linjc16/ctgov huggingface dataset:
Postoperative Identification of Tumor Cells at the Lumpectomy Site of Patients With Early Breast Cancer

Study Overview
=================
Brief Summary
-----------------
For early breast cancer, local surgery followed by breast radiation is a standard local treatment. It has been found that the original primary tumor site, the lumpectomy site, is the commonest location of local relapse. The researchers think that such relapse occurs because of persistent tumor cells (PTCs) at the lumpectomy site even when conventional pathology reports indicate complete resection with clear margins. The researchers propose to analyze the lumpectomy fluid (seroma) of patients who are one to six weeks post-surgery for the presence or absence of tumor cells using new technology. Results of this study may help identify women who may have increased local relapse risk beyond that suggested by conventional pathology and clinical features; it may also help identify women at very low risk of local relapse who could avoid any additional treatment after local surgery.

Official Title
-----------------
Postoperative Identification of Tumor Cells at the Lumpectomy Site of Patients With Early Breast Cancer

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

Intervention / Treatment
-----------------
* Procedure: Aspiration of seroma fluid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with pathologic stage I to IIB invasive mammary breast cancer. Tumor size over 1 cm. Patient age 50 years or younger. Primary tumor non-lobular. Primary tumor non-low grade or Oncotype DX score > 18. Patient is six weeks or earlier post-lumpectomy. Seroma is clinically palpable and symptomatic causing discomfort and/or swelling of the lumpectomy site OR re-excision of the lumpectomy site is planned.

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Aspiration of seroma fluid|Fluid will be collected from the lumpectomy site of patients between one to six weeks post-surgery and tested for the presence of persistent tumor cells (PTCs).|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of Persistent Tumor Cells (PTCs) | 5 ml (one teaspoon) of fluid from the breast surgery site will be collected using a needle and syringe. This fluid will be sent to a laboratory in London Health Sciences Centre where it will be tested for the presence of cancer cells. | Through study completion, an average of 2 years. |
Choice of Material for Above-Knee Femoro-Popliteal Bypass Prosthetic Graft (PopUp)

Study Overview
=================
Brief Summary
-----------------
This trial was designed to challenge the wide held view that polytetrafluoroethylene (PTFE) performs better than Dacron for above knee femoropopliteal bypass.

Detailed Description
-----------------
Objective: To investigate whether patency rates of 6 mm gelatine coated, knitted, double velour polyester prostheses are equal to the 6 mm thinwalled ePTFE prostheses as above-knee femoro-popliteal bypass graft

Official Title
-----------------
Choice of Material for Above-Knee Femoro-Popliteal Bypass Prosthetic Graft. Multicenter Randomized Study of an Impregnated Knitted Polyester Prosthesis Vs. PTFE (Uni-Graft Vs Gore-Tex).

Conditions
-----------------
Intermittent Claudication, Critical Limb Ischemia

Intervention / Treatment
-----------------
* Device: 6 mm Uni-graft® (B-Braun)
* Device: 6 mm Gore-Tex® (WL Gore)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who require revascularisation of the lower extremity suitable for above-knee femoro-popliteal bypass surgery. Exclusion Criteria: pregnancy No consent to participate in the study Previous enrollment in the study follow-up is not possible

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

| Intervention/Treatment |
| --- |
|Device: 6 mm Uni-graft® (B-Braun)|nan|
|Device: 6 mm Gore-Tex® (WL Gore)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary uncorrected graft patency after 2 years |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - Secondary graft patency after two years |  |  | 
| - Limb survival after two years |  |  | 
| - Complication rate perioperatively |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lower extremity bypass surgery, femoro-popliteal bypass, Dacron material, PTFE material
Study of the Influence of the Expression of the Calcium-sensitive Receptor (CaSR) by Monocytes in the Synovial Liquid on Structural Alterations in Patients Diagnosed With Rheumatoid Arthritis in the Previous Two Years

Study Overview
=================
Brief Summary
-----------------
Rheumatoid arthritis (RA) is the most frequent form of chronic inflammatory rheumatism in adults. The erosive damage influences the functional prognosis in patients with RA. At present, there are no sufficiently sensitive and specific predictive markers of erosive damage.

Official Title
-----------------
Study of the Influence of the Expression of the Calcium-sensitive Receptor (CaSR) by Monocytes in the Synovial Liquid on Structural Alterations in Patients Diagnosed With Rheumatoid Arthritis in the Previous Two Years

Conditions
-----------------
Arthritis, Rheumatoid

Intervention / Treatment
-----------------
* Biological: blood


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients consulting in the Department of Rheumatology at Amiens University Hospital Age ≥ 18 RA meeting the 2010 ACR/EULAR criteria Less than 2 years of RA progression Effusion in at least 1 joint Exclusion Criteria: Inability to give informed consent Ongoing pregnancy Previous treatment with an anti-osteoporosis medication Intra-articular corticoid or hyaluronic acid injection in the previous 6 months Coagulation disorders preventing arthrocentesis Incarceration or legal guardianship

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 |
| --- |
|Biological: blood|measurement of CaSR expression levels on synovial fluid monocytes|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CaSR expression rate level on synovial monocytes | measured by flow cytometry | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
calcium-sensitive receptor
Survey on the Clinical Use of Recombinant Human Erythropoietin in VLBW and ELBW Infants

Study Overview
=================
Brief Summary
-----------------
Recombinant human erythropoietin (rhEPO) has been shown to effectively and safely prevent the anemia of prematurity and to reduce the transfusion need in very low birth weight (VLBW) and extremly low birth weight (ELBW) infants and has been licensed for this indication in Europe in 1997. The objective of the study was to obtain information on the use or nonuse of rhEPO in neonatal units in China.

Detailed Description
-----------------
The survey was developed by a team of neonatologists at Shenzhen People's hospital . The survey consisted of 26 questions covering three areas: the characteristics of the survey respondents, the use of rhEPO in VLBW and ELBW infants , and other related questions. The questionnaire was presented in the Questionnaire Star format (https://www.wjx.cn/, Hangzhou Oway Medical Technology,Changsha, China). we plan to conduct a cross-sectional survey through the Neonatal Professional Committee of the Chinese Medical Doctor Association WeChat platform. The questionnaire is going to be distributed to nearly 500 representative neonatologists and pediatricians from general hospitals, maternity and infant hospitals, and children's hospitals across the country. Furthermore, this study was approved by the ethics committee of the Shenzhen People's Hospital.

Official Title
-----------------
Clinical Use of Recombinant Human Erythropoietin in VLBW and ELBW Infants: a National Survey in China

Conditions
-----------------
Erythropoietin; Infant; Surveys and Questionnaires

Intervention / Treatment
-----------------
* Other: not use of any intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: neonatologists and pediatricians from general hospitals, maternity and infant hospitals, and children's hospitals across China Exclusion Criteria: neonatologists and pediatricians from same hospitals
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| General hospital group<br>Questionnaires collected from general hospitals in China | Other: not use of any intervention<br>* not use of any intervention<br>|
| Maternity and infant hospital group<br>Questionnaires collected from Maternity and infant hospitals in China | Other: not use of any intervention<br>* not use of any intervention<br>|
| Children's hospital<br>Questionnaires collected from Children's hospitals in China | Other: not use of any intervention<br>* not use of any intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The survey (the clinical use of rhEPO) | the clinical use of rhEPO in VLBW and ELBW infants | 01-june-2022 |
Quality of Life Following Gastric Bypass Surgery.

Study Overview
=================
Brief Summary
-----------------
A central goal of health care is to maximize patient functioning and well-being. This has prompted measurement of health-related quality of life (HRQOL) that encompasses physical, psychological, and social functioning. While obese people have generally impaired HRQOL, people seeking bariatric surgery for obesity appear to have poorer HRQOL than obese individuals seeking non-surgical treatment or obese individuals not seeking weight-loss treatment. HRQOL improves significantly after bariatric surgery, but often with large individual variations in outcome. As gastric bypass is an invasive procedure with irreversible influences on eating behaviour and possible serious adverse events, it is important to identify potential risk factors for a poorer long-term result. In Denmark, bariatric surgery is free of charge for patients fulfilling the Danish Health and Medicines Authority guidelines, which until 2011 were in line with international guidelines. However, in 2011 access to surgery was dramatically restricted and the annual number of operations reduced from 0.9 per 1000 inhabitants (2010) to 0.2 per 1000 inhabitants (2012). The restrictions involved a tightening of the criteria for patients without manifest obesity comorbidities, raising lower body mass index (BMI) threshold from 40 to 50 and increasing the lower age limit from 18 to 25 years (11). It is not known whether patients fulfilling the tighter criteria benefit more from surgery than patients who only met the previous criteria. This study assessed HRQOL changes associated with Roux-en-Y gastric bypass with follow-up over an average of 22 months. The aim was to explore whether postoperative HRQOL variations were associated with identifiable socio-demographic or clinical characteristics. In particular, whether HRQOL changes differed for patients fulfilling the current Danish criteria and patients only fulfilling the previous criteria.

Official Title
-----------------
A Prospective Analysis of Changes in Health-Related Quality of Life Following Roux-en-Y Gastric Bypass.

Conditions
-----------------
Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients referred for gastric bypass. Exclusion Criteria: Patients who did not fulfill the national criteria.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 36-Item Short Form Health Survey v2 (SF-36) |  | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastric bypass, Health-related quality of life, SF-36, Questionnaire, Treatment guidelines
Phase II Study of 2-weekly RAILIRI Versus FOLFIRI as Second-line Treatment in Advanced Colorectal Cancer Patients

Study Overview
=================
Brief Summary
-----------------
This study is designed to compare the efficacy and safety of two-weekly RAILIRI regimen with FOLFIRI regimen in the treatment of advanced colorectal cancer patients in the second-line setting.

Official Title
-----------------
Phase II Study of 2-weekly Raltitrexed Plus Irinotecan Regimen (RAILIRI) Versus Fluorouracil, Leucovorin, and Irinotecan Regimen (FOLFIRI) as Second-line Treatment in Advanced Colorectal Cancer Patients

Conditions
-----------------
Colorectal Carcinoma

Intervention / Treatment
-----------------
* Drug: Raltitrexed
* Drug: Irinotecan
* Drug: 5-fluorouracil
* Drug: Leucovorin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged 18-70 years with histologically or cytologically confirmed advanced colorectal adenocarcinoma Eastern Cooperative Oncology Group performance status of 0 to 1 life expectancy of ≥ 3 months patients who had failed first-line treatment with either XELOX (capecitabine combined with oxaliplatin) or FOLFOX (5-fluorouracil/leucovorin with oxaliplatin) at least one measurable disease lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria have adequate bone marrow, hepatic, and renal function Exclusion Criteria: patients with previous chronic inflammatory bowel disease, chronic diarrhea or recurrent bowel obstruction patients with symptomatic brain metastases active clinical severe infection previously received irinotecan or raltitrexed dihydropyrimidine dehydrogenase (DPD) enzyme adequate

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RALIRI<br>Raltitrexed combined with irinotecan | Drug: Raltitrexed<br>* 2mg/m2 iv gtt, d1<br>Drug: Irinotecan<br>* 180 mg/m2 iv gtt, d1<br>|
| Placebo Comparator: FOLFIRI<br>5-fluorouracil,folinate combined with irinotecan | Drug: Irinotecan<br>* 180 mg/m2 iv gtt, d1<br>Drug: 5-fluorouracil<br>* 5-FU 400mg/m2 iv, 2400mg/m2 civ 46h<br>* Other names: 5-FU;Drug: Leucovorin<br>* 400mg/m2 iv gtt,d1<br>* Other names: LV;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free survival |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 6 months | 
| overall response rate |  | 2 months | 
| disease control rate |  | 2 months | 
| Number of Participants with Adverse Events |  | 2 months | 
| quality of life questionnaire |  | 2 months |
Para-vertebral Dexmedetomidine and the Incidence of Postoperative Chronic Pain

Study Overview
=================
Brief Summary
-----------------
Up to our knowledge there is no study focused upon the incidence of post VATS chronic pain when dexmedetomidine is used.

Detailed Description
-----------------
Most Video-Assisted Throcoscopy Surgery (VATS) procedures are considered low-risk interventions requiring short hospital stays or even outpatient settings. Because of these factors, VATS did not raise as much interest as thoracotomy in its postoperative pain management. However, it is a fact that pain following VATS can be severe and long-lasting .According to Richardson and colleagues, 38% of VATS procedures present persistent pain two months after surgery as a result of acute nerve damage during the surgical procedure.

Official Title
-----------------
Para-Vertebral Dexmedetomidine in Video-Assisted Thoracic Surgeries for Acute and Chronic Pain Prevention; A Randomized Double Blinded Clinical Trial

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA II-III Adult Video-assisted thoracic surgery Exclusion Criteria: Patient refusal Allergy to medication Coagulopathy Malformation

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexmedetomidine<br>Dexmedetomidine is added to bupivacaine the paravertebral block | Drug: Dexmedetomidine<br>* isobaric bupivacaine 0.5% (0.3ml/kg) and dexmedetomidine (1 mcg/kg)<br>|
| Other: Bupivacaine<br>Bupivacaine only in the paravertebral block | Drug: Bupivacaine<br>* isobaric bupivacaine 0.5% (0.3ml/kg)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acute postoperative pain | assessment of pain by visual analog scale (VAS) by cm with minimal =0 and maximal =10, worst pain mean scale of 10 | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| chronic post thoracic surgery pain | Chronic neuropathic pain was assessed using the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Pain Scale with non-neuropathic pain if the scale <12, and neuropathic pain is likely to be the contributing cause of pain if the scale >12 | 3 months |
Prevalence of Bruxism in a Group of Preschool Egyptian Children

Study Overview
=================
Brief Summary
-----------------
The protocol is to show the prevalence of bruxism among a group of Egyptian children

Detailed Description
-----------------
Many studies are done on children to show the prevalence of bruxism among different ages , reports of prevalence range from 8-31% in the general population, the prevalence of bruxism in Egyptian children is unknown. Several symptoms are commonly associated with bruxism, including hypersensitive teeth, aching jaw muscles, headaches, tooth wear, damage to dental restorations (e.g. crowns and fillings) and damage to teeth. However it may cause minimal symptoms, and therefore people may not be aware of the condition,so this study is important to determine the prevalence of bruxism of preschool Egyptian children

Official Title
-----------------
Prevalence of Bruxism in a Group of Preschool Egyptian Children

Conditions
-----------------
Bruxism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cooperative children from 3-6 years Children without any Medical problems Children of families who accept to participate in the study Exclusion Criteria: 1- Children with caries in posterior teeth

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 6 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 |
| --- | --- | --- |
| Prevalence of Bruxism |  | 1 year |
Evaluation of the Efficacy of Cesamet™ for the Treatment of Pain in Patients With Multiple Sclerosis

Study Overview
=================
Brief Summary
-----------------
This study was designed to evaluate the safety and efficacy of Cesamet™ in controlling pain in subjects experiencing pain due to Multiple Sclerosis.

Detailed Description
-----------------
The purpose of this study is to determine the safety and efficacy of Cesamet™ in the symptomatic treatment of pain due to Multiple Sclerosis. This is a phase IV, multi-center, open label outpatient clinical trial evaluating Cesamet™ treatment for control of pain due MS. The study has two phases: a Pretreatment Phase and a Treatment Phase.

Official Title
-----------------
A Multicenter Trial Evaluating the Efficacy of Cesamet™ for the Symptomatic Treatment of Pain in Patients With Multiple Sclerosis

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Drug: Cesamet™ (nabilone)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with MS Chronic daily pain present for at least 2 months. On stable analgesic regimen for one month Baseline pain score greater than 40mm on a visual analog scale. Exclusion Criteria: Hypersensitivity to compounds in study drug or similar drugs Pregnant or lactating females Drug or alcohol abuse Unstable medical condition

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Cesamet™ (nabilone)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Average Pain Score at target site. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Worst Pain Score at target site. |  |  | 
| The Pain at Night Score at target site. |  |  | 
| Quality of Life measures. |  |  | 
| Patient satisfaction with treatment. |  |  | 
| Safety will be assessed through the collection of AEs and vital signs. |  |  |