linjc16/ctgov huggingface dataset:
Cerebral Oximetry in Newborns - Comparing INVOS 5100c and OxyPrem vs. 1.2

Study Overview
=================
Brief Summary
-----------------
Regional tissue oxygenation (cStO2) can be monitored by near infrared spectroscopy. The commercial device INVOS 5100 (COVIDIEN, Mansfield, MA, USA) and the prototype OxyPrem vs. 1.2 (Biomedical Optics Research Laboratory, Zurich, Switzerland) will be used simultaneously to test for their relative sensitivity for low oxygen levels just after birth on term infants born by elective caesarean section. Reproducibility will be examined by replacements of the sensors six times the next day when the infant is stable and quiet. The Adult Somasensor (INVOS) will be used together with the OxyPrem sensor.

Official Title
-----------------
Cerebral Oximetry in Newborns - Comparing INVOS 5100c and OxyPrem vs. 1.2's Absolute Values, Sensitivity for Low Oxygen Levels and Reproducibility

Conditions
-----------------
Near-infrared Spectroscopy, Transition, Caesarean Section

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Term infants Elective caesarean section Exclusion Criteria: Thick hair that makes good measurements difficult/impossible obvious malformations or syndromes Complications in relation to caesarean section Depression after birth (APGAR < 8 after 1 minute)

Ages Eligible for Study
-----------------
Maximum Age: 10 Minutes

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 |
| --- | --- |
| Near-infrared spectroscopy sensors<br>Term infants born by elective Caesarean section | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebral oxygenation | The sensors of both instruments will be placed on each side of the head. They will be held by hand by self-adhesive tape as appropriate. | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reproducibility | The sensor will be placed 6 times alternating on each frontoparietal region and held by hand, obtaining 30 seconds of signal for each placement. The placements will be in the same region but not in exactly the same spot. This will be done for both devices. | 10 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Near-infrared spectroscopy, cerebral oxygenation, term newborn, reproducibility,
Bioequivalency Study of Mycophenolate Mofetil 250 mg Capsules Under Fasted Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to prove the bioequivalence of Mycophenolate Mofetil 250 mg Capsules under fasted conditions.

Official Title
-----------------
A Single Dose, 2-Period, 2-Treatment 2-Way Crossover Bioequivalency Study of Mycophenolate Mofetil 250 mg Capsules Under Fasting Conditions

Conditions
-----------------
Prophylaxis of Organ Rejection

Intervention / Treatment
-----------------
* Drug: Mycophenolate Mofetil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening Exclusion Criteria: Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to mycophenolate mofetil or any comparable or similar product.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Mycophenolate Mofetil|mycophenolate mofetil 250 mg capsule|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bioequivalence determined by statistical comparison Cmax |  | baseline, 2-period, 14 day washout |
Cd11b and Cd56 as Prognostic Markers in Acute Myeloid Leukemia

Study Overview
=================
Brief Summary
-----------------
Detect the expression of marker CD56 and CD11b in newly diagnosed cases of adult AML. Study correlation between CD56 and CD11b expression with haematological parameters in cases of adult AML.

Detailed Description
-----------------
CD11b expression level is a prognostic biomarker for AML patient. CD11b positivity could predict a poor prognosis for AML patients. CD56 antigen expression, an inexpensive, easy to detect and reproduce index, is closely related to the prognosis of AML patients

Official Title
-----------------
Cd11b and Cd56 as Prognostic Markers in Acute Myeloid Leukemia

Conditions
-----------------
Adult Acute Myeloid Leukemia

Intervention / Treatment
-----------------
* Diagnostic Test: Cd11b and Cd56 markers


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Anew diagnosis cases of adult AML Exclusion Criteria: Pediatric AML . follow up cases of adult AML

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CD11b and CD56 markers<br>Cd11b and Cd56 as Prognostic Markers in Acute Myeloid Leukemia | Diagnostic Test: Cd11b and Cd56 markers<br>* The expression of CD11b and CD56 in newly diadnosed cases of AML<br>* Other names: Cd11b and Cd56 as Prognostic Markers in Acute Myeloid Leukemia;|
| Haematological parameters in cases of adult AML<br>Study correlation between CD56 and CD11b expression with haematological parameters in cases of adult AML | Diagnostic Test: Cd11b and Cd56 markers<br>* The expression of CD11b and CD56 in newly diadnosed cases of AML<br>* Other names: Cd11b and Cd56 as Prognostic Markers in Acute Myeloid Leukemia;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CD11b and CD56 marker | Detect the expression of marker CD56 and CD11b in newly diagnosed cases of adult AML. | 24 month |
Prevalence of Depression and Anxiety in Patients Seeking Medical Care at General Health Care Settings in China

Study Overview
=================
Brief Summary
-----------------
Objectives: Primary: To estimate the prevalence of depression and/or anxiety disorder in outpatients attending the general health care settings in China. Secondary: To estimate gender- and age-specific prevalence of depression and/or anxiety disorder in outpatients attending the general health care settings in China. To estimate the prevalence of depression and/or anxiety disorder in outpatients attending the general health care settings such as departments of neurology, gastroenterology, cardiology, and gynecology. To describe the recognition and treatment rate by treating physicians as depression and/or anxiety for outpatients in the general health care settings in China.

Detailed Description
-----------------
This study is designed to investigate the status of identifying depression and/or anxiety disorder with somatic symptoms in general hospitals in China. The study will generate valuable information to the medical community; therefore the early and vigorous treatment is possible. It's in line with China government authorities' target to increase the recognition rate of depression and/or anxiety in primary care settings to more than 50% by the end of 2010. The study will also help to identify specific diagnosis and treatment patterns for depressive / anxious patients and their comorbid conditions.

Official Title
-----------------
Prevalence of Depression and Anxiety in Patients Seeking Medical Care at General Health Care Settings in 5 Large Cities in China

Conditions
-----------------
Adult

Participation Criteria
=================
Eligibility Criteria
-----------------
Main Inclusion Criteria: Greater than or equal to 18 years. Consecutive general internal medical outpatients attending the selected general hospitals in the investigate days(Department of neurology, gastrointestinal, cardiology and gynecology). Informed consent obtained for all patients who will undergo a standardized diagnostic assessment by specialized psychiatrists. Main Exclusion Criteria: Patients who have been screened on a previous visit. Patients who are unable to complete the survey because of mental or physical incapacity.

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 and Interventional Therapy in Acute Pancreatitis

Study Overview
=================
Brief Summary
-----------------
The study aims to evaluate the course of patients with acute pancreatitis. Thereby we analyze different diagnostics and compare ultrasound, MRI and CT-scan in detection of necrotic areas and evaluate interventional therapy methods like percutaneous drainage techniques regarding the outcome. Laboratory values were assessed as well.

Detailed Description
-----------------
For laboratory values different inflammation markers were measured and compared.

Official Title
-----------------
Diagnostic and Interventional Therapy in Acute Pancreatitis

Conditions
-----------------
Acute Pancreatitis

Intervention / Treatment
-----------------
* Other: CT-guided percutaneous drainage technique


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years Acute pancreatitis Written formal consent Exclusion Criteria: Pregnancy Missing formal consent Individual contraindications for CT-scan MRI or endoscopic ultrasound

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Evaluation of one study cohort | Other: CT-guided percutaneous drainage technique<br>* Evaluation of different diagnostics and evaluation of outcome of patients who received percutaneous CT-guided drainage for necrotic debridement and analyze the further outcome<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay |  | weekly | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to surgery |  | weekly | 
| active necrosectomy |  | weekly | 
| ICU stay |  | weekly | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acute pancreatitis, interventional therapy, CT-guided drainage therapy, percutaneous necrosectomy, Comparison of different diagnostic procedures: MRI, CT, Ultrasound, Evaluation of interventional therapy including percutaneous drainage techniques und necrosectomies
Treatment Response Evaluation in Gastrointestinal Stromal Tumor (GIST) Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare sensitivity, specificity and accuracy of PET, DW MRI and CT separately and combined for the evaluation of treatment response and progression-free survival in patients with GIST.

Official Title
-----------------
Treatment Response Evaluation in Patients With Gastrointestinal Stromal Tumor Using PET/CT and DW MRI

Conditions
-----------------
Soft Tissue Neoplasms, Gastrointestinal Tract

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Metastatic GIST patients suitable for TKI treatment GIST patients pursuing preoperative neoadjuvant TKI treatment Exclusion Criteria: Patients with contraindications to MRI and/or TKI treatment. For patients with renal failure, CT without intravenous contrast will be performed according to clinical practice. Patients who do not sign the consent paper for any reason or do not accept the study premises or patients who wish to withdraw for any reason during the study
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 |
| --- | --- | --- |
| Radiologic-pathologic correlation |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GIST, Response Monitoring, Functional Magnetic Imaging, Positron Emission Tomography, Computer Tomography
Feasibility Study of Deep Brain Recordings for Learning and Memory

Study Overview
=================
Brief Summary
-----------------
Background: - Some people with movement disorders are in another NIH protocol. They will have electrodes placed in deep brain areas. They may do tasks before, during, and after surgery. Researchers want to learn more about how brain cells and networks work while people learn and remember. They want to use the data from the other NIH study to do this. Objective: - To share data from before and during deep brain stimulation surgery. The data will be used in a study of how the brain learns and remembers. Eligibility: - People at least 18 years old who are in protocol 11-N-0211 and have certain movement disorders. Design: As part of protocol 11-N-0211, data on participants brainwave activity is collected. In this protocol, they will have that data stored and shared. Researchers will access imaging data from deep brain stimulation surgery. Researchers will access other medical records.

Detailed Description
-----------------
OBJECTIVES: The purpose of this protocol is to share neural data collected before and during deep brain stimulation surgery with the University of Pennsylvania to identify biomarkers of successful learning and memory. STUDY POPULATION: Up to twenty (20) adult subjects who are participating in NIH protocol 11-N-0211 Deep Brain Stimulation Surgery for Movement Disorders who provide written informed consent for sharing and the additional use of their data. STUDY DESIGN: This protocol only involves providing consent to share learning and memory data collected under Protocol 11-N-0211. There are no separate or additional participant procedures involved in this protocol.

Official Title
-----------------
A Feasibility Study of Deep Brain Recordings for Learning and Memory

Conditions
-----------------
Movement Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA: Adults at least age 18 Currently enrolled in 11-N-0211 EXCLUSION CRITERIA: Unable to provide own informed consent

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 |
| --- | --- | --- |
| Permission to share data from partiicpation on NIH protocol #11-N-0211 |  | ongoing | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MEMORY TESTING, Biomarkers, Learning
Fluoride Metabolism, Bone Remodelling and Mineral Density in HIV Patients Treated With Tenofovir +/- Emtricitabine

Study Overview
=================
Brief Summary
-----------------
HIV+ patients are considered at risk for excessive bone fragility. Several factors could contribute: age, male sex, low body mass index (BMI), HIV infection per se, vitamin D deficiency, using tenofovir/a protease inhibitor (time on and/or current use). Tenofovir is used in a backbone of nucleosides/nucleotides analogues with emtricitabine (FTC), licensed as TRUVADA®, or without this analogue, licensed as VIREAD®. FTC closely resembles lamivudine (3TC) but is 5-fluorinated, the daily intake of fluoride is  15 mg. Fluoride induces bone formation by stimulating osteoblasts, of often impaired bone quality. The aim of the study is to compare in a cross-sectional design fluoride levels, bone renewal, bone mineral density (BMD) in HIV+ male patients treated by TRUVADA® or VIREAD® for more than 60 months. The patients will be randomly selected, then matched according to age, ethnic origin, BMI.

Detailed Description
-----------------
Fluoride metabolism will be studied by measurement of fluoride in blood and in daily urine, bone remodelling by measurement of P1NP. Dual X-ray absorptiometry (DXA) will be used to determine the areal bone mineral density (aBMD) of the lumbar spine, femoral neck and distal radius. Volumetric BMD (v-BMD) and micro-architecture of distal radius and tibia will be studied using a HR-pQCT scan (Xtreme, Scanco).

Official Title
-----------------
Comparative Study of Fluoride Metabolism, Bone Remodelling and Mineral Density in HIV + Men Being Given Tenofovir With FTC, Emtricitabine (TRUVADA®), or Without (VIREAD®), as Part of Their Antiretroviral Therapy.

Conditions
-----------------
HIV Seropositivity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV+ patients male patients patients treated by tenofovir+emtricitabine(TRUVADA®) or tenofovir(VIREAD®) for more than 60 months. Exclusion Criteria: chronic use of fluoroquinolones, antifungal agents, steroids malignancy (current or previous) requiring chemotherapy or radiotherapy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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 |
| --- | --- | --- |
| Areal bone mineral density (aBMD) of the lumbar spine, femoral neck and distal radius measured by Dual X-ray absorptiometry (DXA) |  | ongoing, during the study period, according to the availability of DXA | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
male patients, treated by TRUVADA® or VIREAD® for more than 60 months
Efficacy Study of Activated Prothrombin Complex for Prevention of Bleeds in Hemophilia A With Inhibitors

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to assess whether prophylactic therapy with an activated prothrombin complex concentrate (FEIBA)will result in a significant reduction in the number of bleeds in patients with hemophilia and persistent high responding inhibitors.

Official Title
-----------------
A Prospective, Randomized, Cross-over Study of an Activated Prothrombin Complex Concentrate for Secondary Prophylaxis in Patients With Hemophilia A and Inhibitors

Conditions
-----------------
Hemophilia A With Inhibitors

Intervention / Treatment
-----------------
* Drug: activated prothrombin complex concentrate (FEIBA)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hemophilia A, any severity, with documented history of high-titer inhibitor (>5BU); current use of bypassing agents (PCCs, aPCCs or rFVIIa) for treatment of bleeds; >/= 6 bleeds requiring bypassing therapy in the previous 6 months Exclusion Criteria: concomitant immune tolerance therapy; clinically symptomatic liver disease, platelet count less than 100,000

Ages Eligible for Study
-----------------
Minimum Age: 24 Months

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: On-demand first<br>Patients receive 6 months of on-demand therapy with study drug followed by 6 months of prophylaxis therapy with study drug | Drug: activated prothrombin complex concentrate (FEIBA)<br>* FEIBA for prophylaxis therapy dosed at 85 U/Kg +/- 15% on three non-consecutive days each week for 6 months FEIBA for on-demand therapy dosed at 85 U/Kg +/- 15% for bleeding episodes for 6 months<br>|
| Other: Prophylaxis first<br>Patients receive 6 months of prophylaxis therapy with study drug followed by 6 months on-demand therapy with study drug | Drug: activated prothrombin complex concentrate (FEIBA)<br>* FEIBA for prophylaxis therapy dosed at 85 U/Kg +/- 15% on three non-consecutive days each week for 6 months FEIBA for on-demand therapy dosed at 85 U/Kg +/- 15% for bleeding episodes for 6 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Bleeds During 6 Month Treatment Period |  | 6 months |