linjc16/ctgov huggingface dataset:
Comparative Study Between Posterior Lumbar Interbody Fusion(PLIF) and Intertransverse Process Fusion in Treatment of Spodylolithesis

Study Overview
=================
Brief Summary
-----------------
The first technique described for interbody fusion was the anterior lumbar interbody fusion (ALIF).(20) For this technique, the intervertebral disc is accessed through a retroperitoneal or transperitoneal approach. While the posterior approach was first described by Russell Hibbs in 1911, in the 1950's, Cloward (7)popularized the posterior approach for a posterior lumbar interbody fusion (PLIF).

Detailed Description
-----------------
In this study we will try to identify the benefits and outcome of posterior lumbar interbody fusion and inter transverse process bone graft fusion.

Official Title
-----------------
Comparative Study Between Posterior Lumbar Interbody Fusion(PLF) and Intertransverse Process Fusion in Treatment of Spodylolithesis

Conditions
-----------------
Lumbar Spondylolisthesis

Intervention / Treatment
-----------------
* Procedure: Posterior lumbar interbody fusion
* Procedure: Inter transverse bone grafting


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: lumbar spondylolisthesis Exclusion Criteria: infection of lumbar spine

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
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Posterior inter body fusion and inter transverse process bone graft
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lumbar spondylolisthesis1<br> | Procedure: Inter transverse bone grafting<br>* Inter transverse process bone grafting by bone graft from illiac crest or other sites<br>|
| Active Comparator: Lumbar spondylolisthesis 2<br> | Procedure: Posterior lumbar interbody fusion<br>* Lumbar fusion by screws and inter vertebral cage<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Back pain | Back pain severity grading mild, moderate, severe | 1year postoperative |
Enteral Fish Oil is Superior to Ursodeoxycholic Acid (UDCA) and Placebo for the Treatment of Cholestasis in Infants

Study Overview
=================
Brief Summary
-----------------
To investigate the effect of enteral fish oil and UDCA on the time of cholestasis resolution and other markers of parenteral nutrition-associated liver disease.

Official Title
-----------------
Enteral Fish Oil is Superior to Ursodeoxycholic Acid (UDCA) and Placebo (?) for the Treatment of Cholestasis in Infants

Conditions
-----------------
Cholestasis, Liver Disease

Intervention / Treatment
-----------------
* Drug: Enteral fish oil
* Drug: Ursodeoxycholic Acid
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Neonates admitted to the Neonatal Intensive Care Unit (NICU) at University Hospital (UH) in San Antonio, Texas, who: Are >14 days old and <24 months of age Have a serum direct bilirubin of ≥2 mg/dL Are receiving <3 g/k/day of Intralipid via TPN Are expected to remain hospitalized for at least an additional 21 days Exclusion Criteria: Have a congenitally lethal condition (e.g. Trisomy 13) Have clinically severe bleeding not able to be managed with routine measures Have evidence of a viral hepatitis or primary liver disease as the etiology of their cholestasis Have other health problems such that survival is extremely unlikely even if cholestasis improves Known allergy to eggs or fish products Receiving IV Fish oil Phenobarbital therapy at enrollment

Ages Eligible for Study
-----------------
Minimum Age: 14 Days
Maximum Age: 24 Months

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: Enteral fish oil<br>Infants will receive enteral fish oil at a dose of 1mg/kg/day divided in two daily doses given enterally. | Drug: Enteral fish oil<br> <br> * Other names: Nordic Natural Omega 3;|
| Active Comparator: UDCA (ursodeoxycholic acid)<br>Infants will receive UDCA at a dose of 10mg/kg/dose in two daily doses given enterally | Drug: Ursodeoxycholic Acid<br> <br> * Other names: Actigall;|
| Placebo Comparator: Placebo<br>Infant will receive placebo in two daily doses given enterally | Drug: Placebo<br> <br> * Other names: Sterile Water;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Direct Bilirubin | Direct bilirubin less than 1 mg/dL considered resolution of cholestasis | Evaluated every 7 days up to 180 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parental nutrition, associated
HEmiplegia Arrhythmia Retrospective Trial

Study Overview
=================
Brief Summary
-----------------
Alternating Hemiplegia of Childhood (AHC) is a rare and severe disease that is in need of effective, and hopefully even curative, therapies. Afflicted patients suffer from severe paralyzing crises, often excruciatingly painful muscle spasms, severe often life threatening epileptic seizures, frequently severe developmental and psychiatric/psychological disabilities and other comorbidities, such as cardiac disturbances. Recent data indicate that AHC genotype is in relation to cardiac repolarization troubles and to cardiac arrhythmias. The primary hypothesis to explore is that there is an association between genotype and cardiac phenotype in AHC.

Official Title
-----------------
Role of Alternating Hemiplegia of Childhood Genotype in Cardiac Repolarization. HEART: HEmiplegia Arrhythmia Retrospective Trial

Conditions
-----------------
Alternating Hemiplegia of Childhood

Intervention / Treatment
-----------------
* Other: Recording of clinical parameters and electrocardiogram parameters


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients that meet the clinical diagnostic criteria (Aicardi et al, 1995) for typical alternating hemiplegia with or without identified mutations in ATP1A3. At least one ECG study is required. Patients ages yearand more Exclusion Criteria: Informed consent or assent not obtainable ATP1A3 testing not performed No ECG studies are available

Ages Eligible for Study
-----------------
Minimum Age: 12 Months

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with Alternating Hemiplegia of Childhood<br>Patients that meet the clinical diagnostic criteria (Aicardi et al, 1995) for typical alternating hemiplegia with or without identified mutations in ATP1A3. At least one prolonged ECG study available is required. | Other: Recording of clinical parameters and electrocardiogram parameters<br>* Retrospective recording of demographic information (age, sex, age at diagnosis), genetic information, cardiological information, pharmacological treatments, electrocardiogram data. All above data will be deidentified.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of QTc interval and all relevant cardiac repolarization measurements | Outcome measure: QTc interval and cardiac repolarization measurement in milliseconds. | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ECG, QTc, Cardiac repolarization and arrhythmia, Alternating Hemiplegia
Study of the Effects of Temperature on Metabolism in Human Muscle

Study Overview
=================
Brief Summary
-----------------
This study will examine the role of temperature in changing energy metabolism in human muscle. In order to do this, researchers will use magnetic resonance imaging (MRI) to provide information about how parts of muscle operate during exercise. Magnetic resonance imaging (MRI) is a diagnostic tool that creates high quality images of the human body without the use of X-ray (radiation). In this study, MRI will be used to measure the temperature and energy level of specific muscles during rest and exercise. In addition, the muscles being tested will be heated and cooled to see if temperature directly affects levels of energy in muscle.

Detailed Description
-----------------
This study will examine the role of temperature in modulating aspects of energy metabolism in human skeletal muscle. Tests will be conducted at rest and during concentric dorsiflexion exercise of the Tibialis anterior (TA) muscle using an existing custom-designed dynamometer in conjunction with mild local heating and cooling. Magnetic resonance spectroscopy (MRS), performed in a 4-tesla whole-body NMR system, will be used to non-invasively measure muscle temperature and energy-state. Specifically these tests will assess the extent to which temperature changes occur during aerobic exercise and how small temperature changes affect mitochondrial function in-vivo.

Official Title
-----------------
Study of Temperature Effects on Skeletal Muscle Aerobic Energy Metabolism

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

Intervention / Treatment
-----------------
* Procedure: Magnetic resonance imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Ages 18 to 50. Male and female subjects. Capable of giving informed consent. Healthy normal volunteers. No cardiac pacemaker of implantable defibrillator. No aneurysm clip. No neural stimulator (e.g. TENS-unit). No ear implant of any type. No metal in the eye (e.g. from machining). No implanted device (e.g. insulin pump, drug infusion device). No metallic foreign body, shrapnel, or bullet.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Magnetic resonance imaging|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
-----------------
Exercise, MRI, MRS, Normal Volunteer, Tibialix Anterior
A Study of 1592U89 in HIV-Infected Adults

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if it is safe and effective to give 1592U89 to HIV-positive adults. This study also examines the influence previous anti-HIV treatment has on the effectiveness of 1592U89.

Detailed Description
-----------------
Patients receive open-label 1592U89 administered orally in combination with at least one other antiretroviral agent that the patient has not previously received.

Official Title
-----------------
A 1592U89 Open-Label Protocol for Adult Patients With HIV-1 Infection.

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Abacavir sulfate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Concurrent Medication: Allowed: Erythropoietin, G-CSF and GM-CSF. Patients must have: CD4+ cell count < 100 cells/mm3. HIV-1 RNA > 30,000 copies/ml. Signed, informed consent from parent or legal guardian for patient under 18 years of age. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Renal failure requiring dialysis. Hepatic failure evident by grade 3/4 hyperbilirubinemia and AST 5 times the upper limit of normal. Documented hypersensitivity to 1592U89. Serious medical conditions, such as diabetes, congestive heart failure, cardiomyopathy, or other cardiac dysfunction, that would compromise the safety of the patient. Participation in or ability to participate in an enrolling study of 1592U89. Required: At least 2 nucleoside reverse transcriptase inhibitors (NRTI) and one protease inhibitor (or intolerance to one protease inhibitor and one NRTI due to trying at least 2 different regimens with at least one protease inhibitor). Alcohol or illicit drug use that may interfere with the patient's compliance.

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

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Abacavir sulfate|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
-----------------
HIV-1, Administration, Oral, CD4 Lymphocyte Count, RNA, Viral, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load, abacavir
Ethnic/Racial Variations of Intracerebral Hemorrhage (ERICH)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find risk factors for hemorrhagic stroke, specifically intracerebral hemorrhage (ICH), among Caucasians, African Americans, and Hispanics.

Official Title
-----------------
Ethnic/Racial Variations of Intracerebral Hemorrhage (ERICH)

Conditions
-----------------
Intracerebral Hemorrhage

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All cases must meet the following eligibility criteria: Age 18 years or greater, fulfillment of the criteria for intracerebral hemorrhage Resident for at least 6 months within 50 miles of the recruiting center No evidence of trauma, vascular malformation or aneurysm, or brain tumor as a cause of the hemorrhage Ability of the patient or legal representative to provide informed consent Exclusion Criteria: Exclusion Criteria: Malignancies leading to coagulopathy Hemorrhagic transformation of ischemic infarct Hemorrhage secondary to dural venous sinus thrombosis

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 |
| --- | --- |
| Cases<br>3000 Cases | |
| Controls<br>3000 Controls | |

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
-----------------
Intracerebral Hemorrhage, ICH, Stroke, Cerebrovascular accident
New Ultrasound Parameters for Predicting Birthweight

Study Overview
=================
Brief Summary
-----------------
Babies that are either very small or very big have increased perinatal morbidity and mortality. Predicting which babies will fall into these groups is traditionally done with risk assessment and third trimester manual palpation, however neither of these techniques are sensitive and a considerable number of affected pregnancies are missed. This results in stillbirth for small babies or birth trauma for larger ones. Serial scanning in the third trimester can improve detection rates but this is expensive and cannot currently be provided to all NHS patients. A more sensitive test that can be performed earlier in pregnancy would allow identification of at risk pregnancies allowing for increased monitoring. New three dimensional ultrasound techniques that measure volume and volumetric flow have become available that may allow this to happen. This study proposes to trial newer ultrasound techniques on a cohort of pregnant women. The findings from these scans will then be correlated with actual birth weights at the end of pregnancy to determine the ability of these parameters to act as screening tools for babies at the extremes of size.

Official Title
-----------------
New Ultrasound Parameters for Predicting Birthweight

Conditions
-----------------
Fetal Development

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women the beginning of pregnancy to term Exclusion Criteria: Pregnancies in women previously affected by unclassfied fetal abnormality Multiple pregnancy
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant mothers<br>No intervention | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kidney volume, thigh volume, placental volume, brain volume, final birthweight |  | up to 34-36 weeks pregnancy gestation |
Bosutinib in Combination With Pemetrexed in Patients With Selected Metastatic Solid Tumors

Study Overview
=================
Brief Summary
-----------------
This study will determine the maximum-tolerated dose (MTD) for oral bosutinib when used in combination with pemetrexed. The MTD is the highest dose of bosutinib with pemetrexed that can be given without causing severe side effects. This study will also test the safety of this combination and see what effects (good or bad) it has on participants and their cancer.

Official Title
-----------------
Phase I Study of the Non-receptor Kinase Inhibitor Bosutinib in Combination With Pemetrexed in Patients With Selected Metastatic Solid Tumors

Conditions
-----------------
Carcinoma, Non-Small-Cell Lung, Mesothelioma, Bladder Cancer, Ovarian Cancer, Peritoneal Cancer, Thymoma, Thymus Cancer, Uterine Cervical Cancer

Intervention / Treatment
-----------------
* Drug: Bosutinib
* Drug: Pemetrexed


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pathologically or cytologically proven advanced, metastatic non-squamous non-small cell lung cancer, pleural malignant mesothelioma, bladder or urethral cancer, ovarian cancer, primary peritoneal cancer, thymoma and thymic cancer and uterine cervical cancer. Measurable disease Life expectancy of greater than 3 months. Ability to take folic acid, vitamin B12, and dexamethasone according to protocol. Exclusion Criteria: - Untreated or symptomatic brain metastases.

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bosutinib and Pemetrexed<br>Bosutinib and pemetrexed | Drug: Bosutinib<br>* 100mg daily for 4 cycles (21 days per cycle)<br>Drug: Pemetrexed<br>* 500 mg/m2 every 21 days for 4 cycles<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose-limiting toxicity of the combination of bosutinib and pemetrexed | CTCAE Grade 3 or 4 non-hematologic toxicities other than alopecia, nausea and vomiting. | 21 days | 
| Maximum tolerated dose of the combination of bosutinib and pemetrexed |  | completion of dose escalation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events of the combination of bosutinib and pemetrexed |  | 16 weeks | 
| Anti-tumor response rate |  | 6 and 12 weeks | 
| Progression-free survival |  | 6 and 12 weeks |
Thalassemia Screening by Third Generation Sequencing

Study Overview
=================
Brief Summary
-----------------
Test globin gene in participants

Detailed Description
-----------------
Recruit individuals who documented as thalassemia carrier or disease and who positive thalassemia screening but unknown mutation. Blood will be sent for third generation sequencing to review alpha and beta globin gene mutation.

Official Title
-----------------
Thalassemia Screening by Third Generation Sequencing (TGS): Pilot Study in Thai Population

Conditions
-----------------
Thalassemia Trait, Thalassemia; Mixed

Intervention / Treatment
-----------------
* Procedure: blood draw


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Thalassemia carriers or disease individuals with documented as known globin gene mutation. Thalassemia carriers or disease individuals whose mutation did not retrieve from conventional technique and were assigned as no known mutation Exclusion Criteria: -incomplete medical data
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 |
| --- | --- |
| Other: Thalassemia screening positive<br>In this study only 1 group of participants. No comparative. Only description | Procedure: blood draw<br>* 10 ml of blood will be draw to genetic analysis (sequencing)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validate accuracy of TGS to provide globin gene mutation compared with conventional testing | Percentage of accuracy to give the mutation diagnosis | 6 months after blood test | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Additional mutation added by TGS | Percentage of mutation are added by sequencing | 6 months after blood test |