linjc16/ctgov huggingface dataset:
Study of miRNA-155 in Acute Leukemia

Study Overview
=================
Brief Summary
-----------------
The leukaemias are a heterogeneous group of blood cancers, Acute leukaemia (AL) is caused by malignant proliferation of blood cells arrested at an immature stage of development, They are very aggressive diseases that run a rapidly fatal course if not promptly diagnosed and appropriately treated. Misdiagnosis is very common with delay in diagnosis and prompt treatment being the causes of high morbidity and mortality in acute leukaemias. Although with the continuous improvement of clinical and laboratory diagnosis and treatment methods, the prognosis of AML has been significantly improved, but there are still about 70% of patients who cannot survive more than 5 years after diagnosis The activity of miRNAs in tumors is regulated by the same alterations affecting protein-coding genes, such as chromosomal rearrangements, genomic amplifications or deletions or mutations, abnormal transcriptional control, dysregulation of epigenetic changes and defects in the biogenesis machinery A typical chromosomal rearrangement is a chromosomal translocation, especially in hematological malignancies, in which it promotes tumor development and progression by the promoter exchange or by the creation of chimeric genes translated as fusion proteins. In Acute Myeloid Leukemia (AML) patients with myeloid/lymphoid leukemia gene (or mixed-lineage leukemia, MLL) rearrangement, by large-scale genome-wide microarray analysis, it was demonstrated that among 48 selected miRNAs, 47 of them are increased

Official Title
-----------------
Study of miRNA-155 in Acute Leukemia

Conditions
-----------------
Acute Leukemia

Intervention / Treatment
-----------------
* Diagnostic Test: BM aspirate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: approval to sign an informed written consent, patient with newly diagnosed AL. Exclusion Criteria: Refusal to sign an informed written consent, Cases with Chronic leukemias, Lymphoma or Leukemic phase of lymphoma or patients on chemotherapy.
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 |
| --- | --- |
| control group<br>represents the control group ( ITP cases | Diagnostic Test: BM aspirate<br>* Bone Marrow aspiration & Examination<br>|
| AL group<br>cases of AcuteLeukemia. | Diagnostic Test: BM aspirate<br>* Bone Marrow aspiration & Examination<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of miRNA-155 | Detection of miRNA-155 using real time PCR on bone marrow aspirate samples | one year |
Efficacy and Safety of CKDB-501A in Subjects With Moderate-to-severe Glabellar Lines in Phase 3 Trial

Study Overview
=================
Brief Summary
-----------------
A Randomized, Double-blind, Active-controlled, Multi-center Phase 3 Trial to Investigate the Efficacy and Safety of CKDB-501A in Subjects with Moderated-to-severe Glabella Lines

Official Title
-----------------
A Randomized, Double-blind, Active-controlled, Multi-center Phase 3 Trial to Investigate the Efficacy and Safety of CKDB-501A in Subjects With Moderate-to-severe Glabellar Lines

Conditions
-----------------
Glabellar Lines

Intervention / Treatment
-----------------
* Drug: CKDB-501A
* Drug: Botox®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Subjects with at least moderate glabellar lines at maximum frown as determined by severity score of at least 2-point (moderate) on the Facial Wrinkle Scale (4-point FWS) as assessed by investigator. Exclusion Criteria: Any medical condition that can affect the neuromuscular function History of facial nerve paralysis or ptosis Significant facial asymmetry Subjects whose glabellar lines cannot be sufficiently improved by physical method Subjects who have a previous surgical history that could result in any anatomical changes related to corrugator muscle, procerus muscle, or any relevant nerves Subjects with skin abnormalities at potential injection sites

Ages Eligible for Study
-----------------
Minimum Age: 19 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CKDB-501A<br> | Drug: CKDB-501A<br>* Intramuscular injection CKDB-501A<br>|
| Active Comparator: Botox®<br> | Drug: Botox®<br>* Intramuscular injection Botox®<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with a ≥ 2-point improvement on the FWS score at maximum frown from baseline, as assessed by the investigator post-administration of the investigational product |  | Week 4 |
Retrospective Study of High Dose Follitropin Delta in a Mixed Protocol With Human Chorionic Gonadotropin

Study Overview
=================
Brief Summary
-----------------
Follitropin delta is a rFSH, uniquely expressed in a human fetal retinal cell line, which owing to differences in glycosylation profile has a lower clearance and induces a higher ovarian response in humans than existing rFSH preparations when administered at equal doses of biological activity. A noninferiority clinical trial (ESTHER-1) in which individualized dosage of follitropin delta according to each patient's profile (AMH and weight) was compared to conventional follitropin alfa dosing for IVF have demonstrated that an individualized follitropin delta dosing is noninferior to conventional follitropin alfa with respect to ongoing pregnancy rate, ongoing implantation rate, and also live births, with a concomitant reduction in iatrogenic complications, including OHSS

Official Title
-----------------
Retrospective Study of High Dose Follitropin Delta in a Mixed Protocol With Human Chorionic Gonadotropin

Conditions
-----------------
IVF, Infertility

Intervention / Treatment
-----------------
* Drug: Follitropin delta


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women 18 to 42 years of age undergoing IVF/ICSI cycle IVF antagonist protocol Regular menstrual cycles of 24-35 days Presence of both ovaries Exclusion Criteria: Endometriosis stage III/IV History of recurrent miscarriages, defined as ≥ 3 consecutive losses Women undergoing ovarian stimulation for oncologic or elective fertility preservation Women participating in any other research project Hypersensitivity to follitropin delta and/or human chorionic gonadotropin Use of Growth Hormone (GH) during the stimulation cycle

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 42 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Follitropin delta + hCG<br>Combination of follitropin delta and serial hCG injections at individualized doses, where dosing regimen was determined according to AMH and weight in women undergoing an IVF antagonist cycle | Drug: Follitropin delta<br>* Evaluation of the IVF cycle using the prescribed medication<br>|
| Follitropin delta + HP-hMG<br>Combination of follitropin delta and highly-purified human menopausal gonadotropin (HP-hMG) where dosing regimen was determined according to AMH and weight in women undergoing an IVF antagonist cycle | Drug: Follitropin delta<br>* Evaluation of the IVF cycle using the prescribed medication<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of good quality blastocysts | Number of good quality oocytes fertilized | Up to 6 day |
Effect of Respiratory Muscle Training on Lung Function on Quarry Workers in Minia Government Egypt

Study Overview
=================
Brief Summary
-----------------
forty quarry workers participated in the study with age range (40-60 years), body mass index (BMI) from 25 to 34.9 kg/m2 (over weight and class 1 obesity). The patients divided into two groups randomly. (Group A) received aerobic exercises (Group B) receive aerobic exercises with moderate intensity in the form of walking on electrical treadmill for 30 min and inspiratory muscle training for 10 minutes., 3 sessions per week for 8 consecutive weeks. Pulmonary function test was applied by spirometry to assess lung function

Official Title
-----------------
Effect of Respiratory Muscle Training on Lung Function on Quarry Workers in Minia Government Egypt

Conditions
-----------------
Lung Function Decreased

Intervention / Treatment
-----------------
* Procedure: aerobic exercises with electrical treadmill for 30 min and inspiratory muscle training for 10 minutes.,


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: quarry workers working in the quarries for five years ago at least saver from chest diseases\\ BMI ranged from 25 to 34.9 kg/cm2 Exclusion Criteria: Subject with infected chest disease, unstable mental condition and chest cancer patients musculoskeletal disease

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group A<br>received aerobic exercises only | Procedure: aerobic exercises with electrical treadmill for 30 min and inspiratory muscle training for 10 minutes.,<br>* aerobic exercises with moderate intensity in the form of walking on electrical treadmill<br>|
| Experimental: Group B<br>aerobic exercises with moderate intensity in the form of walking on electrical treadmill | Procedure: aerobic exercises with electrical treadmill for 30 min and inspiratory muscle training for 10 minutes.,<br>* aerobic exercises with moderate intensity in the form of walking on electrical treadmill<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adequate lung function | Spirometer test, The patient was instructed to take a big breath in and then exhale as forcefully and quickly as they could, continuing until there was no more air remaining, in order to measure FVC and FEV1 | 8 weeks | 
| patient satisfaction | VAS scoring, (no pain=0) and the other end (worst pain=10). | 8 weeks |
Role of Faecal Calprotectin in Patients With Abdominal Pain

Study Overview
=================
Brief Summary
-----------------
The evaluation of patients with abdominal pain is a challenge for the emergency physician and the selection of patients for second-level radiological examinations or endoscopic procedures is not always easy to perform. Faecal calprotectin could be a useful diagnostic marker to distinguish between organic or functional form and its determination could be helpful to select patients for further examinations, in the context of emergency setting.

Official Title
-----------------
Role of Faecal Calprotectin in Patients Presenting to the Emergency Department With Abdominal Pain

Conditions
-----------------
Inflammation

Intervention / Treatment
-----------------
* Diagnostic Test: calprotectin levels


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with abdominal pain and/or diarrhea and/or rectal bleeding Exclusion Criteria: patients with age < 18 years pregnant women; patients with oncological, cardiological, nephrological terminal diseases; patients on antibiotic therapy or who have taken it during the last month; patients with a history of colic resection or gastrointestinal surgery; patients with a previous diagnosis of inflammatory bowel disease (Crohn's disease, ulcerative colitis)

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| abdominal pain<br>patients with abdominal pain | Diagnostic Test: calprotectin levels<br>* dosage of calprotectin levels in patients with abdominal pain<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| inflammation | assess the degree of intestinal inflammation by fecal calprotectin assay in patients with abdominal pain | 3 days |
Prospective Validation of CARPET Prognostic Model for Septic Shock After Allo-HSCT

Study Overview
=================
Brief Summary
-----------------
Validation of CARPET prognostic model for septic shock after allo-HSCT: a multicenter, prospective, and cohort study

Detailed Description
-----------------
A clinical prognostic model named CARPET model for septic shock after allo-HSCT has been developed and internally retrospectively validated. A multicenter, prospective cohort study is planned to validate this clinical prediction model again. The equation of the prediction model for 28-day mortality was as follows: Probability(28-day mortality)=(exp⁡(Y))/(1+exp⁡(Y)) where Y=2.343+1.328* Time of septic shock- 0.085* Albumin + 0.016 * Bilirubin-0.003*PaO2/FiO2 +0.127*Lactate- 0.011 * Glomerular filtration rate

Official Title
-----------------
Prospective Validation of CARPET Prognostic Model for Patients With Septic Shock After Allogeneic Hematopoietic Stem Cell Transplantation

Conditions
-----------------
Stem Cell Transplant Complications

Intervention / Treatment
-----------------
* Other: CARPET prognostic model


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age >18 years underwent allo-HSCT diagnosed with septic shock Exclusion Criteria: experienced septic shock before enrollment relapsed or progressed after HSCT

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Patients with septic shock after allo-HSCT<br>patients who underwent allo-HSCT and experienced septic shock | Other: CARPET prognostic model<br>* For patients diagnosed with septic shock, we obtained the information in CARPET prognostic model including time of septic shock, albumin, bilirubin, PaO2/FiO2, lactate, and GFR. We calculated the CARPET risk score and the 28-day mortality probability according to CARPET logistic regression model.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28-day mortality | Dead or alive at day 28 after septic shock diagnosis | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU length of stay | Days in the ICU after septic shock diagnosis | up to 1 year | 
| 90-day mortality | Dead or alive at day 90 after septic shock diagnosis | 90 days | 
| Time on ventilator | Days in need of mechanical ventilation | up to 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
septic shock, prognostic model, allogeneic hematopoietic stem cell transplant
Caries Risk Assessment in Egyptian Children in Mixed Dentition Stage

Study Overview
=================
Brief Summary
-----------------
This study aim to assess the validity of ADA caries risk assessment tool on the Egyptian Children in mixed dentition stage .

Detailed Description
-----------------
Dental caries is the most common chronic disease of childhood that causes health problems such as pain and infection in children reducing their quality of life. Risk for caries includes physical, biological, environmental, behavioral, and lifestyle-related factors as insufficient fluoride exposure, poor oral hygiene,inappropriate methods of feeding infants, and poorness . Risk is a probability that an event will occur. Caries Risk Assessment (CRA) is prediction of future caries based on the diagnosis of current disease by evaluation of risk and protective factors for making evidence-based clinical decisions. Individual risk assessment constitutes the cornerstone of the treatment plan for the management of early childhood caries for pediatric patients. Caries risk assessment should be included in the treatment plan to facilitate The decision-making process concerning preventive care (both home and office) treatment, recall appointments. An ideal risk assessment model should be inexpensive, easy to use and time efficient with a high degree of accuracy in caries predictive value. American Dental Association (ADA) is a tool for caries risk assessment and Management , that when modified to meet the needs of an environment Will be of tremendous use in caries risk assessment. The ADA's mission is to help dentists succeed and support the advancement of the health of the public.

Official Title
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Caries Risk Assessment Using ADA Tool Among A Group of Egyptian Children in Mixed Dentition Stage : A Cross-Sectional Study

Conditions
-----------------
Caries Risk Assesment

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children age range from 6 to 12 years. Apparently healthy children. Children affected by dental caries. Parents acceptance for their children's participation in the study. Exclusion Criteria: Children on long-term medication.

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

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 |
| --- | --- | --- |
| Caries Risk Assessment using ADA | Measurement Method Questions Measurement Method :Questions | one year |
The Effects of Mesenchymal Stem Cell Secretome in Lupus Patients

Study Overview
=================
Brief Summary
-----------------
This research is a clinical trial of administering mesenchymal stem cell secretome to lupus patients.

Detailed Description
-----------------
This research is experimental. The study was conducted on 30 SLE patient subjects. the treatment group who got the mesenchymal stem cell secretome on the 1st, 2nd day, 3rd, 4th, 5th, 6th, 7th, 14th, 21st, and 28th days. ESR, hs-CRP, C3, C4, interlukin 6, anti-ds-DNA antibody, MEX SLEDAI score, and assessment of drug side effects before and after therapy were collected. Statistical test with paired difference test with p < 0.05

Official Title
-----------------
The Effects of Mesenchymal Stem Cell Secretome in Lupus Patients

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

Intervention / Treatment
-----------------
* Drug: Secretome
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Lupus paatients Exclusion Criteria: Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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
Interventional Model Description: This study was divided into two groups, namely, control and treatment. Both received intervention in the form of a 1.5 cc injection on the scheduled day
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Messenchymal stem cell secretome<br>The hypoxic mesenchymal stem cell secretome has been developed up to chapter 7, stored at -196 C to -135 C in cryopreservation, and has passed quality tests. | Drug: Secretome<br>* Mesenchymal stem cell secretome obtained from Kalbe Pharma Company<br>* Other names: Messenchymal stem cell Concitioned Media;|
| Placebo Comparator: Placebo<br>Nacl 0,9% infusion | Drug: Placebo<br>* NaCl 0,9% infusion<br>* Other names: NaCl 0,9% infusion;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lupus Disease activity | The data collected were MEX SLEDAI score (range 0-32) before and after therapy. | Change of Lupus Disease Activity at 1 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Messenchymal Stem Cell Secretome, Lupus