------------
18F-fluoroestradiol (FES) is radioactive labeled estradiol, developed for in vivo visualization of estrogen receptor (ER) using positron emission tomography (PET). In this prospective study, 18F-FES PET/CT will be used to evaluate ER activity of metastatic disease and their potential sensitivity to endocrine therapy in ER-positive breast cancer.

Official Title
-----------------
A Prospective Pilot Study to Explore Performance and Efficacy of 18F-FES PET/CT in ER-positive Breast Cancer Patients

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: 18F-FES PET/CT scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: suspected or confirmed metastatic ER-positive breast cancer; 18F-FDG PET/CT within two weeks; signed written consent. Exclusion Criteria: pregnancy; breastfeeding; any medical condition that in the opinion of the investigator may significantly interfere with study compliance.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Experimental: 18F-FES PET/CT<br>Inject 18F-FES and then perform PET/CT scan. | Diagnostic Test: 18F-FES PET/CT scan<br>* Patients with suspected metastatic ER-positive breast cancer underwent 18F-FES PET/CT after an injection of 185-222 MBq (5-6 mCi) 18F-FES to image lesions of metastatic breast cancer.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standardized uptake value of 18F-FES in BC | The max standard uptake value (SUVmax) was measured in the breast cancer lesions on 18F-FES PET/CT. | through study completion, an average of 1 year | 
| Lesions detected by 18F-FES PET/CT | The number of target lesions was calculated by 18F-FES PET/CT. | through study completion, an average of 1 year | 
| Compared with 18F-FDG PET/CT | The number of lesions detected by 18F-FES PET/CT was compared with 18F-FDG PET/CT. | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Evaluate overall survival (OS) in patients receiving regimens containing endocrine therapy | 3 years |
Local Infiltration With Levobupivacaine During Laparoscopic Cholecystectomy

Study Overview
=================
Brief Summary
-----------------
Randomized controlled trial on laparoscopic cholecystectomy. Interventional group: preincisional infiltration with levobupivacaine. Control group: no local infiltration. Postoperative pain with numeric rating scale is registered, besides other parameters like heart rate, blood pressure, rescue analgesia requirements, nausea and vomiting, etc.

Official Title
-----------------
Laparoscopic Cholecystectomy: Use of Infiltration With Levobupivacaine and Postoperative Pain: A Randomized Controlled Trial

Conditions
-----------------
Laparoscopic Cholecystectomy, Postoperative Pain, Local Infiltration, Levobupivacaine

Intervention / Treatment
-----------------
* Drug: Preincisional infiltration with levobupivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective laparoscopic cholecystectomy Exclusion Criteria: Patient refusal Open surgery Reintervention surgery Drain tube placement Cognitive impairment Allergic reactions to local anesthetics

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Local infiltration<br> | Drug: Preincisional infiltration with levobupivacaine<br>* Local, preincisional infiltration of port sites with levobupivacaine 5 mg/ml 20 ml<br>|
| No Intervention: No local infiltration<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain assessed by visual numeric scale. | Values come from 0 to 10, where 0 means no pain and 10 means the worst imaginable pain. Best outcome would be 0 or close to 0 | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative administration of analgesics | Record of dose of analgesics needed: nonsteroidal anti-inflamatory drugs, opioid requirements, other analgesics requirements | 24 hours | 
| Postoperative nausea and vomiting episodes | Record of episodes of nausea or vomiting during first 24 postoperative hours | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Laparoscopic cholecystectomy, Postoperative Pain, Local Infiltration, Levobupivacaine, Randomized controlled trial
Intracranial Atherosclerosis and Depression After Coronary Artery Bypass Graft

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to examine if blood flow in the brain before coronary artery bypass graft surgery has an effect on depression after surgery. The main hypothesis of the study states that pre-surgical blood flow in the brain will be an independent risk factor for depression after surgery after adjusting for other risk factors such as gender, pre-CABG depression, social support, medical comorbidity burden, socioeconomic status, and neuroticism.

Official Title
-----------------
Intracranial Atherosclerosis and Predictors of Post-CABG Depression

Conditions
-----------------
Depression, Intracranial Atherosclerosis, Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 40 years or older Will be having CABG surgery at the Yale New Haven Hospital Be able to provide informed consent Have a household telephone A fluent English speaker, and possessing no communication barrier Be able to come to the study site or to have the study team come to his/her home. Has a family member or partner/ friend who could provide collateral information Exclusion Criteria: Has had previous CABG surgery History of dementia diagnosis or cognitive impairment (CDR >/= 1) Auditory or visual impairment that would interfere with study procedures Active alcohol or substance abuse problem based CAGE-AID (endorsing two or more items) History of Bipolar Disorder, Schizophrenia, Schizoaffective Disorder, or any Psychotic Disorder by medical history or self-report. Presence of non-cardiovascular conditions likely to be fatal within 1 year

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- |
| No treatment.<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-surgical intracranial atherosclerosis as measured by transcranial doppler ultrasound relative to depressive symptoms post-surgically as measured by DISH. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Examine neurocognitive function relative to post-CABG depression through a series of neurocognitive tests. | Neurocognitive tests are aimed at evaluating memory, processing speed, and global cognition. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Depression, Vascular depression, Intracranial atherosclerosis, Coronary artery disease, Coronary artery bypass graft, Cognitive impairment
Marcaine Post-Operative Pain Study

Study Overview
=================
Brief Summary
-----------------
The study examines the efficacy of Marcaine in post-operative pain reduction for patients receiving breast reduction surgery. Patients who consent will be randomized to which breast receives a Marcaine injection and the other breast will have saline injected. Pain will be assessed one time post-operatively using a 1-10 pain scale.

Official Title
-----------------
Marcaine Post-Operative Pain Study

Conditions
-----------------
Effect of Drug

Intervention / Treatment
-----------------
* Drug: Bupivacaine Injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be receiving bilateral breast reduction surgery Exclusion Criteria: Unilateral breast reduction surgery

Ages Eligible for Study
-----------------
Maximum Age: 89 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group (Marcaine 1 Breast)<br>Marcaine will be injected into one randomized breast and saline into the other in the treatment group. | Drug: Bupivacaine Injection<br>* Treatment group receives Marcaine (Bupivacaine) injected into one breast following breast reduction surgery and a saline injection in the other group.<br>* Other names: Marcaine;|
| No Intervention: Control Group (Marcaine 2 Breasts)<br>Marcaine will be injected into both breasts as is currently the standard of care. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Marcaine Use in Breast Reconstruction: Post-Operative Pain Scale Assessment per Breast | Minimum score: 1 (minimal pain), Maximum score: 10 (worst pain possible/worst outcome), higher pain scores associated with worse outcomes | through study completion, an average of 1 year |
Correlation of Changes in PaO2 and ORi in Adult Patients

Study Overview
=================
Brief Summary
-----------------
The Oxygen Reserve Index (ORi) is a reference that could help clinicians with their assessments of normoxic and hyperoxic states by scaling the measured absorption information between 0.00 and 1.00. An ORi of 0.00 corresponds to PaO2 values of 100mmHg and below and an ORi of 1.00 corresponds to PaO2 values of 200mmHg and above. This is a prospective, non-blinded, non-randomized study of the Oxygen Reserve Index (ORi) in a clinical setting. It is designed to evaluate the correlations with ORi and changes in PaO2 and the potential use of ORi as an early warning of impending arterial oxygen desaturation.

Official Title
-----------------
Correlation of Changes in PaO2 and ORi in Adult Patients

Conditions
-----------------
Hyperoxia

Intervention / Treatment
-----------------
* Device: ORi sensor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age greater than 18 years ASA physical status III or IV Scheduled for an elective surgical procedure requiring endotracheal intubation and the use of an arterial pressure monitoring catheter placed prior to induction of general anesthesia Exclusion Criteria: Age less than 18 years Adults unable to give primary consent Pregnancy Prisoners

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ORi sensor<br>All subjects are enrolled in the test group and receive an ORi sensor during their scheduled, general surgery procedure | Device: ORi sensor<br>* Noninvasive pulse oximeter sensor that is placed on the finger for measurement of ORi<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values. | ORi is an index value without a unit and ORi does not directly measure PaO2. Therefore, sensitivity is calculated to evaluate changes in ORi relative to the changes in PaO2. | Less than 30 mins | 
| Specificity for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values. | ORi is an index value without a unit and ORi does not directly measure PaO2. Therefore specificity is calculated to evaluate changes in ORi relative to the changes in PaO2. | Less than 30 mins | 
| Concordance for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values. | ORi is an index value without a unit and ORi does not directly measure PaO2. Therefore concordance is calculated to evaluate changes in ORi relative to the changes in PaO2. | Less than 30 minutes |
Ability of a Molecule (Prima) to Restore Physiological Differentiation in Epithelium Expressing Gene p63

Study Overview
=================
Brief Summary
-----------------
Ectodermal dysplasia associated with p63 is a rare disease which, in addition to limbic abnormalities, primarily affects the skin and cornea. The most common forms are called Ectrodactyly, Ectodermal dysplasia, palate Key for cleft lip and palate (EEC) and Ankyloblepharon, Ectodermal dysplasia, cleft lip and palate (AEC). Apart from symptomatic treatment, no cure is available. To understand the molecular defects associated with this disease and to identify therapeutic tools, a research team modelized the disease by reprograming EEC and AEC patient fibroblasts in pluripotent stem cells (iPSC), then induced iPSC differentiation in patients and controls epidermal (skin) and limbic (cornea) cells and demonstrated that the mutated cells can reproduce in vitro the abnormalities observed in patients. P63 gene belongs to the family of p53 gene. The functions of the two proteins are very similar. Data suggest that molecule Prima could reactivate the p63 protein mutated in patients and thus alleviate skin defect healing and limbic regeneration.

Official Title
-----------------
Ex Vivo and in Vitro Assessment of the Pharmacological Properties of Molecule Prima in the Restoration of Physiological Differentiation of Gene p63 Dependant Epithelium

Conditions
-----------------
Ectodermal Dysplasia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with genetic pathology of the ocular surface Age ≥ 7 years Exclusion Criteria: Agonal glaucoma low vision mostly related to retinal pathology Pregnant or breast-feeding patient

Ages Eligible for Study
-----------------
Minimum Age: 7 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 |
| --- | --- | --- |
| the differentiation of corneal epithelium by histological observation | the differentiation of corneal epithelium by histological observation | baseline |
Prediction of Pain in Total Hip Arthroplasty

Study Overview
=================
Brief Summary
-----------------
In this consecutive, prospective cohort study the investigators evaluate if preoperative pain response upon heat stimulation is predictive for acute and subacute postoperative pain after total hip arthroplasty.

Detailed Description
-----------------
The preoperative heat stimulation consists of short and long tonic heat stimulation. Pain response is evaluated with an electronic visual analog scale. Furthermore the investigators evaluate other factors possibly predictable for acute and subacute postoperative pain after total hip arthroplasty - demographic factors, preoperative pain related factors, psychosocial factors (Hospital Anxiety and Depression Scale and Pain Catastrophizing Scale).

Official Title
-----------------
Is Preoperative Pain Response Upon Tonic Heat Stimulation Predictive for Pain After Total Hip Arthroplasty?

Conditions
-----------------
Pain, Postoperative

Intervention / Treatment
-----------------
* Device: heat pain test (Modular Sensory Analyzer, Somedic AB, Horby, Sweden).


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ethnic danes, above 18 years and able to give informed consent scheduled for primary, unilateral total hip arthroplasty Exclusion Criteria: Bilateral/revision arthroplasty Disease affection central or peripheral nerve function Alcohol and medical abuse Daily use of opioids or glucocorticoids Malignancy BMI > 40 Depression Dementia or other cognitive dysfunction

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 |
| --- | --- |
| THA (total hip arthroplasty)<br>Patients undergoing THA, preoperatively heat tested | Device: heat pain test (Modular Sensory Analyzer, Somedic AB, Horby, Sweden).<br>* pain during heat test preoperatively<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain (from 0-24 hours after surgery) | Pain assessed with the visual analog scale | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain (from day 1 to day 7 after surgery) | Pain assessed with the visual analog scale | 7 days | 
| Pain at day 14 after surgery | Pain assessed with the visual analog scale | 14 days | 
| Pain at day 30 after surgery | Pain assessed with the visual analog scale | 30 days |
A Safety and Effectiveness Study of Aroplatin in Patients With Advanced Solid Malignancies

Study Overview
=================
Brief Summary
-----------------
To determine the rate of response and the duration of the response following therapy with Aroplatinin patients with advanced solid malignancies.

Detailed Description
-----------------
Primary Objective: Determine response rate (RR; complete and partial response [CR, PR]) and duration after therapy with Aroplatin™ in patients with advanced solid malignancies. Secondary Objective: Determine the safety and tolerability of Aroplatin

Official Title
-----------------
A Phase I/II Study of Aroplatin™ in Patients With Advanced Solid Malignancies

Conditions
-----------------
Esophageal Neoplasms, Hepatocellular Carcinoma, Colorectal Neoplasms, Ovarian Neoplasms, Pancreatic Neoplasms, Neoplasms

Intervention / Treatment
-----------------
* Drug: Aroplatin (Liposomal NDDP, L-NDDP)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Advanced solid malignancies; Amenable to therapy with DACH platinum agents; Measurable disease (RECIST criteria); ECOG performance score of 0-2; Adequate hematopoietic, liver and renal function; Adequate cardiac function (maximum of class II, NYHA); Women of childbearing potential must have a negative urine or serum pregnancy test; Signed written informed consent; Subjects must be willing to be followed during the course of treatment/observation and follow-up. Exclusion Criteria: No other active malignancies; No prior therapy with oxaliplatin; No known brain metastases; Active, uncontrolled infection or other serious medical illnesses; Not using or have used any investigational therapy during four weeks before start of protocol treatment.

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: Aroplatin (Liposomal NDDP, L-NDDP)|nan|

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
-----------------
Esophageal Neoplasms, Esophagus Neoplasm, Esophagus Cancer, Esophageal Cancer, Esophageal Tumors, Esophagus Tumors, Neoplasms, Esophageal, Hepatocellular Carcinoma, Carcinoma, Hepatocellular, Hepatoma, Colorectal Neoplasms, Colorectal Cancer, Colorectal Carcinoma, Colorectal Tumor, Neoplasms, Colorectal, Ovarian Neoplasms, Ovary Neoplasms, Ovary Cancer, Ovary Carcinoma, Ovarian Cancer, Ovarian Carcinoma, Neoplasms, Ovarian, Pancreatic Neoplasms, Pancreatic Cancer, Pancreas Neoplasms, Pancreas Cancer, Neoplasms, Pancreatic, Neoplasms, Pancreas, and other solid tumors