linjc16/ctgov huggingface dataset:
Patterns of Use of Belatacept: Analysis of Data From the Collaborative Transplant Study

Study Overview
=================
Brief Summary
-----------------
The primary purpose is to describe the pattern of Belatacept use at the time of transplant and up to three years post-transplantation for all Belatacept treated patients.

Detailed Description
-----------------
Time Perspective: Prospective design, Retrospective data collection and analysis

Official Title
-----------------
Belatacept in Renal Transplantation: Patterns of Use Analysis Using the Collaborative Transplant Study (CTS)

Conditions
-----------------
Transplantation, Organ

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who received solid organ transplantation during study period in one of the transplant centers involved in CTS

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 |
| --- | --- |
| Patient treated with Belatacept at the time of transplantation<br>Patients undergoing solid organ transplantation, whose transplant center participates in CTS and who are treated with Belatacept at the time of transplantation | |
| Patient treated with CNI at the time of transplantation<br>Patients undergoing solid organ transplantation, whose transplant center participates in CTS and who are treated with a Calcineurin inhibitor (CNI) based regimen at the time of transplantation | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number and percent of belatacept users overall, by Epstein-Barr Virus (EBV) serostatus and by Cytomegalovirus (CMV) serostatus |  | At the time of transplantation | 
| The number and percent of belatacept users overall, by Epstein-Barr Virus (EBV) serostatus and by CMV serostatus |  | 1 year post transplantation | 
| The number and percent of belatacept users overall, by Epstein-Barr Virus (EBV) serostatus and by CMV serostatus |  | 2 year post transplantation | 
| The number and percent of belatacept users overall, by Epstein-Barr Virus (EBV) serostatus and by CMV serostatus |  | 3 year post transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extent of switches to or from Belatacept within three years post transplantation, and the temporal trend in switches post regulatory approval of Belatacept |  | At transplantation, 12 month, 24 month and 36 month post transplantation | 
| Characteristics of Belatacept users vs. Calcineurin inhibitor (CNIs) users at transplantation |  | At the time of transplantation | 
| Characteristics of those who switch to or from Belatacept vs. those who do not switch one year post-transplant |  | At transplantation and 12 month post transplantation |
Behavioral Studies and Practices

Study Overview
=================
Brief Summary
-----------------
The focus of this study is to evaluate whether a new fraud material will be suitable for a technological device and or software. ***For consultation purposes only.***

Official Title
-----------------
Fraud Case Study - The Tone At The Top and What Constitutes Criminal Behavior.

Conditions
-----------------
Behavioral

Intervention / Treatment
-----------------
* Behavioral: Behavioral Advisory System
* Drug: Behavioral Treatment
* Device: Behavioral Division


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: College Student Exclusion Criteria: Age Over 40

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 40 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 |
| --- | --- |
| Group A<br>Subject(s): A Subgroup | Behavioral: Behavioral Advisory System<br>* Support and training to help increase throughput while promoting upstanding stature and reproducibility in behavioral testing using cutting edge methodologies.<br>* Other names: Triple Helix Methodology System;Drug: Behavioral Treatment<br>* This study addressed the efficacy of cognitive-behavioral therapy (CBT) treatment.<br>Device: Behavioral Division<br>* This study is relative to minimal contact control (MCC).<br>|
| Group B<br>Subject(s): B Subgroup | Behavioral: Behavioral Advisory System<br>* Support and training to help increase throughput while promoting upstanding stature and reproducibility in behavioral testing using cutting edge methodologies.<br>* Other names: Triple Helix Methodology System;Drug: Behavioral Treatment<br>* This study addressed the efficacy of cognitive-behavioral therapy (CBT) treatment.<br>Device: Behavioral Division<br>* This study is relative to minimal contact control (MCC).<br>|
| Group C<br>Subject(s): C Sub Group | Behavioral: Behavioral Advisory System<br>* Support and training to help increase throughput while promoting upstanding stature and reproducibility in behavioral testing using cutting edge methodologies.<br>* Other names: Triple Helix Methodology System;Drug: Behavioral Treatment<br>* This study addressed the efficacy of cognitive-behavioral therapy (CBT) treatment.<br>Device: Behavioral Division<br>* This study is relative to minimal contact control (MCC).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire/Screening | The tool, intended to assess college students' by classmates, includes one portion that is an online self-administered questionnaire. Guidance counselors can use the questionnaire to identify college students students who have been targeted for Fraud. | 30 days |
Atrial Fibrillation Burden and Long-term Risk of Thromboembolic Complications- the FinCV-4 Study

Study Overview
=================
Brief Summary
-----------------
This study explores the association of symptomatic episodes of atrial fibrillation (AF) occurrence and long-term risk of thromboembolic complications in a retrospective setting.

Detailed Description
-----------------
The study population consists of the FinCV-dataset, which includes 7660 acute cardioversions for atrial fibrillation. The electronic patient records of FinCV-study patients are reviewed to collect data on anticoagulation, number of cardioversions as well as mortality and stroke data. We seek to explore the possible association between the frequency of AF paroxysms in low stroke risk patients and the occurrence of death, stroke and major bleed as well as the net clinical benefit of anticoagulation. Data collection is performed by reviewing electronic patient records.

Official Title
-----------------
Effect of Atrial Fibrillation Burden on Long-term Risk of Thromboembolic Complications- the FinCV-4 Study

Conditions
-----------------
Atrial Fibrillation, Stroke, Ischemic

Intervention / Treatment
-----------------
* Drug: Anticoagulation Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
primary diagnosis of atrial fibrillation (ICD-10 code I48) Cardioversion for acute (<48 h) atrial fibrillation >18 years of age living within the catchment area of the hospital

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 |
| --- | --- |
| No oral anticoagulation<br>Patients without oral anticoagulation for AF | |
| Oral anticoagulation<br>Patients with long term oral anticoagulation | Drug: Anticoagulation Therapy<br>* Long term oral anticoagulation with VKA (vitamin K antagonist) or NOAC (non-vitamin K oral anticoagulant)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death | Death from any cause | From the first cardioversion through study completion, an average of 6 years | 
| Ischemic stroke or TIA (transient ischemic attack) | Ischemic stroke or TIA diagnosed by neurologist | From the first cardioversion through study completion, an average of 6 years | 
| Major Bleed | Major Bleeding complication according to ISTH (International Society on Thrombosis and Haemostasis) | From the first cardioversion through study completion, an average of 6 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Permanent oral anticoagulation | Initiation of permanent oral anticoagulation therapy, information on oral anticoaglation initiation done by reviewing electronic patient records | From the first cardioversion through study completion, an average of 6 years. |
QUality of Life in pAtients With Mild to modeRate Active procTitis Treated by mesalaZine (Pentasa®)

Study Overview
=================
Brief Summary
-----------------
This national, observational and multicentre study aims at establishing a picture of real clinical practices management among patients treated with Pentasa®, according to the current therapeutic strategy in proctitis or distal proctosigmoiditis. This study should be able to provide data on patients' health related quality of life, compliance and efficacy in real clinical practice

Official Title
-----------------
QUality of Life in pAtients With Mild to modeRate Active procTitis Treated by mesalaZine (Pentasa®)

Conditions
-----------------
Distal Ulcerative Colitis

Intervention / Treatment
-----------------
* Drug: mesalazine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient aged 18 years or older. Patient suffering from mild to moderate active proctitis or distal proctosigmoiditis (MAYO score ≥ 3 and ≤ 10) at inclusion based on clinical and endoscopic findings within 6 months before study inclusion. Patient with evidence of endoscopic active proctitis or distal proctosigmoiditis (Montreal classification E1 or E2 defined by an involvement not exceeding 25 cm from the anal margin) within 6 months before study inclusion. Treatment of the current flare with Pentasa® to induce a remission initiated by the patient, the general practitioner or the gastroenterologist, during the inclusion visit or during the week before the inclusion visit. Patient having received oral and written information on the study, without any objections for the use of his/her personal data, and having signed a written Informed Consent Form. Exclusion Criteria: Patient included in an interventional study assessing treatment for active proctitis or distal proctosigmoiditis. Patient with left sided, colitis or pancolitis. Patient with severe proctitis (MAYO score ≥ 11 at inclusion). Patient previously treated with biologics. Patient treated with immunosuppressive within 1 month before study inclusion. Patient treated with corticosteroids within 2 weeks before study inclusion.

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 |
| --- | --- |
| mesalazine<br>Treatment according to standard clinical practice. | Drug: mesalazine<br> <br> * Other names: Pentasa®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) total score |  | From baseline to week 8 |
Evaluation of Safety and Efficacy of Artemether-Lumefantrine Tablets in African Infants and Children With Uncomplicated P. Falciparum Malaria

Study Overview
=================
Brief Summary
-----------------
This study will assess the safety and efficacy of artemether-lumefantrine tablets (6-dose regimen) in African infants / children with acute uncomplicated falciparum malaria.

Official Title
-----------------
Open Label, Multicenter Study for Evaluation of Safety and Efficacy of Artemether-Lumefantrine Tablets (6-Dose Regimen) in African Infants and Children in the Treatment of Acute Uncomplicated Falciparum Malaria

Conditions
-----------------
Plasmodium Falciparum Malaria

Intervention / Treatment
-----------------
* Drug: Artemether-lumefantrine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male or female weighing ≥ 5kg and ≤ 25kg P. falciparum parasitemia between 1,000 and 100,000 parasites/mm3 with confirmed diagnosis of uncomplicated malaria caused P. falciparum parasite Exclusion Criteria: complicated malaria ingestion of various antimalarial drugs, or other drugs influencing cardiac function in the previous 4 weeks before study entry to 8 weeks severe anaemia severe malnutrition malaria due to other than P. falciparum Other protocol-defined inclusion/exclusion criteria may apply
Sexes Eligible for Study
-----------------
All

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: 1<br>Artemether-lumefantrine | Drug: Artemether-lumefantrine<br>* 20mg artemether and 120 mg lumefantrine, tablet, dose based on body weight, 3 days treatment 5 - < 10kg (BWG 1) = 6 doses of 1 tablet / 10 - < 15kg (BWG 2) = 6 doses of 1 tablet / 15 - ≤ 25kg (BWG 3) = 6 doses of 2 tablets<br>* Other names: Coartem®, Riamet®, co-artemether;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events, SAEs; hematology and biochemistry parameters; electrocardiogram; urine values; vital signs; physical neurological examinations; and neurological examinations |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients free of parasites at 7, 14 and at 28 days |  |  | 
| Time to clearance from parasites (asexual forms) |  |  | 
| Time to clearance of fever |  |  | 
| Time to clearance of gametocytes (parasite sexual forms) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Malaria, co-artemether, auditory, Plasmodium falciparum, marsh fever, remittent fever, artemether, artemisinins, lumefantrine, child, infant, Africa
Inflammatory Responses to Lipid Emulsions in Children Before and After Open Heart Surgery

Study Overview
=================
Brief Summary
-----------------
This study is a blinded, randomized, controlled prospective trial comparing immune response (sepsis, inflammatory response, pulmonary vasoconstriction) in 2 groups of infants less than 3-month old receiving pre and post cardiopulmonary bypass surgery. The infants will receive 1 out of the 2 following intravenous lipid preparations: Soybean Oil (n-6), or a combination of Medium Chain Triglyceride i.e. coconut oil, Long Chain Triglyceride i.e. Soybean Oil, and Fish Oil (MCT:LCT:FO). There will be 16 subjects in each group.

Official Title
-----------------
Inflammatory Responses of Intravenous Fish Oil, Soybean Oil and Medium Chain Triglyceride Fat Emulsions in Young Children Before and After Open Heart Surgery

Conditions
-----------------
Inflammation, Cardiac Surgical Procedures

Intervention / Treatment
-----------------
* Drug: a combination of MCT, LCT , and Fish Oil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 36 weeks gestation 3 months corrected age appropriate for gestational age (AGA) admitted for surgical correction of congenital heart defects (single ventricle, tetralogy of Fallot, truncus and complex biventricular repairs) enteral nutrition at 30 kcal/kilogram/day Exclusion Criteria: 5 minute Apgar score of 4 major congenital defect other than heart defect presence of significant neonatal morbidity (intraventricular hemorrhage (IVH) grade 3 or greater, necrotizing enterocolitis (NEC) and surgical abdomen) any metabolic disorder any endocrine disorder medications which alter eicosanoid metabolism including indomethacin, acetylsalicylate (with exception of steroids which will be analyzed independently)

Ages Eligible for Study
-----------------
Maximum Age: 3 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: a combination of MCT, LCT , and Fish Oil|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine whether incidence of sepsis and degree of inflammatory response is altered |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterize serum arachidonic acid and eicosapentaenoic acid levels, leukotriene B 4/leukotriene B 5 levels and incidence of nosocomial infection |  |  | 
| To characterize incidental findings as a result of attaining complete fatty acid and cytokine profiles |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intensive Care,Neonatal, Parenteral nutrition, Fat emulsions,Intravenous
Long-term Prognosis of Cluster Headache: a Retrospective Cohort Study

Study Overview
=================
Brief Summary
-----------------
Cluster headache is a syndrome characterized by disabling headache and accompanying autonomic symptoms. Despite cluster headache is called suicide headache, its natural history has not been well investigated. The investigators aimed to investigate its disease course, overall prognosis, and treatment pattern in retrospective cohort.

Conditions
-----------------
Cluster Headache, Disease Course

Intervention / Treatment
-----------------
* Drug: Any treatment for cluster headache


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who were diagnosed as cluster headache More than 5 years after the first visit Exclusion Criteria: Subjects who refused the telephone visit
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Any treatment for cluster headache|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall prognosis | active disease: at least one bout within the past 5 years Remission: no headache for 5 years and twice of the usual remission period | at least 5 years after the first visit | 
| Changes in the length of active/inactive periods |  | at least 5 years after the first visit | 
| Changes in seasonal and diurnal predilections |  | at least 5 years after the first visit | 
| Changes in autonomic symptoms |  | at least 5 years after the first visit | 
| Changes in treatment responses |  | at least 5 years after the first visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Any depression |  | at least 5 years after the first visit | 
| Any suicidal thoughts (active/passive), plans, and attempts | ictal vs interictal | at least 5 years after the first vis |
Randomized Comparison of Sharp Versus Blunt Techniques at Cesarean

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether a specific surgical technique, blunt compared with sharp expansion of the transverse lower uterine incision, is associated with risk of unintended extension of uterine incision

Official Title
-----------------
Unintended Extension of the Lower Segment Uterine Incision at Cesarean Delivery;A Randomized Comparison of Sharp Versus Blunt Techniques

Conditions
-----------------
Disruption of Uterine Incision After Cesarean Section

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Term pregnancy(> 38 weeks of gestation) Required elective cesarean delivery maternal age between 18-40 years Exclusion Criteria: Required emergency cesarean delivery Abnormal presentation Planned cesarean hysterectomy History of low segment vertical uterine incision History of classical upper segment uterine incision multiple pregnancy cases with a high risk for bleeding(HELLP send, preeclampsia, placental insertion anomalies) Grand multiparity(parity>5)

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| blunt<br>Blunt expansion of the primary incision was derived by placing the index fingers of the operating surgeon into the incision and pulling the fingers apart laterally and cephalad. | |
| sharp<br>Sharp expansion of the primary incision was developed by cutting laterally and cephalad using bandage scissors | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| unintended extension of uterine incision |  | during the operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraoperative maternal blood loss |  | after 48 hours than operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
unintended extension, blunt, sharp, maternal blood loss