linjc16/ctgov huggingface dataset:
IFM 99-02 Thalidomide in Myeloma

Study Overview
=================
Brief Summary
-----------------
Principal objective is to evaluate the impact of Thalidomide to prolong the duration of response after autologous transplantation for myeloma

Conditions
-----------------
Multiple Myeloma

Intervention / Treatment
-----------------
* Drug: Thalidomide
* Drug: Biphosphonates


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: de novo myeloma according to Durie and Salmon classification stage II, III and stage I with a lytic bone lesion patients from 18 to 65 years old beta2microglobulin < 3 mg/l or del13 absent signed informed consent eligible for transplantation Exclusion Criteria: peripheral neurological toxicities uncontrolled or severe cardiovascular disease other malignancy except basocellular carcinoma or FIGO stage I carcinoma of the cervix patient who received biphosphonate during the last 60 days renal failure definited as creatinine > 150 µmol/l patient with obvious vascular cerebral medical history liver dysfunction definited as bilirubin > 35 µmol/l or ASAT, ALAT, PAL > 4N respiratory dysfunction HIV + Patient who refused to use an acceptable barrier method for contraception

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br>No specific intervention | |
| Active Comparator: 2<br>Biphosphonates | Drug: Biphosphonates<br>* Biphosphonates<br>|
| Experimental: 3<br>Thalidomide | Drug: Thalidomide<br>* Per os thalidomide<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of response |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  | 3 years | 
| Toxicity |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Myeloma, Autologous transplantation, Maintenance therapy, Thalidomide
Liraglutide in Adolescents With Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to study the effect of a liraglutide, a glucagon-like peptide agonist, on post-meal blood glucose concentrations, glucagon levels, mean weekly blood sugars, and insulin doses in adolescents with Type 1 diabetes. Type 1 diabetes is an autoimmune disease that is usually diagnosed before the age of 20. Individuals with this disease are completely dependent on insulin for survival. While significant advances have been made in technological support for improving diabetes control, insulin remains the only effective treatment for Type 1 diabetes. Liraglutide is a long-acting glucagon-like peptide-1 analog. This drug is approved for the treatment of Type 2 diabetes in adults. This study will test the effect of liraglutide on blood sugar control in adolescents with Type 1 diabetes.

Official Title
-----------------
Effect of Liraglutide on Glycemic Control, Glucagon Secretion and Inflammatory Markers in Adolescents With Type 1 Diabetes Mellitus

Conditions
-----------------
Type 1 Diabetes

Intervention / Treatment
-----------------
* Drug: Liraglutide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Type 1 Diabetes Mellitus greater than 1 year Insulin regimen - continuous subcutaneous insulin infusion with continuous glucose monitoring device HbA1c <10% Exclusion Criteria: Previous exposure to liraglutide History of abdominal surgery Gastrointestinal reflux disease History of acute or chronic pancreatitis History of alcohol abuse or unwillingness to abstain from alcohol during the study History of thyroid cancer Family history of Multiple Endocrine Neoplasia 2B syndrome Pregnant/breastfeeding females Individuals with antibody-negative insulin requiring diabetes that is consistent with Monogenic Diabetes of Youth Individuals with steroid induced or cystic fibrosis related diabetes

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 21 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: Liraglutide 0.6 mg<br>Liraglutide 0.6 mg daily injection x 7 days | Drug: Liraglutide<br>* Liraglutide 0.6 mg<br>* Other names: Victoza;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean weekly blood glucose | The primary outcome is to determine whether liraglutide decreases mean weekly blood glucose in adolescents with Type 1 diabetes | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Daily insulin dose | U/kg/day | 2 weeks |
Orthopaedic Implant Removal

Study Overview
=================
Brief Summary
-----------------
The necessity of orthopedic implant removal is under intense discussion and even if it is performed as an elective procedure, the risk of complications is present. Aim of the study is to identify parameters responsible for an increased risk of early post-operative complications after elective aseptic orthopedic implant removal.

Official Title
-----------------
High Early Post-operative Complication Rate After Elective Aseptic Orthopedic Implant Removal of Upper and Lower Limb

Conditions
-----------------
Implant Complication, Complication, Postoperative, Implant Site Infection

Intervention / Treatment
-----------------
* Procedure: Orthopaedic Implant Removal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective aseptic orthopaedic Implant removal Exclusion Criteria: Arthroplasty present infection
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Orthopaedic Implant Removal|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications after implant Removal |  | 4 weeks postoperatively |
Treatment of Hepatitis c by Using Direct-acting Antiviral

Study Overview
=================
Brief Summary
-----------------
Patients with hepatitis c showed increased level of oxidative stress. Increased level of serum lipid peroxidation leads to the production of toxic mediators as malondialdehyde (MDA) which lead to disease progression. Chronic stress shunt tryptophan which is essential amino acid toward kynurenic pathway leading to lower level of serotonin and melatonin level. Currently, direct-acting antivirals (DAAs) show well-established efficacy against hepatitis C virus (HCV).

Official Title
-----------------
Evaluation of the Effect of Direct-Acting Antiviral Agents on Melatonin Level in Chronic Hepatitis C Patients in Egypt.

Conditions
-----------------
Hepatitis C

Intervention / Treatment
-----------------
* Drug: Direct Acting Antivirals


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chronic hepatitis C patients had no other cause of liver disease Exclusion Criteria: Patients with hepatitis B virus (HBV). Patients with acute hepatitis. Patients with renal insufficiency. Patients with Hepatocellular carcinoma (HCC) or other types of malignancy. Patients on current use of melatonin. Patients using of any of medications that have interaction with melatonin. Patients work in night shifts. Patients are consuming a lot of caffeine or heavy smokers.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy voluntaries control group (Group 1)<br> | |
| sofosbuvir/daclatasvir treated group (group 2)<br> | Drug: Direct Acting Antivirals<br>* hepatitis C patients will be treated by direct acting antiviral drugs (DAAs)for 12 weeks.<br>|
| sofosbuvir /daclatasvir/ ribavirin treated group (group 3)<br> | Drug: Direct Acting Antivirals<br>* hepatitis C patients will be treated by direct acting antiviral drugs (DAAs)for 12 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in malondialdehyde (MDA) level. | Malondialdehyde (MDA) levels will be measured by the TBARS assay (thiobarbituric acid reactive substance assay) | 12 weeks following end of treatment. | 
| Change in melatonin level. | Melatonin will be measured by using immunological method. | 12 weeks following end of treatment. |
Acute Kidney Injury in Patients With Sickle Cell Disease

Study Overview
=================
Brief Summary
-----------------
Patients with sickle cell disease may be at risk for acute kidney injury (AKI)during sickle cell crisis (pain or acute chest syndrome). This study will evaluate the role of hemolysis during SCD crisis on the development of AKI and the role for monitoring urine biomarkers during an admission for crisis and during well clinic follow-up.

Detailed Description
-----------------
Patients admitted to the hospital for acute chest syndrome or vaso-occlusive pain events may consent to participate in this study. Patients will consent to daily blood and urine collection during their hospitalization and during well clinic visits. Each AM, participants will have blood and urine collected, processed, and strored for future analysis of hemolytic markers and biomarkers of kidney injury. Patients will also have strict urine output recorded. Acute kidney injury (AKI) will be defined by the current KDIGO definition based on either a rise in serum creatinine or decline in urine output. Patient medical course will be reviewed to determine interventions and outcomes of their admission based on the development of AKI.

Official Title
-----------------
Acute Kidney Injury in Patients With Sickle Cell Disease

Conditions
-----------------
Sickle Cell Disease, Kidney Injury, Kidney Diseases, Kidney Disease, Chronic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with HbSS or SB0 thalassemia admitted for vaso-occlusive pain crisis or acute chest syndrome Able to sign informed consent Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 25 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 |
| --- | --- | --- |
| Incidence of Acute Kidney Injury | Evaluate the incidence of KDIGO defined AKI among patients admitted for pain or acute chest syndrome. AKI is defined by KDIGO as an increase in SCr by 50% or ≥0.3mg/dL from baseline, or UOP <0.5mL/kg/hr for 12 hrs | Hospitalizations through study completion, an average of one year | 
| Impact of Acute Kidney Injury during Pain or Acute Chest Syndrome Hospitalizations on the Development of Chronic Kidney Disease as defined by KDIGO. | We will evaluate the impact of AKI on eGFR. To evaluate this impact, we will compare the change in eGFR, as measured by cystatin C, obtained from each patient during their non-acute clinic visit both immediately prior to their AKI events and after AKI events. | One year | 
| Impact of free heme and endothelin on development of AKI | We will test the hypothesis that free heme and endothelin are elevated in patients that develop AKI as compared to patients without AKI. | two years |
Combined tDCS+PNS After Acute Stroke

Study Overview
=================
Brief Summary
-----------------
Recent work showed that application of peripheral nerve and cortical stimulation independently can induce 10-15 % improvement in motor performance in patients with chronic stroke. The purpose of this study was to compare in post-stroke hemiplegic patients the effect on motor recovery of one session of anodal transcranial direct current stimulation to the ipsilesional primary motor cortex (M1) combined with a peripheral radial nerve electrical stimulation (rEPNS) to the paretic hand repeated 5 successive days with the effect of the same peripheral nerve stimulation combined with sham tDCS. Design: randomized, double-blind, parallel controlled clinical trial. Patients eligible for the study: Acute ischaemic stroke Primary outcome measure: Jebsen Taylor test Secondary outcome measures Nine peg hole test Hand tapping grip and wrist force Cortical excitability of Ipsilesional M1(TMS) Follow-up: 30 days

Official Title
-----------------
Effect of Combined Anodal tDCS and Peripheral Nerve Stimulation on Motor Recovery in Acute Stroke

Conditions
-----------------
Acute Ischaemic Stroke

Intervention / Treatment
-----------------
* Device: combined transcranial direct current stimulation and electrical peripheral nerve stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - first -ever ischemic stroke within 5-30 days a paresis of the arm/hand with NIHSS <15 age 35-85 years Exclusion Criteria: Pregnancy psychiatric disease patients with history of alcohol or drug abuse or severe depression patients with a severe language disturbances, particularly of receptive nature patients with increased intracranial pressure or serious cardiac disease patients with contraindication to TMS

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 85 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

| Intervention/Treatment |
| --- |
|Device: combined transcranial direct current stimulation and electrical peripheral nerve stimulation|tDCS: 1,2 mA 13 minutes rEPNS (radial nerve): 5 Hz, 0,7 x MT|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Jebsen Taylor test |  | 5-15-30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grip and wrist force Nine peg hole Cortical excitability ofIpsilesional M1 (TMS) |  | 5-15-30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stroke, rehabilitation, transcranial direct current stimulation, nerve stimulation
a Clinical Risk Score to Predict Bloody Stool in Neonates

Study Overview
=================
Brief Summary
-----------------
Bloody stool is a main focus in non-neonatal intensive care unit ward, and it is one of the risk factors in neonates with subsequent necrotizing enterocolitis(NEC) and usually lead to longed duration of hospitalization. NEC is one of the most serious disease in the newborn infants, and two and more grades of NEC might lead to surgery, even death. But, it is difficult to predict when the bloody stool comes and develop to two and more grades of NEC.

Detailed Description
-----------------
NEC is characterized by vomit, abdominal distention, hypoactive bowel sounds and bloody stools, even shock, disseminated intravascular coagulation(DIC) and sepsis. X-ray is shown Intestinal wall gas and/or portal vein pneumatosis and pneumoperitoneum. Bloody stool in newborn infant is a urgent condition, and neonatologist usually need to predict whether or not two and more grades of NEC it is. Here, the investigators will develop a score system in one retrospective cohort to predict bloody stool, and the score system is validated in another prospective cohort.

Official Title
-----------------
Development and Validation of a Clinical Risk Score to Predict the Occurrence of Bloody Stool in Hospitalized Neonates in Non-neonatal Intensive Care Unit

Conditions
-----------------
Bloody Stool, Necrotizing Enterocolitis

Intervention / Treatment
-----------------
* Other: bloody stool group
* Other: non-bloody stool group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: more than or equal to 35 weeks' gestational age(GA) less than or equal to 28 days non-neonatal intensive care unit ward Exclusion Criteria: parents' rejection main congenital malformation

Ages Eligible for Study
-----------------
Minimum Age: 1 Minute
Maximum Age: 28 Days

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| bloody stool group<br>bloody stool appear in the hospitalized neonate | Other: bloody stool group<br>* bloody stool appear in the hospitalized neonate<br>|
| non-bloody stool group<br>bloody stool do not appear in the hospitalized neonate | Other: non-bloody stool group<br>* bloody stool do not appear in the hospitalized neonate<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| a Clinical Risk Score | a Clinical Risk Score is developed in a retrospective cohort | up to 28 days or discharge from hospital | 
| validation of a Clinical Risk Score | a Clinical Risk Score is validation in another prospective cohort | up to 28 days or discharge from hospital |
Comparison Between Histidine-tryptophan-ketoglutarate Cardioplegia and Cold Blood Cardioplegia for Myocardial Protection for Fallot Tetralogy Patients Undergoing Total Repair

Study Overview
=================
Brief Summary
-----------------
Randomized clinical trial: comparison between Histidine-tryptophan-ketoglutarate cardioplegia and cold blood cardioplegia for myocardial protection for Fallot tetralogy patients undergoing total repair This study aims to compare HTK cardioplegic solution and cold blood cardioplegia to provide optimal myocardial protection for a patient with tetralogy of Fallot planned for total repair.

Official Title
-----------------
Randomized Clinical Trial: Comparison Between Histidine-tryptophan-ketoglutarate Cardioplegia and Cold Blood Cardioplegia for Myocardial Protection for Fallot Tetralogy Patients Undergoing Total Repair

Conditions
-----------------
Anesthesia

Intervention / Treatment
-----------------
* Drug: HTK cardioplegia
* Drug: Cold Cadioplegia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric patients with tetralogy of Fallot spectrum. Sex (males and females) Age 6 months- 5 years. Exclusion Criteria: Persistent left SVC draining in the coronary sinus. Mental or neurologic disorders. Preoperative critically ill patients. Parents or legal guardian refusal. Fallot repair with transannular patch( as it will affect on the RV function as a single agent after reperfusion)

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 5 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 |
| --- | --- |
| Active Comparator: Group A (HTK cardioplegia)<br>will receive HTK cardioplegia in volume 30 ml/Kg given by antegrade route through an aortic route cannula. | Drug: HTK cardioplegia<br>* will receive HTK cardioplegia in volume 30 ml/Kg given by antegrade route through an aortic route cannula.<br>|
| Active Comparator: Group B ( Cold Cardioplegia)<br>will receive group cold Blood Cardioplegia in volume 20mL/kg given by antegrade route through an aortic route cannula and repeated 10mL/kg/dose every 25minutes at 8-12°C for maintenance. This technique considered the standard management in this age. | Drug: Cold Cadioplegia<br>* as the will receive group cold Blood Cardioplegia in volume 20mL/kg given by antegrade route through an aortic route cannula and repeated 10mL/kg/dose every 25minutes at 8-12°C for maintenance. This technique considered the standard management in this age.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • Vasoactive-Inotropic Score | Calculate the doses of vasoactive drugs used | From time of separation of cardioplumonary bypass till 24 hours post operative |