linjc16/ctgov huggingface dataset:
Repeat-Dose Pharmacokinetics and Pharmacodynamics of Bortezomib in Patients With Relapsed Multiple Myeloma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to characterize the clinical pharmacokinetic and pharmacodynamic profiles of the 2 doses of VELCADE (bortezomib) for Injection. Patients who volunteer to participate in the pharmacogenetic portion of the study, an additional blood sample will be collected before the Cycle 1 Day 1 dose of bortezomib to assess the genotype of drug metabolizing enzymes.

Official Title
-----------------
Repeat-Dose Pharmacokinetics and Pharmacodynamics of Bortezomib in Patients With Relapsed Multiple Myeloma

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

Intervention / Treatment
-----------------
* Drug: Bortezomib


Participation Criteria
=================
Eligibility Criteria
-----------------
Male and female adult patients 18 years or older with a diagnosis of relapsed multiple myeloma requiring therapy will be eligible for this study. Key inclusion criteria include: Karnofsky Performance Status (KPS) equal to or greater then 70%, normal liver function tests (aspartate transaminase [AST] or alanine transaminase [ALT] equal to or less then 2 x upper limit of normal [ULN], total bilirubin equal to or less then 1.5 x ULN), hemoglobin equal to or greater then 10 g/dL, platelets equal to greater then 50 x 10 to ninth power/L, and absolute neutrophil count (ANC) equal to or greater then 1000/uL; calculated creatinine clearance equal to or greater then 50 mL/min, and normal serum calcium. Key exclusion criteria include: Patients with significant cardiac disease, equal to or greater then Grade 2 neuropathy, active hepatitis, HIV infection, secondary malignancy, POEMS syndrome, plasma cell leukemia, or who are transfusion-dependent or received extensive radiation therapy, systemic chemotherapy, or other antineoplastic therapy within 4 weeks of enrollment will be excluded. Patients taking concurrent medications at entry that may act as inducers or inhibitors of CYP 3A4 are excluded. Patients receiving thalidomide must discontinue that drug at least 2 weeks prior to enrollment. Patients receiving concurrent corticosteroids must have tapered their dose of corticosteroid to to equal to or less then 10 mg/day of prednisone or prednisone equivalent at least 2 weeks prior to enrollment.

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: Bortezomib|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
-----------------
Relapsed, Multiple Myeloma, Pharmacokinetic, Pharmacodynamic
A Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects With Moderate to Severe Crohn's Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether CCX282-B is effective in treating patients with moderate to severe Crohn's Disease.

Official Title
-----------------
A Multinational, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects With Moderate to Severe Crohn's Disease

Conditions
-----------------
Crohn's Disease

Intervention / Treatment
-----------------
* Drug: CCX282-B


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: moderate to severe Crohn's Disease CDAI 250-450 CRP >7.5 signed written informed consent Key Exclusion Criteria: > 100 cm of small bowel resected ileostomy, colostomy or rectal pouch diagnosis of ulcerative colitis or indeterminate colitis evidence of short bowel syndrome requiring enteral or parenteral supplementation or total parenteral nutrition hepatitis B, C or HIV infection history of infection requiring IV antibiotics serious or GI infection in the previous 12 weeks

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 |
| --- | --- |
| Experimental: 1<br>Blinded study arm | Drug: CCX282-B<br>* CCX282-B or placebo capsules<br>|
| Experimental: 2<br>Blinded study arm | Drug: CCX282-B<br>* CCX282-B or placebo capsules<br>|
| Experimental: 3<br>Blinded study arm | Drug: CCX282-B<br>* CCX282-B or placebo capsules<br>|
| Experimental: 4<br>Blinded study arm | Drug: CCX282-B<br>* CCX282-B or placebo capsules<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects achieving a clinical response (defined as a decrease from baseline in Crohn's Disease Activity Index [CDAI] score of at least 70) on Day 57 |  | Day 57 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects achieving clinical remission (defined as a Crohn's Disease Activity Index [CDAI] score less than or equal to 150) on Day 57 |  | Day 57 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
double-blind, placebo-controlled, multicenter, efficacy, safety
Post-Cesarean Wound Drainage is Not Necessary in Women at Increased Risk of Hemorrhage

Study Overview
=================
Brief Summary
-----------------
Randomized controlled trial assessing the benefit of cesarean wound drainage in pregnant women at increased risk of hemorrhage. The pregnant women at increased risk of hemorrhage were randomised in two groups. In one group 2 wound drainages were placed during the cesarean section, in the other group none. Outcome measures were difference between preoperative and postoperative hemoglobin, postoperative fever, cumulative opiate dose adjusted to body weight, length of stay and operation time. It is postulated that the pregnant women with increased risk of hemorrhage do not profit from the routine placement of wound drainages. Trial with surgical intervention

Conditions
-----------------
Pregnancy, Hemorrhage

Intervention / Treatment
-----------------
* Procedure: Placement of drainages


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: All pregnant women with increased risk of hemorrhage carrying singleton pregnancies, who had to undergo cesarean section. Exclusion criteria: Twin-pregnancies

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

| Intervention/Treatment |
| --- |
|Procedure: Placement of drainages|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
-----------------
women, increased, risk
Clinical Implication of 3-vessel Fractional Flow Reserve (FFR)

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the influence of total atherosclerotic burden assessed by 3-vessel fractional flow reserve (FFR) on the clinical outcomes of the patients with multi-vessel disease. For this purpose, the clinical data of the patients with 3-vessel intermediate coronary artery disease, whose FFR was measured at all 3-vessels due to their own clinical needs, will be analyzed.

Detailed Description
-----------------
Primary Analysis The Primary Analysis will be performed after 2-year follow-up data will be completed. Pre-specified Subgroup Analysis The pre-specified subgroup analysis will perform after 1-year follow-up data will be completed according to the following subjects: Concordant and discordant results between FFR and angiographic stenosis severity (patients and lesions with pre-PCI FFR will be analyzed.). Association between total atherosclerotic burden and total ischemic burden, coronary CT angiography substudy (after 2-year follow-up will be completed). Validation of total ischemic burden (sum of 3 vessel FFR) with Duke score, measured by treadmill test. Comparison of clinical outcomes of deferred lesions according to pre-PCI FFR levels (Pre-PCI FFR <0.75, 0.75-0.80, and >0.80). Comparison of clinical outcomes of deferred lesions according to iFR and FFR values ⑥ Prognosis of functional complete revascularization versus incomplete revascularization

Official Title
-----------------
Influence of Total Atherosclerotic Burden Assessed by 3-vessel Fractional Flow Reserve (FFR) on the Clinical Outcomes of the Patients With Multi-vessel Disease

Conditions
-----------------
Multivessel Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject must be at least 18 years of age. Subject must have stenosis (>30% by visual estimate) in all 3-epicardial coronary arteries. FFR should be measured at all 3-vessels at the end of a procedure. Exclusion Criteria: Depressed left ventricular systolic function (ejection fraction < 35%) ST-elevation myocardial infarction within 72 hours, Prior coronary artery bypass graft surgery Creatinine level >= 2.0mg/dL or dependence on dialysis Abnormal final myocardial flow (TIMI flow < 3) Planned bypass surgery Failed FFR measurement Failed intended revascularization
Sexes Eligible for Study
-----------------
All

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of the composite of major adverse cardiac events (MACE: cardiac death, myocardial infarction, revascularization) at 2 years per 3-vessel FFR |  | 2 years after FFR measurement | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
coronary artery, atherosclerosis, angina pectoris
The Osteosarcoma Biobank in Peking University People's Hospital

Study Overview
=================
Brief Summary
-----------------
Osteosarcoma is very rare bone tumor. The investigator set up the biobank to ensure the patients has the chance to participate in future research

Detailed Description
-----------------
Samples of blood and other stored material such as slides,frozen tissues and so on . Questionnaire information, including health history, growth and development, physical activity and family medical history information.

Official Title
-----------------
Establishment of Osteosarcoma Biobank

Conditions
-----------------
Osteosarcoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Proband Inclusion criteria: A diagnosis or suspected diagnosis of osteosarcoma Exclusion Criteria: non-asian pulmonary metastasis
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 |
| --- | --- | --- |
| Examine VEGFR-2 and PD-L1 gene expression osteosarcoma | To examine the VEGFR2 and programmed cell death ligand 1 (PD-L1) genes expression of the patients with osteosarcoma.And Analyze their differences. | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bone tumor osteosarcoma
Clinical Qualification Study of Electroencephalographic Mobile Equipment for the Capture of Emotions

Study Overview
=================
Brief Summary
-----------------
The study aim to determine the reliability of various EEG wireless headsets. Their signal will be compared to standard high-density EEG recording during music listening.

Official Title
-----------------
Clinical Qualification Study of Electroencephalographic Mobile Equipment for the Capture of Emotions

Conditions
-----------------
Musical Emotions

Intervention / Treatment
-----------------
* Device: Electroencephalography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Right handed healthy people sensitive to music chill (Barcelona Reward music Questionnaire>50) having given their participation agreement individual with health insurance coverage. Exclusion Criteria: Pregnant women individuals in exclusion period of another study subjects with auditory deficits

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Basic Science
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EEG Device 1<br>Participants are listening to music while their neural activity is recorded with Emotiv Epoc+ | Device: Electroencephalography<br>* Cerebral measurements from electroencephalography devices while music is presented to the participant<br>|
| Experimental: EEG Device 2<br>Participants are listening to music while their neural activity is recorded with g.tec | Device: Electroencephalography<br>* Cerebral measurements from electroencephalography devices while music is presented to the participant<br>|
| Active Comparator: High density EEG<br>Participants are listening to music while their neural activity is recorded with high density 256 electrodes EEG Geodesic | Device: Electroencephalography<br>* Cerebral measurements from electroencephalography devices while music is presented to the participant<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality and spatial/temporal coherence in oscillatory responses patterns recorded with EEG wireless headsets (Emotiv and g.tec) and with the EEG high density gold standard | Brain activity will be recorded continuously during musical extract listening. The coherence of EEG activity between the three different devices on similar electrodes will be measured and compared for several brainwaves (delta, theta, alpha, beta, gamma) | Up to 2 weeks |
Safety, Pharmacokinetic Study of PRIC in Healthy Adult Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is Safety, Pharmacokinetic Study of PRIC

Detailed Description
-----------------
To Compare Pharmacokinetics of PRIC and Pranlukast Dry Syrup To evaluate the safety and tolerability of PRIC and Pranlukast Dry Syrup

Official Title
-----------------
A Randomized, Open-label, Single-dose, Crossover Study to Compare Pharmacokinetics of PRIC and Pranlukast Dry Syrup in Healthy Male Volunteers

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

Intervention / Treatment
-----------------
* Drug: PRIC
* Drug: Pranlukast hydrate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 19 to 45 years old healthy male subject at the screening Subject who is able to provide written informed consent and decided on his own participation after understanding fully to hear a detailed explanation in the clinical study Exclusion Criteria: Subject with hereditary diseases of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption etc. Subjects with history of clinically significant allergy, cardiovascular, peripheral vascular, skin, mucocutaneous, ocular, ear, nose and throat (ENT), respiratory, musculoskeletal, infectious, gastrointestinal, liver, biliary, endocrine, renal, genitourinary, nervous, psychiatric, blood disorders, tumors, fractures or any other conditions

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 40 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A group<br>Period 1: PRIC Period 2: Pranlukast hydrate | Drug: PRIC<br>* Pranlukast hydrate 50mg<br>* Other names: PRIC 50mg;Drug: Pranlukast hydrate<br>* Pranlukast hydrate 225mg/2.25g<br>|
| Experimental: B group<br>Period 1: Pranlukast hydrate Period 2: PRIC | Drug: PRIC<br>* Pranlukast hydrate 50mg<br>* Other names: PRIC 50mg;Drug: Pranlukast hydrate<br>* Pranlukast hydrate 225mg/2.25g<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve (AUC) to last time point (t) | Area under the PRIC/Pranlukast dry syrup concentration in blood-time curve from zero to the final | 0, 0.5, 0.75, 1, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10 and 12hours postdose | 
| Maximum concentration of drug (Cmax) | The maximum PRIC/Pranlukast dry syrup concentration in blood sampling time t | 0, 0.5, 0.75, 1, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10 and 12hours postdose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pranlukast hydrate
Carperitide in Acute Respiratory Distress Syndrome (ARDS)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether Carperitide is safe and effective in the management of Acute Respiratory Distress Syndrome (ARDS).

Detailed Description
-----------------
Acute respiratory distress syndrome (ARDS is a severe form of acute lung injury. ARDS is characterized by an increase in pulmonary vascular permeability resulting from a non-cardiogenic cause, leading to an increased vascular water volume, pulmonary inflammation, and severe hypoxemia. Conventional therapy for ARDS is primarily respiratory management by mechanical ventilation using positive end-expiratory pressure (PEEP). Mechanical ventilation is the major management concern in patients with ARDS, due to its higher risk of infections and morbidity. Treatment with Carperitide may reduce time on the ventilator by reducing pulmonary edema and by improving gas exchange. The results of Carperitide studies in animals and humans support the idea that the hormone will be effective in managing the acute pulmonary complications and hypoxemia seen in ARDS.

Official Title
-----------------
A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Evaluation of the Safety and Efficacy of Carperitide Infusion in Patients With ARDS

Conditions
-----------------
Respiratory Distress Syndrome

Intervention / Treatment
-----------------
* Drug: recombinant human atrial natriuretic polypeptide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: In order to participate in the study, patients must: be 18 years or older have an acceptable PF ratio have adequate fluid volume be intubated less than 7 days Exclusion: In order to participate in the study, patients must not meet any of the following criteria: be moribund be immunocompromised have pneumonia (caused by Pneumocystis carinii) have recieved another investigational drug or device within the last 30 days have a Do not Resuscitate order

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: recombinant human atrial natriuretic polypeptide|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
-----------------
Acute Respiratory Distress, Acute Lung Injury
Correlation Between Maternal Vitamin D Level And Preterm Birth

Study Overview
=================
Brief Summary
-----------------
Assessment of correlation between vitamin D level and prevalence of preterm births remains limited. The exact role of vitamin D in preterm birth has not yet been clearly defined ,where some studies showed vitamin D deficiency increased the risk of preterm birth while other studies found no correlation. In this study will try to continue research on this subject.

Official Title
-----------------
Correlation Between Maternal Vitamin D Level And Preterm Birth

Conditions
-----------------
Preterm Birth, Preterm Labor, Vitamin D Deficiency

Intervention / Treatment
-----------------
* Diagnostic Test: Vitamin D measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Singleton gestation. Maternal age: 20-35 years. Exclusion Criteria: Multi fetal pregnancy. Anatomical or genetic defect of the fetus. Iatrogenic preterm delivery. Maternal medical disorder e.g diabetes millets (D.M). Antepartum hemorrhage. Hypertensive disorders. Polyhydromins or oligolydromins Premature rupture of membranes ± Chorioamnionitis Incompetent cervix. Post IVF. Uterine Fibroid or malformation.

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study<br>69 women, delivered preterm babies (less than 37weeks). | Diagnostic Test: Vitamin D measurement<br>* Maternal serum 25- hydroxyl vitamin D level<br>|
| Control<br>69 women, delivered at term (38-42 weeks) of full tem babies. | Diagnostic Test: Vitamin D measurement<br>* Maternal serum 25- hydroxyl vitamin D level<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of patients with severe vitamin D deficiency | vitamin D deficiency defined as vitamin D level <10ng/mL | 3 months |