linjc16/ctgov huggingface dataset:
A Randomized Controlled Trial Comparing Two Timing Regimens of Pico-salax for Colon Cleansing Prior to Colonoscopy

Study Overview
=================
Brief Summary
-----------------
Pico-Salax is an osmotic and stimulant bowel cleansing agent used prior to colonoscopy. It is unknown whether splitting the doses (i.e. taking the second dose the morning of the colonoscopy) results in a better bowel cleansing, as research with other agents suggests this may be the case. This study aims to assess whether splitting the dose of Pico-Salax results in a better bowel cleansing than traditional dosing.

Official Title
-----------------
A Randomized Controlled Trial Comparing Two Timing Regimens of Pico-salax for Colon Cleansing Prior to Colonoscopy.

Conditions
-----------------
Colonoscopy

Intervention / Treatment
-----------------
* Drug: Pico-Salax
* Drug: Split Dose Pico-Salax


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: colonoscopy indicated Exclusion Criteria: congestive heart failure ascites renal failure hyponatremia previous intestinal 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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Split Dose<br>Doses of Pico-Salax split: one dose administered the night prior to colonoscopy and the other dose administered the day of the procedure. | Drug: Split Dose Pico-Salax<br>* One dose of Pico-Salax taken the evening prior to colonoscopy and the other the morning of the procedure.<br>|
| Active Comparator: Traditional Dose<br>Both doses of Pico-Salax taken the evening prior to colonoscopy. | Drug: Pico-Salax<br>* Both doses of Pico-Salax taken the evening prior to colonoscopy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bowel cleansing assessed by the Ottawa Bowel Preparation Scale |  | day of colonoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient tolerance of preparation |  | day of colonoscopy |
Assessment of the Anesthetic Effect on the Activity of Immune Cell in Patient With Breast Cancer

Study Overview
=================
Brief Summary
-----------------
Anesthetics agents has variety inflammation during the cancer surgery. This perioperative inflammation can influence to cancer metastasis or recurrence. The purpose of this study is to prove the variation of immune cell activity between preoperative and postoperative period.

Detailed Description
-----------------
The patients were allocated randomly to receive propofol or sevoflurane. Also, a total of 18ml of blood sample was obtained for total 3 times in consecutive order. immediate before anesthesia induction postoperative 1 hours postoperative 24 hours Serum in blood will be obtained and activity of helper T cell, natural killer cell and level of serum cytokine will be evaluated by flow cytometry or enzyme-linked immunosorbent assay

Official Title
-----------------
Assessment of the Anesthetic Effect on the Activity of Immune Cell in Patient With Breast Cancer

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

Intervention / Treatment
-----------------
* Drug: propofol group
* Drug: sevoflurane group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient who was planned to undergo colon cancer surgery. Exclusion Criteria: age < 20 years old history of hypersensitivity reaction in propofol or sevoflurane history of previous cancer patient with ongoing inflammation

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

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: propofol group<br>The patient who anesthetized by using propofol. | Drug: propofol group<br>* Patient will be anesthetized by using propofol infusion during operation.<br>* Other names: propofol;|
| Active Comparator: sevoflurane group<br>The patient who anesthetized by using propofol | Drug: sevoflurane group<br>* Patient will be anesthetized by using sevoflurane inhalation during operation.<br>* Other names: sevoflurane;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CD39 and CD73 on circulating regualtory T cells | change of percentage of CD39 and CD73 (scores range from 0 to 100) | preoperative time. postoperative 1 hours and 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Circulating natural killer cells | change of percentage of circulating natural killer cell (scores range from 0 to 100) | preoperative time. postoperative 1 hours and 24 hours |
A Survey of Factors Affecting an Early or Delayed Diagnosis of IgA Nephropathy

Study Overview
=================
Brief Summary
-----------------
This is a survey of factors which affect a pathologically defined early or delayed diagnosis of IgA nephropathy in Guangdong General Hospital, Guangzhou, China. An early or delayed diagnosis of IgA nephropathy is pathologically defined using the recently published Oxford classification of IgA nephropathy. The factors to be surveyed include health examination including urine test, socioeconomic status of patients including education,etc.

Official Title
-----------------
A Survey of Factors Affecting an Early or Delayed Diagnosis of IgA Nephropathy: an Observational Study

Conditions
-----------------
IgA Nephropathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: biopsy-proven IgA Nephropathy patients in Guangdong General Hospital, Guangzhou,China

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 80 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 |
| --- | --- |
| biopsy-proven IgA nephropathy<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Factors potentially affecting an early or delayed diagnosis of IgA Nephropathy |  | Before the biopsy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glomerular filtration rate(GFR) decline rate or reaching end-stage renal disease (ESRD) or doubling of serum creatinine |  | after the biopsy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diagnosis, IgA nephropathy
The Correlation Between Outcome and Infarct Growth in Patients With Acute Ischemic Stroke

Study Overview
=================
Brief Summary
-----------------
Previous research has shown there wasn't inevitable relationship between mismatch area and infarct growth according to Volumetric-subtraction mismatch volume.The recently published on Stroke paper has proposed Coregistration mismatch to calculate the mismatch to replace ischaemic penumbra, and it reignites hope for clinical application of the PWI/DWI mismatch. But the correlation between the mismatch, calculated by Coregistration mismatch method,and the clinical outcome of the patients with acute ischemic stroke is still unknown. so the investigators plan to conduct a prospective observational cohort study.

Detailed Description
-----------------
NIHSS,mRS and MR PWI/DWI/MRA are performed within 48 hours of stroke onset and final MR T2/flair image at ≈1 month. And then,Volumetric-subtraction mismatch and Coregistered mismatch will be calculated,respectively.finally,we will assess and compare the Volumetric-subtraction mismatch and Coregistered mismatch, and to clarify which method match the clinical outcome more better.

Official Title
-----------------
A MRI-based Study of Ischaemic Penumbra: the Correlation Between Outcome and Infarct Growth in Patients With Acute Ischemic Stroke

Conditions
-----------------
Ischemic Stroke

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged eighteen or above Acute middle cerebral artery ischemic stroke Stroke onset within 48 hours Included a complete set of initial MR images and final outcome MR images up to 1 months Exclusion Criteria: History of stroke in the past 6 weeks Pre-existing neurological or psychiatric disease that could confound the study results such as a pre-stroke mRS score greater than 3 CT evidence of the following conditions before enrollment: Significant mass effect with midline shift Evidence of intracranial hemorrhage With contraindication to MR such as severe allergy to contrast media

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stroke, Ischaemic Stroke, Cerebral Infarction, Cerebrovascular Disorders, Brain Diseases, Nervous System Diseases, Vascular Diseases, Brain Infarction, Brain Ischemia, mismatch, PWI/DWI mismatch, ischaemic penumbra, image analysis
A Risk Scores for Predicting Prevalence of Diabetes in the LAO Population

Study Overview
=================
Brief Summary
-----------------
This was a cross-sectional investigation conducted from December 2015 to July 2017, in 15 selected rural villages of 2 districts of Vientiane municipality, Lao PDR. Target population was interested people, both men and women of age range between 30 to 70 years, living in the selected community. Someone diagnosed with diabetes and/or using any anti-diabetic drug was excluded. The study protocol initiated with the interview on demographic and behavior information with each participant, followed by physical exam and blood pressure measurement. Fasting glucose were measured.

Detailed Description
-----------------
All participants were invited to meet with the researcher. Demographic data comprises of age, gender, family history of diabetes including parents and sibling, female with history of having baby weighing more than 4 kg, gestational diabetes, and history or current of dyslipidemia (triglycerides >150 mg/dl, LDL-C ≥ 100 mg/dl, HDL-c < 35 mg/dl), and behavior data were smoking habit, physical inactivity (less than 150 min/week or 3 day/week) were collected by interview. After that each participant was appointed for blood pressure measurement. Body mass index was computed from body weight (kg) divided by body height (m2) using the weight and height scale. Waist Circumference was measured at the midpoint between the superior border of iliac crest and the lowest rib using measuring tape with the subject in the position of standing relax and in underclothes Hip circumference is measured at the level of maximal gluteal protrusion Blood pressure (BP) value was done with the participants, after 5 minutes relaxing, sitting up right with their upper arm positioned at heart level and measured by Omron blood pressure monitor. Fasting Plasma Glucose was utilized to identify an individual who is normal, has either pre-diabetes or undiagnosed diabetes. Venous blood samples were collected 5 ml from antecubital vein into the test tube

Official Title
-----------------
A Risk Scores for Predicting Prevalence of Diabetes in the LAO Population

Conditions
-----------------
Undiagnosed Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: of age range between 30 to 70 years, living in the selected community. Exclusion Criteria: diagnosed with diabetes and/or using any anti-diabetic drug
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 |
| --- | --- |
| 1<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fasting plasma glucose | overnight fasting blood glucose | 06.00-09.00 am |
Factors Predicting Erythropoietin Responsiveness in Children on Hemodialysis at Sohag University Hospital

Study Overview
=================
Brief Summary
-----------------
Anemia is common in patients on hemodialysis (HD) due to lack of erythropoietin (EPO) synthesis and iron deficiency is occurring in HD patients due to chronic blood loss through the dialysis circuit, repeated blood sampling, shortened red blood cell life span and lack of adherence to treatment . Anemia is one of the most important complications that affects morbidity and mortality in chronic kidney disease (CKD) patients. It has significant impacts on those patients such as fatigue, weakness, shortness of breath, decreased quality of life, exercise capacity and physical activity, growth retardation and decreased cognitive functions, left ventricular hypertrophy, and congestive heart failure So, proper management of anemia is very important .

Official Title
-----------------
University Hospital

Conditions
-----------------
Pediatric Patients on Hemodialysis

Intervention / Treatment
-----------------
* Diagnostic Test: seum zinic,vit B12, parathyriod function


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: (1) patients started dialysis in the age range of 1-18years. (2) Patient will be on regular hemodialysis. Exclusion Criteria: Children who have no other co existent hematological disorder .

Ages Eligible for Study
-----------------
Minimum Age: 1 Year

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| responsiveness to erythropoietin stimulating agent<br>we evolute responsiveness of patients on hemodialysis for erythropoietin stimulating agents or not and factors effecting this response | Diagnostic Test: seum zinic,vit B12, parathyriod function<br>* seum zinic,vit B12, parathyriod function<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hb g/dl | measure hemoglobin level | one year | 
| Iron profile | measure iron profile on blood | one year | 
| Serum creatinine | serum creatinine | one year |
Dose Escalation Study of RSLV-132 in Subjects With Systemic Lupus Erythematosus

Study Overview
=================
Brief Summary
-----------------
A one month multi-dose study will evaluate the safety and tolerability of 3 intravenous infusions of RSLV-132 in subjects with inactive to mild SLE.

Official Title
-----------------
A Double-Blind, Placebo-Controlled Dose Escalation Study of the Administration of Multiple Intravenous Doses of RSLV-132 in Subjects With Systemic Lupus Erythematosus

Conditions
-----------------
Systemic Lupus Erythematosus

Intervention / Treatment
-----------------
* Biological: RSLV-132


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stable SLE with no anticipated change in medications for the next 60 days Exclusion Criteria: Other biologic drugs

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Saline infusion | Biological: RSLV-132<br>* 0.3 - 10.0 mg/kg RSLV-132 weekly for 4 weeks<br>|
| Experimental: RSLV-132<br>0.3 - 10 mg/kg experimental drug | Biological: RSLV-132<br>* 0.3 - 10.0 mg/kg RSLV-132 weekly for 4 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 |  | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
RSLV-132, Systemic Lupus Erythematosus, Lupus, SLE, Resolve
Does Immunotherapy Have a Role in the Management of Endometriosis?

Study Overview
=================
Brief Summary
-----------------
Pathological specimens of 40 women that had been operated for endometriosis will be included in this study. These tissues will be stained with a marker named as PDL-1 in pathological examination. programmed cell death (PD-1) is expressed on T cells. The immunotherapies in which antibodies against these PD-1 and its ligands (PDL-1) have been used are accepted as very effective in the treatment of many cancers. If these ligands can be shown in the endometriosis, it will be an important step for the treatment of endometriosis.

Detailed Description
-----------------
40 women who had been operated for endometriosis between 2013 and 2014 will be included in this study. Pathological specimens will be stained with an immunohistochemical marker named as PDL-1. programmed cell death (PD-1) is a protein containing 288 aminoacids and expressed on T cells. It was shown on apoptotic cells in earlier times, but then it has been understood that its physiologic role is not cell death. The upregulation of PD-1 is a result of the activation of T cells and it is necessary for the termination of immune response. PD-L1 is a ligand for PD-1. The immunotherapies in which antibodies against these PD-1 and its ligands (especially PDL-1) provides significant improvements in many cancers such as melanoma. Evidence about the role of these ligands in endometriosis will be an important step in its management.

Official Title
-----------------
Does Immunotherapy Have a Role in the Management of Endometriosis?

Conditions
-----------------
Endometriosis

Intervention / Treatment
-----------------
* Other: immunohistochemical staining


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients operated for endometriosis between 2013 and 2014 pathological examinations proving the diagnosis of endometriosis Exclusion Criteria: patients operated for cysts other than endometriosis
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: immunohistochemical staining|immunohistochemical staining|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| immunohistochemical staining | immunohistochemical staining with PD-L1 | 6 months |
Single-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ONO-2952 in Healthy Adult Subjects

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to evaluate the safety and tolerability of ONO-2952 across ascending single doses in healthy adult male and female subjects. The secondary objective is to characterize the pharmacokinetic (PK) profile of ONO-2952. The tertiary objective of this study is to preliminarily evaluate the effect of a meal upon the PK profile of ONO-2952.

Official Title
-----------------
A Double-Blind, Placebo-Controlled, Single-Dose Escalation and Food Effect Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ONO-2952 in Healthy Adult Subjects

Conditions
-----------------
Healthy Adult Subjects

Intervention / Treatment
-----------------
* Drug: ONO-2952
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy non-smoking male or female subjects (18-55 inclusive) Body mass index (BMI) of 19-35 kg/m2 (inclusive) For females, surgically sterilized, postmenopausal, or who are non- lactating and agree to use a double barrier method of contraception Exclusion Criteria: History or presence of clinically significant disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: P<br> | Drug: Placebo<br>* Placebo dosed in the same manner as ONO-2952<br>|
| Experimental: E<br> | Drug: ONO-2952<br>* 3 mg to 800 mg at a single dose; 10 mg and 200 mg for food effect study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of ONO-2952 using vital signs, ECGs, laboratory tests, physical examinations, and incidence/severity of adverse events |  | up to 8 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterization of PK of ONO-2952 through measurement of drug concentration in plasma and urine sample |  | up to 8 days | 
| Effect of food on ONO-2952 pharmacokinetics by comparison of PK profile between fasted and fed conditions |  | up to 24 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ONO-2950, healthy adult subjects, first in human, safety, tolerability, pharmacokinetics