linjc16/ctgov huggingface dataset:
A Study Comparing Quality of Life in Patients With Lymphedema Who Undergo Surgical Treatment Versus Non-Surgical Management

Study Overview
=================
Brief Summary
-----------------
This study is being done to see the long-term results for patients who choose to have surgery for lymphedema (with the vascularized lymph node transfer), compared to patients who choose not to have surgery.

Official Title
-----------------
A Prospective Study Comparing Quality of Life in Patients With Lymphedema Who Undergo Surgical Treatment Versus Non-Surgical Management

Conditions
-----------------
Lymphedema

Intervention / Treatment
-----------------
* Behavioral: Quality of Life Assessments


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 18-80 years Primary and secondary lymphedema of the upper or lower extremity International Society of Lymphology (ISL) Stage 1, 2, or 3 lymphedema Proficiency in English language Exclusion Criteria: Patients with clotting disorders, venous insufficiency, end-stage lymphedema unless they are on the non-surgical arm. Additionally, if the patient refuses to complete questionnaires, the patient will be excluded from the study and replaced at the discretion of the principal or co-principal investigator.

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| vascularized lymph node transfer (VLNT)<br>This is an observational study to assess QOL in patients who have elected to undergo or considered undergoing VLNT. There is no therapeutic intervention involved during the follow-up study period. | Behavioral: Quality of Life Assessments<br>* Upper Limb Lymphedema (ULL-27), Lymphedema Life Impact Scale, version 2 (LLISv2), LYMQOL-Leg.<br>|
| non-surgical treatment<br>This is an observational study to assess QOL in patients who have elected to undergo or considered undergoing VLNT. There is no therapeutic intervention involved during the follow-up study period. | Behavioral: Quality of Life Assessments<br>* Upper Limb Lymphedema (ULL-27), Lymphedema Life Impact Scale, version 2 (LLISv2), LYMQOL-Leg.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | Questionnaire to assess quality of life changes | up to 40 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Quality of Life (QoL), 17-377
Prostate Volume Changes Following Prostate Brachytherapy With Iodine-125 Seeds

Study Overview
=================
Brief Summary
-----------------
The size of the prostate changes due to insertion of the radioactive seeds. We will measure the prostate size, before and after the procedure.

Detailed Description
-----------------
The prostate size will be measured using the TRUS and CT scan on days -1, 0, 1, 9, 30, and 60 days after the brachytherapy procedure.

Official Title
-----------------
An Observational Study to Evaluate the Changes in Prostate Volume Over Time With The Use of Transrectal Ultrasound and Computed Tomography Following Permanent Prostate Brachytherapy With Iodine-125 Seeds.

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Procedure: Brachytherapy with Iodine-125 seeds


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pathologically confirmed diagnosis of prostate cancer T1-3 disease PSA <20 ng/ml Patient must sign a study-specific informed consent prior to enrollment. Exclusion Criteria: Patients ineligible to brachytherapy

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Brachytherapy with Iodine-125 seeds|Brachytherapy of the prostate, and measurements of the prostate volume using CT scan and TURS|

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
-----------------
Brachytherapy, Prostate volume
Validation Use of Implants and Abutments With Biologically Oriented Preparation Technique

Study Overview
=================
Brief Summary
-----------------
This randomized clinical trial aims to validate and to establish indications for using implants with biological oriented preparation technique (I.B.O.P.T.) for implant supported prosthetic treatment as an option looking for better stability and control of associated soft and hard tissues compared with conventional implants and conventional abutments with finishing lines preparation technique.

Official Title
-----------------
Randomized Clinical Trial to Validate Use of Implants and Abutments With Biologically Oriented Preparation Technique (I.B.O.P.T.)

Conditions
-----------------
Dental Implant-Abutment Design

Intervention / Treatment
-----------------
* Procedure: Implant surgery and restoration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female ≥18 years old. Need for implant-supported fixed prosthesis in the posterior area of the upper or lower jaw (up to 2 implants and three units bridge); Adequate bone quality and quantity at the implant site to allow the insertion of Sweden and Martina Premium or Prama (Due Carrare, Padova, Italy), of diameters 3.8, 4.25 or 5 mm and lengths between 10 and 13 mm. Healthy ASA type I and II patients. Full-mouth plaque index <20. Exclusion Criteria: Smokers ≥10 cigarettes/day. Presence of implant-supported restorations adjacent to the study site. Active periodontitis defined as the presence of pockets with probing depth (PD) ≥5 mm and bleeding on probing (BoP). Systemic medication that contraindicates surgery (bisphosphonates or steroid therapy). Uncontrolled diabetes. Severe bruxism. Pregnancy. Previous history of radiotherapy.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiographic bone level<br> | Procedure: Implant surgery and restoration<br>* Implants with two different transmucosal neck configuration are placed.<br>|
| Experimental: Peri implant soft tissue volume<br> | Procedure: Implant surgery and restoration<br>* Implants with two different transmucosal neck configuration are placed.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Marginal bone level | Changes in interproximal marginal bone level with standardization of the radiograph | Baseline to 12-months follow-up | 
| Soft tissue volumetric analysis | Soft tissue volumetric analysis with digital impressiones taken at baseline and at 12-month follow-up visit | Baseline to 12-motnhs follow-up |
Application of DWI in Diagnosis of Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
This study compared the performance of different models of multiple b-value DWI in diagnosing prostate cancer.

Detailed Description
-----------------
Diffusion weighted imaging (DWI) plays an important role in the diagnosis and stratification of prostate cancer. Traditional DWI apply the apparent diffusion coefficient (ADC) to reflect the diffusion of tissue water, which is a parameter calculated by a monoexponential model with 2b values. In recent years, the development of multiple b-value DWI facilitates the appearance of many new mathematical models. Different models have different features, but their value of applications in prostate cancer still need to be confirmed. This study was aiming to: (1) compare the parameters derived from monoexponential model, intravoxel incoherent motion (IVIM) model and stretched exponential model between prostate cancer and benign prostatic hyperplasia; (2) compare the difference of these parameters between low-grade (Gleason score ≤ 3+4) and high-grade (Gleason score ≥ 4+3) cancer; (3) find whether these parameters derived from new models are superior to ADC derived from traditional monoexponetial model.

Official Title
-----------------
Different Models of Multiple B-value DWI and Their Applications in Diagnosis of Prostate Cancer

Conditions
-----------------
Prostate Cancer, Benign Prostatic Hyperplasia

Intervention / Treatment
-----------------
* Diagnostic Test: MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The exam including T1WI、T2WI and multiple b-value DWI. Comfired by pathology as prostate cancer or benign prostatic hyperplasia in one month after the MRI exam. Exclusion Criteria: 1.No Gleason score data. 2.Awful quality of imagings or artifacts affectting diagnosis. 3.No lesion larger than 0.5cm. 4.Any surgery or treatment before MRI exam. 5.Biopsy in 4 weeks before MRI exam.
Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| prostate cancer<br>The patient was pathologically diagnosed with prostate cancer | Diagnostic Test: MRI<br>* monoexponential model, intravoxel incoherent motion (IVIM) model and stretched exponential model<br>|
| benign prostatic hyperplasia<br>The patient was pathologically diagnosed with benign prostatic hyperplasia | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pathological diagnosis | prostate cancer or benign prostatic hyperplasia | 2013.10-2018.6 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
benign prostatic hyperplasia, Diffusion weighted imaging
A Study in Healthy Volunteers to Assess the Tolerability and Blood Levels of a Single Dose of AZD7687

Study Overview
=================
Brief Summary
-----------------
This is a Phase I, first time in human, randomised, blinded, placebo-controlled, single ascending dose study in healthy male volunteers conducted at a single centre. The effect of food on the pharmacokinetics of AZD7687 will also be studied. The study will consist of two parts, a dose escalation part and a food interaction part. The two parts will be run in parallel. In total, 64 healthy volunteers divided in 8 different panels (8 volunteers per cohort) will be exposed to single doses during the dose escalation. Each subject will receive dose only once, except for the volunteers included in the dose steps repeated for food interaction.

Official Title
-----------------
A Randomized, Blind, Placebo-controlled, Single-centre Phase I Study in Healthy Volunteers to Assess the Safety, Tolerability and Pharmacokinetics of AZD7687 After Single Ascending Oral Doses

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

Intervention / Treatment
-----------------
* Drug: AZD7687
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy BMI between 19-30 Exclusion Criteria: No blood donation prior 30 days No other clinical study prior 3 months

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>AZD7687 oral suspension | Drug: AZD7687<br>* Single oral dose<br>|
| Experimental: Placebo<br>placebo oral suspension | Drug: Placebo<br>* Single oral dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety variables (adverse events, vital signs, physical examination, telemetry, digital electrocardiograms (dECGs), safety 12-lead paper electrocardiograms (pECG), and clinical laboratory assessments) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentrations of AZD7687 and plasma pharmacokinetic parameters. |  |  | 
| Exploratory pharmacogenetic blood sampling. |  |  | 
| Pharmacodynamic biomarker sampling; blood samples. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
First in human, Safety
A Study of Sinotecean on Tolerance and Pharmacokinetics

Study Overview
=================
Brief Summary
-----------------
This study is conducted to assess the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT), to evaluate the pharmacokinetics, safety and preliminary anti-tumor activity of Sinotecean.

Official Title
-----------------
A Phase I Study of Sinotecean on Tolerance and Pharmacokinetics

Conditions
-----------------
Advanced Cancer

Intervention / Treatment
-----------------
* Drug: Sinotecean


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: late malignant tumor patients diagnosed with the pathological and/or cytological; lack of the standard treatment or treatment failure; 18-65years, ECOG:0-1,expected survival period >3 months; main organs function is normal; signed and dated informed consent Exclusion Criteria: participated in other clinical trials in four weeks; currently under other effective treatment; end of anti-tumor treatment within 4 weeks(end of Nitrosourea/Mitomycin within 6 weeks); AE ≥ Grade 2(according to NCI-CTC 4.0),except hair loss; with ischemic heart disease, heart failure, severe arrhythmia, cerebrovascular disease, asthma, severe infections, active peptic ulcer; urine protein: ++, and urinary in 24 hours > 1.0g; uncontrolled primary or metastatic brain; have immunodeficiency history; according to the researcher's judgment,there are concomitant diseases which will seriously endanger the patients or obstruct the patients to complete the clinical trial;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Sinotecean<br> | Drug: Sinotecean<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic Assessments for Area Under Curve（AUC） | To collect point with single drug:5 min/10 min/15 min/30 min/1 h/2h/4h/6 h/8h/10h/12 h/24 h/32h/48 h | Day 1-2 Single Dose | 
| Pharmacokinetic Assessments for Cmax |  | Day 1-2 Single Dose | 
| Pharmacokinetic Assessments for Tmax |  | Day 1-2 Single Dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate （ORR) |  | each 42 days up to intolerance the toxicity or progression of disease（PD） (up to 24 months) | 
| Maximum tolerated dose(MTD) |  | up to 24 months | 
| Dose-limiting toxicity(DLT) |  | up to 24 months |
Evaluation of Accuvein in Cirrhotics Patients

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the effectiveness of AccuVein AV400 to facilitate placement of peripheral intravenous catheters in cirrhotic adults by comparing the success rate of the first attempt to install a peripheral venous catheter with or without AccuVein AV400®.

Official Title
-----------------
Study of the Effectiveness of a Venous Illumination System for Peripheral Venous Pathways in Cirrhotic Patients

Conditions
-----------------
Liver Cirrhosis

Intervention / Treatment
-----------------
* Device: Cannulation with AccuVein AV400


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient older than 18 years old Patient presenting a liver cirrhosis Patient requiring the placement of a venous peripheral catheter Patient informed and giving free and informed consent Patient affiliated to a French social security scheme Exclusion Criteria: Patient under 18 years old Patient unable to give consent Patient under guardianship or curatorship

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental : Cannulation with AccuVein AV400<br>Cirrhotic patients benefit from the support of a venous illumination device for each peripheral venous cannulation | Device: Cannulation with AccuVein AV400<br>* Cannulation using AccuVein AV400 device<br>* Other names: AccuVein AV400;|
| No Intervention: Control<br>Cirrhotic patients benefit from the standard technique of peripheral veinous catheter placement. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First Attempt Success Rate of Cannulation | Firt attempt success of positional for each peripheral venous catheter and expressed as a percentage in cirrhotic patients during hospitalization. | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of the score A-DIVA | Scores A-DIVA between beginning and end of hospitalization between the two groups | baseline and end of hospitalization (up to a month) | 
| Cost | Cost of consumables used in euro between the two groups | baseline | 
| Life expectancy of the catheter | Life expectancy of the catheter between the two groups | baseline | 
| Utilisation of a central venous catheter | Use of a central venous catheter (y/n) | baseline | 
| Pain's score | visual analogic scale | baseline | 
| Numbers of attempts | Number of attempts between two groups | baseline |
Urinary Aquaporine 2 in Patients With Syndrome of Inappropriate ADH-secretion Caused by Treatment With Antiepileptic Medicine

Study Overview
=================
Brief Summary
-----------------
Patients treated with the antiepileptic drug Oxcarbazepine often develop syndrome of inappropriate secretion of antidiuretic hormone(SIADH)We want to test the hypothesis, that these patients have a higher reabsorption of water during the Aquaporine2 water channels,a higher concentration of Vasopressine (AVP), and a lower clearance of water.This situation will tend to normalize, when the patients are treated with fluid restriction

Detailed Description
-----------------
The purpose of the study is to determine the amount of Aquaporine2(AQP2)in the urine in patients treated with the antiepileptic drug Oxcarbazepine before and after the administration of fluid restriction

Official Title
-----------------
Urinary Aquaporine 2 in Patients With Syndrome of Inappropriate ADH-secretion Caused by Treatment With Antiepileptic Medicine

Conditions
-----------------
Syndrome of Inappropriate ADH-secretion

Intervention / Treatment
-----------------
* Procedure: fluid restriction for 14 days (15ml fluid per kg weight)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age more than 18 years, both men and women, patients with epilepsia treated with Oxcarbazepine, and a Sodium content in plasma lower than 130 mmol/liter Exclusion Criteria: severe diseases in the heart, lungs or liver;diabetes mellitus, other not-well treated diseases in endocrine organs, cancer; unwillingness to participate

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

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

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

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

Design Details

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: fluid restriction for 14 days (15ml fluid per kg weight)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
An Observational Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Metastatic or Recurrent Non-Squamous Non-Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
This observational study will evaluate modality, efficacy and safety of Avastin (bevacizumab) as first-line treatment in combination with chemotherapy in patients with inoperable advanced, metastatic or recurrent non-squamous non-small cell lung cancer in clinical practice. Data will be collected for each patient for 18 months from initiation of Avastin therapy.

Official Title
-----------------
A Cohort Study of First-line Treatment of Patients With Unresectable Advanced (Stage IIIB), Metastatic (Stage IV) or Recurrent Non Squamous Non-small Cell Lung Cancer (NSCLC), Starting a Treatment With Bevacizumab (Avastin®) in Combination With Chemotherapy.

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, >/= 18 years of age Inoperable advanced, metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC) Treating physician's decision to initiate first-line Avastin treatment Exclusion Criteria: Participation in a clinical trial evaluating anti-cancer therapies

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 |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical (diagnosis, therapies, comorbidity) and demographic characteristics of patients initiated on Avastin treatment |  | 18 months | 
| Modality of treatment with Avastin (dose, duration, associated chemotherapy) |  | 18 months | 
| Overall survival |  | 18 months | 
| Safety: Incidence of adverse events |  | 18 months | 
| Quality of Life: Functional Assessment of Cancer Therapy-Lung (FACT-L) questionnaire |  | 18 months | 
| Treatment of non-squamous NSCLC in clinical practice |  | 18 months |