linjc16/ctgov huggingface dataset:
A Study of MORAb-009 in Patients With Solid Tumor

Study Overview
=================
Brief Summary
-----------------
MORAb-009 is intravenously administered to patients with solid tumor once a week for 4 weeks as 1 cycle in order to investigate dose-limiting toxicity and estimate maximum tolerated dose.

Official Title
-----------------
A Phase 1 Study of MORAb-009 in Patients With Solid Tumor

Conditions
-----------------
Cancer, Mesothelin-positive

Intervention / Treatment
-----------------
* Drug: MORAb-009


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria; Japanese male and female patients aged from 20 to less than 80 years at obtaining informed consent Patient with histologically or cytologically diagnosed solid tumor Patient who is mesothelin-positive confirmed by immunohistochemistry (IHC) (except for pancreatic cancer and mesothelioma that mesothelin-positive is frequently reported) Patient with solid tumor who is non responder to or resistant to standard therapy and has no other appropriate treatment Performance Status (PS) is 0 to 1 by Eastern Cooperative Oncology Group ECOG criteria Exclusion criteria Brain metastasis presenting clinical symptoms or requiring medical treatment Serious and systemic infection requiring medical treatment History of hypersensitivity to protein formulations including monoclonal antibody With active multiple carcinoma (except for carcinoma in situ and intramucosal carcinoma) With celomic fluid (pleural effusion or ascites) uncontrolled by drainage, or with a large volume of celomic fluid

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 79 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: MORAb-009<br> | Drug: MORAb-009<br>* MORAb-009 is intravenously administered to patients with solid tumor once a week for 4 weeks as 1 cycle.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate dose-limiting toxicity and estimate maximum tolerated dose. |  | 4 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The best overall response rate in the RECIST evaluation and the preliminary evaluation calculating the frequency of Completed response and Partial Response. |  | During Study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer, Mesothelin-positive
Celebrex - Cervix: Celecoxib in the Treatment of Patients With Locally Advanced Carcinoma of the Cervix

Study Overview
=================
Brief Summary
-----------------
This is a phase I/II study to evaluate the safety and toxicity of celecoxib in combination with standard concurrent cisplatin and radiotherapy in women with locally advanced cervix cancer. In addition, we aim to determine the effect of celecoxib (Celebrex) on tumour oxygenation, interstitial fluid pressure, COX-2 levels, prostaglandin E2 levels, angiogenesis and apoptosis.

Official Title
-----------------
A Phase I/II Trial of the Cyclooxygenase-2 Inhibitor Celecoxib in the Treatment of Patients With Locally Advanced Carcinoma of the Cervix

Conditions
-----------------
Cervix Neoplasms

Intervention / Treatment
-----------------
* Drug: Celecoxib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Biopsy-proven carcinoma of the cervix, with visible/palpable tumours; FIGO stage T1B-3B, NO/1, MO, to be treated with definitive radiotherapy and chemotherapy ECOG performance status of 0, 1, or 2 Adequate hematologic function; Granulocyte count greater than 1.5 x 109/L, Platelet count greater than 100 x 109/L Adequate organ function; Serum creatinine £ 1.25 x ULN, or a calculated creatinine clearance ³ 50 mL/min, Serum bilirubin £ 1.25 x ULN and AST/ALT £ 3xULN No prior treatment for cervix cancer Informed consent Exclusion Criteria: Use of an NSAID in the 2 weeks prior to study enrollment Patients with an active malignancy at another site Patients with significant cardiac, renal, or pulmonary disease or any other medical conditions that may preclude radical therapy Patients who have significant history of ischaemic heart disease or stroke who would be deemed not suitable for cessation of their daily prophylactic aspirin Patients with history of peptic ulcer disease or previous NSAID related gastrointestinal bleeding Patients with hypersensitivity to NSAIDS or celecoxib, or sulfonamides Patients who unwilling or unable to give informed consent

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Celecoxib<br>Celecoxib | Drug: Celecoxib<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety - Tolerance of concurrent celecoxib with standard cisplatin/radiotherapy |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective changes in tumour oxygenation and IFP |  | 1 year | 
| Objective molecular marker response (COX-2, PGE2, VEGF, apoptosis) |  | 1 year |
Fluorine-18-α-Methyltyrosine Positron Emission Tomography (18F-FMT PET) for Therapy Response in Lung Cancer

Study Overview
=================
Brief Summary
-----------------
L-[3-18F]-α-methyltyrosine (18F-FMT) is an amino-acid tracer for positron emission tomography (PET). The investigators evaluated the value of 18F-FMT PET for the assessment of therapy response in patients with lung cancer as compared with that of 2-[18F]-fluoro-2-deoxy-D-glucose (18F-FDG) PET. The patients with lung cancer underwent PET studies with 18F-FDG and 18F-FMT before and after radio-/chemotherapy. The investigators used the ratio of the SUVmax of the mediastinal (N2) lymph node to the SUVmax of the primary tumor (N/P ratio ). All patients were divided into two groups of N/P ratio<1 and N/P ratio≥1, and the survival time was estimated by Kaplan-Meier method.

Official Title
-----------------
Fluorine-18-α-Methyltyrosine Positron Emission Tomography to Measure Therapy

Conditions
-----------------
Non-Small Cell Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primary lung cancer All patients received first-line chemotherapy Exclusion Criteria: Patients with diabetus mellitus

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Therapy monitoring<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
-----------------
Fluorine-18-α-methyltyrosine, Positron emission tomography, Lung cancer, chemotherapy, monitoring
Mitochondria (MI) Energy - Linking Bioenergetic Phenotypes in Circulating Cells With Cardiometabolic Health in School-age Children

Study Overview
=================
Brief Summary
-----------------
This research study is about how daily activities, behaviors, and fitness affect the health and function of blood cells and their mitochondria, which are the powerhouses of the cells. These small mitochondria inside the cells make energy, and are very important for the health of the body.

Detailed Description
-----------------
Determine the impact of physical activity and obesity status on circulating cells mitochondrial function (e.g., fat vs. carbohydrates combustion capacity, total oxidative capacity, mitochondrial number and proton leak).

Official Title
-----------------
Linking Bioenergetic Phenotypes in Circulating Cells With Cardiometabolic Health in School-age Children

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages 8-10 years Boys and girls All ethnicity All BMI Exclusion Criteria: severe persistent asthma exercise induced asthma autism spectrum disorder attention deficit hyperactivity disorder attention deficit disorder Opposition defiant disorder conduct disorder epilepsy chronic kidney disease hormonal disease autoimmune diseases bleeding disorders chronic infections mental health disorder Type 2 and Type 1 diabetes Other pre-existing medical conditions or medications as determined by the investigators to affect the outcomes of interest

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 10 Years

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

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 |
| --- | --- | --- |
| Platelet mitochondrial respiration and its association with adiposity and peak aerobic capacity in children 8 to 10 years old. | Platelet mitochondrial respiration from isolated platelets will be measured using a flux analyzer. Adiposity will be measured with dual X-ray absorptiometry, and peak aerobic capacity with an incremental cycle ergometer test. measure physical activity | 8 days |
Thermal Camera Detection of Ventriculoperitoneal Shunt Flow

Study Overview
=================
Brief Summary
-----------------
There have been reports in the past of using thermal cameras to demonstrate flow in the tubing as a surrogate of proper shunt function. This was shown to have almost 90% accuracy at determining proper functioning but required expensive equipment that was not universally available. There is now smart phone based thermal camera technology (Flir One: http://www.flir.com/flirone/) that could make this technique widely available for health care use. The goal of the study is to determine if this device can demonstrate flow in the distal tubing of a VP shunt.

Official Title
-----------------
Thermal Camera Detection of Ventriculoperitoneal Shunt Flow

Conditions
-----------------
Hydrocephalus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with known VP shunt Status of shunt function known. Patients with well healed wounds (no immediately post op patients) Exclusion Criteria: Patients in urgent need of shunt revision Age less than 18

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Shunt suspected to be functioning<br> | |
| Shunt suspected to not be functioning<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine if a smartphone based thermal camera can determine flow in the distal tubing of a VP shunt. |  | 3 years |
Proton Therapy Patient Registry

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to establish a database (or registry) of patients treated with proton beam therapy at the University Hospitals (UH) Proton Therapy Center. By keeping track of the patients treated it will allow the investigators to periodically evaluate the outcomes of patients.

Detailed Description
-----------------
The primary objective of this non-therapeutic registry study is to create a secure longitudinal database of patients treated with proton therapy at the UH Proton Therapy Center. This will allow reporting patient, tumor, and treatment characteristics as well as outcome data pertaining to disease control and complications for this relatively rare radiation modality.

Official Title
-----------------
Proton Therapy Patient Registry

Conditions
-----------------
Treatment With Proton Beam Radiation Therapy

Intervention / Treatment
-----------------
* Other: Proton Beam Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients treated with proton beam at the UH Proton Therapy Center Patients who have the ability to understand and be willing to sign a written informed consent document Exclusion Criteria: Patients or legal guardians who are unable to understand informed consent document
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Proton Beam Therapy<br>All patients treated with proton beam therapy at the UH Proton Therapy Center who consent to have their health information recorded, including whether the cancer was cured and if any complications occur ed due to treatment | Other: Proton Beam Therapy<br>* Intervention is not assigned. Only patient data is being collected<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants treated at UH Proton Therapy Center by proton beam therapy |  | Up to 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
proton beam, registry, radiation, cancer
Ultrasonography and Cone-Beam Computed Tomography for Peri-implant Tissue Evaluation

Study Overview
=================
Brief Summary
-----------------
Objectives: Although cone-beam computed tomography (CBCT) is becoming a standard of care in implant therapy, concerns have been raised recently about its limitation in imaging peri-implant tissues due to artifacts. The aim of present study was to demonstrate the complementary role of ultrasound (US), for a comprehensive examination of peri-implant tissues in live humans. Material and Methods: Patients with > 1 implant, a CBCT scan, an US scan, and clinical photographs taken during the open-bone surgery were included. The crestal bone thickness (CBT) and facial bone level (FBL) were measured on both modalities, and direct FBL measurements were also made on clinical images. The correlation plots were made to evaluate the measurement agreements between the 3 methods.

Official Title
-----------------
A Retrospective Study on Use of Ultrasonography and Cone-Beam Computed Tomography for Evaluating Peri-implant Tissue

Conditions
-----------------
Ultrasonography

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: the patients had to have ≥ 1 implant with a CBCT scan, US scan, and clinical photographs taken during the surgery, e.g. a revision/explantation surgery due to peri-implantitis or a 2nd stage uncover surgery.
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Implant group<br>Patients with 1 or more implants with CBCT, ultrasound and open-bone images | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Crestal bone thickness | facial bone thickness measured at 1 mm apical to bone crest | up to 100 months after implant surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Facial bone height | facial bone height measured from implant platform | up to 100 months after implant surgery. |
Prospective Registry of European Hemophilia B Patients Receiving BeneFIX® for Usual Use

Study Overview
=================
Brief Summary
-----------------
This is an open-label multi-center Registry in patients with hemophilia B receiving BeneFIX. All patients who begin treatment with BeneFIX in European Union countries, will be eligible for participation. Patient demographics will be collected at baseline for all patients. A baseline FIX activity and Bethesda assay for inhibitor based on historical data should be recorded if available. Adverse events as defined in the protocol will also be reported on the appropriate forms. Data will be collected from patients on an ongoing basis to ensure that information is being captured for each patient being treated with BeneFIX.

Official Title
-----------------
A Prospective Registry of European Hemophilia B Patients Receiving BeneFIX®(Nonacog Alfa, Recombinant Human Factor IX) for Usual Use

Conditions
-----------------
Hemophilia B

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Hemophilia B scheduled to begin treatment with BeneFIX are eligible for Registry enrollment Exclusion Criteria:
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 |
| --- | --- | --- |
| Observation for safety |  | Study Duration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hemophilia B
Prevalence of Cesarean Section Niche in Women With Unexplained Abnormal Uterine Bleeding

Study Overview
=================
Brief Summary
-----------------
Prevalence of Cesarean Section Niche in women With Unexplained Abnormal Uterine Bleeding

Detailed Description
-----------------
Prevalence of Cesarean Section Niche as diagnosed by office hysteroscopy and transvaginal sonography in women With Unexplained Abnormal Uterine Bleeding

Official Title
-----------------
Prevalence of Cesarean Section Niche in Women With Unexplained Abnormal Uterine Bleeding

Conditions
-----------------
Cesarean Section; Dehiscence, Abnormal Uterine Bleeding

Intervention / Treatment
-----------------
* Device: Office Hysteroscope


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a history of cesarean section who are complaining of abnormal uterine bleeding with the following criteria : Normal complete blood count apart from paramaters of anemia Not using drugs affecting coagulation profile Bleeding is not related to pregnancy Not using intrauterine contraceptive devices or hormonal contraceptives By ultrasonography : no abnormalities in the pelvis e.g benign or malignant tumors , ovarian cysts or tumors No evidence of cervical abnormalities as cause of bleeding with cervical examination or cervical smears Exclusion Criteria: Any patient not fulfilling the inclusion criteria If the patient refused the technique ( office hysteroscopy )

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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
Interventional Model Description: Hysteroscopic examination for patients with AUB
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Office hysteroscopy<br>Examinatin with Office hysteroscope for women with abnormal uterine bleeding who had a history of previous cesarean section | Device: Office Hysteroscope<br>* Diagnosis of C.S niche in patients wit AUB by office hysteroscope<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of cisarean section niche | Prevalence of cisarean section niche in women complainig of unexplained abnormal uterine bleeding | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hytsteroscopy
Kidney Function After Pneumoperitoneum and Analgesia

Study Overview
=================
Brief Summary
-----------------
double blind study of kidney function of two groups of adult patients submitted to laparoscopic cholecystectomy and analgesia from tramadol associated to dipyrone or ketorolac

Detailed Description
-----------------
Background: The laparoscopic cholecystectomy (LC) reduces surgical trauma and hospital stay but requires effective and safe postoperative analgesia. This prospective and double blind study aimed to study the effects of tramadol analgesia associated to dipyrone or ketorolac in the kidney function of patients submitted to LC, using creatinine (Cr), cystatin C, and enzymuria evaluations. Methods: In the pre- and postoperative (PO) periods, estimated glomerular filtration rates (GFR), obtained from two formulas dependants of blood Cr and one from blood cystatin C values, and tubular enzymuria - alkaline phosphatase (AP), γ-glutamyltransferase (γ-GT) - were determined in patients who underwent LC and analgesia with tramadol and dipyrone (G1, n=63) or tramadol and ketorolac (G2, n=63). In the recovery room (RR), pain and need of rescue analgesia with morphine were evaluated.

Official Title
-----------------
Kidney Function After Laparoscopic Cholecystectomy and Tramadol Anesthesia Plus Dipyrone or Ketorolac

Conditions
-----------------
Laparoscopic Cholecystectomy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: From 18 to 60 years Normal kidney function Free consented participation Exclusion Criteria: Renal and hepatic dysfunction Prior (one month) use of anti-inflammatory agents

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 tramadol plus ketorolac<br> | |
| group tramadol plus dypirone<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
-----------------
kidney function tests, anti-inflammatory agents, non-steroidal, laparoscopic cholecystectomy, adult