linjc16/ctgov huggingface dataset:
Efficacy and Safety of Rituximab Given at Fixed Dose (1000 mg on Days 1 and 15) Compared to the Standard Regimen in Adult's Immune Thrombocytopenia

Study Overview
=================
Brief Summary
-----------------
The aim of this large French multicentric retrospective study was to compare the efficacy and safety of two (the standard and the Rheumatoid arthritis) rituximab regimens in adult's immune thrombocytopenia .

Detailed Description
-----------------
Every adult (age ≥ 18 years) seen in one of the 3 participating centre (dijon, Marseille, Mondor) over a 7-year period (2005-2012) with a definite diagnosis of primary ITP according to the American Society Hematology guidelines who received RTX regardless the regimen could be included.

Official Title
-----------------
Efficacy and Safety of Rituximab Given at Fixed Dose (1000 mg on Days 1 and 15) Compared to the Standard Regimen in Adult's Immune Thrombocytopenia

Conditions
-----------------
Primary Immune Thrombocytopenia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary ITP Age > 18 years Exclusion Criteria: Secondary ITP Age < 18 years

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 |
| --- | --- |
| Standard regimen<br>Patients received the standard regimen (i.e 4 weekly infusions of 375 mg/m2)of rituximab | |
| Rheumatoid arthritis regimen<br>Patients received the RA regimen (i.e two infusions of 1000 mg, 2 weeks apart) of rituximab | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary end point of the study was to assess the response rate to treatment 1 year after the first rituximab infusion. | A complete response (CR) was defined as a platelet count >100 x 109/l and a response (R): by a platelet count >30 x 109/l with a least a doubling of the baseline value without any rescue intervention within 8 weeks before assessment, and no response (NR) was defined as a platelet count lower than 30 x 109/ | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The response rate 3months, and at the last follow-up after the first rituximab infusion. Variable associated with RTX response. |  | 3 months, one year, last follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ITP, Rituximab, Efficacy, Anti-CD20, Regimen
Role of CD28null NKG2Dpos T Cells on Human Alloimmune Reactivity T Cell Population

Study Overview
=================
Brief Summary
-----------------
This is an observational multi-center study to determine whether any single immune monitoring test or a combination of tests obtained in the first 6 months after renal transplantation correlates with acute rejection or graft loss in renal allograft recipients receiving commonly used immunosuppressive.

Official Title
-----------------
Role of CD28null NKG2Dpos T Cells on Human Alloimmune Reactivity: An Untargeted T Cell Population (# 859869783).

Conditions
-----------------
Kidney Transplant

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: human kidney transplant recipients ATG or basiliximab induction therapy Exclusion Criteria: induction therapy other than ATG or basiliximab
Sexes Eligible for Study
-----------------
All

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To document the prevalence and frequencies of CD4+ and CD8+ CD28null/NKG2Dpos T cells at the time of transplantation. |  | 6 months | 
| To test whether CD28null/NKG2Dpos T cells have unique rapid activation properties to allogeneic HLA antigens in vitro |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To study the clinical correlations between the frequencies of alloreactive CD28null/NKG2Dpos T cells with kidney graft function and histopathology. |  | 6 months | 
| To test the effects of induction therapy with rabbit anti-thymocyte globulin (ATG) vs. IL-2 receptor blocker antibodies on circulating CD28null/NKG2Dpos T cells. |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
T cells, Human Alloimmune Reactivity, immunosuppression
NESP Pediatric Study

Study Overview
=================
Brief Summary
-----------------
Open-label, randomized study of NESP in pediatric subjects 18 years of age or younger. Subjects will receive study drug (NESP or rHuEPO) for 28 weeks after a 2 week screening and baseline period. During the study, procedures include bloodwork for laboratory assessments and vital signs. Dose titration determined by hemoglobin values taken weekly during the study. Antibody samples taken at baseline and during the end of study assessments. A physical examination and laboratory tests will conclude the study.

Official Title
-----------------
An Open-label, Randomized, Non-inferiority Study of Novel Erythropoiesis Stimulating Protein (NESP) and Recombinant Human Erythropoietin (rHuEPO) for the Treatment of Anemia in Pediatric Subjects With Chronic Renal Insufficiency (CRI) or End-stage Renal Disease (ESRD) Receiving Dialysis

Conditions
-----------------
Pre-dialysis, End Stage Renal Disease

Intervention / Treatment
-----------------
* Drug: darbepoetin alfa
* Drug: rHuEPO


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1 to 18 years of age ESRD receiving dialysis or CRI with eGFR less than 30 mL/min Baseline hemoglobin 9.5 - 12.5 g/dL and iron replete Stable rHuEPO therapy for 8 weeks Exclusion Criteria: Scheduled for a living-related kidney transplant Uncontrolled blood pressure seizure activity Hyperparathyroidism Major surgery within 12 weeks or active inflammatory disease Currently receiving antibiotics Clinical evidence of malignancy Pregnant or breast-feeding

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 |
| --- | --- |
| Active Comparator: rHuEPO<br> | Drug: rHuEPO<br>* same as previous rHuEPO dose at randomization; adjust as necessary (+/- 25% of the starting dose) to maintain Hb withing 10.0 - 12.5 g/dL<br>|
| Experimental: darbepoetin alfa<br> | Drug: darbepoetin alfa<br>* Dose 100U rHuEPO = 0.42 mcg NESP; adjust as necessary (+/- 25% of the starting dose) to maintain Hb withing 10.0 - 12.5 g/dL<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate that NESP is comparable (not inferior) to rHuEPO for the treatment of anemia in pediatric subjects with CRI or ESRD receiving dialysis |  | Entire Study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the safety and tolerability of NESP in the treatment of anemia in the pediatric population with CRI or ESRD |  | Entire Study |
Low Concentration Atropine for Myopia Progression in School Children

Study Overview
=================
Brief Summary
-----------------
Myopia is the leading cause of blindness in Taiwan. The younger children with myopia, the higher risk of high myopia in later life and complications such as retinal detachment and maculopathy will occur. We have reported the low concentration of atropine (0.05%) with the effect on retarding the myopia progression. Recently the 0.01% atropine was also reported effective and with less visual side effects such as mydriasis. The aim of this study is to compare the efficacy in controlling myopia progression and visual side effects of 2 low concentration of atropine(0.05% vs 0.01%) in children aged 6-12 years with myopia of at least -0.5 diopters (D) and astigmatism of -1.50 D or less.

Official Title
-----------------
Low Concentrations of Atropine for Controlling Myopia Progression in School Children

Conditions
-----------------
Myopia Progression

Intervention / Treatment
-----------------
* Drug: Atropine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Myopia of at least -0.5 diopters (D) and astigmatism of -1.50 D or less. Exclusion Criteria: strabismus, amblyopia. cataract, glaucoma or any ocular diseases ocular surgery history systemic diseases (ex. asthma, heart disease...)

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 12 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.01% Atropine<br> | Drug: Atropine<br>* Compare different concentrations of atropine eye drops (0.01% vs 0.05%) in the efficacy of controlling myopia progression and side effects of atropine<br>|
| Active Comparator: 0.05% Atropine<br> | Drug: Atropine<br>* Compare different concentrations of atropine eye drops (0.01% vs 0.05%) in the efficacy of controlling myopia progression and side effects of atropine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cycloplegic spherical refraction change | Cycloplegic spherical refraction change is the main indicator of the myopia progression. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Axial length change | Axial length change is another indicator of the myopia progression.Using non-contact biometry. unit: millimeter(mm) | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Myopia progression, Low concentration atropine
Association Between Local Cerebral Oxygenation Monitoring and Postoperative Delirium in Carotid Endarterectomy

Study Overview
=================
Brief Summary
-----------------
Postoperative delirium (POD) is a common perioperative complication, which can lead to adverse outcomes. Patients undergoing carotid endarterectomy (CEA) were elderly, complicated with vascular risk factors, cognitive dysfunction, some also had a history of stroke, and the circulation fluctuated greatly during the operation, often resulting in hypoperfusion of cerebral tissue and hypoxia. Therefore, they're the high-risk group of POD. Near-infrared Spectroscopy (NIRS) can continuously and noninvasively monitor local cerebral oxygen saturation (SctO2) to identify the mismatch of oxygen supply and demand in brain tissue. However, for CEA patients, the association between intraoperative SctO2 changes and POD remains unclear. This study intends to explore the association between them and determine the SctO2 threshold for predicting POD. We will monitor SctO2 intraoperatively, follow up and collect data postoperatively.

Official Title
-----------------
Association Between Local Cerebral Oxygen Saturation Monitoring and Postoperative Delirium in Carotid Endarterectomy：A Prospective Cohort Study

Conditions
-----------------
Cerebral Oxygen Saturation, Postoperative Delirium, Carotid Endarterectomy

Intervention / Treatment
-----------------
* Device: local cerebral oxygen saturation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Scheduled carotid endarterectomy; Signed informed consent. Exclusion Criteria: Severe cognitive impairment(Mini-Mental State Examination, MMSE<18); History of psychotropic drugs; Previous intracranial surgery history; Poor hearing or vision; Language barriers
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br> | Device: local cerebral oxygen saturation<br>* minimum SctO2, SctO2 drop/rise defined by different thresholds, and area under/above the threshold<br>|
| Group 2<br> | Device: local cerebral oxygen saturation<br>* minimum SctO2, SctO2 drop/rise defined by different thresholds, and area under/above the threshold<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative delirium | Postoperative delirium is assessed by the Confusion assessment method for intensive care unit (CAM-ICU) or the 3-minute diagnostic interview for CAM (3D-CAM) when the patient is in intensive care unit or general ward, respectively. | With postoperative 5 day |
Academic Self-regulation, Parenting Dimensions and Academic Procrastination

Study Overview
=================
Brief Summary
-----------------
the method was the correlational way. The statistical population of the was all of the boy students of the second-period elementary school in Garmeh city (Iran). the sample size was 278. The age of participants was in the range of 9 to13 years old.

Official Title
-----------------
University of Bojnord

Conditions
-----------------
Self-regulation, Parenting, Procrastination

Intervention / Treatment
-----------------
* Other: descriptive method


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: be the male student, having the age of 9 to 13 years, having the ability of reading and writing Exclusion Criteria: be female, no be student, no having age of 9 to 13 years, disability of reading and writing, having psychotic disorders

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 13 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: descriptive method|After obtaining relevant permissions from the university and organization of education and selecting participants, the study was explained for students and their satisfaction obtained. Then questionnaires were given to participants. To observe ethical considerations, questionnaires were anonymous and has been confided that the participants' responses was maintained in the study and is not given anyone|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-Regulation | self-regulation was measured by the Academic Self-Regulation Questionnaire. this questionnaire has 30 items to measure memory, targeting, self-evaluation, assistance, responsibility and organization strategies. items are assessed on a six-point score of never (1), rarely (2), sometimes (3), usually (4), most times (5) and always (6). the high scores indicate level high of the self regulation | 2 days | 
| Procrastination | procrastination was measured by Procrastination Academic Scale. This scale has 27 items that examine components of preparation for exams, preparation for tasks and preparation class projects. It is responded to items on a four-point scale namely, rarely, sometimes, most and always.the high scores indicate the high level of procrastination. | 2 days | 
| parenting | parenting was measured by the Scale of parenting style. This scale has parental responsiveness and parental control dimension. Items measure the adolescents' perception from their parents' responsiveness and control. The scale of parenting style has 38 items and it is responded on the five-point scale as always true to always false. the high scores indicated the high level in control and responsiveness. | 2 days |
Laparoscopic Assisted Doderlin Vaginal Hysterectomy

Study Overview
=================
Brief Summary
-----------------
This prospective randomized clinical trial will be conducted in Ain Shams University Maternity Hospital during the period from May 2017 to December 2017. Group Ι: 30 patients will undergo conventional laparoscopic assisted vaginal hysterectomy (LAVH). Group ΙΙ: 30 patients will undergo laparoscopic assisted Doderlein vaginal hysterectomy (LADH)

Official Title
-----------------
Laparoscopic Assisted Doderlin Vaginal Hysterectomy vs. Laparoscopic Assisted Vaginal Hysterectomy: A Randomized Clinical Trial.

Conditions
-----------------
Laparoscopic Hysterectomy

Intervention / Treatment
-----------------
* Procedure: Laparoscopic hysterectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 40 years. Uterine size ≤ 14weeks. Benign uterine pathology (Fibroid uterus, endometrial hyperplasia, DUB, uterine prolapse). No contraindication for laparoscopic surgery. Exclusion Criteria: Gynecologic malignancy. Contraindications to laparoscopy like any medical condition worsened by pneumoperitoneum or the Trendelenburg position. Large abdominal hernia Large ovarian mass History of previous laparotomy finding extensive adhesions

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- |
| Active Comparator: LAVH<br>Laparoscopic Assisted Vaginal Hysterectomy | Procedure: Laparoscopic hysterectomy<br>* Laparoscopic hysterectomy<br>* Other names: Laparoscopic Assisted Hysterectomy;|
| Active Comparator: LADH<br>Laparoscopic Assisted Doderlin Vaginal Hysterectomy | Procedure: Laparoscopic hysterectomy<br>* Laparoscopic hysterectomy<br>* Other names: Laparoscopic Assisted Hysterectomy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain | questionnaire using Visual Analogue scale | 24 hours | 
| operative complications |  | 24 hours | 
| Hospital stay |  | 24 hours | 
| Blood loss |  | 24 hours |
Group Empowerment of Battered Women as a Tool for Violence Prevention

Study Overview
=================
Brief Summary
-----------------
Intimate partner violence against women is a significant global health problem. This study was designed to test the hypothesis that a group intervention based on empowerment theory of Paolo Freire would be effective as a means to reduce the extent and prevent violence among women whose partners were violent toward them.

Detailed Description
-----------------
A randomized controlled trial (N=141) with two control groups (one individual psychotherapeutic treatment and the other a usual care group treatment) was conducted in a violence treatment center in the South of Israel The treatment protocol designed to empower battered women (EBW) was conducted with 12 groups over a period of two years. Assessments were made before, immediately following and at an 8 month follow up following the intervention.

Conditions
-----------------
Domestic Violence

Intervention / Treatment
-----------------
* Behavioral: EBW group intervention to empower battered women


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women living in the south, who had approached the center for help as battered women Could fill out forms in Hebrew Aged 20 and above Exclusion Criteria: Age younger than 20 Not able to fill out forms in Hebrew Not living in the southern district of Israel

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: EBW group intervention to empower battered women|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conflict tactics scale, Posttraumatic stress scale for |  |  | 
| family violence |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
women experiencing domestic violence