linjc16/ctgov huggingface dataset:
Misoprostol Before and After Cesarean Section

Study Overview
=================
Brief Summary
-----------------
comparison of the effect of misoprostol before and after cesarean on the blood loss

Detailed Description
-----------------
70 women who received 600 mg misoprostol rectally preoperatively versus 70 women who received 600 mg misoprostol postoperatively at operating theatre

Official Title
-----------------
The Effect of Misoprostol Given Preoperative Versus Postoperative on Blood Loss With Elective Cesarean Section: Randomized Controlled Trial

Conditions
-----------------
Post Partum Hemorrhage

Intervention / Treatment
-----------------
* Drug: rectal misoprostol 600mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women not in active labor have reactive non-stress test. No contraindications to prostaglandins. Have no history of coagulopathy. Exclusion Criteria: Placenta previa. Maternal hypertension. Diabetes mellitus. Previous CS and those with active labor. Multiple Fibroid uterus. Multiple pregnancies or polyhydramnios. Previous myomectomy, previous history of PPH.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: preoperative misoprostol group<br>70 women who received 600 mg misoprostol rectally preoperatively before cesarean section | Drug: rectal misoprostol 600mg<br>* 70 women who received 600 mg misoprostol postoperatively at operating theatre<br>|
| Active Comparator: postoperative misoprostol group<br>70 women who received 600 mg misoprostol postoperatively at operating theatre after cesarean section | Drug: rectal misoprostol 600mg<br>* 70 women who received 600 mg misoprostol postoperatively at operating theatre<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraoperative blood loss | Difference in weight of linen towels (gm)+Volume of contents of suction bottle (ml) | the operation time | 
| postoperative blood loss | weighing the soaked napkins after collection of soaked towel | every 6 hours during first 24 hours. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
misoprostol, postpartum haemorrhage
A Multicenter, Prospective, Randomized, Double-Blind Clinical Trial Comparing Itraconazole Oral Solution in Cyclodextrin to Placebo in the Treatment of Aspergilloma

Study Overview
=================
Brief Summary
-----------------
To compare the safety and effectiveness of itraconazole oral solution to placebo in the treatment of a pulmonary aspergilloma. Aspergilloma is a fungal ball in the lungs caused by Aspergillus. The infection can spread from the lungs through the blood to other organs. Aspergilloma can be life-threatening; therefore, an effective treatment is needed.

Detailed Description
-----------------
Patients are randomly selected to receive itraconazole oral solution by mouth or the inactive placebo (oral cyclodextrin solution) twice daily for 12 months.

Official Title
-----------------
A Multicenter, Prospective, Randomized, Double-Blind Clinical Trial Comparing Itraconazole Oral Solution in Cyclodextrin to Placebo in the Treatment of Aspergilloma

Conditions
-----------------
Aspergillosis, Lung Diseases, Fungal

Intervention / Treatment
-----------------
* Drug: Itraconazole oral solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: You may be eligible for this study if you: Are 18 years of age or older. Have been diagnosed with aspergilloma within the last month. Have (or have a history of) at least one of the following: positive test for Aspergillus species. presence of antibodies to Aspergillus. Are willing to participate in the study for 2 full years. Are female and not pregnant. Are not breast-feeding. Agree to use barrier methods of birth control / contraception during the study and for 30 days after. Exclusion Criteria: You will not be eligible for this study if you: Have a history of allergy to triazole or imidazole drugs. Are unable to take oral medication. Are not expected to live for more than a month. Have had a lung biopsy indicating Aspergillus infection. Have had radiation therapy within the last 6 months. Require treatment with certain medications. Received amphotericin, amphotericin lipid formulation, fluconazole, or itraconazole in the two weeks prior to study entry. Received chemotherapy within the last 6 months.

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: Treatment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Itraconazole oral solution|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
[S,S]-Reboxetine Dose-Range Finding Trial

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effectiveness of different doses of [S,S]-Reboxetine in the treatment of chronic pain following a shingles infection

Official Title
-----------------
[S,S]-Reboxetine Dose-Range Finding Trial: A 16-Week, Randomized, Double-Blind, Placebo And An Active Comparator Controlled, Multi-Center Trial Of [S,S]-Reboxetine In Patients With Postherpetic Neuralgia (PHN)

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: [S,S]-Reboxetine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have pain present for more than 3 months after the healing of shingles skin rash Patients at screening must have a score >/=40 mm on the pain visual analogue scale Exclusion Criteria: Patients with significant renal and hepatic impairment Patients with other severe pain, that may impair the self-assessment of the pain due to shingles Patients with clinically abnormal electrocardiogram

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: [S,S]-Reboxetine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The numerical pain intensity rating scale is used to assess pain and a change from baseline in pain score for week 14 will be calculated |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - The mean endpoint (week 14) sleep interference score change from baseline - Analysis of the Medical Outcomes Study Sleep Scale - Analysis of the Patient Global Impression of Change - Analysis of the SF-36 Health Survey |  |  |
Multicenter Observational Study on Myocardial Iron Overload in 3 Multitransfused Populations

Study Overview
=================
Brief Summary
-----------------
The investigators' primary objective is to study prevalences of myocardial iron overload, defined as a cardiac T2*< 20 ms, in 3 populations of multiply transfused patients, affected with thalassemia, sickle cell disease, and myelodysplasia.

Detailed Description
-----------------
The inevestigators' primary objective is to study prevalences of myocardial iron overload, defined as a cardiac T2*< 20 ms, in 3 populations of multiply transfused patients, affected with thalassemia, sickle cell disease, and myelodysplasia. The investigators will record concomitantly parameters which, according to literature data, may influence the occurrence of this complication, and will look for correlations with these parameters and iron overload (secondary objectives), in each of the 3 cohorts. 14 centres are involved and enrol patients with thalassemia, or sickle cell disease, or myelodysplasia having received in the past year > 8 erythrocyte concentrates, and having had a cardiac MRI. Patients files register the type of the disease, age at the beginning of transfusion and chelation, chelator type and dosage, liver and cardiac T2*.

Official Title
-----------------
Multicenter Observational Study on Myocardial Iron Overload in 3 Multitransfused Populations

Conditions
-----------------
Thalassemia, Sickle Cell Disease, Myelodysplasia

Intervention / Treatment
-----------------
* Biological: Blood sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Thalassemia, sickle cell disease, myelodysplasia having received in the past year > 8 erythrocyte concentrates > 6 years of age Exclusion Criteria: preexisting cardiac disease

Ages Eligible for Study
-----------------
Minimum Age: 6 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 |
| --- | --- |
| thalassemia<br>patients affected with thalassemia | Biological: Blood sample<br>* a blood sample was taken on the day of inclusion<br>|
| sickle cell disease<br>patients affected with sickle cell disease | Biological: Blood sample<br>* a blood sample was taken on the day of inclusion<br>|
| myelodysplasia<br>patients affected with myelodysplasia | Biological: Blood sample<br>* a blood sample was taken on the day of inclusion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac T2* (MRI) |  | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver T2*(MRI) |  | Day 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Thalassemia, sickle cell disease, myelodysplasia, transfusion, chelation
B Cell Repertoires in Chronic Lymphocytic Leukemia and Aging

Study Overview
=================
Brief Summary
-----------------
B-CLL is the most prevalent leukemia in the Western hemisphere, accounting for  25% of all leukemia's (1). This disease occurs virtually exclusively in the aging population, with the median age of diagnosis ranging between the mid 60s and the early 70s. Indeed, its occurrence before the age of 50 is quite unusual. This increase in occurrence with age is not unique to B-CLL; rather, it is characteristic several B cell lymphoproliferative disorders (e.g., non-Hodgkin's lymphoma, multiple myeloma). Gender and race also influence the development of B-CLL. Thus, the ratio of men: women is  2:1 and the prevalence is increased in Caucasians. The rate of occurrence of B-CLL among Asians is significantly lower than for Caucasians and this does not increase with immigration to the West. DNA sequence analyses performed in our laboratory and in those of others indicate that B-CLL cells from unrelated patients share Ig V gene characteristics. These include the use of selected genes, the association of these genes with certain D and JH gene segments that code for unique CDR3 motifs, and the occasional occurrence of highly similar VHDJH + VLJL pairs. In  50% cases, these rearranged genes are mutated, whereas in the others mutations are infrequent; this difference is related to the VH gene family used by the B-CLL cell.

Official Title
-----------------
B Cell Repertoires in Chronic Lymphocytic Leukemia and Aging

Conditions
-----------------
Chronic Lymphocytic Leukemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age Patients must be willing to be contacted in the future Exclusion Criteria: Patients who are known to be anemic, with a hemoglobin <8 PAtients who are known to be infected with HIV

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

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 |
| --- | --- |
| Chronic Lymphocytic Leukemia<br>Chronic Lymphocytic Leukemia | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| expression of cell surface antigens HLA-DR and CD38+ markers in B-CLL cells compared to normal B-lymphocytes |  | samples will be taken at the beginning, week 2, 4,6,8,12,and 24 (for blood), and bone marrow samples at weeks 2 and 6. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Lymphocytic Leukemia
Effects of Silybum Marianum on Treatment of Patients With Chronic Hepatitis C

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effects of silymarin on outcomes of patients with hepatitis C.

Detailed Description
-----------------
Silymarin has been claimed to have a beneficial effect in various types of liver injury, including alcoholic liver disease, drug and toxin induced hepatotoxicity, and acute and chronic viral hepatitis.

Official Title
-----------------
Study of Silymarin for Improving Hepatitis C

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

Intervention / Treatment
-----------------
* Drug: Silymarin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: confirmed chronic hepatitis C (HCV Ab (+), HCV RNA (with PCR) (+)) normal or increased liver enzymes (ALT and AST) not using interferon or ribavirin due to patient sensitivity or not consenting. Exclusion Criteria: The pregnant patients patients with side effect which confirmed with rechallenge test
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Silymarin<br>Silymarin drived from Silybum marianum (milk thistle), a flowering member of the daisy family, may benefit liver function in people infected with the hepatitis C virus. | Drug: Silymarin<br>* Tab 210 mg, 630 mg, daily, six months.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum aminotransferases (ALT, AST) | The investigators measured serum amino transferases by commercial AST kit,. ALT kits(Bayer Diagnostics,. Tarrytown, NY, USA) at six months after silymarin admission | at six months after admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HCV-RNA | The investigators measured serum HCV-RNA by Polymerase Chain Reaction (PCR) at six months after silymarin admission | at six months after admission | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatitis C, Silymarin, Quality of life
Citrate Versus Heparin for the Lock of Non-tunneled Hemodialysis Catheters in Patients Hospitalised in ICU

Study Overview
=================
Brief Summary
-----------------
After obtaining written informed consent and inclusion, patients will be randomised into 2 groups for the type of dialysis catheter lock: The first group will have a citrate lock The second group will have a heparin lock Patients will be stratified according to the centre and type of Renal Replacement Therapy (RRT) continuous or intermittent. The daily surveillance of patients will not be different from the usual surveillance of patients on Renal Replacement Therapy. The hemodialysis catheters used will be specific Renal Replacement Therapy catheters. The decision to withdraw the catheter will be made by the investigator and based on clinical criteria (complications related to the catheter, termination of Renal Replacement Therapy…)

Official Title
-----------------
Citrate Versus Heparin for the Lock of Non-tunneled Hemodialysis Catheters in Patients Hospitalised in ICU = Multicentre, Controlled, Randomised Superiority Trial

Conditions
-----------------
Patients With Acute Renal Insufficiency

Intervention / Treatment
-----------------
* Drug: Citrate 4%
* Drug: unfractionated heparin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged > 18 years Requiring RRT for acute renal insufficiency For which a 1st non-tunneled catheter is placed In the jugular or femoral position After written informed consent has been obtained from the patient, a member of the family or a person of trust Exclusion Criteria: Patient presenting active poorly controlled bleeding Known allergy to citrate Acute liver failure (Prothrombin level <30%) Thrombopenia < 30 000/mm3 Known or suspected heparin-induced thrombopenia Known systemic bacterial infection at the time the catheter is placed catheter in the subclavicular position Persons not affiliated to a national health insurance scheme Pregnant women Adults under guardianship

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Heparin lock<br> | Drug: unfractionated heparin<br> <br> |
| Experimental: Citrate lock<br> | Drug: Citrate 4%<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of event-free survival of the first non-tunneled hemodialysis catheter (defined at the time in days from catheter insertion to withdrawal whatever the reason) |  | up to 28 days |
Probiotics Supplementation Effect on Glucose Homeostasis in Children With Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
Background: Probiotics influence immune homeostasis, through altering gut microbiota. The efficacy of probiotics in diabetes has been shown in preclinical settings as well as in human trials. Interleukin (IL)-21 and IL22 have been implicated in the pathogenesis of T1D. Objectives: to assess the effect of oral supplementation with probiotics on glycemic control as well as IL-21 and IL-22 levels in children with T1D. Methods: This randomized-controlled trial study included 70 children with T1D. Enrolled children aged 5-18 years with disease duration > 1 year. They were randomly assigned into two groups; intervention group (group A) who received oral probiotics containing Lactobacillus acidophilus La-14 (108 CFU) 0.5 mg once daily. The other group (group B) did not receive any supplementation and served as a control group. Both groups were followed-up for 6 months with assessment of fasting blood glucose (FBG), HbA1c, IL-21 and IL-22 levels.

Official Title
-----------------
The Effect of Probiotics Supplementation on Glucose Homeostasis, Lipid Profile and Interleukin (IL)-21 and IL-22 Levels in Children With Type 1 Diabetes: A Randomized Placebo-controlled Trial

Conditions
-----------------
Diabetes Mellitus, Type 1

Intervention / Treatment
-----------------
* Dietary Supplement: probiotics


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: T1D Exclusion Criteria: other types of DM

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 18 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 |
| --- | --- |
| Active Comparator: probiotics arm<br>probiotics administered in addition to insulin regimen | Dietary Supplement: probiotics<br>* probiotics administration<br>|
| No Intervention: control<br>regular insulin regimen | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glycemic control | HbA1C | 6 months |
Blinded Resection in Case of the Pancreatic Insulinoma

Study Overview
=================
Brief Summary
-----------------
The blinded resection avoided in case of pancreatic insulinoma

Detailed Description
-----------------
Despite of the technique and technology developement there are still a lot of troubles to verify small benign-looking pancreatic NETs. It can be especially important in case of insulinoma. The organic hyperilsulinism and severe hypoglicemia causeb by the insulin/proinsulin - producing lesion can lead to severe complications and evem death. There are some cases of the blinded resections of the pancreas in patients with the hidden insulinoma when the tumor can't be revealed during the preoperative diagnostics and intraoperatively. Unfortunately, blind resection do not solve the problem of the hypoglicemia but also cause the specific pancreatic complications.

Official Title
-----------------
Blinded Resection Avoided in Case of the Pancreatic Insulinoma

Conditions
-----------------
Insulinoma; Pancreas

Intervention / Treatment
-----------------
* Procedure: Pancreatic resection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The blinded resection of the insulinoma Exclusion Criteria: Other tumors
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Revealed insulinoma<br>Cases when the tumor was revealed by the preoperative diagnostics and confirmed after the tumor elimination | Procedure: Pancreatic resection<br>* Different pancreatic resections<br>|
| Hidden Insulioma<br>Group when the insulinoma haven't been revealed preoperative and intraoperatively and the blind resection was performed. | Procedure: Pancreatic resection<br>* Different pancreatic resections<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| No hidden insulinomas | To improve the diagnostics of the tumor before and during the surgery. The hidden insulinomas haven't been diagnosed. The frozen section have to be routinely performed. The surgery haven't been finished before the morphologic confirmation of the resected lesion. | 2010 June - 2020 June | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Insulinoma, Hypoglicemia, Blind resection, Hidden Insulinoma, ASVS