linjc16/ctgov huggingface dataset:
Neurocognitive Impact of Hypoglycemia in Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
125 children with Type 1 Diabetes mellitis (T1DM) between 4 and 16 were recruited and 62 healthy siblings also enrolled in the study. Children with T1DM and sibling controls ages 4 to 16 were assessed on memory and executive control skills at entry to the study (Test 1) and after two years of close monitoring for blood sugar events (Test 2). Diabetic children have their blood sugar tested directly before and after cognitive testing to ensure their blood sugar is within range during the testing. The 2-year follow-up period involves parents/child reporting any severe diabetic episode and periodically providing the results of the diabetic child's usual blood tests from their glucose monitoring device. Children 7 and older also underwent high resolution MRI scans.

Official Title
-----------------
Neurocognitive Impact of Hypoglycemia in Type 1 Diabetes

Conditions
-----------------
Type 1 Diabetes Mellitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 4 - 16 (for MRI, must be 7 or older) Exclusion Criteria: Pregnant or lactating (females 13+) Chronic disease other than T1DM, well-controlled asthma, or Hashimoto's thyroiditis. (Exclude for hypothyroidism) Other current serious medical illness Co-morbid psychiatric illness: such as mania, ADHD, LD, major depression, mental retardation, or psychoactive drug dependence Co-morbid neurological illness: stroke, seizure, major loss of consciousness, other brain trauma/surgery, or head injuries (i.e. near drowning), encephalitis, or hydrocephalus, blindness, deafness EXCEPT T1DM-related Pre-maturity at birth >4 wks early (<36 wk term) w/ sequelae e.g. on respirator at NICU Use of psychoactive medications or exposure to neuroleptics (except that exposures of less than 1 month, occurring more than 5 years ago, will be allowed) or pts. w/recent tx w/dopamine depleting agents or stimulants such as Ritalin, Cylert, Adderall Contraindication to MRI scan (e.g. claustrophobia, metal implants, foreign bodies) - N/A if < 4 years old Full set (top and bottom) orthodontic braces. (Half set braces, fillings, and retainers are OK)

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 16 Years

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 |
| --- | --- |
| Type 1 Diabetes Mellitis<br>Children with Type 1 Diabetes Mellitis (T1DM) between 4 and 16 were recruited. | |
| Non diabetic Control<br>62 healthy siblings also enrolled in the study between the ages of 4 and 17. | |

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
-----------------
Type 1 Diabetes Mellitis, MRI
Clinical and Functional Consequences of Photodynamic Diagnosis (PDD) and Intravesical Instillation Therapy

Study Overview
=================
Brief Summary
-----------------
The aim is to evaluate and compare treatment strategies for non-muscle invasive bladder cancer. Furthermore, the impact of intravesical instillations on bladder function will be examined by urodynamic examination both prior to and following instillation therapy.

Official Title
-----------------
Clinical and Functional Consequences of Photodynamic Diagnosis (PDD) and Intravesical Instillation Therapy

Conditions
-----------------
Non-muscle Invasive Bladder Cancer

Intervention / Treatment
-----------------
* Other: Urodynamic examination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: non-muscle invasive bladder tumour Exclusion Criteria: more than one previous bladder tumour recurrence muscle invasive bladder cancer (at baseline or prior to inclusion) utilization of urinary catheter have had heart valve replacement performed pregnant or lactating
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TURBT alone<br>Patients treated with TURBT without adjuvant instillation therapy | Other: Urodynamic examination<br>* A urodynamic examination is performed in all patients four to six weeks following TURBT and repeated six months later in order to obtain bladder function and possible changes.<br>|
| TURBT and mitomycin C<br>Patients treated with TURBT followed by six adjuvant instillations with mitomycin C | Other: Urodynamic examination<br>* A urodynamic examination is performed in all patients four to six weeks following TURBT and repeated six months later in order to obtain bladder function and possible changes.<br>|
| TURBT and bacillus Calmette-Guerin<br>Patients treated with TURBT followed by six adjuvant instillations with BCG | Other: Urodynamic examination<br>* A urodynamic examination is performed in all patients four to six weeks following TURBT and repeated six months later in order to obtain bladder function and possible changes.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in urodynamic specifics (bladder compliance, detrusor overactivity, maximal cystometric capacity) | Obtained from the urodynamic test | examined at time 0 and after six months |
CT and Radiologist RCT

Study Overview
=================
Brief Summary
-----------------
The use of computed tomography (CT) imaging is rapidly increasing in healthcare. Despite physicians' growing reliance on radiological assessments, however, the reliability and accuracy of reads are highly variable. Inconsistencies may result from multiple factors. The researchers hypothesize that the presence and quality of clinical information will affect radiologist's assessment of CT scans for the presence/absence of a ventral hernia.

Official Title
-----------------
How Important is a Clinical Data for a Radiologist? A Double-Blinded Randomized Controlled Trial of Radiologic Interpretation of Ventral Hernias Following Selectively-Provided Clinical Information

Conditions
-----------------
Hernia

Intervention / Treatment
-----------------
* Other: Clinical Exam Findings
* Other: Inaccurate Clinical Exam Findings
* Other: No clinical exam findings


Participation Criteria
=================
Eligibility Criteria
-----------------
Participants are radiologists at LBJ Hospital.

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

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Accurate Clinical Exam Findings<br>Radiologists will be provided with accurate clinical exam data. | Other: Clinical Exam Findings<br>* Findings found on clinical exam of a patient the radiologist will be reading CT scans of.<br>|
| Other: Inaccurate Clinical Exam Findings<br>Radiologists will be provided with purposefully incorrect clinical exam data | Other: Inaccurate Clinical Exam Findings<br>* Inaccurate findings are given to the radiologists<br>|
| Other: No Clinical Exam Findings<br>Radiologists will be not be provided with any clinical exam data | Other: No clinical exam findings<br>* No clinical exam findings are given to the radiologists<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hernia detected on CT | proportion of hernias detected on CT | CT taken within 1 year |
Patient Outcomes With Endoscopic Versus Open Carpal Tunnel Release

Study Overview
=================
Brief Summary
-----------------
Although some surgeons prefer one technique rather than the other, both endoscopic and open carpal tunnel release procedures are accepted as standard of care surgeries to relieve carpal tunnel syndrome. The investigator's research is designed to evaluate the significant difference in patient satisfaction between endoscopically-released wrists and open-released wrists. The goal of the study is to compare the two techniques using the following criteria: Primary outcome: patient satisfaction via surveys used in prior publications Secondary outcome: length of time to return to work Secondary outcome: clinical data for recovery from carpal tunnel syndrome including a thorough physical exam and EMG's Secondary outcome: complication rates

Official Title
-----------------
Endoscopic vs Open Carpal Tunnel Release: Comparison of Patient Satisfaction, Outcomes, and Complications

Conditions
-----------------
Carpal Tunnel Syndrome

Intervention / Treatment
-----------------
* Procedure: endoscopic carpal tunnel release
* Procedure: open carpal tunnel release


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients between the ages of 18 and 75 Documented clinical and electromyography (EMG) proven carpal tunnel syndrome Exclusion Criteria: Recurrent carpal tunnel syndrome Inflammatory arthropathy Peripheral neuropathy Diabetes < 18 or > 75 years old Pregnant at the time of enrollment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: endoscopic surgery<br> | Procedure: endoscopic carpal tunnel release<br>* endoscopic surgery, which is standard of care for carpal tunnel release<br>|
| Active Comparator: open surgery<br> | Procedure: open carpal tunnel release<br>* open surgery, which is standard of care for carpal tunnel release<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary outcome: patient satisfaction via surveys used in prior publications |  | 24 weeks |
Pomegranate Juice Effect on Oxidative Stress in Infertile Women During IVF Treatment

Study Overview
=================
Brief Summary
-----------------
tTe investigators estimate pomegranate supplementation effect on oxidative stress in infertile women with PCOS, endometriosis and advanced maternal age during IVF treatment. The primary aim is to compare the obtained oxidative stress markers in follicular fluid with pomegranate supplementation vs control.

Official Title
-----------------
Pomegranate Juice Effect on Oxidative Stress in Infertile Women During IVF Treatment

Conditions
-----------------
PCOS, Endometriosis, Advised Maternal Age, Male Factor Infertility

Intervention / Treatment
-----------------
* Other: Pomegranate juice
* Other: Apple juice


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergo IVF treatment with diagnosis of PCOS/Endometriosis/MF or AMA Exclusion Criteria: Patients who do not meet the inclusion criteria, as above

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: RCT
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pomegranate<br> | Other: Pomegranate juice<br>* Pomegranate juice<br>|
| Active Comparator: Apple<br> | Other: Apple juice<br>* Apple juice<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cytokines levels in follicle fluid | Cytokines (pg/mL) will be mesured by elisa. | 2 weeks |
Infant Medical Records: Case Report Proposal

Study Overview
=================
Brief Summary
-----------------
Infants with congenital long QT syndrome (LQTS) and 2:1 atrioventricular block (AVB) have been recognized as a clinical subset of children with LQTS. The purpose of this study is to describe the clinical course and outcome of a patient with congenital long QT syndrome (LQTS).

Detailed Description
-----------------
It has been previously reported that 2:1 AVB in neonatal LQTS seems preferentially associated with HERG mutations . It has also been reported in association with the SCN5A gene. We report on a neonate with congenital LQTS and congenital complete heart block who experienced frequent episodes of torades des pointe and ventricular tachycardia, which, over the first 2 days of life, was recalcitrant to traditional therapy of beta-blockers and other antiarrhythmics. Eventually hypotension necessitated the use of an epinephrine infusion, which halted the ventricular tachyarrhythmias. A pacemaker was implanted once the infant was stable and, currently, he is thriving. Genetic analysis revealed a HERG mutation. For this study, we will need access to the infant's inpatient and outpatient medical records at Children's Healthcare of Atlanta at Egleston Children's Hospital and Sibley Heart Center Cardiology to include his age, date of birth, medical record number, inpatient labs, inpatient echo reports, outpatient echo reports, inpatient and outpatient EKG's, inpatient pharmacy records, the results of his genetic analysis, his history and physical, transfer notes, daily progress notes, consultation reports and operative reports from his admission beginning 9/30/04.

Official Title
-----------------
Baby R. Case Report Proposal

Conditions
-----------------
Congenital Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Congenital long QT Syndrome single case report Exclusion Criteria: Single case report

Ages Eligible for Study
-----------------
Maximum Age: 21 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pediatric, cardiac, Long QT Syndrome, Pacemaker, Herg mutation
Treatment of Incomplete Abortion With 600 Mcg Oral Misoprostol Compared to Standard Surgical Treatment

Study Overview
=================
Brief Summary
-----------------
This study aims to compare the efficacy, side effects profile and acceptability of a single dose of 600mcg misoprostol taken orally compared to standard surgical treatment as per local protocols for the treatment of incomplete abortion.

Official Title
-----------------
Misoprostol for Treatment of Incomplete Abortion

Conditions
-----------------
Incomplete Abortion

Intervention / Treatment
-----------------
* Drug: 600 mcg misoprostol
* Procedure: Surgical treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: past or present history of vaginal bleeding during pregnancy open cervical os evidence of incomplete abortion with substantial debris in the uterus (if using ultrasound) surgical evacuation of the uterus would be advised as course of action if misoprostol was not available generally in good health woman lives or works within one hour of study site woman willing to provide contact information for follow up purposes informed consent given Exclusion Criteria: contraindications to study drug uterine size larger than 12 weeks LMP signs of severe infection

Ages Eligible for Study
-----------------
Minimum Age: 14 Years

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

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Misoprostol<br>Group 1 randomized to take single dose of 600 mcg oral misoprostol | Drug: 600 mcg misoprostol<br>* single dose of misoprostol taken orally<br>* Other names: Cytotec;|
| Other: Surgical treatment<br>Group 2 randomized to receive standard surgical treatment as per local protocol (D&C or MVA) | Procedure: Surgical treatment<br>* Either dilation and curettage or manual vacuum aspiration, as per local protocol<br>* Other names: D&C, MVA;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete resolution of signs/symptoms of incomplete abortion without recourse to surgery at any point for any reason |  | one week after initial treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| side effects |  | measured at follow up visit one week after initial treatment | 
| acceptability |  | measured at follow up visit one week after initial treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
incomplete abortion, spontaneous miscarriage
Relative Bioavailability of Phase II and Phase III Formulations of AZD0530

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to compare how different formulations of AZD0530 are absorbed by the body. As for all clinical trials, safety and tolerability of the drug will be evaluated.

Official Title
-----------------
A Phase I, Randomised, Open-Label, Cross-Over, Single Centre Study in Healthy Volunteers to Determine the Relative Bioavailability of the Phase III Tablet Formulation to the Phase II Tablet Formulation of AZD0530

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

Intervention / Treatment
-----------------
* Drug: AZD0530
* Drug: AZD0530


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female subjects must be of Non- child-bearing potential Body mass index between 19 and 30 kg/m2 and weigh between 50-100 kg Exclusion Criteria: Presence of any clinically significant illness Abnormal vital signs History of any conditions that may put the subject at risk by participating in the study Participation in another clinical study.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: AZD0530<br>* of both the Phase II and Phase III AZD0530 125mg tablet variants (A and B) in a random order.<br>Drug: AZD0530<br>* Part II: Single doses of AZD0530 125mg oral solution and 2 out of 4 125mg tablet variants (C, D, E and F) in a random order.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the pharmacokinetic parameters for AZD0530 when administered as Phase III formulation in relation to Phase II formulation. |  | Pre-dose sample, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168 hours post dose samples. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To monitor the safety of all subjects by assessment of vital signs, ECG, clinical chemistry, haematology, urinalysis and adverse events. |  | From time of consent to last visit. | 
| An exploratory objective is to characterise the Pharmacokinetic profile of an oral solution of AZD0530 and 4 additional tablet variants of the Phase III formulation of AZD0530 |  | Pre-dose sample, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168 hours post dose samples. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy Volunteers, Relative Bioavailability
Prognosis in Patients With Guillain-Barre Syndrome

Study Overview
=================
Brief Summary
-----------------
The goal of this observational study is to explore significant indicators to predict the early prognosis and late prognosis in patients with Guillain-Barre syndrome.

Detailed Description
-----------------
This is a multicenter study(approximately three) with over 450 subjects.Clinical data were collected by consulting the patient's electronic history. The data included demographic information, blood biochemical markers, clinical characteristics and electromyography. All participants provided their written informed consent to participate in this study.

Official Title
-----------------
Prognosis in Patients With Guillain-Barre Syndrome

Conditions
-----------------
Guillain-Barre Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients fulfilled clinical, biological, and electrophysiology criteria for Guillain-barre syndrome. Exclusion Criteria: nonidiopathic Guillain-barre syndrome and Miller Fisher syndrome
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| mechanical ventilation group<br>Patients with Guillain-Barré Syndrome require mechanical ventilation during hospitalization | |
| no mechanical ventilation group<br>Patients with Guillain-Barré Syndrome do not require mechanical ventilation during hospitalization | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the severity of Guillain-barre syndrome | The Guillain-Barre syndrome disability score is a wide scale for the severity of Guillain-Barre syndrome (0, optimal health; 1, minor symptoms, able to run; 2, able to walk unaided 10 m, unable to run; 3, able to walk 10 m across an open space with help; 4 bedridden or wheelchair users; 5, require assisted ventilation; 6, dead)(deceased).The higher the score, the worse the prognosis. | baseline, at 1 week, at 26 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Guillain-Barre Syndrome