linjc16/ctgov huggingface dataset:
Palliative Radiotherapy Protocol in Head and Neck Cancer

Study Overview
=================
Brief Summary
-----------------
Phase II prospective study or Palliative Radiotherapy of 25 Gy in 5 fractions, Intensity Modulated, for frail patients with incurable head and neck cancer. Comprehensive Quality of life (QLQ-C30, head and neck module, QLQ C15 PAL) and toxicity data (CTCAE v 4.0) collected.

Detailed Description
-----------------
Patients deemed too frail for radical treatment or incurable because of tumour extension, as determined by an experienced tumour board, were eligible for this study of palliative radiotherapy delivered by intensity modulation, 25 Gy in 5 daily fractions over one week. This study was conducted in two academic centers.

Official Title
-----------------
Palliative Radiotherapy for Advanced Head and Neck Carcinomas, a Phase II Study

Conditions
-----------------
Head and Neck Neoplasms, Quality of Life

Intervention / Treatment
-----------------
* Radiation: palliative radiation therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to give an informed consent Able to complete QOL questionnaires Deemed incurable by an experienced tumour board or unwilling to receive a radical course of radiation therapy Presence of measurable disease Biopsy proven squamous or salivary cancer of the head and neck region Expected survival of at least 2 months. Exclusion Criteria: Pregnancy No previous RT to the neck and no plan to receive concomitant chemotherapy Special histology (Lymphoma, small cell cancer, metastasis from a site other than the head and neck region) Unavailable for follow-up

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: palliative radiation therapy<br>25 Gy in 5 daily fractions | Radiation: palliative radiation therapy<br>* thermoplastic mask immobilization. CT in treatment position. radiation dose of 25 Gy in 5 daily fractions over one week 6 MV photons by intensity modulation. Target volume is the symptomatic tumour volume with a 5 mm margin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | EORTC QLQ-C30 questionnaire (QLQ-C15-PAL and H&N35 modules) | from radiation treatment until 24 months planned follow-up or death | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity (CTCAE v 4.0 graded) | CTCAE v 4.0 graded toxicities | from radiation treatment until 24 months planned follow-up or death | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Palliative Care, IMRT, Radiotherapy
Intraoperative Flow Cytometry In Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
This study was designed to investigate the efficacy of flow cytometry to accurately identify between normal and cancer cells in colon epithelium in humans diagnosed with colorectal cancer.

Detailed Description
-----------------
Tissue samples from normal and cancerous colon epithelium are collected intraoperatively following standard colectomy and analyzed blindly by flow cytometry, which reports, in less than 10 min, on the origin of the sample based in the estimation of DNA and tumor index.

Official Title
-----------------
Detection of Cancer Cells and Tumor Margins During Colorectal Cancer Surgery by Intraoperative Flow Cytometry

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: flow cytometry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: biopsy proven colorectal cancer signed informed consent for participation Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 90 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 |
| --- | --- |
| normal colorectal epithelium<br>Tissue samples from normal colorectal epithelium are collected during colectomy in every colorectal cancer patient | Diagnostic Test: flow cytometry<br>* evaluation of intraoperative flow cytometry in detecting cancer cells in colorectal epithelium<br>|
| cancer colorectal epithelium<br>Tissue samples from colorectal cancer are collected during colectomy in every colorectal cancer patient | Diagnostic Test: flow cytometry<br>* evaluation of intraoperative flow cytometry in detecting cancer cells in colorectal epithelium<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of intraoperative Flow Cytometry for cancer cell identification in colorectal cancer. | Samples from cancer and normal colon epithelium are prospectively collected intraoperatively and assessed with intraoperative Flow Cytometry. Following comparative DNA content and phenotypic analysis, the receiver operating characteristic (ROC) curve analysis is used to evaluate the performance of intraoperative Flow Cytometry to distinguish between normal and cancer tissue. The optimal cut-off value is determined to delineate the status of tumor tissue, resulting in the highest sensitivity and specificity and hence the optimal accuracy. | 2017-2021 |
The Impact of Postoperative Catheterization Time After Stress Incontinence Surgery to Success of Surgery

Study Overview
=================
Brief Summary
-----------------
After incontinence surgery, the patients randomly will be divided two groups. In group A postoperative urinary catheterization time will be applied one day, In group B catheterization will be applied two days. After removal of urinary catheter, residual volume will be measured and voiding function will be controlled. In postoperative period; third, sixth month and one year after surgery stress test will be applied to control success of surgery

Official Title
-----------------
The Impact of Postoperative Catheterization Time After Stress Incontinence Surgery to Voiding Dysfunction, Urinary Retention and Success of Surgery

Conditions
-----------------
Stress Urinary Incontinence, Surgery

Intervention / Treatment
-----------------
* Diagnostic Test: to measure the residual volume after catheterization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: stress incontinence resistant to medical treatment Exclusion Criteria: had no surgery before has no accompanying uterine descensus has no neurogenic disorder

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 60 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| urinary catheterization time; one day<br>the patient urinary catheterization after surgery; one day | Diagnostic Test: to measure the residual volume after catheterization<br>* after first micturition to measure the residual volume in bladder<br>|
| urinary catheterization time; two day<br>the patient urinary catheterization after surgery; two day | Diagnostic Test: to measure the residual volume after catheterization<br>* after first micturition to measure the residual volume in bladder<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| early postoperative voiding dysfunction and urinary retention | after removal of urinary catheter, has residual volume much more than 150cc (to be measured with urinary catheterization) | two days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The success of stress urinary incontinence surgery | third, sixth month and one year after surgery, absence of stress urinary incontinence | third month, sixth month and one year |
Follow-up Care After Treatment for Endometrial Cancer

Study Overview
=================
Brief Summary
-----------------
The purposes of this study are to examine the needs (symptoms, support, information) and satisfaction of women during follow-up in the community after completing treatment for endometrial cancer. This information will be collected from the perspective of the women themselves, their primary care providers (family physician or gynecologist) and the health care providers (oncologist, nurses, social worker, psychologist) at the cancer centre.

Detailed Description
-----------------
Research Question How has this transfer in follow-up care impacted performance indicators? Volume of follow-up care transferred Percentage of women, who have required a re-entry consultation Fiscal implication of this transfer of follow-up care Patient stakeholders: What are women's perceptions of the transition of follow-up care? What are women's supportive care needs during the transition of follow-up care and ongoing needs? Primary Care Practitioner stakeholders: What are the primary care practitioners' perceptions of the process of transition of follow-up care? What are the primary care practitioners' educational needs? What are the primary care practitioners' perceptions of the process of re-entry for in women with suspected recurrence? Tertiary Centre: Health care providers stakeholders o What are the perceptions of tertiary health care providers about the transition of follow-up care?

Official Title
-----------------
Follow-up After Primary Therapy for Endometrial Cancer; Implementation of a Cancer Care Ontario Guideline: A Pilot Evaluation Study.

Conditions
-----------------
Endometrial Neoplasm

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants- women diagnosed with endometrial cancer: 18 years of age or older. speak English or French who have been treated (surgery and/or radiation therapy) at TOH. who have been discharged from follow-up in the cancer centre in the past 6 months. Participants-primary care provider practitioner: providing follow-up care to at least one woman with endometrial cancer Participants- health care providers at the tertiary centre : physicians, nurses or allied health care providers whose primary responsibility are to provide care to women with gynecological cancer. Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Qualitative description of participants perception |  | after 6 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endometrial neoplasia, Follow-up care, survivorship, Primary care provider
GLPG0259 Multiple Ascending Dose and Methotrexate Drug-drug Interaction (DDI) in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the safety and tolerability of multiple increasing oral doses of GLPG0259 compared to placebo. Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0259 after multiple increasing oral doses, and potential drug-drug interaction with single dose methotrexate will be assessed.

Official Title
-----------------
Double Blind, Placebo Controlled, Dose Ranging and Methotrexate Interaction Study for the Assessment of Safety, Tolerability and Pharmacokinetics (PK) of Multiple Oral Doses of GLPG0259 in Healthy Subjects

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

Intervention / Treatment
-----------------
* Drug: placebo
* Drug: GLPG0259
* Drug: Methotrexate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy male, age 18-50 years BMI between 18-30 kg/m², inclusive. Exclusion Criteria: significantly abnormal platelet function or coagulopathy smoking drug or alcohol abuse

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>GLPG0259 25/50/75 mg/day for 14 days | Drug: GLPG0259<br>* oral solution<br>Drug: Methotrexate<br>* 7.5 mg (3 tablets, 2.5 mg/tablet) on study days D-1 and D14<br>* Other names: Ledertrexate®;|
| Placebo Comparator: 2<br>placebo for 14 days | Drug: placebo<br>* oral solution, daily for 14 days<br>Drug: Methotrexate<br>* 7.5 mg (3 tablets, 2.5 mg/tablet) on study days D-1 and D14<br>* Other names: Ledertrexate®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of oral multiple ascending doses |  | up to 10 days postdose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of multiple oral doses |  | up to 10 days postdose | 
| To explore the pharmacokinetic interaction between GLPG0259 and methotrexate (MTX). |  | up to 10 days postdose | 
| To explore biomarkers of GLPG0259 activity after multiple oral administrations. |  | up to 24 hours postdose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Safety, Tolerability, Pharmacokinetics
Genetic Study in Young Onset Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
Parkinson's disease (PD) is the second most frequent neurodegenerative disorder after Alzheimer's disease. It causes motor dysfunctions, such as bradykinesia, resting tremor, rigidity and postural instability. Although PD appears to be sporadic in most cases, several causative genes and susceptibility factors have been identified that cause familial forms of the disease with Mendelian inheritance with autosomal dominant or autosomal recessive inheritance. Approximately 5 10% of patients with the clinical picture of PD carry a mutation in one of the known genes that cause monogenic forms of the disorder. The average age at onset is between 60 and 80 years and the average age of diagnosis is 60 years. Onset of primary parkinsonism before 50 years is known as early onset parkinsonism(EOP). Onset between 20 and 50 years is known as young-onset PD. Onset at younger than 20 years is known as juvenile parkinsonism (JP). At least, 13 loci and 9 genes are reported. The investigators study is aimed to screen the clinical diagnosed familial EOP for the common mutation site by PCR/DNA sequencing. The gene for screen are Parkin (pattern: PARK2), PINK1 (pattern: PARK6) and ATP13A2 (pattern: PARK9).

Conditions
-----------------
Parkinson Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Idiopathic Parkinson's disease (according to UK Parkinson's Disease Society Brain Bank clinical diagnosis criteria) Onset before 50-year-old or positive family history Exclusion Criteria: Secondary parkinsonism

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| parkinson's disease, young onset<br> | |
| Normal<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Louisville Cooperative Tissue Biorepository

Study Overview
=================
Brief Summary
-----------------
To provide appropriate collection, storage, and distribution of specimens and medical data to local investigators who have approved IRB protocols for their specific research purposes.

Detailed Description
-----------------
The mission of the Louisville Cooperative Tissue Biorepository is to appropriately collect normal and abnormal tissues that are removed from the human body as a part of standard medical and surgical practice after adequate portions are secured by surgical pathologists to allow for correct diagnoses to be made. The LCTB securely stores appropriately collected human samples for research purposes and appropriately allocates these samples to local investigators for research purposes. The LCTB team appropriately documents all points in the process of obtaining informed consent, collection, storage, and allocation of tissues.

Official Title
-----------------
Louisville Cooperative Tissue Biorepository of the James Graham Brown Cancer Center Tissue Collection Consent

Conditions
-----------------
Normal and Abnormal Tissue

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing surgery for removal or normal and abnormal tissues as part of standard medical and surgical practice Exclusion Criteria: Patients with known systematic infections including septic patients with bacterial and viral infections, hepatitis, HIV, TB and other defined pathogens will not be included.

Ages Eligible for Study
-----------------
Minimum Age: 7 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 |
| --- | --- | --- |
| Collect normal and abnormal tissues that are removed from the human body as a part of standard surgical practice after adequate portions are secured by surgical pathologists to allow for correct diagnoses to be made. |  | 15 Years |
The Female Health Dietary Intervention Study

Study Overview
=================
Brief Summary
-----------------
This study has two phases: In phase 1 of the study (8 weeks),the effect of two different low calorie diets on manifestations of PCOS, including risk factors for the metabolic syndrome and cardiovascular risk profile will be compared. In phase 2 the long term effect (next 44 weeks) on sustained weight-loss and the above mentioned parameters will be compared and evaluated.

Detailed Description
-----------------
Weight loss is an important and effective treatment of morbidly obese women with PCOS. Effective weight reduction will improve manifestations of PCOS and risk factors for developing type 2 diabetes and coronary heart diseases. We compare the effect of two isocaloric low calorie diets (LCD), - one powder-based shake-diet and a fiber rich diet on the above mentioned parameters. In addition we want to compare the weight-maintenance effect the next 44 weeks of two different follow-up programs: A usual care- and a lifestyle-program.

Official Title
-----------------
Treatment of PCOS (Polycystic Ovary Syndrome)in Morbidly Obese Women - A Randomized Controlled Prospective Dietary Intervention Study

Conditions
-----------------
Polycystic Ovary Syndrome, Morbid Obesity

Intervention / Treatment
-----------------
* Behavioral: Crispbread


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Woman (European Caucasian) PCOS BMI = or > 35 Exclusion Criteria: Cushing syndrome Adrenal hyperplasia Androgen-producing tumors Anovulation caused by hyperprolactinemia Pregnancy, breast feeding Use of oral contraceptives/hormone treatment/insulin-sensitizing agents

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 38 Years

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

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: Crispbread<br>Intervention: Crispbread LCD | Behavioral: Crispbread<br>* 8 week low calorie diet<br>|
| Active Comparator: Liquid meal replacement<br>Intervention: LMR LCD | Behavioral: Crispbread<br>* 8 week low calorie diet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of PCOS, diabetes type 2- and coronary heart disease-risk factors |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Polycystic Ovary Syndrome, Morbid Obesity, Type 2 DM, Coronary heart disease
R-CHOP + GM-CSF for Previously Untreated LCL in Elderly

Study Overview
=================
Brief Summary
-----------------
Patients will receive 6 to 8 cycles of R-CHOP (Rituximab, Cyclophosphamide, doxorubicin, vincristine, and prednisone), with GM-CSF.

Detailed Description
-----------------
The objective of this study is to estimate complete response rates for patients treated with this regimen, to assess overall response rates, event-free survival and overall survival; and to assess toxicities associated with R-CHOP + GM-CSF. Patients will receive 6 to 8 cycles of R-CHOP (Rituximab, Cyclophosphamide, doxorubicin, vincristine, and prednisone), with GM-CSF.

Official Title
-----------------
Phase II Trial of Rituximab-CHOP (R-CHOP) Plus GM-CSF for Previously Untreated Diffuse Large Cell Lymphoma in the Elderly

Conditions
-----------------
Lymphoma, Large B-Cell, Diffuse

Intervention / Treatment
-----------------
* Drug: R-CHOP+GM-CSF


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed, CD20+ B cell diffuse large cell lymphoma, with measurable or evaluable disease Having no prior chemotherapy, immunotherapy or radiotherapy except for one cycle of CHOP or R-CHOP. Exclusion Criteria: Pregnant Hepatitis B Surface Antigen positive Have known CNS disease or HIV infection Have NY Classification III or IV disease.

Ages Eligible for Study
-----------------
Minimum Age: 60 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: R-CHOP + GM-CSF<br>R-CHOP therapy (6-8 cycles) with GM-CSF | Drug: R-CHOP+GM-CSF<br>* addition of GM-CSF<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate to Therapy |  | Dec 2005 approx | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DLBCL, Elderly, previously untreated DLBCL in the elderly