linjc16/ctgov huggingface dataset:
Survey Evaluating the Psychosocial Effects of Living With Haemophilia

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Africa, Asia, Europe, North America and South America. The purpose of the survey is to identify the key psychosocial issues affecting patients with haemophilia.

Official Title
-----------------
Haemophilia, Experiences, Results and Opportunities (HERO): A Community-based Evaluation of the Psychosocial Effects of Haemophilia on Patients and Their Carers

Conditions
-----------------
Congenital Bleeding Disorder, Haemophilia A, Haemophilia B, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors, Relatives to/Carers of Patients

Intervention / Treatment
-----------------
* Other: No treatment given


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males with haemophilia A or B (with or without inhibitors) Parents/carers of children aged below 18 years with haemophilia A or B (with or without inhibitors) Patients currently receiving treatment for haemophilia with one of the following: replacement factor VIII or replacement factor IX or a bypassing agent (recombinant factor VIIa or aPCC (Activated prothrombin complex concentrate)) Patients with haemophilia, not currently receiving treatment with replacement factor VIII or IX or a bypassing agent (as appropriate), but who have had at least one spontaneous bleed into one or more joints within the last 12 months Subjects must have access to the internet, either at home or at a location convenient to them, be able to complete a paper questionnaire, or be available to attend a face-to-face interview (Algerian subjects only), to participate in the survey Exclusion Criteria: Inability to understand and comply with written and verbal instructions unless assisted at the haemophilia treatment centre (HTC) or by a relative

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br> | Other: No treatment given<br>* No treatment given. Participants are to complete a questionnarie in the study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To quantify the extent of key psychosocial factors affecting patients with haemophilia in their daily lives |  | After 6 weeks (recruitment and data collection) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To quantify how psychosocial factors are associated with treatment outcomes, compliance, health and general well-being |  | After 6 weeks (recruitment and data collection) |
Prevalence of Keratoconus in Inflammatory Bowel Diseases

Study Overview
=================
Brief Summary
-----------------
A retrospective study has shown the association between the inflammatory bowel diseases (IBD) and the presence of a keratoconus. This new study will measure the prevalence of keratoconus and follow its activity in patients affected by IBD and followed up in hepatology-gastroenterology department at Nancy Hospital. The prevalence of keratoconus will be compared to known data of literature about general population. The secondary purpose is to search for a relationship between the presence of a keratoconus and activity criteria of IBD. Perspectives are a systematic screening for keratoconus in patients affected by IBD with the amelioration of the ophthalmologic care of IBD patients and confirmation of the recent hypothesis of inflammatory origin of keratoconus.

Official Title
-----------------
Prevalence of Keratoconus in Inflammatory Bowel Diseases

Conditions
-----------------
Inflammatory Bowel Diseases, Keratoconus

Intervention / Treatment
-----------------
* Device: Opthalmologic measure with DM OPD scan III (Nidek)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent Affiliation to social security plan Diagnosis of IBD since more than 3 years, under treatment or not Exclusion Criteria: Protected person Pregnant or breastfeeding women Person in life-and-death emergency Person deprived of liberty Refusal to remove contact lenses, where necessary

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Keratoconus and IBD<br>Opthalmologic measure with DM OPD scan III (Nidek) | Device: Opthalmologic measure with DM OPD scan III (Nidek)<br>* Bilateral measure of corneal refractometry, pachymetry, topography and aberrometry<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence or presence of keratoconus in IBD patients | Data from OPD scan III corneal analyzer according to Rabinowitz and Klyce Maeda criteria. The presence of a keratoconus in at least one eye is considered positive. | day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IBD clinical features using the Montreal classification for IBD |  | day 0 |
Health Effects Following Use of Lead Free Ammunition Used With HK416

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether use of lead free ammunitions cause more respiratory problems than use of lead containing ammunitions.

Official Title
-----------------
In Norwegian: Helseffekter av Stoff Som Avgis Ved Skyting Med HK416

Conditions
-----------------
Lung Function Tests, Markers of Inflammation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy volunteers Exclusion Criteria: active respiratory disease

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Leaded ammunition<br> | |
| Non-leaded ammunition<br> | |
| Modified non-leaded ammunition<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced Expiratory Volume (FEV1) |  | Before, Immediately after, and 24 hrs after exposure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammation markers |  | Before and 24 hrs after esposure |
Retrospective/Prospective Study of Pediatric Surgical Patients

Study Overview
=================
Brief Summary
-----------------
UIC Division of pediatric surgery has IRB approval to perform retrospective and prospective study of their pediatric surgical patients. At UIC Dr. Lobe performed the first known single port robotic splenectomy on a child and as a surgical first this case is worthy of a case report. Since it is a surgical and therapeutic first it needs to be aon regestiry of health research prior to publication.

Official Title
-----------------
Retrospective/Prospective Study of Pediatric Surgical Patients

Conditions
-----------------
Pediatric Robotic Surgery

Intervention / Treatment
-----------------
* Procedure: Single Port Robotic Splenectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric patient with splenomegaly Exclusion Criteria: NOn pediatric patients

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 18 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Single Port Robotic Splenectomy|Pediatric patient with splenomegaly underwent a single port robotic splenectomy.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Did the patient die from the operation | 30 days post op |
Comparative Study of Oral Eletriptan (40mg and 80mg), Oral Sumatriptan (25mg and 50mg) and Placebo

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to compare the efficacy, toleration and safety of eletriptan 40mg and 80mg, with sumatriptan 25mg and 50mg, and placebo when given orally to subjects with an acute migraine.

Official Title
-----------------
A Multicenter, Double-blind, Placebo Controlled, Parallel Group, Study of Two Dose Levels of Oral Eletriptan and Two Dose Levels of of Oral Sumatriptan Given for the Acute Treatment of Migraine

Conditions
-----------------
Migraine With or Without Aura

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: Eletriptan 40 mg
* Drug: Eletriptan 80 mg
* Drug: Sumatriptan 25 mg
* Drug: Sumatriptan 50 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who expected to suffer at least one acute attack of migraine, with or without aura, each 6 weeks (The diagnosis of migraine was to comply with the criteria proposed by the International Headache Society (IHS)) Subjects capable of taking medication as outpatients, and recording the effects of such medication. Exclusion Criteria: Pregnant or breast-feeding women Migraine subjects who also suffered from concomitant frequent (non-migrainous) headache, defined as more than six attacks per month on average.

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Matching Placebo<br>|
| Experimental: Eletriptan 40 mg<br> | Drug: Eletriptan 40 mg<br>* 40mg oral<br>|
| Experimental: Eletriptan 80 mg<br> | Drug: Eletriptan 80 mg<br>* 80mg oral<br>|
| Experimental: Sumatriptan 25 mg<br> | Drug: Sumatriptan 25 mg<br>* 25mg oral<br>|
| Experimental: Sumatriptan 50 mg<br> | Drug: Sumatriptan 50 mg<br>* 50mg oral<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache response at 1 hour after the first dose for the first attack. | Headache response was defined as improvement from a severe or moderate headache at baseline to either a mild or absent headache post-dose. | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain-free response at 1 hour after the first dose for the first attack. | A pain free response was defined as an improvement from a severe or moderate headache at baseline to an absent headache post-dose. | 1 hour |
Central Arterial Pressure Changes With Use of Regional Anesthesia in Obstetric Patients

Study Overview
=================
Brief Summary
-----------------
Plan to monitor central arterial pressure in women who are undergoing spinal anesthesia for cesarean delivery or epidural anesthesia for vaginal delivery.

Detailed Description
-----------------
Subjects will be screened as they are admitted to the maternity care floor (5th floor St. Mary's Hospital). Subjects will be approached if they are desiring regional anesthesia. The subject will have an additional blood pressure cuff placed on the arm that anesthesia is not using for their blood pressure cuff. Central arterial pressure will be measured from the cuff: Prior to regional anesthesia placement Every 15 minutes for 1 hour Every 30 minutes for 2 hours Routine sphygmomanometer measurements will also completed at the above times. These are all study procedures. Anesthesia will use their usual protocol for blood pressure monitoring and management during placement of, and after the procedure. No changes in patient management will be made based upon the central arterial pressure as the guidelines were developed with routine brachial pressure.

Official Title
-----------------
Central Arterial Pressure Changes With Use of Regional Anesthesia in Obstetric Patients

Conditions
-----------------
Central Blood Pressures

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Singleton pregnancy Planned regional anesthesia Exclusion Criteria: Multiple pregnancy Emergent cesarean delivery Irregular heart rhythms or arrhythmias Peripheral arterial disease, leg artery disease Reynaud's phenomena Intense cold/hypothermia If there is a wound at location of where central arterial cuff would be placed or tonometer for carotid assessment Severe tachycardia (>120) Greater than 1st degree heart block Congestive heart failure or heart disease Inability to adequately monitor BP Use of magnesium sulfate

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 50 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of change in central arterial pressure in obesity. | To determine if women who are obese undergo a larger change in their central arterial pressure than is seen by routine brachial cuff assessment, and if this effect is dependent on the level of obesity. | 3 hours |
The Effect of Inhalation Agent on the QTc Interval During Liver Transplantation: Sub Study (NCT01886664)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the effects of inhalation agent on corrected QT interval duration during liver transplantation.

Conditions
-----------------
Anesthesia, General

Intervention / Treatment
-----------------
* Drug: Sevoflurane
* Drug: Desflurane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elective liver transplantation Exclusion Criteria: age < 18, age > 65 patient refusal re-transplantation

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 |
| --- | --- |
| Sevoflurane<br>Performing liver transplantation under general anesthesia using sevoflurane | Drug: Sevoflurane<br> <br> |
| Desflurane<br>Performing liver transplantation under general anesthesia using desflurane | Drug: Desflurane<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| corrected QT interval (QTc interval) | up to 10 minutes after tracheal intubation, up to 60 minutes after reperfusion, at 10 minutes after hepatectomy, at 10 minutes after biliary anastomosis, at skin closure, at the arrival on ICU, on postoperative day 1. | up to postoperative day 1 after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of patients whose QTc interval is more than 450 ms for men and 470 ms for women |  | up to postoperative day 1 after surgery | 
| proportion of patients who have more than 500 ms of QTc interval |  | up to postoperative day 1 after surgery | 
| Tp-e interval | up to 10 minutes after tracheal intubation, up to 60 minutes after reperfusion, at 10 minutes after hepatectomy, at 10 minutes after biliary anastomosis, at skin closure, at the arrival on ICU, on postoperative day 1. | up to postoperative day 1 after surgery |
[F-18]Fluoro-DOPA PET Imaging of Brain Tumors in Children

Study Overview
=================
Brief Summary
-----------------
The first phase of the study will investigate if there is increased uptake of [F-18]FDOPA in pediatric brain tumors when compared to normal brain tissue.

Detailed Description
-----------------
The first phase of the study will investigate if there is increased uptake of [F-18]FDOPA in pediatric brain tumors when compared to normal brain tissue. Tne subjects between ages 5 and 17 years will be studies, to determine if there is increased uptake of [F-18]FDOPA in pediatric brain tumors when compared to normal brain tissue. Drug safety will also be monitored.

Official Title
-----------------
[F-18]Fluoro-DOPA PET Imaging of Brain Tumors in Children

Conditions
-----------------
Brain Tumors

Intervention / Treatment
-----------------
* Drug: [F-18]Fluoro-DOPA PET, a diagnostic radiopharmaceutical


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented brain tumor at diagnosis or relapse, including high grade glioma, low grade glioma, medulloblastoma including PNET, optic pathway glioma, brainstem glioma, ependymoma. Exclusion Criteria: Pregnancy Requirement for sedation Lack of informed consent

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 15 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 |
| --- | --- |
| Phase I<br>Children, ages 5-15 years with brain tumors | Drug: [F-18]Fluoro-DOPA PET, a diagnostic radiopharmaceutical<br>* A single dosage of the diagnostic drug will be administered to individuals who meet inclusion criteria after informed consent.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increased uptake of [F-18]FDOPA in pediatric brain tumors compared to contralateral normal brain tissue as measured by standardized uptake value and tumor/non-tumor uptake ratios |  | 15-30 minutes after IV administration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
brain tumors, children
Safety and the Pharmacokinetic Study of Characteristics of MKT-N2 (Montelukast) and Singulair® (Montelukast Sodium)to Treat Asthma

Study Overview
=================
Brief Summary
-----------------
The Purpose of A center, Randomized, Open label, single dose, Placebo-controlled, 2-Treatment, 2-Way, 2-Period Crossover Study to Compare the Safety and the Pharmacokinetic Characteristics of MKT-N2 (Montelukast) and Singulair® (montelukast sodium) tablet 10mg in Healthy Male Korean Subjects

Official Title
-----------------
A Randomized, Open-label, Single-Dose, 2-Treatment, 2-Way, 2-Period Crossover Study to Compare the Safety and the Pharmacokinetic Characteristics of MKT-N2 (Montelukast) and Singulair® (Montelukast Sodium) Tablet 10mg in Healthy Male Korean Subjects

Conditions
-----------------
Asthma and Allergic Rhinitis

Intervention / Treatment
-----------------
* Drug: Montelukast
* Drug: Montelukast sodium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Korean Male over20, under 45 years old 55kg over weight, IBW +-20% range male Exclusion Criteria: Males who have gotten a clinically significant of liver, pancreas, kidneys, nervous system, respiratory system, endocrine system, blood cancer, mental illness, cardiovascular, urinary tract disease, or a history corresponding Males who have gotten a history of gastrointestinal disease Males who have gotten a history of hypersensitivity to montelukast or reaction to other drugs(aspirin, antibiotics)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MKT-N2<br>Montelukast | Drug: Montelukast<br> <br> Drug: Montelukast sodium<br> <br> |
| Active Comparator: Singulair<br>Montelukast sodium | Drug: Montelukast<br> <br> Drug: Montelukast sodium<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with Adverse event |  | 1day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic profiles | Blood evaluation variables: Cmax, AUCt (t=24 h), AUC∞, tmax | 1day |