linjc16/ctgov huggingface dataset:
Value of Fetal Scalp Lactate Sampling During Labour in Cases of Abnormal Fetal Heart Rate

Study Overview
=================
Brief Summary
-----------------
ST-analysis of the foetal ECG (STAN®) is another second line technique for intrapartum foetal monitoring. Combining ST-analysis with standard CTG interpretation aims to identify hypoxic foetuses more accurately than CTG alone. The STAN® method identifies changes in the ST-interval of the foetal ECG that occur in the presence of foetalcentral hypoxia The aim of this studie is to investigate if the foetal lactate blood sampling is still useful when STAN® monitoring is already being used as a second line technique for intrapartum foetal monitoring if the fetal heart rate is abnormal without a significant ST event Nowadays in the Montpellier hospital's protocol, the investigators have to check the value of lactate sampling in case of le STAN doesn't detect an ST event. So this studie can change the Montpellier hospital's protocol and avoid useless fetal blood sampling

Official Title
-----------------
Value of Fetal Scalp Lactate Sampling During Labour in Cases of Abnormal Fetal Heart Rate During Labor Over 60 Minutes Without a Significant ST-event

Conditions
-----------------
Metabolic Acidosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: patient with labor monitoring by ST segment analysis (STAN) according to current guidelines patient who received a fetal lactate sample for fetal heart rate classified as pathological for more than 60 minutes Exclusion criteria: STAN guidelines not respected before installation and during work misclassification of fetal heart rate obstetrical complications during labor

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

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

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 incidence of serious metabolic acidosis | the incidence of serious metabolic acidosis (defined as pH < 7 and Bdecf > 12 mmol/L in the umbilical cord artery). | day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of the instrumental delivery | Apgar score | day 1 | 
| Number of the neonatal outcome | admission to a neonatal ward | day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
serious metabolic acidosis, T segment analysis, Blood samples, instrumental delivery, Apgar score, admission to a neonatal ward
Randomized Phase 2 With CpG-ODN in Malignant Glioblastoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the immunostimulating agent CpG-ODN is effective in the treatment of glioblastoma

Official Title
-----------------
Multicentric Randomized Phase 2. Immunotherapy With CpG-ODN in Malignant Glioblastoma

Conditions
-----------------
Glioblastoma

Intervention / Treatment
-----------------
* Drug: CpG-ODN


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Glioblastoma Karnofsky Performance Status ≥ 60% Exclusion Criteria: Severe or uncontrolled systemic disease Active auto-immune disease Uncontrolled epilepsia Platelets < 100 000/mm3 ; or Neutrophils <500 /mm3 ; or lymphocytes <300/ mm3

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control<br> | |
| Experimental: CpG-ODN<br> | Drug: CpG-ODN<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  | 2 years | 
| Tolerance |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glioblastoma, Immunotherapy
Bioequivalence Study of Sertraline 100 mg Tablet and ZOLOFT Following a 100 mg Dose in Healthy Subjects Under Fasting Conditions

Study Overview
=================
Brief Summary
-----------------
Objective: To compare the rate and extent of absorption of Torrent Pharmaceuticals Limited, India, sertraline and Pfizer, Inc., USA (Zoloft) sertraline, administered as a 1X100 mg tablet, under fasted conditions. Study Design: Single-dose, open-label, randomized two-way crossover.

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

Intervention / Treatment
-----------------
* Drug: Sertraline
* Drug: Sertraline Hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, smoker or non smoker, 18 years of age and older. Capable of consent. BMI>= 19.0 and <30.0 kg/m2 Exclusion Criteria: Subjects to whom any of the following applies will be excluded from the study: Clinically significant illness or surgery within 4 weeks prior to the administration of the study medication. Positive testing for hepatitis B, hepatitis C, or HIV at screening. ECG abnormalities or vital sign abnormalities(blood pressure). History of significant alcohol or drug abuse within one year prior to the screening visit. History or allergic reactions to heparin, sertraline or other related drugs. Use of an investigational drug or participation in an investigational study with in 30 days prior to administration of the study medication. Clinically significant history of gastrointestinal pathology, liver or kidney disease, neurological, cardiovascular, pulmonary, hematologic, immunologic, psychiatric or metabolic disease. History of seizures, suicide attempt, bipolar disorder or manic episodes. Depot injection or an implant of any drugs with in 6 months prior to administration of study medication. Breastfeeding subject. Positive urine pregnancy test at screening. female subject of child bearing potential having unprotected sexual intercourse with any non-sterile mail partner within 14 days prior to study drug administration. Acceptable methods of contraception: Intra-uterine contraceptive device(placed at least 4 weeks prior to study drug administration) Condom or diaphragm + spermicide.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Sertraline|nan|
|Drug: Sertraline Hydrochloride|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Trial of Erlotinib, Gemcitabine and Cisplatin in Metastatic Pancreatic Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the response rate of gemcitabine, cisplatin and erlotinib in metastatic pancreatic cancer.

Official Title
-----------------
A Phase II Trial of Erlotinib in Combination With Gemcitabine and Cisplatin in Metastatic Pancreatic Cancer

Conditions
-----------------
Metastatic Pancreatic Cancer

Intervention / Treatment
-----------------
* Drug: Gemcitabine, Cisplatin, Erlotinib (Tarceva)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age older than 18 Younger than 75 ECOG performance status 0 or 1 Histologically confirmed adenocarcinoma of the pancreas Metastatic pancreatic cancer No prior chemotherapy for metastatic pancreatic cancer A patient with at least one measurable primary lesion of which the diameter is confirmed to be 10mm in Spiral CT or multidetector CT (MD CT) Exclusion Criteria: A patient with no measurable disease A patient who received previous palliative chemotherapy for pancreatic cancer A patient with locally advanced pancreatic cancer A patient who received adjuvant chemotherapy for pancreatic cancer within 1 year A patient with previous active or passive immunotherapy A pregnant or lactating patient

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GPE<br>Gemcitabine-Cisplatin-Erlotinib | Drug: Gemcitabine, Cisplatin, Erlotinib (Tarceva)<br>* Erlotinib 100 mg po q d daily AND Gemcitabine 1000 mg/m² with 250 mL of normal saline intravenously infusion over 30 mins on Day 1, 8 Cisplatin 25 mg/m2 with 150 mL of normal saline intravenously infusion over 60 mins on D1,8 Every 3 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the response rate associated with gemcitabine, erlotinib and cisplatin in patients with advanced pancreatic cancer |  | Clinically assessed every cycle (month) and radiologically assessed every 2 cycles (6 weeks) with CT scan | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gemcitabine, Cisplatin, Erlotinib
Diagnostic of Iron Deficiency by Means of Non Invasive Measurement of Zink Protoporphyrin IX

Study Overview
=================
Brief Summary
-----------------
ZnPP is being build in the case of a functional iron deficiency. Zinc instead of iron is implemented into protoporphyrin IX. This ZincProtoporphyrin (ZnPP) can be detected non invasively. Non invasive and invasive optical measurement of ZnPP will be compared. Additionally ZnPP measurements will be compared to other iron deficiency parameters for validation by the investigators.

Detailed Description
-----------------
Zinc-protoporphyrin (ZnPP) will be measured by a fluorescence technique. Restricted wave light (407/425 nm) is used to detect ZnPP in the bloodstream non-invasively through the oral mucosa. The spectroscopic measurements are translated into a ZnPP value (mumol/mol heme). The non-invasive measurement of ZnPP is validated and compared to optical measurement of ZnPP in whole blood and high performance liquid chromatography (HPLC) measurement of ZnPP in whole blood. The ZnPP value is compared to other iron-deficiency parameters: Ferritin, Transferrin saturation and soluble Transferrin receptor.

Official Title
-----------------
Diagnostic of Iron Deficiency by Means of Non Invasive Measurement of Zink Protoporphyrin IX

Conditions
-----------------
Iron-deficiency

Intervention / Treatment
-----------------
* Diagnostic Test: Non-invasive measurement of ZincProtoporphyrin IX


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients seen preoperatively in the Anesthestic clinic Patients > 18 years of age Understood and signed patient consent Exclusion Criteria: transfusion of blood products 8 weeks prior to screening Pregnancy Porphyria

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 |
| --- | --- |
| Preoperative patients<br>Patients present themselves before an operation to the Anesthesiologist. They are screened for study eligibility. | Diagnostic Test: Non-invasive measurement of ZincProtoporphyrin IX<br>* Within 30 seconds, a measurement is performed on the lip of a patient to determine a ZincProtoporphyrin value<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of the non-invasive ZincProtoporphyrinIX measurement | The value is compared to optical measurement of ZincProtoporphyrin in whole blood; in addition the value is compared to HPLC measurement in whole blood | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the ZincProtoporyphyrinIX value to other iron-deficiency parameters | The value is compared to Ferritin, Transferrin saturation and soluble transferrin receptor | Baseline |
Multicenter Registry Comparing Preoperative Imaging for Primary Hyperparathyroidism

Study Overview
=================
Brief Summary
-----------------
The study aims are: To compare the diagnostic performance of parathyroid four-dimensional CT (4D-CT), scintigraphy, and ultrasound in patients who underwent parathyroid surgery for primary hyperparathyroidism. To compare 4D-CT, scintigraphy, and ultrasound for the ability to perform focused parathyroidectomy, and for rates of persistent hyperparathyroidism and complications from parathyroid surgery. Methods The investigators will create a multicenter registry consisting of patients having parathyroid surgery for primary hyperparathyroidism from July 2009 to June 2016. Initial participating centers include Duke University Medical Center, University California Los Angeles (UCLA) and University of Arkansas for Medical Sciences (UAMS). There will be no intervention in the patient's treatment or imaging. The management will be determined by the surgeon or clinician supervising the patient's care. The registry will consist of patient data regarding basic demographics, history of prior neck/chest surgery or radiation, parathyroid imaging, biochemical evaluation, intraoperative surgical findings, parathyroid pathology, and surgical outcomes within the first 6 months (persistent disease, recurrent laryngeal nerve injury, and hypoparathyroidism). Data will be entered into REDCap with no PHI. The investigators expect to include 3000 patients in the registry (1000 from Duke).

Official Title
-----------------
Multicenter Registry Comparing Preoperative Imaging for Primary Hyperparathyroidism

Conditions
-----------------
Parathyroid Adenoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients having parathyroid surgery for primary hyperparathyroidism from July 2009 to June 2016 Exclusion Criteria: age less than 18 years parathyroid carcinoma secondary or tertiary hyperparathyroidism

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

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 |
| --- | --- | --- |
| diagnostic performance of imaging |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ability to perform focused parathyroidectomy |  | 6 months | 
| rates of persistent hyperparathyroidism after parathyroidectomy |  | 6 months | 
| parathyroidectomy surgical complications |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CT, Scintigraphy, Ultrasound
Multiparametric Imaging in Multiple Myeloma

Study Overview
=================
Brief Summary
-----------------
Patients with Multiple Myeloma will undergo single timepoint Positron Emission Tomography imaging with intravenously injected C11 Methionine to detect viable lesions.

Official Title
-----------------
Multiparametric Imaging in Multiple Myeloma

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

Intervention / Treatment
-----------------
* Drug: C11 Methionine positron emission tomography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Multiple Myeloma with symptomatic bone or soft tissue disease Eastern Cooperative Oncology Group status 0 to 2 Life expectance >= 12 weeks Ability to understand and willingness to sign informed consent Tissue sampling with genotype data planned within 3 months of C11 positron emission tomography (PET) imaging Exclusion Criteria: Pregnant or breast feeding Claustrophobic reactions and unable to lie still on a bed inside the PET scanner for 60 minutes Research related radiation exposure exceeding 50 millisieverts

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 75 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: Intervention<br>C11 Methionine positron emission tomography (PET/CT) studies will be performed as hybrid PET/CT examinations for attenuation correction and lesion localization. A bolus of 10 millicuries of C11 Methionine will be injected intravenously. Approximately 60 minutes following tracer injection, the patient will be positioned on a Siemens Biograph PET/CT scanner. A low milliampere CT of from the mid skull to mid thigh will be acquired first with while the patient is free breathing. PET will be acquired at 3 minutes per bed position using the 3D mode, approximately 6-7 bed positions. C11 Methionine PET/CT imaging will take less than 60 minutes. | Drug: C11 Methionine positron emission tomography<br>* diagnostic positron emission tomography imaging after intravenous injection of C11 Methionine<br>* Other names: L-methionine [C-11] methyl positron emission tomography;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitative measure of C11 Methionine uptake | Standardized uptake value (a semiquantitative, unit less measure of radioactivity normalized for injected activity and body weight) will be measured for individual C11 Methionine uptake abnormalities (defined as focally increased uptake higher than background levels in a similar tissue type). All abnormal uptake not in locations common for benign etiologies, such as fracture and degenerative change, will be measured. | 12 months |
Open-Label Extension to Evaluate the Longer Term Efficacy and Safety of LIB003

Study Overview
=================
Brief Summary
-----------------
To assess the longer term safety, tolerability, and LDL C lowering efficacy after 52 weeks of additional treatment with LIB003 with subcutaneous (SC) dosing every 4 weeks (Q4W)

Detailed Description
-----------------
To assess the longer term safety, tolerability, immunogenicity, PK, PD and LDL C lowering efficacy after 52 weeks of additional treatment with LIB003 with subcutaneous (SC) dosing every 4 weeks (Q4W) in patients on stable maximally tolerated statins with or without ezetimibe who completed the phase 2 dose ranging trial LIB003-002

Official Title
-----------------
Open-Label Extension, Phase 2b Study to Evaluate the Longer Term Efficacy and Safety of LIB003 in Patients on Stable Lipid Lowering Therapy Requiring Additional LDL-C Reduction

Conditions
-----------------
Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: LIB003


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: men and women 18 years or older Elevated LDL-C on current lipid lowering therapy and; prior atherosclerotic cardiovascular disease (CVD) event or evidence of CVD or without CVD but at high risk for CVD based on American Heart Association/American College of Cardiology (AHA/ACC) CVD risk calculator, or aged 40 years and older with diabetes and moderate- to high-intensity statin, or pre-treatment LDL-C 190 mg/dL or greater or heterozygous familial hypercholesterolemia (HeFH) patients who met original entry criteria in, and completed, the double-blind, placebo-controlled 16-week Phase 2 study (LIB003-002) Exclusion Criteria: patients who did not who complete the double-blind, placebo-controlled 16-week Phase 2 study (LIB003-002) <18 years of age pregnant or women of childbearing potential not using acceptable birth control

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
Intervention Model: Single Group Assignment
Interventional Model Description: open-label
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LIB003<br>LIB003 | Drug: LIB003<br>* 300 mg SC Q4W<br>* Other names: lerodalcibep;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | safety and tolerability will be based on the incidence and severity of treatment emergent adverse events | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in LDL-C at 52 Weeks | percent change in serum LDL-C from baseline at 52 weeks | 52 weeks |