linjc16/ctgov huggingface dataset:
An Open-label, Intermediate Size, Expanded Access Study of BHV-3000 in the Acute Treatment of Migraine

Study Overview
=================
Brief Summary
-----------------
The purpose of this protocol is to allow subjects who completed any BHV3000 (rimegepant) clinical study to continue to have access to rimegepant while collecting ongoing safety data. (NOTE: ONLY FOR PATIENTS who participated in a previous BHV-3000/Rimegepant Clinical Trial in the past)

Official Title
-----------------
BHV3000-401: An Open-label, Intermediate-size, Expanded Access Study of BHV-3000 in the Acute Treatment of Migraine

Conditions
-----------------
Migraine

Intervention / Treatment
-----------------
* Drug: rimegepant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1.Subjects who have completed any BHV3000 (rimegepant) clinical study without significant protocol violations. Exclusion Criteria: History of basilar migraine or hemiplegic migraine History with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease HIV history Uncontrolled hypertension or uncontrolled diabetes Current diagnosis of major depression, other pain syndromes, psychiatric conditions (e.g., schizophrenia), dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion, might interfere with study assessments History of gastric, or small intestinal surgery, or has a disease that causes malabsorption

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: rimegepant|rimegepant 75 mg|

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
-----------------
Migraine prevention, phonophobia, photophobia, nausea
Fetal Pulmonary Artery Acceleration to Ejection Time Ratio (PATET) in the Prediction of Subsequent Development of Respiratory Distress Syndrome (RDS)

Study Overview
=================
Brief Summary
-----------------
Fetal PATET ratio evaluation to predict neonatal RDS

Detailed Description
-----------------
115 patients were enrolled in this study.Population was recruited from singleton pregnancies beyond 27 weeks of gestation.All participants underwent a ultrasound examination to measure fetal pulmonary artery acceleration to ejection time ratio (PATET) by a single experienced clinician. After the delivery respiratory distress diagnosis made by a pediatrician who were blinded the doppler waveform measurements.Following the diagnosis, neonates divided into 2 groups as RDS (+) and RDS (-). In addition of RDS diagnosis, neonatal features like 1st and 5th minute APGAR scores, neonatal intensive care unit (NICU) admission and duration in NICU were also recorded. Afterwards all parameters were statistically analyzed if there is any significant differences between those two groups.

Official Title
-----------------
Fetal Pulmonary Artery Acceleration to Ejection Time Ratio (PATET) in the Prediction of Subsequent Development of Respiratory Distress Syndrome (RDS)

Conditions
-----------------
RDS

Intervention / Treatment
-----------------
* Device: ultrasound examination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant women within the 27 weeks of gestation and beyond Exclusion Criteria: patients who did not give birth within 3 days after the ultrasonographic doppler examination fetuses with Any congenital abnormalities amniotic fluid abnormalities any chronic maternal diseases or pregnancy complications such as;gestational diabetes mellitus,preeclampsia
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 |
| --- | --- |
| RDS +<br>postpartum RDS developed group | Device: ultrasound examination<br>* intrauterine fetal pulmonary artery acceleration time to ejection time ratio measurement via ultrasound<br>|
| RDS -<br>postpartum RDS undeveloped group | Device: ultrasound examination<br>* intrauterine fetal pulmonary artery acceleration time to ejection time ratio measurement via ultrasound<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of fetal pulmonary acceleration time to ejection time ratio via ultrasonography in the 115 pregnant women between 27 to 37 weeks of gestation for prediction of respiratory distress syndrome | The aim of this study is to obtain the effectiveness of fetal pulmonary artery acceleration time to ejection time ratio in fetal lung maturity evaluation | Ten months |
DPBRN Patient Satisfaction With Dental Restorations

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to administer two questionnaires. The first, a Dental Satisfaction Questionnaire to assess patient satisfaction with a restoration visit using patients recruited from practices participating in the Dental PBRN Reasons for replacement or repair of dental restorations study. The second questionnaire (completed by the practitioner) was a brief single page questionnaire to evaluate the patient visit.

Detailed Description
-----------------
This study was to assess a comprehensive range of determinants of patient satisfaction following the restoration replacement or repair to study the relative contribution of each determinant towards overall patient satisfaction.

Official Title
-----------------
Patient Satisfaction With Dental Restorations

Conditions
-----------------
Patient Satisfaction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: participants directly involved in this study were patients who sought dental treatment in the practitioner investigators' practices patient with replaced or repaired restorations placed in the treatment of permanent teeth who were also enrolled in the DPBRN Reasons for replacement or repair of dental restorations Exclusion Criteria: children younger than 13 years of age were excluded from this study because of issues related to comprehension and validity of responses

Ages Eligible for Study
-----------------
Minimum Age: 13 Years

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
patient satisfaction, assessments, dental caries, dental materials
Feasibility Study: MRI on 6 Months, 1 Year, and 2 Years Old Children Without Sedation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to perform brain scans using magnetic resonance imaging (MRI) instrument on children aged 6 months up to 5 year old children. This procedure is usually done with sedation but the study will see if it can be done without sedation.

Detailed Description
-----------------
MRI examination of term infants without sedation at a later age (than newborn) can be feasible.

Official Title
-----------------
Feasibility Study: MRI on 6 Months, 1 Year, and 2 Years Old Children Without Sedation

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

Intervention / Treatment
-----------------
* Other: MRI without sedation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Term born Mother is 18 years or older Exclusion Criteria: Any previous or current neurological illness or other serious medical conditions Any conditions deemed by the investigators that are not suited for a MRI scan.

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 5 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: MRI without sedation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants that can perform an MRI exam without sedation | Perform MRI exam without sedation at a later age than newborn | From the time of the start of the MRI until the end of the MRI exam ( 2 hours) |
Comparing the Effects of Ondansetron Versus Dexamethasone on the Incidence of Post-dural Puncture Headache (PDPH) , Nausea and Vomiting After Spinal Anaesthesia of Parturients Undergoing Caesarean Section

Study Overview
=================
Brief Summary
-----------------
Comparing dexamethasone and ondanestrone injection in ncidence of postdural puncture headache and post-partum nausea and vomiting

Official Title
-----------------
Comparing the Effects of Ondansetron Versus Dexamethasone on the Incidence of Post-dural Puncture Headache (PDPH) , Nausea and Vomiting After Spinal Anaesthesia of Parturients Undergoing Caesarean Section

Conditions
-----------------
Post-Dural Puncture Headache

Intervention / Treatment
-----------------
* Drug: Intravenous drug


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A total of one hundred and fifty parturients in child bearing period (20-40 years), with BMI of 23-27, and ASA physical status II, who were candidate for elective caesarean section, were enrolled in this prospective randomized study. Exclusion criteria Exclusion Criteria: 1 - Lady refusal to participate. 2. All pregnant women candidate for emergency caesarean section elligible for general anaesthesia (GA). 3.presence of any contraindications of dexamethasone (as DM and uncontrolled infection ) or any contraindication of ondansetron (as prolonged QT interval 6. Presence of cardiac, respiratory, hepatic, renal and mental diseases. 7. Coagulopathy, or any contraindication to spinal anaesthesia. 8. Presence of complicated pregnancies (such as pregnancy induced hypertension, placenta previa or eclmpsia).

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: dexamethasone<br> | Drug: Intravenous drug<br>* intravenous drug injection<br>|
| Active Comparator: ondanestrone<br> | Drug: Intravenous drug<br>* intravenous drug injection<br>|
| Placebo Comparator: control group<br> | Drug: Intravenous drug<br>* intravenous drug injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of post-dural puncture hedache |  | 24 hours post-partum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of post-partum nausea and vomiting |  | 24 hours post-partum |
Phase 2 Study MPC-6827 for Recurrent Glioblastoma Multiforme

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and effectiveness of Azixa in patients with recurrent glioblastoma multiforme

Official Title
-----------------
Phase 2 Study of Azixa (MPC-6827) for the Treatment of Patients With Recurrent Glioblastoma Multiforme

Conditions
-----------------
Glioblastoma Multiforme

Intervention / Treatment
-----------------
* Drug: Azixa


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have histologically proven malignant Glioblastoma Multiforme in first or second relapse Have failed prior Fractionated External Beam Cranial Irradiation or IMRT Be at least 18 years old and with a life expectancy ≥ 8 weeks or ≥ 4 weeks if failed prior Avastin therapy Have a Karnofsky performance status of ≥ 60 Have adequate bone marrow function, liver function, and renal function before starting therapy Exclusion Criteria: Have had more than two relapses Have had radiosurgery Have a cardiac ejection fraction < 50% by MUGA or ECHO Have Troponin-I elevated above the normal range Have an increasing steroid requirement Have MRI evidence at baseline of enlarging or clinically significant intratumor hemorrhage Have active stroke and/or transient ischemic attack not optimally managed Have active cardiovascular disease (e.g. sub-optimally managed angina, impending myocardial infarction, or uncontrolled hypertension) Be pregnant or breast feeding Have had prior hypersensitivity reaction to Cremophor EL Be HIV positive

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Azixa|3.3 mg/m2 of Azixa administered by intravenous infusion over 2 hours once weekly for 3 consecutive weeks every 4 weeks (1 cycle = 4 weeks)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the progression-free survival (PFS) rate |  | Six 28-day cycles from start of therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 36 months | 
| Overall response rate |  | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glioblastoma, Brain Neoplasms, Recurrence
Assessment of Fluid Responsiveness in Patients After Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
To overcome the limited accuracy of functional hemodynamic parameters such as stroke volume and pulse pressure variation (SVV and PPV) during spontaneous breathing, a Passive Leg Raising (PLR) manoeuvre has been suggested as a reliable predictor of fluid responsiveness. Aim of this study was to evaluate fluid responsiveness using SVV, PPV and PLR during the transition from controlled to spontaneous breathing in cardiac surgery patients

Detailed Description
-----------------
In patients after elective off-pump CABG are enrolled hemodynamic measurements are performed in the postoperative period upon arrival in the ICU using a PiCCO2 system (Pulsion Medical Systems, Munich, Germany). Controlled fluid challenges (500 ml) are done at 3 time-points: A) during controlled mechanical ventilation B) during pressure support ventilation with spontaneous breathing and C) after extubation. Stroke volume (SV), SVV and PPV as well as standard hemodynamic parameters (MAP = mean arterial pressure, HR = heart rate) are assessed. A PLR is performed before fluid administration at all 3 time points. A positive response is defined as an increase in SV>15 %. Prediction of fluid responsiveness will be tested by AUC (area under the receiver operating characteristic - ROC - curve).

Official Title
-----------------
Assessment of Fluid Responsiveness in Patients After Cardiac Surgery Comparison of Different Functional Hemodynamic Parameters and Tests

Conditions
-----------------
Hemodynamics, Patient Monitoring

Intervention / Treatment
-----------------
* Other: Passive leg raising test and fluid challenge


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: preserved left ventricular function regular heart rhythm Exclusion Criteria: emergency procedures intra- and extra-cardial shunts aortic and tricuspid valve insufficiencies peripheral arterial occlusive disease

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Passive leg raising test and fluid challenge|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke volume increase > 15% | Stroke volume increase defines fluid responsiveness | 20 min | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
functional hemodynamic parameter, passive leg raising, stroke volume variation, pulse pressure variation
SWOG 8897-A DNA Analysis in Predicting Treatment Outcome in Women With Breast Cancer in SWOG 8897

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict a patient's response to treatment. PURPOSE: This laboratory study is looking at DNA in tissue samples from women with breast cancer to see if it can predict treatment outcome.

Detailed Description
-----------------
OBJECTIVES: Determine if polymorphisms resulting in greater activation of cyclophosphamide (CYP2B6, CYP3A4, and CYP3A5) are associated with disease-free survival and treatment toxicities in women with breast cancer. Determine if polymorphisms resulting in less production of quinone-related oxidative damage of doxorubicin hydrochloride (NQO1, NQO2, NOS2, NOS3, CBR3) are associated with disease-free survival and treatment toxicities in these patients. OUTLINE: This is a multicenter study. Tissue samples archived on clinical trial SWOG-8897 are genotyped for polymorphisms in the CYP3A4, CYP3A5, CYP2B6, NQO1, NQO2, NOS2, NOS3, and CBR3 genes by matrix-assisted laser desorption ionization-time-of-flight mass spectrometry. Variant alleles are correlated with patient outcome. PROJECTED ACCRUAL: A total of 1,577 patients will be accrued for this study.

Official Title
-----------------
Pharmacogenetics in Relation to Breast Cancer Outcomes in SWOG 8897

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

Intervention / Treatment
-----------------
* Genetic: mutation analysis
* Genetic: polymorphism analysis
* Other: surface-enhanced laser desorption/ionization-time of flight mass spectrometry


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Diagnosis of breast cancer Node-negative breast cancer Enrolled on clinical trial SWOG-8897 Archived tissue from patients with normal lymph nodes in the low-risk group receiving no treatment and those in the intermediate group receiving treatment Hormone receptor status known PATIENT CHARACTERISTICS: Female Pre- or post-menopausal PRIOR CONCURRENT THERAPY: Not specified

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: mutation analysis|nan|
|Genetic: polymorphism analysis|nan|
|Other: surface-enhanced laser desorption/ionization-time of flight mass spectrometry|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in outcome according to common variant alleles |  | Through study follow-up an average of 10.8 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stage I breast cancer, stage II breast cancer
A Pharmacokinetic Study to Investigate the Effect of Food on the Pharmacokinetics of YM150 Tablet

Study Overview
=================
Brief Summary
-----------------
This study is to evaluate the effect of food on the pharmacokinetics of YM150 in healthy make adult subjects.

Detailed Description
-----------------
To evaluate the effect of food on the pharmacokinetics of YM150 in healthy non-elderly adult male subjects using a 2×2 crossover design. Also, to evaluate the safety of YM150.

Official Title
-----------------
Pharmacokinetic Study of YM150 - A Pharmacokinetic Study to Investigate the Effect of Food on the Pharmacokinetics of YM150 Tablet-

Conditions
-----------------
Healthy Volunteer, Pharmacokinetics of YM150

Intervention / Treatment
-----------------
* Drug: YM150


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body weight: ≥50.0 kg, <80.0 kg BMI: ≥17.6, <26.4 Healthy, as judged by the investigator or sub-investigator based on the results of physical examinations and lab tests Exclusion Criteria: Received any investigational drugs within 120 days before the study Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or blood components within 14 days before the study Received medication within 7 days before the study A deviation from the assessment criteria of physical examinations or laboratory tests A deviation from the normal reference range of coagulation test [PT (INR) or aPTT] History of drug allergies Upper gastrointestinal disease within 7 days before the study Concurrent or previous hepatic, gastrointestinal, heart, cerebrovascular or respiratory diseases Concurrent or previous malignant tumor Previous treatment with YM150

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 44 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: fast-fed sequence group<br> | Drug: YM150<br>* oral<br>|
| Experimental: fed-fast sequence group<br> | Drug: YM150<br>* oral<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentration of YM150 and its metabolites measured by blood samples |  | for 3 days after drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessed by AEs, vital signs, 12-lead ECG and lab tests |  | for 3 days after drug administration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
YM150, Food effect