linjc16/ctgov huggingface dataset:
Pulse Oximeter Responses to Multiple Levels of Stable Hypoxia in Neonates

Study Overview
=================
Brief Summary
-----------------
Validate pulse oximeter sensors in neonates by comparing sensor readings to blood samples during cardiac surgery.

Detailed Description
-----------------
Researchers at the University of California, San Francisco have developed methods that permit them to test multiple pulse oximeter sensors on neonates simultaneously during cardiac surgery. During this type of surgery, the arterial oxygen saturation changes over a wide range, providing an ideal arena for the assessment of neonatal pulse oximeter sensors at many levels of oxygen saturation. Several arterial blood gas samples are typically obtained during these procedures. Saturation of each arterial blood sample is determined by direct oximetry in a hemoximeter and this measurement is compared to the reading displayed on the pulse oximeter.

Official Title
-----------------
Pulse Oximeter Responses to Multiple Levels of Stable Hypoxia in Neonates

Conditions
-----------------
Hypoxia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Neonatal patient scheduled to undergo cardiac surgery where routine blood draws would be taken Understand and provide signed parental/guardian consent Exclusion Criteria: Failure to obtain parental consent Patients shown to have an adverse reaction to medical tape/adhesive

Ages Eligible for Study
-----------------
Maximum Age: 6 Months

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 |
| --- | --- | --- |
| SpO2 Accuracy Verification Study (ARMS) of ≤ 3% |  | During Analysis - data were collected anywhere from the beginning of surgery until the completion of the procedure |
Gait Analysis in MPS IVA

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to learn about gait (walking) characteristics in MPS IVA and possible changes in gait with enzyme replacement therapy.

Detailed Description
-----------------
The purpose of this 3-year study is to conduct a longitudinal investigation using motion analysis of gait to objectively and quantitatively assess gait characteristics of MPS IVA patients. Data documenting gait characteristics and abnormalities will be gathered in patients initiating enzyme replacement therapy. Inclusion criteria Individuals with MPS IVA diagnosed by enzyme or molecular studies Exclusion Criteria Individual with MPS IVA previously enrolled in BMN-110 Individual is non-ambulatory The individual is unable to complete longitudinal study visits at least yearly

Official Title
-----------------
Gait Analysis in Patients With MPS IVA Treated With Enzyme Replacement Therapy

Conditions
-----------------
MPS IVA, Morquio Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Diagnosis of MPS IVA Exclusion Criteria: Non-ambulatory Previous enrolled in clinical trial BMN-110

Ages Eligible for Study
-----------------
Minimum Age: 1 Year

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 |
| --- | --- | --- |
| Measurable changes in gait | Data acquired on patients will be compared with age-matched standardized norms. The normal data is available from a pre-existing Gait Repository, a collection of gait parameters in children without a specific diagnosis studied at Oregon Health and Science University. The results will be converted to centile charts with the aid of a biostatistician. Centile charts will be used to track statistical changes over time in the following gait parameters including but not exclusive to: velocity, cadence, step length, and base of support. | 36 months |
Studying Biomarkers in Samples From Younger Patients With Wilms Tumor

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Studying samples of tissue and urine from patients with cancer in the laboratory may help doctor learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This research trial studies biomarkers in samples from younger patients with Wilms tumor.

Detailed Description
-----------------
OBJECTIVES: To determine a unique molecular finger print of primary Wilms tumor arising in ethnically diverse children who are at increased risk to develop this lethal malignancy and subsequently relapse. To determine a unique protein finger print from the urine of ethnically diverse children who develop Wilms tumor and subsequent relapse. OUTLINE: Formalin-fixed paraffin-embedded and snap-frozen primary tissue samples, and urine samples collected at the time of diagnosis and before treatment, are analyzed for molecular and protein profile by MALDI-TOF mass spectroscopy, western blotting, immunohistochemistry, and reverse-transcriptase polymerase chain reaction (RT-PCR) assays.

Official Title
-----------------
Biological Analysis of Ethnic Variations in Wilms Tumor

Conditions
-----------------
Kidney Cancer

Intervention / Treatment
-----------------
* Genetic: gene expression analysis
* Genetic: proteomic profiling
* Genetic: reverse transcriptase-polymerase chain reaction
* Genetic: western blotting
* Other: immunohistochemistry staining method
* Other: laboratory biomarker analysis
* Procedure: spectroscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Diagnosed with Wilms tumor Specimens from African-American and from Caucasian children Specimens from each ethnicity who relapsed Specimens from each ethnicity who did NOT relapse PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: Not specified
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: gene expression analysis|nan|
|Genetic: proteomic profiling|nan|
|Genetic: reverse transcriptase-polymerase chain reaction|nan|
|Genetic: western blotting|nan|
|Other: immunohistochemistry staining method|nan|
|Other: laboratory biomarker analysis|nan|
|Procedure: spectroscopy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Molecular finger print of primary Wilms tumor in ethnically diverse children |  |  | 
| Protein finger print from the urine of ethnically diverse children |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
recurrent Wilms tumor and other childhood kidney tumors, stage I Wilms tumor, stage II Wilms tumor, stage III Wilms tumor, stage IV Wilms tumor, stage V Wilms tumor
Investigating Project of the Functional C13 Test Pilot Study

Study Overview
=================
Brief Summary
-----------------
The aim of this pilot study is to evaluate the validity and reproducibility of a functional test Test C13 ureogenesis to measure in vivo, using the methodology Laboratory of Metabolic Diseases of Cliniques Universitaires Saint-Luc

Official Title
-----------------
Investigating Project of the Functional C13 Test

Conditions
-----------------
Disorder of the Urea Cycle

Intervention / Treatment
-----------------
* Drug: Oral C13


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy or with a disorder of the urea cycle Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: C13<br>The dose of sodium [1-13C] acetate is calculated according to patient weight (27mg/kg) or (0.33 mmol / kg). | Drug: Oral C13<br>* Ingestion of C13 and follow up of the ureogenesis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject with a disorder of the urea cycle |  | Day 1 |
Shared Decision Making for Patients With First-admission Schizophrenia

Study Overview
=================
Brief Summary
-----------------
To determine whether shared decision making (SDM) intervention improves patient satisfaction in patients with first-admission schizophrenia compared with usual care.

Official Title
-----------------
Shared Decision Making for Patients With First-admission Schizophrenia: a Randomized Controlled Trial

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Behavioral: Shared Decision Making


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Admitted to an acute care psychiatric ward. Diagnosed with schizophrenia (ICD-10 codes: F20-F29) Aged 16 to 65 years old at admission No prior experience of psychiatric admission (first-admission) Exclusion Criteria: Diagnosed with moderate to severe mental retardation Diagnosed with organic mental disorders (ICD10 codes: F00-F09) Having poor Japanese language skill Severe conceptual disorganization as measured by brief psychiatric rating scale of 5 or more.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 65 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Shared Decision Making<br>The present SDM intervention is based on principles derived from previous randomized controlled trials of SDMs. SDM meetings comprise at least 4 weekly 20 minutes sessions. Meetings have at least three professionals: a case manager (psychiatrists or nurses), a primary doctor, and a nurse/social worker. The focus of the meeting is to empower patients to discuss their attitudes and preferences toward treatments. | Behavioral: Shared Decision Making<br>* The focus of the SDM is to empower patients to discuss their attitudes and preferences toward treatments.<br>|
| No Intervention: Usual Care<br>Patients with no special program about decision making. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction as measured by the Japanese version of the Client Satisfaction Questionnaire (CSQ-8) |  | Within 7days before the date of discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attitude toward medication as measured by the Japanese version of the Drug Attitude Inventory (DAI-10) |  | Within 7days before the date of discharge | 
| Treatment continuation as measured by the rate of outpatient attendance during the 30 days |  | 6 months after discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
First hospitalization
Intravenous Iron Pre-treatment in Prognathic Surgery

Study Overview
=================
Brief Summary
-----------------
The objective of the present study is to determine the impact of preoperative IV-iron (ferric carboxy maltose) supplementation on postoperative hematocrit values and allogenic blood transfusion amount in patients undergoing elective prognathic surgery.

Official Title
-----------------
Preoperative Intravenous Iron Supplementation on Postoperative Hematocrit and Intraoperative Transfusion Amount in Prognathic Surgery

Conditions
-----------------
Prognathic Surgery

Intervention / Treatment
-----------------
* Drug: Ferric carboxymaltose
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with prognathism in undergoing elective prognathic surgery Patients provided a written informed consent. Patients with s-ferritin < 300 mg/dl (male) or 200 mg/dl (female) Patients with preoperative Hematocrit > 39% (male) and > 36% 9female)serum hemoglobin >13 g/dL (male) and >12 g/dL (female) Exclusion Criteria: Patients with history of anaphylaxis, iron overload, active infection. Patients with endocrine disease Patients received or receiving intraoperative and preoperative blood salvaged, allogenic blood transfusion, anti-fibrinolytic agents or recombinant human erythropoietin, or undergoing acute normovolemic hemodilution.

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>Ferric carboxymaltose | Drug: Ferric carboxymaltose<br>* Ferric carboxymaltose 15 mg/kg mg is intravenously administered on 7-10 day before surgery.<br>|
| Placebo Comparator: Control Group<br>Placebo | Drug: Placebo<br>* normal saline 100 ml is intravenously administered on 7-10 day before surgery<br>* Other names: normal saline;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum-Hematocrit | intergroup-difference immediately after surgery, % | Postoperative 2 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum-Ferritin level | intergroup-difference in postoperative hematocrit level, % | Postoperative 2 hour | 
| Changes of serum-Ferritin level | Intragroup-difference in the s-ferritin before and immediately after surgery, mg/dl | Postoperative 2 hour | 
| Transfusion amount | intergroup-difference in the amount of packed RBC transfused during surgery, unit | Postoperative 2 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prognathic surgery, intravenous iron
Study of a Candidate Gene Involved in Goldenhar Syndrome.

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to identify of the first gene involved in the Goldenhar syndrome in a cohort of 120 affected patients.

Detailed Description
-----------------
Goldenhar syndrome belongs to the heterogeneous spectrum of oculoauriculovertebral dysplasia. Several chromosomal abnormalities have been described associated with this spectrum, and furthermore mutations in different genes of development cause abnormalities of the jaw or facial asymmetries in human or mouse. To date, no gene has been identified as formally involved in the genesis of the OAVS, despite evidence of familial cases, mostly with autosomal dominant inheritance. The aim of this study is to identify of the first gene involved in the Goldenhar syndrome in a cohort of 120 affected patients.

Official Title
-----------------
Identification and Investigation of a Gene Involved in Monogenic Forms of Goldenhar Syndrome.

Conditions
-----------------
Goldenhar Syndrome, Oculoauriculovertebral Dysplasia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Spectrum of oculoauriculovertebral dysplasia minimal features include unilateral microtia and hemifacial microsomia Exclusion Criteria: Absence of minimal spectrum of oculoauriculovertebral dysplasia features, molecular anomaly identified, other diagnosis
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 |
| --- | --- | --- |
| presence of sequence variation | Identification of the first gene involved in Goldenhar syndrome | At the screening | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
array-CGH, exome sequencing
Audit of Management of First Stage of Labour in Assiut University Hospitals : a Quality Improvement Project

Study Overview
=================
Brief Summary
-----------------
auditing the current management of first stage of normal vaginal deliveries at Assiut university hospitals emergency obstetric care

Detailed Description
-----------------
Clinical auditing is a quality improvement process that involves reviewing the delivery of healthcare to ensure the best practice is being carried out . it is agreed that caesarean section rates are above the nationally accepted in Egypt . This can be related to many factors and can be associated with risks to morbidities and mortalities

Official Title
-----------------
Audit of Management of First Stage of Labour in Assiut University Hospitals : a Quality Improvement Project

Conditions
-----------------
Vaginal Delivery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: term 37- 41 weeks primigravida single vertex presentation living fetus spontaneous onset no contraindications for vaginal delivary Exclusion Criteria: women with associated co morbidities pre eclampsia and diabetes IUFD previous uterine scar intrauterine growth restriction

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Nice clinical guidelines for intrapartum care for healthy women and babies<br>define gold standards in intrapartum care for healthy women and babies | |
| performance in the care provided to patients in periods of audit<br>measure performance in the care provided to the patients in the period of audit | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measure performance according to gold standers | measure performance and adherence to gold standers during management of first stage of labour in assuit university hospitals | BASELINE | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| introduction of NICE guidelines in practice | introduction of NICE guidelines in management of first stage of labour in practice in assuit university hospitals | baseline |
Observational Study to Evaluate the Safety of Levemir® in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Europe, North America and Asia. The aim of this observational study is to evaluate the safety and effectiveness while using Levemir® once daily in combination with oral antidiabetic drugs in type 2 diabetics during 24 weeks under normal clinical practice. Data from the NN304-3573 study (NCT00740519) will be pooled with data from this study and reported together in the final study report for this study.

Official Title
-----------------
A Multicentre, Open Label, Observational 24-week Study to Evaluate Safety of Initiating Insulin Therapy With Levemir® (Insulin Detemir) Once-daily in Oral Antidiabetic Drug-treated Patients With Type 2 Diabetes

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: insulin detemir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: After the participating physician's decision has been made to initiate once-daily Levemir® therapy, any patient with Type 2 diabetes who is currently treated with diet, exercise and one or more OADs can be offered to participate Exclusion Criteria: Current treatment with insulin Known or suspected allergy to Levemir® or excipients Children below the age of 6 years Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant within the next 6 months or are not using adequate contraceptive methods (contraceptive measures as required by local law or practice)
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Insulin detemir<br> | Drug: insulin detemir<br>* Start dose and frequency to be prescribed by the physician as a result of a normal clinical evaluation<br>* Other names: NN304, Levemir®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of serious adverse drug reactions (SADRs) including major hypoglycaemia |  | during 24 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of all adverse drug reactions (ADRs) |  | during 24 weeks of treatment | 
| Incidence of major and minor hypoglycaemic events |  | in the 4 weeks preceding trial start, and at the 12 and 24 week visits | 
| HbA1c and its change from trial start |  | at the 12 and 24 week visits | 
| Fasting blood glucose (FBG) (average of the self-monitored blood glucose measurements) and its change from trial start |  | at the 12 and 24 week visits | 
| FBG variability (measured as standard deviation of FBG) and its change from trial start |  | at the 12 and 24 weeks visits | 
| Body weight and its change from trial start |  | at the 12 and 24 week visits |