linjc16/ctgov huggingface dataset:
Tracer Targeting FAP PET Imaging in Patients

Study Overview
=================
Brief Summary
-----------------
This is a single arm study to evaluate the safety and biodistribution of tracer targeting FAP PET Imaging in patients

Official Title
-----------------
Tracer Targeting FAP PET Imaging in Patients

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Drug: 18F-FAPI
* Drug: 68Ga-FAPI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients voluntarily signed informed consent; Age 18-75, male or female; Patients diagnosed with cancer confirmed by histopathology or cytology; At least one measurable solid lesion has been examined according RECIST1.1 standard; ECOG score 0 2. Exclusion Criteria: Recovery from major trauma (including surgery) within 4 weeks prior to study treatment; Patients with systemic or locally severe infections, or other serious coexisting diseases; Patients with abnormal immune function or who have recently used immunosuppressive or potentiating agents including various vaccines; Patients with autoimmune diseases, including rheumatoid arthritis; Inadequate control of arrhythmias, including atrial fibrillation; Uncontrolled hypertension; Patients with allergies or allergies to any component of the imaging agent or antibody; Patients who cannot undergo PET/CT imaging scan; Syphilis, HBV, HCV, or HIV positive subjects; Male and female subjects of reproductive age cannot take effective contraceptive measures; Pregnant or lactating women; Patients with a history of mental illness or related conditions; Other subjects considered unsuitable by researchers.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 18F-FAPI<br> | Drug: 18F-FAPI<br>* Patients will receive a tracer dose of 18F (8-10mCi) labelled FAPI<br>|
| Experimental: 68Ga-FAPI<br> | Drug: 68Ga-FAPI<br>* Patients will receive a tracer dose of 68Ga (2-5mCi) labelled FAPI<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of tissue distribution of 18F-FAPI | Biodistribution of 18F-FAPI evaluated by radioactive uptake values (standardized uptake values, SUVs) in various organs during repeated 18F-PET scans will be reported. | 1 day | 
| Evaluation of tissue distribution of 68Ga-FAPI | Biodistribution of 68Ga-FAPI evaluated by radioactive uptake values (standardized uptake values, SUVs) in various organs during repeated 68Ga-PET scans will be reported. | 1 day |
A Study of TCD601 in the Induction of Tolerance in de Novo Liver Transplantation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate if treatment with a siplizumab-based regimen can induce allogeneic tolerance in liver transplant recipients.

Official Title
-----------------
A 60 Month, Single-arm, Proof-of-concept Study to Induce Allogeneic Tolerance in Deceased Donor Liver Transplant Recipients Using Siplizumab, an Anti-CD2 Antibody in Combination With Cyclophosphamide and Splenectomy

Conditions
-----------------
Liver Transplantation

Intervention / Treatment
-----------------
* Biological: TCD601
* Biological: Cyclophosphamide
* Drug: TAC
* Drug: MMF
* Drug: Corticosteroids


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to understand the study requirements and provide written informed consent before and study assessment is performed Adult subjects aged 18-70 receiving an ABO compatible deceased donor liver transplant Male study subjects willing to maintain barrier contraception (condom) and agree not to father a child until 12 weeks after the last dose of MMF Exclusion Criteria: Pregnant or nursing (lactating) women Subjects with a history of TB or latent TB infection Subjects with a history of cancer

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>TCD601administered after liver transplant with splenectomy with cyclophosphamide and immunosuppression therapy | Biological: TCD601<br>* Investigational Product<br>* Other names: siplizumab;Biological: Cyclophosphamide<br>* Conditioning Regimen<br>Drug: TAC<br>* Immunosuppression Therapy<br>* Other names: Tacrolimus;Drug: MMF<br>* Immunosuppression Therapy<br>* Other names: Mycophenolate Mofetil;Drug: Corticosteroids<br>* Immunosuppression Therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine if treatment with siplizumab can induce allogeneic tolerance in liver transplant recipients | The number of transplant recipients patients off of immunosuppression therapy | 30 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To explore the safety of TCD601 | The number of adverse events and serious adverse events | 30 months |
Endoscopic Common Bile Duct Stones Clearance During Pregnancy

Study Overview
=================
Brief Summary
-----------------
Background: Pregnancy is associated with a higher risk of common bile duct stones. Currently Endoscopic Retrograde Cholangiopancreatography (ERCP) is the treatment of choice for symptomatic choledocholithiasis. However, ERCP during pregnancy is associated with hazards of radiation exposure, as well as challenging patient positioning and anesthesia

Detailed Description
-----------------
This is a retrospective analysis of endoscopic common bile duct stone clearance in pregnant patients with symptomatic choledocholithiasis between June 2015 and June 2023. Sedation and anesthesia was done by safe medications by senior anesthetist, and the endoscopic procedure was performed in left lateral decubitus instead of prone position. The gravid uterus was kept away from the monopolar electrocautery current pathway. Radiocontrast injection and fluoroscopy was deleted and replaced by trans-abdominal US and endoscopic bile aspiration Data including perioperative outcomes and follow up data will collected, tabulated and analyzed.

Official Title
-----------------
Endoscopic Common Bile Duct Stones Clearance During Pregnancy: Challenges and Solutions

Conditions
-----------------
Common Bile Duct Calculi

Intervention / Treatment
-----------------
* Other: Endoscopic clearance of common bile duct stones


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women with symptomatic common bile duct stones. Exclusion Criteria: Presence of pancreatitis or cholangitis.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant women with symptomatic common bile duct stones<br>Pregnant women with symptomatic common bile duct stones | Other: Endoscopic clearance of common bile duct stones<br>* Under general anesthesia, in left lateral decubitus, endoscopic clearance of common bile duct stones was done. Ultrasonography was used to ensure right positioning of the guide wire in the common bile duct, and ensure stone clearance.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | any perioperative complications as pancreatitis, perforation, bleeding, abortion, preterm labor. | Till one month after delivery. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Common Bile Duct Stones, Endoscopic clearance, Jaundice, Pregnancy
Health ImprOvement Program of Bone in China

Study Overview
=================
Brief Summary
-----------------
Fracture risk factors have long been identified as key factors in osteoporosis and fragility fractures. The WHO recommended Fracture risk assessmenttool (FRAX) applies clinical risk factors to assess the absolute risk of osteoporotic fractures in each individual. Our preliminary study suggests that FRAX estimates may underestimate the risk of fractures in the Chinese population. In order to optimize the risk prediction model of osteoporotic fractures, a treatment threshold and its optimal cutting point were initially established based on the data of the health management Center of the Second Xiangya Hospital of Central South University.

Official Title
-----------------
Health ImprOvement Program of Bone in China

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Other: Regular follow-up


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Dual-energy X-ray bone mineral density measurement was performed in the health management center of our hospital in the physical examination subjects over 40 years old. Have independent civil capacity and agree to participate, and sign informed consent Exclusion Criteria: Under 40 years of age， Patients who had undergone hip replacement or lumbar surgery and could not perform dual-energy X-ray BMD testing; Patients who have been treated with effective anti-osteoporosis drugs or have a history of malignant tumors.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 100 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Regular follow-up|Follow-up of the population was conducted to track the incidence of fractures|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bone mineral density bone mineral density | Bone mineral density (BMD) data measured by dual-energy X-ray absorptiometry were collected from patients over 40 years old | From 2021 to 2031 | 
| Occurrence of fracture | Follow-up of the population was conducted to track the incidence of fractures | From 2021 to 2031 | 
| clinical risk factors of osteoporotic fracture | The main clinical risk factors of osteoporotic fracture were collected | From 2021 to 2031 |
Bilateral Elective Neck Dissection in Salvage Total Laryngectomy

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the role of elective bilateral neck dissection in patients with clinically negative lymph nodes (cN0) who underwent salvage total laryngectomy, by estimating the prevalence of histologically positive occult lymph nodes (pN+). Secondary objective will be the assessment of complication rate and the evaluation of 5-year Overall Survival (OS) and 5-year Disease-Specific Survival (DSS) in these patients.

Official Title
-----------------
Clinical Value and Prognostic Impact of Bilateral Elective Neck Dissection in Salvage Total Laryngectomy of cN0 Cases

Conditions
-----------------
Neck Cancer, Larynx, Larynx Cancer, Neck

Intervention / Treatment
-----------------
* Procedure: Elective bilateral neck dissection in cN0 patients


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria -patients affected by recurrent laryngeal cancer after primary treatment failure (surgery or radiotherapy or chemoradiotherapy), with no clinical or radiological evidence of lymph node metastasis in the neck (cN0),who underwent salvage total laryngectomy and concomitant bilateral elective neck dissection (levels II, III, IV and VI). Exclusion Criteria: patients who received other salvage laryngeal resection such as open partial horizontal laryngectomy, endoscopic partial laryngectomy, or who did not undergo bilateral selective neck dissection.

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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Elective bilateral neck dissection in cN0 patients|Radical modified type 3 selective bilaterale elective neck dissection|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occult lymph node metastasis | Incidence rate of occult lymph node metastasislaryngectomy with clinically negative lymph nodes (cN0), estimating the prevalence of histologically positive lymph nodes (pN+) and predictive factors for cervical lymph nodes metastasis | At the time of salvage surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications of bilateral neck dissection during hospitalization | Complications of bilateral neck dissection during hospitalization | Up to 15 days from salvage surgery | 
| Overall survival | Survival of the patient from any disease | 5 year | 
| Disease specific survival | Survival of the patient from laryngeal disease | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
neck dissection, SALVAGE TOTAL LARYNGECTOMY
Clinical and Molecular Characterization of Axial Psoriatic Arthritis (PsA), A Pilot Study

Study Overview
=================
Brief Summary
-----------------
Objectives: To identify a candidate set of biomarkers specific to AxPsA. Overview: Clinical and imaging characterization of PsA patients will be combined with extensive molecular assessment of both liquid and tissue compartments to identify biomarkers which differentiate PsA patients with and without axial involvement

Official Title
-----------------
Clinical and Molecular Characterization of Axial Psoriatic Arthritis (PsA), A Pilot Study

Conditions
-----------------
Psoriatic Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Persons with PsA diagnosed by a consultant Rheumatologist with disease duration of > 3 months but < 10 years with or without IBP. Adults between the ages 18 and 80 years, with joint disease onset after 16 years of age Patients able to understand and complete consent procedures Study participants must have PsA, meet CASPAR criteria, and must have active disease as defined by the treating rheumatologist, including an evaluable psoriatic skin lesion amenable to 6mm punch skin biopsy. o Psoriasis should be diagnosed by a consultant rheumatologist or dermatologist. Study participants must have been on consistent therapy for their PsA for the past 90 days Study participants must be naïve to biological treatment and targeted synthetic DMARD treatment (examples: JAK inhibitors, apremilast) Exclusion Criteria: • Persons with musculoskeletal (peripheral or axial) symptoms for >10 years Persons with planned major surgery (e.g., joint replacement) within the duration of the collection of data for the study Persons with a history of chemotherapy, radiation therapy or immunotherapy for cancer in the preceding 5 years. Persons with ongoing cancer (not excluding non-melanoma skin, cervical/breast in-situ carcinoma) but those fully recovered from an episode of cancer (in remission for more than 5 years) may be included at the discretion of the patient's treating rheumatologist. Persons with an active severe or serious infection Patients with non-severe infection at the discretion of the Investigator Persons with other concomitant disorders incompatible with study (at discretion of Investigator).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants with PsA without Axial Involvement<br> | |
| Participants with PsA with Axial Involvement<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target biomarker identification | Identify candidate biomarkers able to discriminate between PsA with and without axial involvement | 18 months |
Endoscopic Management of Non-anastomotic Biliary Strictures Following Liver Transplantation.

Study Overview
=================
Brief Summary
-----------------
The study will evaluate the results of endoscopic treatment of NON-anastomotic biliary strictures following liver transplantation

Official Title
-----------------
Endoscopic Management of Non-anastomotic Biliary Strictures Following Liver Transplantation. Registry of the Italian Society of Digestive Endoscopy.

Conditions
-----------------
Liver Transplant Disorder, Ischemic Cholangiopathy, Non-anastomotic Biliary Stricture, Biliary Stricture, Biliary Stents (Plastic)

Intervention / Treatment
-----------------
* Procedure: ERCP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 Non anastomotic biliary strictures diagnosed by direct cholangiogram (T-tube) or MRCP Stricture involving the hepatic hilum until secondary branches Increase of liver function tests Signature of the informed consent Exclusion Criteria: Previopus endoscopic or percutaneous treatments Patient candidate to metal stents placement Previous surgery resulting in altered anatomy

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

| Intervention/Treatment |
| --- |
|Procedure: ERCP|Endoscopic Retrograde Cholangiopancreatography, placement of stents using a duodenoscope and making an access through the papilla of Vater|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of endoscopic treatment of non-anastomosis biliary strictures | Evaluate biliary stricture resolution rate | 2 Years follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ERCP, Biliary stents, Liver transplantation, Ischemic cholangiopathy
Curcumin Gel On Radiation Induced Oral Mucositis

Study Overview
=================
Brief Summary
-----------------
The goal of this clinical study is to investigate the effect of a curcuma longa oral gel (curenext) on reducing radiation-induced oral mucositis severity in cancer patients and provide a context for understanding if there is a relationship between the curcumin clinical effect and production of EGFs and IL8. Researchers will compare between curcumin group and standard treatment group.

Official Title
-----------------
The Effect of Curcuma Long Oral Gel in Relation to Salivary Epidermal Growth Factor & Interleukin-8 on Radiation Induced Oral Mucositis in Iraqi Cancer Patients

Conditions
-----------------
Radiation-Induced Mucositis, Head and Neck Cancer

Intervention / Treatment
-----------------
* Drug: Curcumin Gel
* Drug: Standard Preparation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients above 16 years having histopathologically confirmed cancer in head and neck region who planned to have radiation with head and neck mask. Scheduled for 6-8 weeks of radiotherapy with 60-70Gy radiation (200cgy/fraction for 5 days/week). Exclusion Criteria: patient with hodgkin lymphoma. Any allergy to curcumin or other condiments.

Ages Eligible for Study
-----------------
Minimum Age: 16 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two groups A) curcuma longa oral gel group B) standard treatment group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Curcuma longa oral gel group<br> | Drug: Curcumin Gel<br>* Curcuma longa oral gel for prevention radiation induced oral mucositis<br>|
| Active Comparator: Standard treatment group<br> | Drug: Standard Preparation<br>* Standard preparation for prevention radiation induced oral mucositis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Onset of radiation induced mucositis | Onset (at which week) of radiation induced mucositis in relation to EGF and IL8 | Assessment every week starting from first visit until the onset of mucositis (up to 2 months) | 
| Change in severity of radiation induced mucositis | Change in severity (degree of illness) of radiation induced mucositis in relation to EGF & IL-8 by World Health Organization (WHO) mucositis scale {0: no. 1: mild. 2 and 3 : moderate. 4: severe} | Assessment every week starting from first visit of radiation unit it completion (average of 2 months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Radiation induced oral mucositis, Head and neck cancer, Curcuma longa, EGF, IL8