linjc16/ctgov huggingface dataset:
Taxane Induced Peripheral Neuropathy in Chinese Patients With Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect clinical data, blood samples, and self reported symptoms of peripheral neuropathy from Chinese patients with breast cancer after treatment with taxanes. This data will be used to develop predictive markers for neuropathy.

Official Title
-----------------
Taxane Induced Peripheral Neuropathy in Chinese Patients With Breast Cancer

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Other: Patient Questionnaires
* Other: Blood Collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of breast cancer Females aged 16 and older Planning to receive or previous treated with taxanes Exclusion Criteria: Poorly controlled or insulin-dependent diabetes or other condition likely to predispose to neurotoxicity

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with CIPN<br>Patients with peripheral neuropathy after treatment with taxanes | Other: Patient Questionnaires<br>* FACT-Ntx, EORTC-CIPN20<br>Other: Blood Collection<br>* biomarker analysis<br>|
| Patients without CIPN<br>Patients treated with taxanes and don't develop will be enrolled to this cohort and matched to a specified subject with neurotoxicity based on age, tumor stage, chemotherapy regimen or total taxane dosage | Other: Patient Questionnaires<br>* FACT-Ntx, EORTC-CIPN20<br>Other: Blood Collection<br>* biomarker analysis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total score from the FACT-GOG-Ntx questionnaire | Total score from the FACT-GOG-Ntx questionnaire for peripheral neuropathy, ranging from 0-44,higher value represents a worse outcome | Up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictive value of genetic variants for the development of neuropathy | SNPs related to peripheral neuropathy | In the two weeks before start treatment | 
| Total score from the EORTC QLQ - CIPN20 questionnaire | Total score from the EORTC QLQ - CIPN20 questionnaire for peripheral neuropathy, ranging from 20-80,higher value represents a worse outcome | Up to 2 years |
Cisplatin With Gemcitabine With Dexamethasone in Patients With Aggressive Non-Hodgkin's Lymphoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study it to evaluate efficacy of gemcitabine with cisplatin and dexamethasone in patients with aggressive non-Hodgkin's lymphoma who have previously progressed on first line of chemotherapy with anthracyclines.

Official Title
-----------------
Phase II Study of Cisplatin With Gemcitabine in Fixed Dose Rate Infusion and Dexamethasone in Second-Line in Patients With Aggressive Non-Hodgkin's Lymphoma

Conditions
-----------------
Non-Hodgkin's Lymphoma

Intervention / Treatment
-----------------
* Drug: gemcitabine
* Drug: cisplatin
* Drug: dexamethasone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patients must have a histological diagnosis of aggressive non-Hodgkin's lymphoma including the following sub-categories of the WHO classification: Diffuse large B-cell lymphoma and its variants (immunoblastic, Burkitt-like, sclerosis of mediastinum, large B-cell MALT, rich in T-cells and anaplastic B-cell lymphoma) Peripheral T-cell lymphoma Anaplastic lymphoma of large T-cells /null cells Patients are eligible if they have documented evidence of progression after prior first-line chemotherapy containing anthracyclines associated or not with Rituximab. Patients with refractory disease to first line of treatment are also eligible. ECOG PS (performance status) less than or equal to 2 Presence of bidimensionally measurable disease in accordance with WHO criteria. Exclusion Criteria: Involvement of the CNS. Any medical condition which contraindicates the degree of hydration required for the safe use of cisplatin. Intermediate degree lymphoma derived from the malignant transformation of a previous low-grade lymphoma. Active infection (in the opinion of the investigator).

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: gemcitabine|nan|
|Drug: cisplatin|nan|
|Drug: dexamethasone|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate response rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess toxicity |  |  | 
| Overall survival |  |  | 
| Event-free survival |  |  | 
| Progression - free survival |  |  | 
| Disease - free survival |  |  | 
| Duration of response |  |  |
Ischemic Memory Imaging With Myocardial Contrast Echocardiography

Study Overview
=================
Brief Summary
-----------------
The overall aim of this study is to determine whether non-invasive imaging with myocardial contrast echocardiography using can provide information on the presence and spatial extent of recent myocardial ischemia by non-invasive echocardiographic imaging.

Official Title
-----------------
Ischemic Memory Imaging With MCE

Conditions
-----------------
Myocardial Ischemia

Intervention / Treatment
-----------------
* Drug: Sonazoid


Participation Criteria
=================
Eligibility Criteria
-----------------
NORMAL CONTROL GROUP Inclusion Criteria: Normal control individuals Exclusion Criteria: History of cardiovascular disease (coronary artery disease, MI, peripheral artery disease) allergy to eggs or ultrasound contrast agents known or detected right to left shunt presence of a wall motion abnormality pregnancy ACS GROUP Inclusion Criteria: Patients with diagnosis of acute coronary syndrome with either unstable angina or non-ST-elevation MI Referred for primary percutaneous intervention At least 1 high risk features (ST changes, positive troponin, wall motion abnormality) Exclusion Criteria: allergy to eggs or ultrasound contrast agents hemodynamic instability or shock known or detected right to left shunt pregnancy multivessel CAD requiring multivessel PCI

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 90 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Normal controls<br>Normal controls who will undergo dose-ranging studies to determine the optimal dose of phosphatidylserine-containing microbubbles that does not produce delayed myocardial opacification on myocardial contrast echocardiography (MCE). | Drug: Sonazoid<br>* Myocardial contrast echocardiography ischemic memory imaging using intravenous administration of Sonazoid<br>|
| Experimental: Patients with ACS<br>Subjects with ACS who have undergone primary percutaneous intervention in whom MCE with phosphatidylserine-containing microbubbles will be performed to determine whether the risk area can be detected and spatially defined. | Drug: Sonazoid<br>* Myocardial contrast echocardiography ischemic memory imaging using intravenous administration of Sonazoid<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose optimization | Dose ranging in normal controls to define highest dose of ultrasound contrast agent that does not produce delayed opacification from myocardial retention | 3 months | 
| Detection of Ischemia |  | 1 year |
A Phase 1 Antiretroviral Drug-Drug Interaction Study in Healthy Volunteers (DDI)

Study Overview
=================
Brief Summary
-----------------
This is an open-label, single sequence, 2-cohort, drug-drug interaction study in healthy male and female subjects. There is no formal hypothesis, however, it is expected that the coadministration of BMS-663068 with darunavir (DRV)/cobicistat (COBI) or COBI will increase the systemic exposure of BMS-626529.

Official Title
-----------------
Open-Label, Single-Sequence, Two-Cohort Study to Evaluate the Effect of Darunavir/Cobicistat and Cobicistat on BMS-626529 in Healthy Subjects

Conditions
-----------------
Infection, Human Immunodeficiency Virus

Intervention / Treatment
-----------------
* Drug: BMS-663068
* Drug: Darunavir
* Drug: Cobicistat


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and female Nonsmoking subjects Ages 18 to 50 years Inclusive with a body mass index of 18.0 to 32.0 kg/m2, inclusive Women of childbearing potential Must agree to follow instructions for methods of contraception for the duration of the study plus 34 days post-treatment completion Exclusion Criteria: Any history of acute or chronic medical and surgical illness. Personal of family history of hemophilia A or B Other protocol defined exclusion criteria could apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1, Treatment A, B<br>Treatment A: BMS-663068 orally twice daily (BID) on Days 1 through 4 Treatment B: BMS-663068 orally BID plus DRV/COBI orally once daily (QD) on Days 5 through 14 | Drug: BMS-663068<br>* BMS-663068<br>Drug: Darunavir<br>* Darunavir<br>Drug: Cobicistat<br>* Cobicistat<br>|
| Experimental: Cohort 2, Treatment C, D<br>Treatment C: BMS-663068 orally BID on Days 1 through 4 Treatment D: BMS-663068 orally BID plus COBI QD on Days 5 through 14 | Drug: BMS-663068<br>* BMS-663068<br>Drug: Cobicistat<br>* Cobicistat<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameters (maximum observed plasma concentration and area under the concentration-time curve in 1 dosing interval) for BMS-626529 | In the presence or absence of multiple doses of DRV/COBI or COBI | predose and up to 12 hours post dose on Days 4 and 14 |
Performance of Cimetidine-corrected MDRD Equation in Renal Transplant Patients

Study Overview
=================
Brief Summary
-----------------
Among the different creatinine-based GFR predicting equations, the MDRD equation gives the best prediction in renal transplantation but does not provide the level of accuracy usually seen in renal patients with native kidneys. Blocking the tubular secretion of creatinine with an oral administration of cimetidine is likely to make creatinine a more accurate marker of GFR. We will test the hypothesis that the accuracy of the MDRD equation will be improved in renal transplant patients by incorporating into the equation a cimetidine-corrected serum creatinine value.

Official Title
-----------------
Performance of Cimetidine-corrected MDRD Equation in Renal Transplant Patients

Conditions
-----------------
Kidney Transplantation

Intervention / Treatment
-----------------
* Drug: cimetidine arrow


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Kidney transplantation > 1 year Patient with immunosuppressant treatment of TACROLIMUS (PROGRAF) Creatinine clearance > 30 ml/min/1,73m2 within 3 months before inclusion Written informed consent Patient affiliated to social insurance Exclusion Criteria: Unstable renal function defined by serum creatinine (J0) > 25% serum creatinine realised in 3 months Treatment: Bactrim, Fansidar, Cimetidine arrow within the week before inclusion Contraindication listed in the labeling of Cimetidine arrow Last residual rate of Tacrolimus > 12 ng/ml. Treatment : carvedilol, phenytoïn (interaction with cimetidine) Serious hepatic insufficiency

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>patients who received cimétidine | Drug: cimetidine arrow<br>* patients who received cimétidine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| performance of inulin clearance and MDRD with or no block of secretion renal tubule with cimetidine |  | two days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance of different prediction equations for estimating renal function with or no block of secretion renal tubule with cimetidine : - Walser equation - Nankivell equation - Cockcroft and Gault equation |  | two days | 
| comparison between inulin clearance and cystatin C |  | two days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
kidney transplantation, Glomerular filtration rate, inulin clearance, MDRD equation, cystatin C, cimetidine
Role of Nefopam in Rituximab Transfusion Reaction

Study Overview
=================
Brief Summary
-----------------
the patients will be taken nefopam ampule 50 mg before rituximab in the first group while the second group will be taken diphenhydramine ampule 10 mg before rituximab in the second group

Detailed Description
-----------------
the two groups will be taken standard therapy (hydrocortisone vial 100 mg and acetaminophen 1000 mg) 30 min before rituximab

Official Title
-----------------
Role of Nefopam in Rituximab Transfusion Reaction

Conditions
-----------------
Nefopam

Intervention / Treatment
-----------------
* Drug: Nefopam ampule
* Drug: diphenhydramine ampule


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 - 80 years old male and female will be taken rituximab Exclusion Criteria: less than 18 years old more than 80 years old diabetic patients

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nefopam<br>administration of intravenous nefopam to prevent Rituximab Transfusion Reaction | Drug: Nefopam ampule<br>* nefopam ampule 50 mg<br>* Other names: ACUPAN;|
| Active Comparator: diphenhydramine<br>administration of intravenous diphenhydramine to prevent Rituximab Transfusion Reaction | Drug: diphenhydramine ampule<br>* diphenhydramine ampule 10 mg<br>* Other names: Allermine;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| transfusion reaction | fever, riger, rash, chills, pruritus and bronchospasm | 30 min |
The Pilot Study of the Efficacy of Polymyxin-B Hemoperfusion in Critically Ill Patients With Severe Sepsis

Study Overview
=================
Brief Summary
-----------------
This research project is a study to immunology changes in critically ill patients with severe sepsis by using Endotoxin Activity Assay (EAA) combined with Polymyxin-B Hemoperfusion.

Conditions
-----------------
Severe Sepsis

Intervention / Treatment
-----------------
* Procedure: Polymyxin-B Hemoperfusion
* Procedure: Standard treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: SIRS Criteria > or = 2 meets definition Source of infection > or = 1 meet definition Evidence of organ dysfunction > or = 1 meet definition Exclusion Criteria: WBC < 5,000 /ul Platelet < 30,000 / ul Pregnancy woman Advance stage cancer patients (terminally ill) who is refuse to be resuscitated Received blood transfusion > 5 units in 24 hrs Allergy to Polymyxin-B High risk and uncontrolled bleeding Organ transplant patients On immunosuppressive agents within 2 weeks before study HIV infection

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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: High EAA and use Polymyxin-B Hemoperfusion<br>EAA level > 0.6 or EAA = 0.6 and use Polymyxin-B Hemoperfusion | Procedure: Polymyxin-B Hemoperfusion<br>* Endotoxin removal<br>|
| Experimental: High EAA and not use Polymyxin-B Hemoperfusion<br>EAA level > 0.6 or EAA = 0.6 and not use Polymyxin-B Hemoperfusion | Procedure: Standard treatment<br> <br> |
| Active Comparator: Low EAA<br>EAA level < 0.6 and not use Polymyxin-B Hemoperfusion | Procedure: Standard treatment<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functions of cell surface markers | CD11b expression on PMN and HLA-DR expression on monocyte | 3 days | 
| Chemotaxis | Neutrophil function | 3 days | 
| EAA level | Endotoxin level | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rate |  | 28 days | 
| Sequential Organ Failure Assessment (SOFA Score) |  | 28 days | 
| Acute Kidney Injury and Renal Replacement Therapy incidences |  | 28 days | 
| ICU length of stay |  | 28 days | 
| Mechanical ventilation free day |  | 28 days |
Effect Of Piperine In Patients With Oropharyngeal Dysphagia

Study Overview
=================
Brief Summary
-----------------
Piperine acts on the oropharyngeal TRPV1, increasing sensory input and the release of substance P. These actions may accelerate the oropharyngeal swallow response, improving the swallowing of dysphagic patients.

Official Title
-----------------
Effect of Natural Agonists of TRPV1 in the Treatment of Functional Oropharyngeal Dysphagia in Neurological Diseases and the Elderly: Piperine

Conditions
-----------------
Deglutition Disorders

Intervention / Treatment
-----------------
* Drug: Piperine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age>18 History of swallowing difficulties associated with aging and/or neurological diseases (neurodegenerative or non-progressive neurological diseases) Study explained and written subject information given Informed consent signed Exclusion Criteria: Patients suffering idiosyncratic phenomena or who are allergic to any medication, especially iodinated contrast media Patients suffering major respiratory disease or undergoing any type of surgery in the three months prior to the study Patients with a background of alcohol dependence or other drug dependence Currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of the study

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Piperine Dose 1<br>Piperine 1 mM | Drug: Piperine<br> <br> |
| Experimental: Piperine Dose 2<br>Piperine 150 microM | Drug: Piperine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of swallow | Prevalence of penetrations at the laryngeal vestibule | 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of swallow | Prevalence of oral and pharyngeal residue | 15 minutes |