linjc16/ctgov huggingface dataset:
Evaluation of UDP-glucose as a Urinary Biomarker for Early Detection of Cardiac Surgery-associated Pediatric Acute Kidney Injury

Study Overview
=================
Brief Summary
-----------------
Acute kidney injury (AKI) is common in children after cardiac surgery with a reported incidence of 20-40%. Pediatric AKI has been found to be associated with important short and long-term adverse outcomes. A major challenge to management of AKI after cardiac surgery and cardiopulmonary bypass is the lack of early diagnostic markers. Current diagnostic criteria for AKI in children relies exclusively on elevation of serum creatinine concentration and oliguria. Both of these markers lack sensitivity and specificity, and result in delayed detection of kidney injury. This study aims to determine if UDP-glucose can be used as a urinary biomarker to detect subclinical acute kidney injury following pediatric cardiac surgery with cardiopulmonary bypass.

Official Title
-----------------
Evaluation of UDP-glucose as a Urinary Biomarker for Early Detection of Cardiac Surgery-associated Pediatric Acute Kidney Injury

Conditions
-----------------
Acute Kidney Injury

Intervention / Treatment
-----------------
* Other: Discarded urine sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: less than or equal to 8 years of age scheduled for cardiac surgery Exclusion Criteria: severe pre-existing renal insufficiency

Ages Eligible for Study
-----------------
Maximum Age: 8 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 |
| --- | --- |
| AKI Group<br>Patients developing AKI after surgery | Other: Discarded urine sample<br>* Collection of discarded urine during surgery and following surgery<br>|
| No AKI Group<br>Patients who do not develop AKI after surgery | Other: Discarded urine sample<br>* Collection of discarded urine during surgery and following surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AKI | development of AKI | within 72 hours after surgery |
Characteristics and Predictors of Progression of an Egyptian Multiple Sclerosis Cohort

Study Overview
=================
Brief Summary
-----------------
Initial recruitment: 1717, 136 (7.92%) were excluded due to missing data that could not be obtained. The diagnosis of multiple sclerosis (MS) was revised according to the 2010 revision of the McDonald criteria. Patients analyses: 1581 Every patient was registered by his/her 14-digit unique identity numbers, (which is mandatory in Egypt since 1999) to make sure that every registered patient in different centers were counted only once.

Detailed Description
-----------------
Patients' records review procedure and sampling strategies. The medical records, administrative data, laboratory and diagnostic tests reports were screened by 3 authors (HS, NS, AE) and these data were extracted in a standard electronic form according to Kasr Alaini Multiple Sclerosis Unit (KAMSU) registry. An assigned coordinator from each center was requested to facilitate data collection from site-specific records. In cases of incomplete documentation or unclear information, verification was done by on-site data coordinator either by phone contact or face-to-face interview with the patients, whether during the routine follow up or in an unscheduled visit. Several measures were taken to ensure the confidentiality of the collected information. No patient names were included in the database presented by site coordinator, and the study staff signed a confidentiality agreement for non-disclosure.

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Other: medical records review


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with suspecting multiple sclerosis attending 4 tertiary referral centers in Egypt Exclusion Criteria: missing data that could not be obtained

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 60 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: medical records review|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evoked Potentials (measure latency in m.sec) | Number of patients with delayed latency of Evoked Potentials | 13 months (through study completion) | 
| Cerebrospinal Fluid (CSF): measure IgG index and Oligoclonal bands (OCB) | Number of patients with elevated IgG index and OCB | 13 months (through study completion) |
Hereditary AngioEdema, Neurobiology and Psychopathology

Study Overview
=================
Brief Summary
-----------------
Since 1963 Hereditary AngioEdema (HAE) is considered an autosomal dominant disorder (Donaldson and Evans), characterized by a quantitative and/or qualitative deficit of C1 esterase inhibitor (C1-INH), which affects approximately 1:50.000 individuals in the general population. From this period the link between HAE and psychiatry was interrupted, however genetic issues could not comprehensively explain the clinical evolution of the disease. Clinical studies show an evident gap between genotype and phenotype of HAE. For this still controversial question, we have designed this cross-sectional study in order to establish the relationship between HAE clinical manifestations and neurobiological/psychopatological parameters.

Conditions
-----------------
Hereditary AngioEdema, Anxiety, Depression

Intervention / Treatment
-----------------
* Other: Clinical and psychopathological assessment of HAE patients


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of HAE Exclusion Criteria: Current pharmacological treatment including ACE-inhibitors, ACE inhibitors, glucocorticoids, oestroprogestative, psychotropic drugs, drugs acting on the immune system (15 days before), anesthetics (in the previous three months). Inflammation / infection (eg, chronic inflammatory diseases, acute) in the last 15 days. Ongoing allergies. Night work over the past 15 days. Vigorous physical activity or alcohol consumption (the day before the assessment). Women in follicular phase of menstrual cycle.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| HereditaryAngioEdema<br>Patients from the Eastern Sicily HAE register | Other: Clinical and psychopathological assessment of HAE patients<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multivariate linear regression analysis of HAE clinical status and psychometric parameters |  | First assessment |
Scapholunate Ligament Partial Tears; Tear Localization, Extrinsic Ligament Injury Association and Conservative Treatment Responses Prior to Instability

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate scapholunate ligament partial tears regarding tear localization, extrinsic ligament accompaniment in stable wrist and accordingly to scrutinize conservative treatment response.

Detailed Description
-----------------
Patients admitted with radial sided wrist pain without carpal instability were retrospectively evaluated. Scapholunate interosseous ligament (SLIOL) tear localization, grade of injury and associated extrinsic ligament injuries were examined on MRI. Patients treated conservatively and recalled at their first year for re-evaluation.

Official Title
-----------------
Retrospective Trial, Scapholunate Ligament Partial Tears in Stable Wrist

Conditions
-----------------
Scapholunate Ligament Partial Tears

Intervention / Treatment
-----------------
* Procedure: Conservative Treatment (splint)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Scapholunate ligament Injury Wrist Extrinsic Ligament Injury Exclusion Criteria: Scapholunate Dissociation Radiological and clinical instable wrist Carpal bone fracture MRI imaging artefact

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Conservative Treatment (splint)|splint 6 weeks|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in visual analog scale for pain, disabilities of the arm, shoulder and hand questionnaire and Patient-Rated Wrist Evaluation scores from baseline and at first year | Visual analog scale for pain scored from 0 to 10, disabilities of the arm, shoulder and hand questionnaire scored and Patient-Rated Wrist Evaluation scores from from 0 to 100 were scaled at initial admission, before treatment and at their first year recruitment after treatment for assessment conservative treatment success. | Baseline and 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Scapholunate interosseous ligament, Extrinsic wrist ligaments, Carpal instability, MRI of wrist, Wrist ligamentous injury,
Optimization of Cardiac Resynchronization Therapy by Non-Invasive Imaging of Cardiac Electrophysiology

Study Overview
=================
Brief Summary
-----------------
The principal aim is to analyze total left and right ventricular activation time in different CRT device programming algorithms (SyncAV) measured by non-invasive electrophysiology

Detailed Description
-----------------
Patient specific anatomic parameters taken from the cardiac magnetic resonance examination will be the base for a semiautomatic model incorporating the conductivity of the heart, the lungs, blood and the torso. For this reason, a software package (AMIRA Developer, TGS Template Graphics Software, France) has been adapted to calculate a quasi static approximation of Maxwell equations. After fusion of the T1 CMR scan and the ECG electrodes a model-based bidomain FEM is used for a step-wise measurement of the local activation times (resting potential: 290 mV; plateau: 0 mV; acceleration time: 3 ms) both Ende- and epicardially.

Official Title
-----------------
Optimization of Cardiac Resynchronization Therapy by Non-Invasive Imaging of Cardiac Electrophysiology: A Pilot Study

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Device: Device programming


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients after successful implantation of a CRT-D or CRT-P device in whom a cardiac magnetic resonance examination is possible and the device is equipped with the SyncAV® programming software left bundle branch block before CRT implantation PQ interval ≤ 250 ms before implantation Exclusion Criteria: high-grade AV block any contraindication concerning a safe CMR performance including claustrophobia terminal heart failure (NYHA IV) or cardiac decompensation life expectancy < 1 year women with child-bearing potential, pregnancy drug abusus

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Device programming<br>according to different settings from the SyncAV algorithm | Device: Device programming<br>* Non-invasive electrophysiology with 65 ECG leads will be performed in 16 different device programming<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optimal (shortest) activation time of the right and left ventricular in heart failure patients after CRT implantation | The activation time will be measured in 16 different device programming settings | The measurements will be done at Day 1 |
Study of Limited Versus Continuous Isoniazid Tuberculosis Preventive Therapy in HIV-infected Persons in Botswana

Study Overview
=================
Brief Summary
-----------------
This is a randomized, blinded, two-arm comparative trial of continued versus limited isoniazid (INH) tuberculosis (TB) preventive therapy in HIV-infected adults in Gaborone and Francistown, Botswana. Subjects will be accrued over two years and followed for a minimum of 36 months.

Detailed Description
-----------------
Randomized, double blinded, two-arm comparative trial of continuous vs. limited isoniazid preventive therapy in HIV-infected adults in Gaborone and Francistown, Botswana. Subjects will be accrued over two years and followed for a minimum of 36 months.

Official Title
-----------------
A Randomized, Placebo-Controlled Study of Limited vs. Continuous Isoniazid Tuberculosis Preventive Therapy in HIV-infected Persons in Botswana

Conditions
-----------------
Tuberculosis, HIV Infections

Intervention / Treatment
-----------------
* Drug: Isoniazid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV-infected Age >=18 years Tuberculin skin test positive or negative Laboratory: Hemoglobin (Hgb) >6.5 gm/dl; Neutrophil count >1,000 cells/mm3; Platelets >75,000/mm3; AST (SGOT) <122 U/L; Creatinine <1.5 mg/dl; Beta HCG = negative Karnofsky performance status >=60 Signed informed consent Exclusion Criteria: History of TB in the last 3 years or current active TB History of noncompliance to chronic therapies

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Continuous vs limited isoniazid<br>The placebo arm will receive 6 months of open label isoniazid before beginning placebo (as a coded medication). The treatment (experimental arm) will receive 6 months of open label isoniazid before beginning coded medication (isoniazid). | Drug: Isoniazid<br>* Daily 300 mg isoniazid supplemented with 25 mg pyridoxine for 6 months vs 36 months.<br>* Other names: Isonicotinic Acid Hydrazide;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incident tuberculosis |  | During enrolment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death |  | During enrolment | 
| Adverse events | After enrolment, half of the participants will receive isoniazid for 6 months and the other half for 36 months. | During provision of study medication | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, TB, Tuberculosis, INH, Isoniazid, Preventive therapy, AIDS, Botswana, LTBI, Latent TB Infection
SK-1403 Long-term Treatment Study; Long-term Study in Patients With Secondary Hyperparathyroidism Receiving Hemodialysis

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and efficacy of treatment with SK-1403 for 52 weeks in patients with secondary hyperparathyroidism on maintenance hemodialysis.

Official Title
-----------------
SK-1403 Long-term Treatment Study - Long-term Study in Patients With Secondary Hyperparathyroidism Receiving Hemodialysis -

Conditions
-----------------
Secondary Hyperparathyroidism

Intervention / Treatment
-----------------
* Drug: SK-1403


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Serum PTH>240 pg/mL at the screening Serum corrected Ca≥8.4 mg/dL at the screening Stable chronic kidney disease patients who undergo hemodialysis or hemodialysis filtration Exclusion Criteria: Primary hyperparathyroidism Severe liver disease Severe cardiac disease History or family history of long QT syndrome Malignant tumor Uncontrolled diabetes mellitus Uncontrolled hypertension A history of severe drug allergy

Ages Eligible for Study
-----------------
Minimum Age: 20 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: SK-1403<br>Patients receive SK-1403 three times a week administered by intravenous bolus injection at the end of each hemodialysis for the whole treatment periods (52 weeks), with individual dose adjustment. | Drug: SK-1403<br>* Patients receive SK-1403 three times a week administered by intravenous bolus injection at the end of each hemodialysis for the whole treatment periods (52 weeks), with individual dose adjustment.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events or adverse drug reactions | Number of participants with adverse events or adverse drug reactions | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of participants who achieved a serum iPTH level of ≥ 60 pg/mL and ≤ 240 pg/mL at each time point | Rate of participants who achieved a serum iPTH level of ≥ 60 pg/mL and ≤ 240 pg/mL at each time point; Assessed by laboratory test value | 52 weeks | 
| Measured values and Changes from baseline in serum PTH, Ca, ionized Ca, P, and serum Ca x P product | Measured values and Changes from baseline in serum PTH, Ca, ionized Ca, P, and serum Ca x P product; Assessed by laboratory test value | 52 weeks |
Use of Acupuncture for Dental Pain: Testing a Model

Study Overview
=================
Brief Summary
-----------------
This study is testing the safety and effectiveness of acupuncture in controlling pain related to the removal of partially impacted mandibular third molars. Acupuncture is the Chinese art of healing by inserting needles into the skin. Participants ages 18 - 40 are given an initial x-ray to determine if one lower molar is partially bony impacted. Eligible participants will then undergo standard oral surgery to remove the impacted molar. A local anesthetic will be used prior to surgery. Directly after surgery the participant will be assigned to one of three groups. Participants will not be able to select which group they are assigned. Participants will receive either real or sham (fake) acupuncture as a treatment for post-extraction pain. After the initial acupuncture treatment, participants are required to remain for six hours at the dental site to be monitored. If a participants discomfort is measured as moderate or higher then a second acupuncture treatment will be administered. All participants will be administered questionnaires during the day of surgery. Participants will also be required to complete two diaries during the seven days following surgery. On the seventh day, participants return to have stitches removed and hand in completed diaries.

Official Title
-----------------
Use of Acupuncture for Dental Pain: Testing a Model

Conditions
-----------------
Tooth, Impacted

Intervention / Treatment
-----------------
* Procedure: Acupuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least one lower mandibular molar with partial bony impaction General good health Minimum body weight of 99 lbs. Able to read and write in English

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Acupuncture|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Evaluating the Patient-Ventilator Synchrony During Mechanical Ventilation in Patients With Acute Lung Injury

Study Overview
=================
Brief Summary
-----------------
The overall purpose to the study is to prospectively study how often patients with and without acute lung injury (ALI) have patient-ventilator asynchrony demonstrated as stacked breaths. The investigators seek to describe the quantity of stacked breaths by continuously recording flow, volume, and pressure waveforms routinely displayed on the vent. The investigators also seek to describe how primary ICU teams manage asynchrony documenting interventions of sedation or vent manipulation and what modality is most successful.

Conditions
-----------------
Mechanically Ventilated ICU Patients

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 18 years intubated and mechanically ventilated diagnosed with acute lung injury (ALI) or requiring mechanical ventilation for reasons other than ALI Exclusion Criteria: neurological deficits (acute or chronic) that prevent effective diaphragm activity. Neuromuscular disease affecting the diaphragm Neuromuscular blockade

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 |
| --- | --- | --- |
| double stacks | ventilator waveform recording | number per minute over 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| level of sedation | Richmond Agitation Sedation Score | baseline | 
| mode of ventilation | ventilator adjustment | 30min |