linjc16/ctgov huggingface dataset:
A Study to Assess SOM230 in Patients With Pituitary Cushing's Disease

Study Overview
=================
Brief Summary
-----------------
The study treatment period is 15 days in length and includes patients with pituitary Cushing's disease who are candidates for surgical intervention as well as and patients who have recurrent Cushing's post operatively.

Official Title
-----------------
A Multicenter, Open Label Study to Assess the Safety and Efficacy of 600 µg SOM230, Administered Subcutaneously, b.i.d. in Patients With Cushing's Disease

Conditions
-----------------
Cushing's Syndrome

Intervention / Treatment
-----------------
* Drug: SOM230 s.c.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with pituitary Cushing's disease within the two months prior to study entry Patients for whom written informed consent to participate in the study has been obtained Female patients of child bearing potential who have not undergone clinically documented total hysterectomy and/or ovariectomy, or tubal ligation must agree to use barrier contraception throughout the course of the study, and for one month after the study has ended Exclusion Criteria: Female patients who are pregnant or lactating Patients who have been previously treated with certain medications may be required to be without certain medications prior to entering the study Poorly controlled diabetes mellitus as indicated by the presence of ketoacidosis or HgbA1C > 10 Patients who have congestive heart failure, unstable angina, cardiac arrhythmia or history of acute MI less than one year prior to the study entry or clinically significant impairment in cardiovascular function (e.g. blood pressure of 190/100mmHg or greater) Patients with chronic liver disease Patients with clotting disorders or abnormal blood counts History of immuno-compromise, including a positive HIV test result Patients with active gall bladder disease Patients who have participated in any clinical investigation with an investigational drug within 1 month prior to dosing Patients with active malignant disease (with the exception of basal cell carcinoma or carcinoma in situ of the cervix)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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

| Intervention/Treatment |
| --- |
|Drug: SOM230 s.c.|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary Free Cortisol after 15 days of treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum cortisol |  |  | 
| ACTH |  |  | 
| Clinical manifestations |  |  | 
| Pharmacokinetics |  |  | 
| Safety |  |  | 
| Tolerability |  |  | 
| Development of biomarkers |  |  |
Renal Magnetic Resonance (MR) Elastography in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
MR Elastography is a new technique aimed at non-invasively measuring the stiffness of tissues. It has recently given interesting results in the assessment of liver fibrosis. The objectives of the current study are: to develop an imaging protocol for MR Elastography of the kidneys; To calculate the stiffness of normal kidneys; To evaluate the variability of the measurements of kidney stiffness by repeating the procedure twice on the same volunteers.

Official Title
-----------------
Renal MR Elastography: Normal Findings and Variability of Stiffness Measurements

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Device: Pneumatic Driver


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 18 and 40 Signed informed consent form Insured by the French Social Security Exclusion Criteria: Pregnancy Personal or familial history of kidney disease Hypertension Diabetes Contraindication to MRI

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Pneumatic Driver|Ten healthy volunteers will undergo MR Elastography using a pneumatic driver connected to a commercially available speaker and the stiffness of the left kidney will be measured. The examination will be repeated on the same volunteers at least one month later and the same stiffness measurements will be performed.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Normal kidney stiffness (measured from MRE data) |  | 2 months | 
| Variability of stiffness measurement (on repeat examination) |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerance of the procedure |  | 2 months | 
| Percentage of partial and total technical failures |  | 2 months | 
| Quality criteria of stiffness measurements (area of the ROIs used for measurement, mean induced displacement measured in the ROIs) |  | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MR Elastography, kidney, fibrosis
Post Authorisation Safety Study of Renvela® in Chronic Kidney Disease Patients Not on Dialysis With Hyperphosphataemia

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to assess in a post-approval clinical setting the safety profile of sevelamer carbonate (Renvela®) tablets and powder in adult hyperphosphataemic chronic kidney disease (CKD) patients not on dialysis with serum phosphorus ≥1.78 mmol/L. Patients will be treated in accordance with the Renvela® Summary of Product Characteristics (SmPC) and followed according to the investigator's standard clinical practice management. Each patient will be followed up for 12 months or up to the time they start dialysis, whichever occurs first.

Official Title
-----------------
Renvela® Post-Marketing Observational Study to Monitor the Clinical Use in Adult Hyperphosphataemic Chronic Kidney Disease Patients Not On Dialysis With Serum Phosphorus ≥1.78 mmol/L

Conditions
-----------------
Hyperphosphataemia, Chronic Kidney Disease

Intervention / Treatment
-----------------
* Drug: sevelamer carbonate (Renvela®)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult Chronic Kidney Disease (CKD) patients not on dialysis with serum phosphorus ≥ 1.78 mmol/L. Prescribed Renvela (800 mg tablets or 2.4 g powder for oral suspension) in accordance with the Renvela SmPC. Provide signed informed consent (patient or their legally authorised representative) Exclusion Criteria: N/A

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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: sevelamer carbonate (Renvela®)|800 mg tablets or 2.4 g powder for oral suspension should be administered as instructed in the Renvela® SmPC.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of non-serious and Serious Adverse Drug Reaction (ADRs) | Assess safety profile of Renvela tablets and powder | 12 Months |
Intravenous Lidocaine and Acute Rehabilitation

Study Overview
=================
Brief Summary
-----------------
Background: Intravenous infusion of lidocaine may decrease postoperative pain and speed return of bowel function. The investigators therefore tested the hypothesis that including perioperative lidocaine infusion improves recovery from laparoscopic colectomy and shortens the duration of hospitalization. Methods: Forty patients scheduled for laparoscopic colectomy were randomly allocated to receive intravenous lidocaine (bolus injection of 1.5 mg.kg-1 lidocaine at induction of anesthesia, then a continuous infusion of 2 mg.kg-1.h-1 intraoperatively and 1.33 mg.kg-1.h-1 for 24 h postoperatively) or an equal volume of saline. All patients received similar intensive postoperative rehabilitation. Postoperative pain scores, opioid consumption, and fatigue scores were measured. Times to first flatus, defecation, and hospital discharge were recorded. Postoperative endocrine (cortisol and catecholamines) and metabolic (leucocytes, C-reactive protein, and glucose) responses were measured for 48 h. Data (median [25%-75% interquartile range] Saline vs Lidocaine groups) were analyzed using Mann-Whitney tests. P<0.05 was considered statistically significant.

Official Title
-----------------
Intravenous Lidocaine Infusion Improves Outcome After Laparoscopic Colectomy

Conditions
-----------------
Pain, Postoperative, Postoperative Fatigue, Opioid Consumption, Postoperative

Intervention / Treatment
-----------------
* Drug: lidocaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I-III non-malignant disease Exclusion Criteria: greater than 70 years history of gastro-duodenal peptic ulcer or renal failure (contraindications to the use of nonsteroidal anti-inflammatory drug) hepatic insufficiency psychiatric disorder steroid treatment chronic treatment with opioid

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: lidocaine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sevoflurane consumption |  |  | 
| Pain scores |  |  | 
| abdominal comfort |  |  | 
| fatigue scores |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bowel function |  |  | 
| hospital stay |  |  | 
| endocrine and metabolic responses |  |  |
A Study to Compare Two Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Previously Received Anti-HIV Treatment

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the safety and effectiveness of 2 anti-HIV drug combinations in HIV-infected patients. Both combinations will include nevirapine (NVP), 2 nucleoside reverse transcriptase inhibitors (NRTIs), and at least 1 protease inhibitor (PI). One combination will include a new protease inhibitor, ABT-378, combined in a capsule with ritonavir (RTV).

Detailed Description
-----------------
Patients receive 1 of the following: ABT-378/RTV plus NVP plus 2 NRTIs; or Investigator-selected PI(s) plus NVP plus 2 NRTIs.

Official Title
-----------------
A Randomized, Open-Label, Phase III Study of ABT-378/Ritonavir in Combination With Nevirapine and Two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) vs. Investigator Selected Protease Inhibitor(s) in Combination With Nevirapine and Two NRTIs in Antiretroviral-Experienced HIV-Infected Subjects

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Lopinavir/Ritonavir
* Drug: Nevirapine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients may be eligible for this study if they: Are at least 12 years old. Are HIV-positive and have a viral load (level of HIV in the blood) of 1,000 - 100,000 copies/ml. Are currently taking an anti-HIV drug combination that includes 1 PI and 2 NRTIs, and that has not been changed in at least 12 weeks. Are naive to (have never taken) at least 1 NRTI, other than zalcitabine or abacavir. Agree to abstinence or use of an effective barrier method (e.g., condom) of birth control. Exclusion Criteria Patients will not be eligible for this study if they: Have an active illness. Have received treatment for any active opportunistic (AIDS-related) infection within 30 days of study entry. Have ever received a nonnucleoside reverse transcriptase inhibitor (NNRTI). Have received investigational (not yet approved by the FDA) drugs within 30 days of study entry. Have received treatment with a PI other than their current PI. Are receiving chemotherapy for cancer. Are pregnant or breast-feeding.

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

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Lopinavir/Ritonavir|nan|
|Drug: Nevirapine|nan|

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
-----------------
Drug Therapy, Combination, Nevirapine, HIV Protease Inhibitors, Ritonavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents, ABT 378
Study to Compare the Safety and Pharmacokinetic Characteristics of LBEC0101 25mg With Those of Enbrel®

Study Overview
=================
Brief Summary
-----------------
To compare the pharmacokinetic characteristic of LBEC0101 25mg with active comparator, Enbrel® 25mg.

Official Title
-----------------
A Randomized, Double-blind, Single-dosing, 2-way Cross-over Study to Compate the Safety and Pharmacokinetic Characteristics of LBEC0101(Etanercept) 25mg With Those of Enbrel® 25mg After Subcutaneous Injection in Healthy Male Volunteers

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: LBEC0101 (Etanercept 25mg)
* Drug: Enbrel (Etanercept 25mg)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy males, 20 to 45 years of age the moment of screening Body mass index is between 18.0 and 30.0 kg/m Exclusion Criteria: The tuberculosis patient of latent tuberculosis patient Hypersensitivity response to the test and comparator drugs

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Enbrel, LBEC0101 | Drug: LBEC0101 (Etanercept 25mg)<br> <br> Drug: Enbrel (Etanercept 25mg)<br> <br> |
| Experimental: Group 2<br>LBEC0101, Enbrel | Drug: LBEC0101 (Etanercept 25mg)<br> <br> Drug: Enbrel (Etanercept 25mg)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Phase 3 Study to Evaluate IOP Lowering Therapy in Open Angle Glaucoma and Ocular Hypertension C-01-70

Study Overview
=================
Brief Summary
-----------------
To compare intraocular pressure lowering effectiveness of a combination drug vs. two individual drugs dosed alone.

Official Title
-----------------
Phase III Safety and Efficacy Study to Evaluate Combination IOP Lowering Therapy in Open Angle Glaucoma and Ocular Hypertensive Patients C-01-70.

Conditions
-----------------
Open-Angle Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: Alcon Investigational Agent


Participation Criteria
=================
Eligibility Criteria
-----------------
Adult subjects of either sex and any race with open-angle glaucoma or ocular hypertension; visual acuity of 20/80 to 20/400 or better (Snellen equivalent) or logMAR visual acuity not worse than 0.6. Clinically relevant ophthalmic or systemic conditions may be excluded.

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: Alcon Investigational Agent|nan|

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
-----------------
open-angle, glaucoma, ocular, hypertension, POAG
Feasibility of Risk-Adapted Therapy in Young Adult Acute Lymphoblastic Leukemia: a Multicenter Trial

Study Overview
=================
Brief Summary
-----------------
Several prognostic predictors, including baseline ALL features and response to initial therapy, have been described in adult ALL raising the issue of whether these predictors might be redundant and which must be considered for treatment stratification. In the GRAALL-2003 prospective Phase 2 study, we aim to hierarchize the following high-risk factors in Ph-negative ALL patients.

Detailed Description
-----------------
1) baseline (BL) : WBC30G/L in B-lineage, CNS involvement, MLL-AF4 and E2A-PBX fusions, haploidy/near-triploidy; 2) early response (ER) : corticoresistance after prophase (CsR), chemoresistance at Day 8 (ChR); all CsR and/or ChR patients are planned to receive higher doses of cyclophosphamide (HyperC) at Day 15 of induction; 3) induction response (IR) : no CR or Ig-TCR minimal residual disease (MRD) 10-2 after standard or HyperC induction. Allogeneic stem cell transplantation is proposed to patients with a donor and at least one BL, ER, or IR factor.

Official Title
-----------------
GRAALL 2003 Trial (ALL 15-59 Years). Feasibility of Risk-Adapted Therapy in Young Adult Acute Lymphoblastic Leukemia: a Multicenter Trial

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

Intervention / Treatment
-----------------
* Procedure: Collection of treatment-stratefying prognostic factors


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 15-59 years acute lymphoblastic leukemia newly diagnosed signed written informed consent Exclusion Criteria: Lymphoblastic lymphoma Acute lymphoblastic leukemia 3 Chronic Myeloid Leukemia acutisation Sever organ condition

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 59 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Collection of treatment-stratefying prognostic factors|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hierarchical evaluation of baseline poor-prognosis factors and response to initial therapy in younger adults with ALL |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hematologic and non hematologic toxicity of induction, consolidation and late intensification. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute lymphoblastic leukemia, adult patient, chemotherapy, stem cell transplantation, Young adult patients
Sevoflurane Protective Effect on Ischemia Reperfusion Injury in Microvascular Surgery

Study Overview
=================
Brief Summary
-----------------
This study aimed to evaluate the possible protective effect of anesthetic technique balanced (BAL) compared to total intravenous anesthetic technique (TIVA-TCI) in ischemia reperfusion injury in microvascular flap in plastic surgery. The investigators will evaluate the viability of the flap using tissue oximetry monitoring and the level of biochemical markers in a circle at the end of the intervention.

Conditions
-----------------
Microvascular Breast Flap in Plastic Surgery

Intervention / Treatment
-----------------
* Drug: Sevoflurane
* Drug: Diprivan + Remifentanil TCI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 18 yr ASA (American Society of Anesthesiology) I-II Exclusion Criteria: Known unusual reaction to anesthetic drugs Evaluation of anesthesia increased risk for malignant hyperthermia. History of vascular disease. History of bleeding diathesis. Tabagism

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Experimental: Bilanced group<br>Sevofluorane adjusted to obtain an Et-Sevo of 1.8-2%, for all the time of the surgical procedure. Remifentanyl TCI adjusted according to protocol to maintain the range of 1-3 ng / ml. | Drug: Sevoflurane<br> <br> |
| Active Comparator: TCI group<br>Propofol 3-4 mg / ml and remifentanyl 1-3 ng / ml according to protocol TCI | Drug: Diprivan + Remifentanil TCI<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tissutal oximetry average value of the flap measured with INVOS (In Vivo Optical Spectroscopy) system continuously. |  | 24 hours from the end of intervention |