linjc16/ctgov huggingface dataset:
Safety, Tolerability and Efficacy of ZD6126 in Combination With Oxaliplatin, 5-Fluorouracil and Leucovorin in Subjects With Metastatic Colorectal Cancer.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the Safety, Tolerability and Efficacy of ZD6126 in Combination with Oxaliplatin, 5-Fluorouracil and Leucovorin in Subjects with Metastatic Colorectal Cancer.

Conditions
-----------------
Colorectal Neoplasms, Metastases, Neoplasm

Intervention / Treatment
-----------------
* Drug: ZD6126
* Drug: Placebo
* Drug: 5-fluorouracil
* Drug: leucovorin
* Drug: oxaliplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Metastatic colorectal carcinoma Suitable for first-line treatment of metastatic disease Exclusion Criteria: Peripheral neuropathy greater than Grade 1 Adjuvant therapy within 6 months prior to study treatment Prior oxaliplatin Prior pelvic or whole abdomen radiation Any history of coronary angioplasty or history of myocardial infarction

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 |
| --- |
|Drug: ZD6126|nan|
|Drug: Placebo|nan|
|Drug: 5-fluorouracil|nan|
|Drug: leucovorin|nan|
|Drug: oxaliplatin|nan|

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
-----------------
metastatic, colorectal, first-line, adjuvant, cancer, Colorectal Cancer, Colorectal Carcinoma, Colorectal Tumors, Neoplasms, Colorectal
Growth Hormone Deficiency in Adults (GHDA)

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Japan. The aim of this trial is to demonstrate superiority of the effect of NN-220 compared with that of placebo as assessed by the change in percent in truncal fat (kg) from baseline to 24 weeks' treatment (end of treatment) in patients with Growth Hormone Deficiency in Adults (GHDA).

Official Title
-----------------
Investigation of the Efficacy and Safety of NN-220 for 24 Weeks in Adults With Growth Hormone Deficiency

Conditions
-----------------
Growth Hormone Disorder, Adult Growth Hormone Deficiency

Intervention / Treatment
-----------------
* Drug: somatropin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with diagnosed GHD If the subject has a history of treatment of treatment for a tumour of pituitary or peripheral site, two years or more must have passed since completion of surgery, radiotherapy or other treatment, and recurrence of the underlying disease to be excluded Appropriate replacement therapy has been administered for more than 24 weeks for the treatment of other pituitary hormone deficiencies Exclusion Criteria: Subject with a history of acromegaly Subject with diabetes mellitus Subject suffering from malignancy Several medical conditions

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: somatropin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in truncal fat (kg) from baseline |  | at 24 weeks (end of treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in total body fat, total LBM, etc. from baseline to 24 weeks |  |  | 
| Lipid-related laboratory tests (total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglyceride) |  |  | 
| IGF-I SDS, IGFBP-3 SDS, and IGF-I/IGFBP-3 molar ratio |  |  | 
| Adverse events |  |  | 
| Clinical laboratory tests |  |  | 
| FPG, insulin, and HbA1c |  |  |
Management of Obstructive Colon Tumors in Istanbul

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the outcome of obstructive colon cancer surgery in terms of days-to-starting adjuvant therapy and quality of life.

Official Title
-----------------
Management of Obstructive Colon Tumors in Istanbul: Multicenter Prospective Observational Cohort

Conditions
-----------------
Colon Cancer, Tumor Obstruction, Emergencies, Quality of Life

Intervention / Treatment
-----------------
* Procedure: Colectomy
* Procedure: Stoma procedures
* Procedure: By-pass/laparotomy/laparoscopy/biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute intestinal obstruction due to colon cancer either preoperatively or intraoperatively detected Clinical findings of obstruction (Abdominal distention and pain, nausea or vomiting, and absence of bowel movements) confirmed by abdominal x-ray or CT Exclusion Criteria: Benign diseases Emergency surgery due to bleeding, perforation and other non-obstructive situations Recurrent colon tumors Rectal cancer

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Colectomy|Colon resection|
|Procedure: Stoma procedures|Any type of colostomy or ileostomy with or without bowel resection|
|Procedure: By-pass/laparotomy/laparoscopy/biopsy|Any palliative surgery without bowel resection|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time-to-starting chemotherapy | Surgical procedures will be compared in terms of days-to-first chemotherapy | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | 90-day mortality | 3 months | 
| Morbidity | 90-day morbidity | 3 months | 
| Colorectal cancer-specific quality of life (EORTC QLQ - CR29) at 1 year | The European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire-Colorectal Cancer (EORTC QLQ-CR29) scale will be recorded preoperatively and at 12 months. Surgical procedures will be compared in terms of improvement in EORTC QLQ-CR29 scores. | 1 year |
Expression of PARP-1 in Multiple Sclerosis Patients

Study Overview
=================
Brief Summary
-----------------
This study will explore the expression of PARP-1 in optic neuritis of multiple sclerosis patients. The data will be collected from Sohag University hospital in the period from the start of August 2021 to the end of December 2021. The study protocol will be approved by the Scientific Research Ethical Committee, Faculty of Medicine, Sohag University.

Official Title
-----------------
Expression of PARP-1 in Optic Neuritis of Multiple Sclerosis Patients

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

Intervention / Treatment
-----------------
* Genetic: Blood sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with multiple sclerosis with or without optic neuritis Multiple sclerosis will be diagnosed according to the McDonald criteria Exclusion Criteria: • Isolated optic neuritis.

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

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control group<br> | Genetic: Blood sampling<br>* Blood sample for detection of PARP-1 gene and correlate to changes of the optic disc, RNFL and GCC layers of the retina of MS patients<br>|
| Active Comparator: MS with optic neuritis<br> | Genetic: Blood sampling<br>* Blood sample for detection of PARP-1 gene and correlate to changes of the optic disc, RNFL and GCC layers of the retina of MS patients<br>|
| Active Comparator: Ms without optic neuritis<br> | Genetic: Blood sampling<br>* Blood sample for detection of PARP-1 gene and correlate to changes of the optic disc, RNFL and GCC layers of the retina of MS patients<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measure PARP-1 mRNA | measure PARP-1 mRNA | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optic nerve, RNFL and GCC layer affection by MS | Optic nerve Retinal nerve fibre layer (RNFL) in um ) and Ganglion cell complex (GCC) layer affection in um by MS in correlation to PARP-1 mRNA | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Optic neuritis-Multiple sclerosis-PARP-1
Feasibility of Transnasal ECHO for Identification of Parapharyngeal Internal Carotid Artery

Study Overview
=================
Brief Summary
-----------------
Identification and preservation of internal carotid artery during endoscopic nasopharyngectomy in cases of malignancy is a main difficulty of this kind of surgery, especially when anatomy is distorted by previous radiation. Intraoperative navigation based on preoperative imaging cannot remain precise throughout the process of resection. We aim to check a feasibility of internal carotid artery localization with the help of transnasal ultrasonic scanning. The most appropriate for this method existing device is an echocardiography system with pediatric transesophageal transducer. We plan to use it in 20 patients undergoing elective surgery for inflammatory sino-nasal disease. After initiatioin of general anesthesia and local decongestion, transducer will be placed transnasally to nasopharynx in order to scan a parapharyngeal space.

Official Title
-----------------
Feasibility of Transnasal ECHO for Identification of Parapharyngeal Internal Carotid Artery

Conditions
-----------------
To Assess Feasibility of the New Application

Intervention / Treatment
-----------------
* Device: EPIQ 5


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Indication for endoscopic nose and paranasal sinuses surgery Exclusion Criteria: Previous nasopharyngeal surgery

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>Consecutive eligible patients requiring endoscopic surgery for sinonasal pathology Transnasal localization of internal carotid artery with TEE ECHO device will be performed | Device: EPIQ 5<br>* As described in summary Trade name of the device Philips EPIQ 5<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| distance from nasopharynx surface to a closest wall of internal carotid arter | cm | 3 minutes |
ADAMTS,Proteoglycan and Oxidant / Antioxidant Enzyme Levels of Placenta Previa Totalis (Accreta, Increta, Percreta).

Study Overview
=================
Brief Summary
-----------------
Placenta previa totalis (accreta, increta, percreta); ADAMTS and proteoglycans and the oxidant / antioxidant enzyme levels.

Detailed Description
-----------------
Placenta previa totalis (accreta, increta, percreta) of pregnant women in the maternal serum, fetal membranes (placenta) and hysterectomy of women with myometrial strips measured the ADAMTS and proteoglycans expression levels, and the oxidant / antioxidant enzyme levels.

Official Title
-----------------
ADAMTS, Proteoglycan and Oxidant / Antioxidant Enzyme Levels of Placenta Previa Totalis(Accreta, Increta, Percreta)

Conditions
-----------------
Placenta Previa

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant women diagnosed with placenta previa by obstetric ultrasound and doppler Exclusion Criteria: Pregnant women with comorbid diseases other than previa totalis .

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placenta previa<br>first; maternal serum, fetal membranes (placenta) and maternal myometrial samples will be investigated for ADAMTS, Proteoglycans and oxidative/antioxidative enzyme status levels in patients with placental invasion anomalies Placenta Previa totalis by ELISA, western blot, immunohystochemistry and PCR (polymerase chain reaction). | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADAMTS,Proteoglycan and Oxidant / Antioxidant Enzyme Levels of maternal serum in patients with the diagnosis of Placenta Previa (Accreta, increta, percreta) |  | Up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADAMTS,Proteoglycan and Oxidant / Antioxidant Enzyme Levels of myometrial samples in patients with the diagnosis of Placenta Previa (Accreta, increta, percreta) |  | Up to 6 months | 
| ADAMTS,Proteoglycan and Oxidant / Antioxidant Enzyme Levels of Fetal Membranes in patients with the diagnosis of Placenta Previa (Accreta, increta, percreta) |  | Up to 6 months | 
| placenta previa totalis in the development, progression and in exacerbating; ADAMTS and proteoglycans, to determine the relationship of changes in expression. |  | Up to 2 years |
Active Surveillance for Low Risk Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
An active surveillance protocol for patients diagnosed low-risk prostate cancer will be held. We plan to use PSA (prostate-specific antigen) testing, DRE (digital rectal examination), TRUS (transrectal ultrasound), MRI (magnetic resonance imaging) and follow-up biopsies to monitor patients and detect cancer progression in time.

Official Title
-----------------
Active Surveillance Methodology for Low Risk Prostate Cancer

Conditions
-----------------
Prostate Cancer, Prostate Adenocarcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: prostate adenocarcinoma verified by at least 12 core biopsy patient must understand the sense of research, agree to participate and sign a form of agreement low oncological risk according to EAU (European Association of Urology) Guidelines: stage T1-T2a, PSA<10 ng/ml, ISUP (International Society of Urological Pathologists score)=1 (Gleason score 3+3=6) not more than 33% cores with adenocarcinoma Exclusion Criteria: previous treatment of prostate cancer other prostatic malignant neoplasms other oncological diseases treatment with 5-alfa-reductase inhibitors patient's refuse to continue study patient's desire to begin treatment

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 75 Years

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

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 |
| --- | --- | --- |
| cancer progression | Number of patients who had one of the following signs of cancer progression: new lesion on DRE proved by biopsy, or histological upgrade on follow-up biopsy, or involvement of more than 33% cores on follow-up biopsy | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| surgical treatment due to infravesical obstruction by BPH | Number of patients who underwent any treatment due to BPH: endoscopic procedures, or simple prostatectomy, or punction cystostomy | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prostate cancer, active surveillance, low oncological risk
Assessment and Tracking of Long-term Alefacept Safety

Study Overview
=================
Brief Summary
-----------------
Subjects exposed to alefacept are to be enrolled. Subjects will be contacted every 6 months to gather general health information.

Detailed Description
-----------------
There are no study-mandated tests, visits or clinical interventions after the 1st (enrolling) visit. After the patient is enrolled in the study, they will be contacted every 6 months to complete structured telephone interviews conducted by the ATLAS Study Center.

Official Title
-----------------
Assessment and Tracking of Long-term Alefacept (LFA-3/IgG1 Fusion Protein) Safety (ATLAS)

Conditions
-----------------
Psoriasis

Intervention / Treatment
-----------------
* Drug: Alefacept exposure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Psoriasis patients who are prescribed alefacept consistent with product labeling are eligible for enrollment.

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 |
| --- | --- |
| 1. Amevive Exposure<br>Patients treated with alefacept for chronic plaque psoriasis | Drug: Alefacept exposure<br>* Observational<br>* Other names: ASP0485;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure the rates of non-Hodgkin's lymphoma (NHL) and infections that require hospitalization occurring in psoriasis patients treated with alefacept |  | At six month intervals for five years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To estimate the rates of lung cancer, breast cancer (female), prostate cancer, colorectal cancer, melanoma and active tuberculosis within a population of patients with psoriasis treated with alefacept. |  | At six month intervals for five years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Psoriasis, Alefacept, Amevive®, Drug exposure
ATM Variants in Radiotherapy Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the baseline incidence of variant alleles in the ATM and/or other DNA repair genes present in the Native American population versus the non-Native American population. It is thought that a higher baseline incidence of the variant alleles in the ATM gene may correlate to higher rates and higher grades of radiation toxicities noted in the Native American population.

Official Title
-----------------
ATM Variants in Radiotherapy

Conditions
-----------------
Radiotherapy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Indication for radiotherapy. Ability or desire to donate a blood sample and be followed closely for radiation toxicities

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

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

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 |
| --- | --- | --- |
| to determine baseline incidence of variant alleles in ATM | to determine the baseline incidence of variant alleles in ATM resent in the population of Native americans with cancer who are undergoing radiation therapy to a similar group of non-native americans who have undergone or are undergoing raditohterapy | one blood draw | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to compare the baseline incidence of variant alleles in ATM | to compare the baseline incidence of variant alleles in ATM resent in the population of Native americans with cancer who are undergoing radiation therapy to a similar group of non-native americans who have undergone or are undergoing raditohterapy | one blood draw | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
patient who will undergo definitive radiotherapy
Micro-RNA Expression Profiles in High Risk Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether specific Micro-RNA expression profiles are related to Prostate cancer outcome.

Official Title
-----------------
Micro-RNA Expression Profiles in High Risk Prostate Cancer

Conditions
-----------------
Prostate Cancer, Radical Prostatectomy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with clinically localised high risk prostate cancer (cT>2, bx GS >7, PSA >20 ng/ml) scheduled for radical prostatectomy. Exclusion Criteria: Non high risk prostate cancer

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Clinical high-risk prostate cancer, radical prostatectomy<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence free survival | The patients will be followed in regular time intervals in accordance with the EAU-Guidelines (2010) and the S-3 Guideline for Prostate cancer of the German Urological Association. Data will be updated once yearly for until death. | Yearly update until clinical progression | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cancer specific survival | The patients will be followed in regular time intervals in accordance with the EAU-Guidelines (2010) and the S-3 Guideline for Prostate cancer of the German Urological Association. Data will be updated once yearly until death. | Yearly update until death | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
high-risk prostate cancer, radical prostatectomy, micro-RNA