linjc16/ctgov huggingface dataset:
Neutrophil to Lymphocyte Ratio in Inflammatory Bowel Disease

Study Overview
=================
Brief Summary
-----------------
Detection of Inflammatory Bowel Disease activity by Using new measure : Neutrophil to lymphocyte ratio

Detailed Description
-----------------
Inflammatory bowel disease (IBD) has been a global healthcare problem with a sustained increasing incidence. It includes two major forms, Crohn's disease (CD) and ulcerative colitis (UC), which are distinct chronic bowel-relapsing inflammatory disorders (Gharagozloo et al., 2015). Ulcerative colitis (UC) is limitd to Mucosa and cause continuous bowel inflammation (Celikbilek et al., 2013) While Crohn disease is more complex because of its transmural inflammation and it is characterized by skip lesions, which are diseased sections of bowel next to uninvolved areas(Nishijima David L; Wisner, David H; Holmes, James F, 2016). The prevalence of IBD is highest in the second to third decade of life with another peak in the 60-70- year-old group.(Silva et al., 2016) Non-invasive tests, such as C reactive protein (CRP), erythrocyte sedimentation rate (ESR) and white blood cells (WBC) are therefore being increasingly recognized as important markers for initial diagnosis and disease activity detection.(Gao et al., 2015) In recent years, the neutrophil-to-lymphocyte ratio (NLR), calculated as total neutrophil count divided by total lymphocyte count, NLR represents two different immune pathways and can be easily derived directly from a standard blood test..(Argeny et al., 2018)

Official Title
-----------------
Evaluation of Neutrophil to Lymphocyte Ratio in Inflammatory Bowel Disease in Assiut University Hospitals

Conditions
-----------------
Inflammatory Bowel Diseases

Intervention / Treatment
-----------------
* Diagnostic Test: Complete Blood Count


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with inflammatory bowel disease, diagnosed by endoscopy, clinical , biochemical correlation and histopathological biopsy Exclusion Criteria: patients have : Appendicitis sigmoid diverticular disease Infectious colitis patients known to have cancer colon

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Complete Blood Count|neutrophil to lymphocyte ratio|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neutrophil to lymphocyte ratio in IBD | Determination of the prognostic value of N/L ratio in patients with IBD as a non invasive measure of disease acitivity | baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
neutrophil to lymphocyte ratio
Allogene MSCs Transplantation in Patients With Chronic Liver Diseases Through Peripheral Vein.

Study Overview
=================
Brief Summary
-----------------
Allogene MSCs transplantation will be performed in patients with chronic liver diseases through peripheral vein and therapeutic effects including short-term effects and long-term follow-up will be compared and investigated.

Official Title
-----------------
Therapeutic Effects of Allogene MSCs Transplantation in Patients With Chronic Liver Diseases Through Peripheral Vein.

Conditions
-----------------
Allogene MSCs Transplantation, Chronic Liver Diseases Patients, Peripheral Vein

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chronic liver diseases including: viral hepatitis, alcoholic liver disease, autoimmune liver disease. age: 15-65 years old. Exclusion Criteria: pregnant women and women in lactation. other systems and organs disfunction space-occupying lesion were found in liver. concurrent infection with HIV and other immunodeficiency diseases. DIC and active bleeding were confirmed.

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 65 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 |
| --- | --- |
| Allogene MSCs transplantation<br>Allogene MSCs transplantation were performed in patients with chronic liver diseases through peripheral vein plus the same medical treatments. | |
| control<br>only medical treatments were performed in patients with chronic liver diseases. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short-term therapeutic effects at 1-8 weeks after Allogene MSCs transplantation through peripheral vein. |  | 1-8 weeks after transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term follow-up of Allogene MSCs transplantation through peripheral vein. |  | 3-60 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
allogene MSCs, transplantation, chronic liver diseases, peripheral vein
Safety and Pharmacokinetics Study of Human Monoclonal Antibody (FGI-101-1A6)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and tolerability of the anti-TSG101 human monoclonal antibody (FGI-101-1A6)when administered intravenously to healthy volunteers.

Detailed Description
-----------------
Primary - - To compare the safety profile of a single intravenous administration of FGI-101-1A6 as compared with Placebo Secondary To evaluate the pharmacokinetics (PK) of a singel intravenous administration of FGI-101-1A6 To evaluate the immunogenicity of FGI-101-1A6

Official Title
-----------------
Phase I Study of Human Monoclonal Antibody (FGI-101-1A6) in Normal Healthy Volunteers

Conditions
-----------------
Influenza

Intervention / Treatment
-----------------
* Drug: FGI-101-1A6


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers ages 18-45 Normal laboratory (blood tests) results Exclusion Criteria: Prior immunization with live-attenuated vaccines

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FGI-101-1A6<br>Intervention: Drug-FGI-101-1A6 | Drug: FGI-101-1A6<br>* anti-TSG101 human monoclonal antibody, single dose<br>|
| Placebo Comparator: Placebo<br>Intervention: Drug-Placebo | Drug: FGI-101-1A6<br>* anti-TSG101 human monoclonal antibody, single dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessments | Safety will be assessed by collecting data (physical exams, adverse event reporting, lab testing/analysis) and concomitant medications at each visit from pre-infusion period through post-infusion day 60, or the early withdrawal, if applicable | 60 days following infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic analysis (PK) | PK parameters will be determined for a single administration of FGI-101-1A6 as measured by an immunoassay for FGI-101-1A6 | 60 days following infusion | 
| Immunogenicity | Immunogenicity will be measured by testing serum on anti-FGI-101-1A6 generation | From day 1 up to day 60 following infusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Influenza, antibodies, monoclonal, virus
Right Ventricular Septal Pacing for the Prevention of Left Ventricular Dysfunction in Patients With Atrio-Ventricular Block

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate the effects of the right ventricular septal pacing on left ventricular function compared with right ventricular apical pacing.

Official Title
-----------------
Right Ventricular Septal Pacing for the Prevention of Left Ventricular Dysfunction in Patients With Atrio-Ventricular Block

Conditions
-----------------
Atrio-Ventricular Block

Intervention / Treatment
-----------------
* Device: Pacemaker Implantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: the patients who need pacemaker implantation for atrio-ventricular block Exclusion Criteria: Pregnancy, left ventricular dysfunction at the time of implantation

Ages Eligible for Study
-----------------
Minimum Age: 20 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

| Intervention/Treatment |
| --- |
|Device: Pacemaker Implantation|Implantation of right ventricular lead at septal or apex.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalization for the heart failure |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of atrial fibrillation |  | 6 months |
A Study of Prevalence of the I50L Mutation When ATV Treated Patients Fail the Regimen

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find out the frequency of the I50L substitution among patients experiencing treatment failure on an atazanavir-containing regimen.

Official Title
-----------------
A Phase IV, Multicenter, Cross-sectional Study to Evaluate the I50L Substitution Among Subjects Experiencing Virologic Failure on a HAART Regimen Containing Atazanavir (ATV)

Conditions
-----------------
HIV Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Atazanavir - containing antiretroviral regimen Confirmed virologic failure defined as either: HIV RNA by PCR greater than or equal to 1000 copies/mL after achieving a value of <400 copies/mL on at least 2 consecutive measurements or HIV RNA greater than or equal to 1000 copies/mL after 24 weeks of continuous therapy At least 18 years old Exclusion Criteria: Unable to give informed consent Prisoners or subjects involuntarily incarcerated for treatment of psychiatric or physical illness

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 |
| --- | --- |
| A<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV/AIDS, Treatment Experienced
Prevalence of Attention Deficit Disorder Among Patients With Constitutional Growth Delay

Study Overview
=================
Brief Summary
-----------------
The aim of the our study is to investigate whether there is an increased incidence of ADHD ( based on self reports and questionnaires) among children with short stature due to constitutional growth delay (CGD) in comparison with children with Familial short stature.

Detailed Description
-----------------
Filling out the study questionnaire by ADHD diagnosed and suspected children (have a positive DBDRS (Disruptive Behavior Disorders Rating Scale Questionnaire) result) who were referred to the pediatric endocrine clinic of our hospital for short statue evaluation. The study questionnaire will be filled by child's guardian. The study and the DBDRS questionnaires will be filled only after obtaining an informed consent. The required data including growth statistics, age at puberty, bone age and other relevant data will be collected from the child's medical records. The data on patients will be processed anonymously.

Conditions
-----------------
Attention-deficit/Hyperactivity Disorder, Constitutional Growth Delay

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: undergo evaluation and follow-up due to short stature caused by either CGD or Familial short stature Exclusion Criteria: Children with short stature due to other reasons such as hormonal disorders (thyroid disorders, growth hormone deficiency), genetic syndromes

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum 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 |
| --- | --- |
| children with constitutional growth delay<br> | |
| children with Familial short stature<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of ADHD among children with short stature due to constitutional growth delay (CGD) in comparison with children with Familial short stature |  | single point in time during the visit at the endocrine clinic |
Effect of Music on Pain and Satisfaction in Infertile Patients Undergoing Hysterosalpingography

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to demonstrate the value of music in infertile patients undergoing hysterosalpingography on patients' level of pain and satisfaction.

Official Title
-----------------
Effect of Music on Pain and Satisfaction in Infertile Patients Undergoing Hysterosalpingography: a Randomized Controlled Trial

Conditions
-----------------
Hysterosalpingography

Intervention / Treatment
-----------------
* Other: music
* Other: no music


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infertility; patients aged 19 to 42 years; candidate for hysterosalpingography. Exclusion Criteria: Severe dysmenorrhea; pelvic infections; drug sensitivity; unwillingness to participate in the study; presence of psychiatric disorders, use of psychotropic medications; secondary infertility.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 42 Years

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

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: music group<br>In the music group, music chosen by the participant will be played through a speaker by the nursing staff during outpatient hysteroscopy. Music will be played through a speaker instead of headphones in order to maintain good communication and interaction between the participant and the doctor. | Other: music<br>* In the music group, music that chosen by the participant will be played through a speaker by the nursing staff during outpatient hysteroscopy. Music will be played through a speaker instead of headphone in order to maintain a good communication and interaction between the participant and the doctor.<br>|
| Other: non-music group<br>Participants in the non-music group will undergo hysterosalpingography in the same setting and standard procedure without listening to any music. | Other: no music<br>* Participants in the non-music group will undergo hysterosalpingography in the same setting and standard procedure without listening to any music.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain During contrast medium injection | pain will be assessed by visual analog scale from 0 to 10 | 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain after hysterosalpingography | pain will be assessed by visual analog scale from 0 to 10 | 10 minutes |
Evaluation of Plasma Catecholamine Concentration During Surgery

Study Overview
=================
Brief Summary
-----------------
Stress during surgery leads to significant increase in plasma catecholamine concentrations in surgeons, anesthesiologists, and patients.

Detailed Description
-----------------
Hypothesis: Resection of pheochromocytomas can lead to more than normal stress in surgeons and because of abrupt hemodynamic changes in patients as well in anesthesiologists. Measurements of catecholamine concentrations at baseline, prior to surgery during and after surgery, are to be performed to test this hypothesis.

Official Title
-----------------
Evaluation of Stress Hormone Concentration During the Resection of Pheochromocytoma. Comparison of Surgeon - Anesthesiologist - Patient

Conditions
-----------------
Stress

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with pheochromocytoma (Older than 18 years) - Exclusion Criteria: Patients younger than 18 years. Conservative treatment. -

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 |
| --- | --- |
| Surgeon<br>To detect the degree of intraoperative stress, venous blod will be drawn from one surgeon during 8 pheochromocytoma resections. | |
| Anesthesiologist<br>To detect the degree of intraoperative stress, venous blood will be drawn from one anesthesiologist during 8 pheochromocytoma resections. | |
| Patients with pheochromocytoma<br>Venous blood will be drawn from 8 patients with pheochromocytoma during tumor resection. | |

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
-----------------
Epinephrine, Norepinephrine, normetanephrine, Catecholamine concentrations during surgery
Short Course Radiotherapy, Unresectable Rectal Cancer, Liver Metastasis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is the increase of resection rate of primary cancer in rectal after short course radiotherapy without interrupt chemotherapy schedule during the period of chemotherapy. Radiation therapy is followed by additional chemotherapy to prevent the progression of systemic metastasis, and to reduce the incidence of rectal carcinoma including metastasis.

Official Title
-----------------
A Phase II Study of Neoadjuvant Systemic Chemotherapy With Short Course Radiotherapy in Patients With Unresectable Rectal Cancer and Liver Metastasis

Conditions
-----------------
Rectal Cancer, Metastatic

Intervention / Treatment
-----------------
* Drug: chemotherapy
* Radiation: radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pathologically confirmed for unresectable (impossible to try Total mesorectal excision) rectal cancer with liver metastasis over 19 years Eastern Cooperative Oncology Group 0-1 Proper organ function more than one target lesion (standard by Response Evaluation Criteria in Solid Tumors 1.1) Who should sign on the Informed consent form before participate the trial. Exclusion Criteria: Metastasis in other organ except liver Chronic active hepatitis or cirrhosis History of treatment for metastatic colorectal cancer Subject pregnant or breast feeding Uncontrolled disease Have had adjuvant therapy Uncontrolled peripheral nerve infection Alcoholic or drug addict Subject currently is enrolled in or ≤30 days from ending other clinical trial. History of other type of cancer except resolved from skin cancer and cervical cancer.

Ages Eligible for Study
-----------------
Minimum Age: 19 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: chemotherapy with radiotherapy<br>Cetuximab or Bevacizumab, FOLFOX or FOLFIRI, radiotherapy | Drug: chemotherapy<br>* cetuximab 250mg/m2 or bevacizumab 5mg/kg, FOLFOX (oxaliplatin 85mg/m2, leucovorin 200mg/m2, 5-FU 400mg/m2, 5-FU continuous 1200mg/m2) or FOLFIRI (irinotecan 180mg/m2, leucovorin 200mg/m2, 5-FU 400mg/m2, 5-FU continuous 1200mg/m2)<br>Radiation: radiotherapy<br>* After FOLFOX 4cycle, subject have short course radiotherapy 5Gy for 5 days.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete resection (R0) rate for rectal and liver lesions |  | after surgical resection, an average of 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate (RECIST V1.1) |  | 8 weeks |