linjc16/ctgov huggingface dataset:
68Ga-FAPI-04 PET/CT for the Detection of Oral Carcinoma

Study Overview
=================
Brief Summary
-----------------
FAPI is a fibroblast activation protein inhibitor and 68Ga-FAPI-04 is a potential new imaging agent for imaging of carcinoma. 68Ga-FAPI-04 PET/CT is helpful to clarify the benign, malignant and invasive range of the oral carcinoma, locate and qualitatively diagnose the tumor, and make early diagnosis and restaging of recurrent tumor.

Detailed Description
-----------------
Sometimes, the traditional 18F-FDG PET/CT diagnosis of head and neck tumors mistakenly diagnosed inflammatory lymph nodes as metastatic lymph nodes, resulting in false positive results. Fibroblast activation protein (FAP) is a serine peptidase on the surface of tumor associated fibroblasts. It plays an important role in promoting the growth, invasion, metastasis and immunosuppression of tumor cells. FAPI is a fibroblast activation protein inhibitor and 68Ga-FAPI-04 is a potential new imaging agent for imaging of carcinoma. 68Ga-FAPI-04 PET/CT is helpful to clarify the benign, malignant and invasive range of the oral carcinoma, locate and qualitatively diagnose the tumor, and make early diagnosis and restaging of recurrent tumor.

Official Title
-----------------
68Ga-FAPI-04 PET/CT for the Detection of Oral Carcinoma

Conditions
-----------------
Oral Carcinoma

Intervention / Treatment
-----------------
* Drug: 68Ga-FAPI-04


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients in suspicion of oral carcinoma, 68Ga-FAPI-04 and 18F-FDG PET/CT within 2 week; being able to provide basic information and sign the written informed consent form. Exclusion Criteria: claustrophobia, pregnancy, breastfeeding, kidney or liver failure, inability to fulfill the study.

Ages Eligible for Study
-----------------
Minimum Age: 16 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-FAPI-04 PET/CT<br>The patients were injected with 55.5-148 MBq (1.5-4mCi) of 68Ga-FAPI-04 in one dose intravenously and underwent SPECT/CT scan 30-90 min later. | Drug: 68Ga-FAPI-04<br>* 68Ga-FAPI-04 were injected into the patients before the PET/CT scans<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic performance1 | comparing the SUV and number of Oral cancer or metastasis detected by 68Ga-FAPI-04 and 18F-FDG PET/CT | 1 year | 
| Diagnostic performance2 | comparing the SUV and number of Oral cancer or metastasis detected by 68Ga-FAPI-04 and 18F-FDG PET/CT | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PET/CT, FAPI
SHR1459 in Combination With YY-20394 in Recurrent and Refractory B-cell Non-Hodgkin's Lymphoma

Study Overview
=================
Brief Summary
-----------------
The study is evaluating the efficacy, and safety of SHR1459 combined with YY-20394 for Recurrent and refractory B-cell non-Hodgkin's lymphoma in adults.

Official Title
-----------------
A Phase I/ II Study of SHR1459 in Combination With YY-20394 in Recurrent and Refractory B-cell Non-Hodgkin's Lymphoma in Adults

Conditions
-----------------
Recurrent and Refractory B-cell Non-Hodgkin's Lymphoma

Intervention / Treatment
-----------------
* Drug: SHR1459 ；YY-20394
* Drug: SHR1459 ；YY-20394
* Drug: Gemcitabine-Oxaliplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed diagnosis of B-cell NHL such as DLBCL, FL and MCL Patients received at least 2 lines of systemic therapy Previously received anti- CD20 treatment Patients in stage II should also be unsuitable or unwilling to receive allogeneic hematopoietic stem cell transplantation Patients must have an acceptable organ function Exclusion Criteria: Previously treated with PI3K inhibitors or BTK inhibitors Unresolved toxicity of CTCAE grade > 1 from prior anti-lymphoma therapy Chemotherapy or other investigational therapy within 28 days (or 5 times the half-life time, whichever is shorter) before starting cycle 1 Significant concurrent medical disease or condition which according to the investigators' judgement Active hepatitis B, C or HIV infection Infection requiring treatment 2 weeks prior to the first dosing

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
Interventional Model Description: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SHR1459 + YY-20394 (Stage 1)<br> | Drug: SHR1459 ；YY-20394<br>* SHR1459 plus YY-20394<br>|
| Experimental: SHR1459 + YY-20394 (Stage 2)<br> | Drug: SHR1459 ；YY-20394<br>* SHR1459 plus YY-20394<br>|
| Experimental: GemOx (Stage 2)<br> | Drug: Gemcitabine-Oxaliplatin<br>* Gemcitabine-Oxaliplatin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stage 1: MTD （Maximum tolerated dose）or RP2D（Recommended Phase II Dose) of SHR1459 and YY-20394; |  | Minimum observation period is 28 days for the maximum dose cohort | 
| Stage 2: Overall response rate (ORR) |  | 8 weeks after last patient first visit (LPFV) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events |  | At every treatment and follow up visit until disease progression. Expected to be for up to 6 months |
A Study to Evaluate Plasmin for the Creation of a Posterior Vitreous Detachment (PVD)

Study Overview
=================
Brief Summary
-----------------
Plasmin is expected to create a posterior vitreous detachment (PVD) when injected directly into the eye. The pharmacological creation of a PVD may be beneficial in helping to treat a variety of conditions.

Official Title
-----------------
An Open Label Sequential Dose Response Observational Study of Intravitreally Administered Plasmin for the Creation of a Posterior Vitreous Detachment (PVD)

Conditions
-----------------
Vitreoretinal Traction Syndrome

Intervention / Treatment
-----------------
* Drug: Plasmin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are in need of a vitrectomy. Exclusion Criteria: A PVD in the study eye as assessed by the investigator using ophthalmic and alternative examination techniques. A history of vitrectomy in the study eye. A media opacity that precludes quality examination of the vitreous and fundus in the study eye.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Plasmin<br>Human-derived plasmin reconstituted with sterile sodium chloride for intravitreal injection. | Drug: Plasmin<br>* 27 mg of human-derived plasmin to be reconstituted with of 0.9% Sterile Sodium Chloride for a single intravitreal injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of a Posterior Vitreous Detachment (PVD) | Presence of posterior vitreous detachment evaluated durning virectomy | 14 days |
Urine Proteome of Surgical Patients and Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to define early urinary biomarkers for diagnosis and prognosis of Renal Cell Carcinoma (RCC) with subsequent development of reliable, cost-effective, screening techniques.

Official Title
-----------------
Urine Proteome of Surgical Patients and Healthy Volunteers.

Conditions
-----------------
Renal Cell Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years and older Planned procedure with presumptive diagnosis of RCC, bladder or prostate cancer OR control patient undergoing non-urological surgery OR normal healthy volunteer OR post surgical patient with a diagnosis of RCC and under surveillance for reoccurrence of RCC or treatment of metastatic RCC Signed, informed consent Exclusion Criteria: Patients on dialysis

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 |
| --- | --- |
| Group 1<br>Enrollment of surgical patients at Barnes Jewish Hospital (BJH) with a presumptive diagnosis of RCC and planned nephrectomy or partial nephrectomy. | |
| Group 2<br>Surgical patients at BJH with non urological cancers | |
| Group 3<br>Surgical patients at BJH with a presumptive diagnosis of RCC and planned nephrectomy or partial nephrectomy | |
| Group 4<br>Surgical patients at BJH with non urological cancers | |
| Group 5<br>Healthy volunteers with no history of cancer or renal disease | |
| Group 6<br>Patients at BJH/Washington University School of Medicine under post procedure surveillance for RCC recurrence and patients under treatment for metastatic disease. | |
| Group 7<br>Patients with a presumptive diagnosis of bladder cancer or prostate cancer | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluation of novel bio markers | The overall objective of our study is to find and evaluate additional novel biomarkers, predictive of disease, that are present and measurable in whole urine of patients undergoing surgery for renal cancer. | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Surgery, Renal Cell Cancer
Efficacy on Height in SGA Children Treated With Growth Hormone

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe and Middle East. Growth hormone in SGA Children This trial compares a treated group of patients with an untreated group of patients.

Official Title
-----------------
Effect of Two Years Treatment With Growth Hormone on Height in SGA Children.

Conditions
-----------------
Foetal Growth Problem, Small for Gestational Age

Intervention / Treatment
-----------------
* Drug: somatropin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Born small for gestational age with length and/or weight at -2 SDS or below at time of birth, according to country specific references. Severe growth failure with no catch up and with height at -2.5 SDS or below, according to country specific references, for chronological age at time of inclusion Exclusion Criteria: Growth Hormone Deficiency (GHD) Treatment with any medical product which may interfere with GH effects Growth retardation associated with infections, severe chronic diseases including chromosomal anomaly or nutritional disorders

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 7 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: somatropin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate effect on Height in SGA Children Treated with Growth Hormone |  | After 2 years of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Appetite |  |  | 
| Height SDS, yearly |  |  |
The Determination of the Effect of Volatile Anesthetics on Leukocyte Function ex Vivo

Study Overview
=================
Brief Summary
-----------------
One of the most common side effects of a surgical procedure is infection. In order to lower the number of infections that occur after surgery, it is important for physicians to know how medications used during surgery affect the way the body fights infection. Often, when anesthesiologists are helping people go to sleep before surgery they give people medications known as volatile anesthetics. Volatile anesthetics are medications that can change from a liquid or solid to a gas very easily. Some studies suggest that these types of medications may change the way white blood cells work in the body. Changing the way white blood cells work could possibly increase the person's risk of infection after their surgery or weaken their body's ability to fight infections. The goal of this research study is to learn about how volatile anesthesia medications change the way white blood cells work in people having anesthesia for cardiac procedures. To do this, investigators will examine the function of while blood cells in the laboratory based setting.

Official Title
-----------------
The Determination of the Effect of Volatile Anesthetics on Leukocyte Function ex Vivo

Conditions
-----------------
Leukocyte Function, Anesthesia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients greater than or equal to 12 months of age scheduled for a cardiac catheterization, cardiac surgery, or cardiac MRI Exclusion Criteria: known underlying hematological disorder known oncological disorder patients who do not require preoperative laboratory testing

Ages Eligible for Study
-----------------
Minimum Age: 12 Months

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Volatile anesthesia exposure<br> | |
| No volatile anesthesia exposure<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leukocyte function under anesthesia | The study will evaluate ex vivo leukocyte function by testing leukocyte activation, TNF-a production, and phagocytic function in the laboratory. | up to 12 months |
Suture Material for Closure of Hysterotomy

Study Overview
=================
Brief Summary
-----------------
Retrospective chart review evaluating different suture types on surgical outcomes for cesarean delivery and vaginal birth after cesarean delivery outcomes when different sutures are used.

Detailed Description
-----------------
Cesarean sections are one of the most common surgeries performed in the United States; approximately 1 out of 3 births are completed by cesarean delivery. In 2014, 1,284,551 cesarean deliveries were performed. Unfortunately, even with this being a very common procedure some surgical topics have not been fully evaluated. One of these topics is the choice of suture for repair of the hysterotomy (uterine) incision. Several suture materials are available, yet only polygatactin-910 and catgut have been evaluated in a single study. In this study, only surgery complications were evaluated. Catgut was found to be associated with less risk of receiving a blood transfusion, otherwise no differences were found. One of the most common suture materials used at our institution is poliglecaprone 25, however no long term studies have been completed for this indication. In addition, no studies have evaluated the risk of uterine rupture with trial of labor after cesarean after using poliglecaprone 25 to repair the hysterotomy. This information could be very useful in counseling for patients. As the cesarean delivery rates continue to climb, information on appropriate technique for surgery are needed.

Official Title
-----------------
Evaluation of Suture Material for Closure of Hysterotomy

Conditions
-----------------
Cesarean Section; Complications, Wound, Hematoma

Intervention / Treatment
-----------------
* Procedure: Suture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women who underwent a cesarean delivery or vaginal birth after cesarean Exclusion Criteria: unable to give consent

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 55 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Suture|To examine different types of suture material used for hysterotomy closure in cesarean section and determine if one is preferred above other types due to a complications profile.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preferred suture | Preferred suture chart review | 3 months |
Duplex US in Pelvic Congestion Syndrome in Females (PCS)

Study Overview
=================
Brief Summary
-----------------
To investigate the feasibility of Duplex US in Diagnosis of Pelvic Congestion Syndrome

Detailed Description
-----------------
In the past, a diagnosis of chronic pelvic pain left many women frustrated with few treatment options and a lack of available resources. Their physicians were likewise perplexed, despite the endless acquisition of negative laboratory and imaging data as well as inconclusive consultations obtained. In the last 10 years, improved scientiﬁc understanding and increased physician awareness have lessened the confusion surrounding this condition and its distinct association with pelvic congestion syndrome (PCS). Furthermore, reﬁnements of medical and minimally invasive surgical solutions give affected patients more therapeutic choices today. Since anatomical venous variations in the pelvis are common, it is important to know the anatomy of these vessels for treatment planning. Imaging is critical in the evaluation of pelvic varices, both to differentiate them from other condition and also because pelvic varices may be secondary to serious underlying pathology, such as inferior vena caval obstruction, portal hypertension, increased pelvic blood flow, and vascular malformations. Sonographic findings of pelvic congestion syndrome were dilated left ovarian vein with reversed caudal flow, presence of varicocele, dilated arcuate veins crossing the uterine myometrium, polycystic changes of the ovary, and variable duplex waveform during the Valsalva's maneuver. Combined transabdominal and transvaginal sonography are potentially useful as a noninvasive screening & grading tool for determining which patients with chronic pelvic pain may benefit from selective ovarian venography and transcatheter embolization

Official Title
-----------------
Duplex US in Pelvic Congestion Syndrome in Females

Conditions
-----------------
Pelvic Pain Syndrome

Intervention / Treatment
-----------------
* Device: Duplex US


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with signs and symptoms of PCS Exclusion Criteria: No

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 55 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Duplex US|Duplex US (Caliper, wave forms...)in evaluation of Pelvic Veins (namely left ovarian vein). in pelvic congestion syndrome|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duplex US in Pelvic Congestion Syndrome in females | to investigate the feasibility of Duplex US in diagnosis of Pelvic Congestion Syndrome | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PCS
Long Term Results in Hypoplastic Aortic Arch Repair in Neonates Using a Glutaraldehyde Treated Autologous Pericardial Patch

Study Overview
=================
Brief Summary
-----------------
Hypoplastic aortic arch is a congenital heart defect that is prejudicial for the growth of newborns. It is often associated to other heart defects. Different surgical techniques exist to address this defect, but the literature is very poor with regards to the use of an autologous pericardial patch. Most use extensive dissection techniques or synthetic patches. Here investigators report institution's original approach using the newborns own pericardium for what investigators believe to be an optimal correction of the hypoplasia., with preserved growth potential.

Detailed Description
-----------------
Retrospective analysis of an already well codified surgical intervention carried out in HUDERF under extra-corporeal circulation

Official Title
-----------------
Retrospective Analysis of Results in Children Treated by an Autologous Pericardial Patch to Repair a Hypoplastic Aortic Arch Associated to Other Congenital Heart Defects

Conditions
-----------------
Congenital Hypoplasia of Aortic Arch

Intervention / Treatment
-----------------
* Procedure: Aortoplasty using autologous pericardial patch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newborns with a hypoplastic aortic arch undergoing a first intervention Exclusion Criteria: none

Ages Eligible for Study
-----------------
Maximum Age: 2 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 |
| --- | --- |
| simple heart defects<br>Newborns with hypoplastic aortic arch in simple congenital heart defects requiring aortoplasty | Procedure: Aortoplasty using autologous pericardial patch<br>* hypoplastic aortic arch repair using a glutaraldehyde treated, autologous pericardial patch.<br>|
| complex heart defects.<br>Newborns with hypoplastic aortic arch in complex congenital heart defects requiring aortoplasty | Procedure: Aortoplasty using autologous pericardial patch<br>* hypoplastic aortic arch repair using a glutaraldehyde treated, autologous pericardial patch.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 30 days post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from re-intervention |  | Up to 18 years post initial surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Single stage repair, Congenital heart defects, Aortic arch hypoplasia, Glutaraldehyde treated autologous pericardium, Newborns