linjc16/ctgov huggingface dataset:
MRI Screening for Patients With Myelodysplastic Syndrome (MDS), Who Have Received Multiple Red Blood Cell Transfusions

Study Overview
=================
Brief Summary
-----------------
A known risk of red blood cell transfusions is that it puts excess iron into the patient's body. Researchers are continually seeking the most effective method of measuring iron concentration. The purpose of this study is to determine how much iron has been deposited in a patient's heart and liver as a result of having received red blood cell transfusions using magnetic resonance imaging (MRI).

Official Title
-----------------
T2* Cardiac MRI Screening of Highly Transfused Patients With Myelodysplastic Syndrome

Conditions
-----------------
Myelodysplastic Syndrome (MDS)

Intervention / Treatment
-----------------
* Other: T2* Cardiac and Liver MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or Female patients will need documentation of diagnosis of Myelodysplastic Syndrome by previous bone marrow exam Male or female patients with MDS who have received at least 50 units of Red Blood Cell Transfusions. Serum ferritin > 1,000 Written informed consent by the patient. Exclusion Criteria: Contraindication to MRI, including cardiac pacemaker, brain aneurysm clip, implanted neurostimulator, insulin pump, cochlear implant, metal slivers in the eyes, intrauterine device or any other MRI incompatible metal implants or intractable claustrophobia.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Patients who meet eligibility will be sent for radiographic imaging to include T2* cardiac and liver MRI to ascertain quantification of organ-specific iron concentrations as well as cardiac left ventricular ejection fraction. | Other: T2* Cardiac and Liver MRI<br>* Patients will undergo an MRI of the heart and liver.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the incidence of clinically significant cardiac iron overload in heavily transfused MDS patients using T2* MRI. |  | A single T2* MRI will be performed on eligible patients. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate left ventricular ejection fraction as assessed by T2* MRI. |  | A single T2* MRI will be performed on eligible patients. | 
| Evaluate liver iron concentration as assessed by R2* MRI |  | A single T2* MRI will be performed on eligible patients. |
Oral Formulation of Insulin for Preterm Infants

Study Overview
=================
Brief Summary
-----------------
The study will evaluate the effect of oral formulation of insulin on preterm infants, born between 26-33 weeks of pregnancy, weighing over 750 grams, who meet the inclusion and exclusion criteria established in this protocol.

Detailed Description
-----------------
The study will aim to determine whether an oral formulation of insulin administration enhances gastrointestinal maturation. The gastrointestinal maturation will be evaluated by the ability of premature infants to achieve complete enteral feeds. The insulin concentration administered in the study is physiological and within the insulin concentration range present in human breast milk and colostrum.

Official Title
-----------------
A Multi-center, Randomized, Double-blinded Clinical Study to Assess the Effect of Insulin Enriched Formula on Gastrointestinal Tract Maturation in Pre-term Infants.

Conditions
-----------------
Premature Birth of Newborn

Intervention / Treatment
-----------------
* Biological: Oral Formulation of Insulin
* Biological: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Pre-term infants 26-33 weeks gestation.

Ages Eligible for Study
-----------------
Minimum Age: 26 Weeks
Maximum Age: 33 Weeks

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

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral Formulation of Insulin<br>Oral formulation of insulin fed concomitantly with premature infant formula | Biological: Oral Formulation of Insulin<br>* Oral formulation of insulin fed concomitantly with infant formula<br>|
| Placebo Comparator: Oral Formulation of Placebo<br>Oral formulation of placebo fed concomitantly with premature infant formula | Biological: Placebo<br>* Oral formulation of placebo fed concomitantly with infant formula<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days to achieve complete enteral feeding |  | Up to 28 days or discharge and at 3 months of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of gastric residual > 2 ml/kg |  | Up to 28 days or discharge, at 3 months of age | 
| Number of gastric residual > 50% of previous feeding |  | Up to 28 days or discharge and at 3 months of age | 
| Number of days to discharge |  | Up to 28 days or discharge and at 3 months of age | 
| Weight gain |  | Up to 28 days or discharge and at 3 months of age |
National Registry of Genetically Triggered Thoracic Aortic Aneurysms and Cardiovascular Conditions

Study Overview
=================
Brief Summary
-----------------
The National Registry of Genetically Triggered Thoracic Aortic Aneurysms and Cardiovascular Conditions (GenTAC) was initiated in 2006 by the National Heart, Lung, and Blood Institute (NHLBI) and the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). GenTAC established a registry of 3706 patients with genetic conditions that may be related to thoracic aortic aneurysms and collected medical data and biologic samples. The study ended in September 2016. Data and samples are available from NHLBI and requests should be made to BioLINCC. See the NHLBI website for more information: https://www.nhlbi.nih.gov/research/resources/gentac/.

Official Title
-----------------
National Registry of Genetically Triggered Thoracic Aortic Aneurysms and Cardiovascular Conditions

Conditions
-----------------
Marfan Syndrome, Turner Syndrome, Ehlers-Danlos Syndrome, Loeys-Dietz Syndrome, FBN1, TGFBR1, TGFBR2, ACTA2 or MYH11 Genetic Mutation, Bicuspid Aortic Valve Without Known Family History, Bicuspid Aortic Valve With Family History, Bicuspid Aortic Valve With Coarctation, Familial Thoracic Aortic Aneurysm and Dissections, Shprintzen-Goldberg Syndrome, Other Aneur/Diss of Thoracic Aorta Not Due to Trauma, <50yo, Other Congenital Heart Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Eligible subjects must have one of the conditions listed below and be enrolled in-person at one of the participating clinical centers.Contact the study coordinator at the location nearest you for more information about participation. Marfan syndrome Turner syndrome Ehlers-Danlos syndrome Loeys-Dietz syndrome FBN1, TGFBR1, TGFBR2, ACTA2 or MYH11 genetic mutation Bicuspid aortic valve without known family history Bicuspid aortic valve with family history Bicuspid aortic valve with coarctation Familial Thoracic Aortic Aneurysm and DissectionsYes Shprintzen-Goldberg syndrome Other aneurysms and dissections of the thoracic aorta not due to trauma, <50yo Other congenital heart disease (e.g., Tetralogy of Fallot, coarctation) Exclusion Criteria: Inability of the patient, parent or guardian to give consent. Unwillingness to provide a blood or buccal specimen.
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 |
| --- | --- | --- |
| Thoracic aortic aneurysms and dissections and their associated surgical interventions |  | bi-annual | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Marfan syndrome, Turner syndrome, Bicuspid aortic valve, Ehlers-Danlos Syndrome, Loeys-Dietz syndrome, Aneurysm, Genetic, aortic, thoracic, mutation, dissection
A Comparison of Post-Operative Analgesia Requirements In Recreational Cannabis Users Versus Cannabis Naïve Inflammatory Bowel Disease Patients

Study Overview
=================
Brief Summary
-----------------
Cannabis is a drug that is widely used for recreational purpose. In most patients undergoing surgery, opioids are the most widely used mode of pain relief, during and following surgery. Anecdotally it has been observed that cannabis users required unexpectedly high doses of opioids. The purpose of this study is to compare opioid requirements between cannabis users and non- users after the surgery. Currently, post-operative opioid doses are determined based on various patient factors such as pre-operative opioid use, patient weight, age and sensitivity to opioids during surgery. Patients' requirements may be underestimated and opioid regimens need to be escalated in the first 24 hours in order to alleviate uncontrolled pain in cannabis users. Better understanding of the impacts of cannabis use on post-operative opioid requirements would help the Acute Pain Service optimize post-operative pain management for patients who use cannabis pre-operatively.

Official Title
-----------------
A Comparison of Post-Operative Analgesia Requirements In Recreational Cannabis Users

Conditions
-----------------
Cannabis Use, Opioid Consumption

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consent to participate and signed consent form. Age: 18-65 years. Elective IBD bowel surgery under general anesthesia. PCA use.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cannabis users<br> | |
| Cannabis naive<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid consumption | Amount of morphine equivalents on PCA | 2 years |
Pharmacokinetics, Pharmacodynamics and Safety of Biphasic Insulin Aspart 30 in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this trial is to investigate pharmacokinetics, pharmacodynamics and safety of biphasic insulin aspart 30 in subjects with type 2 diabetes.

Official Title
-----------------
A Randomised, Double-blind, Single Centre, Two-way Cross-over Trial Comparing the Pharmacokinetics, Pharmacodynamics and Safety of the Biphasic Insulin Aspart 30 and Insulin Mixtard 30/70 After Multiple Dosing With a Twice Daily Dose Regimen in Type 2 Diabetic Patients

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: biphasic insulin aspart 30
* Drug: biphasic human insulin 30


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes for at least 12 months Treated with a combination of soluble/protracted human insulin in the ratio of 30/70 in a twice-daily regimen for at least 6 months BMI (body mass index) below 39 kg/m^2 HbA1c (glycosylated haemoglobin) below 12%

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BIAsp 30<br> | Drug: biphasic insulin aspart 30<br>* Injected subcutaneously (s.c., under the skin) before breakfast and dinner, dosage adjusted throughout the trial according to individual needs<br>Drug: biphasic human insulin 30<br>* Injected subcutaneously (s.c., under the skin) before breakfast and dinner, dosage adjusted throughout the trial according to individual needs<br>|
| Active Comparator: BHI 30<br> | Drug: biphasic insulin aspart 30<br>* Injected subcutaneously (s.c., under the skin) before breakfast and dinner, dosage adjusted throughout the trial according to individual needs<br>Drug: biphasic human insulin 30<br>* Injected subcutaneously (s.c., under the skin) before breakfast and dinner, dosage adjusted throughout the trial according to individual needs<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the serum insulin curve |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall shape of the 24 hour serum insulin profile |  |  | 
| Cmax (maximum plasma concentration) |  |  | 
| tmax (time to reach maximum) |  |  | 
| Area under the curve following each injections derived from 24 hours serum insulin profiles |  |  | 
| Overall shape of the 24 hour serum glucose profile |  |  | 
| Serum glucose excursions (EXC) |  |  |
Bariatric Surgery and Pharmacokinetics of Lercanidipine

Study Overview
=================
Brief Summary
-----------------
Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study the pharmacokinetic effects of bariatric surgery on lercanidipine are investigated.

Official Title
-----------------
Bariatric Surgery and Pharmacokinetics Lercanidipine: BAR-MEDS Lercanidipine

Conditions
-----------------
Obesity, Morbid

Intervention / Treatment
-----------------
* Drug: Lercanidipine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway Being a Norwegian citizen Exclusion Criteria: Having previously undergone resections in the GI-tract

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Lercanidipine|Patients are tested for their normal prescription lercanidipine medication|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lercanidipine concentration in blood serum (area under curve (AUC)) |  | From baseline to 1 year postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bariatric surgery, Gastrointestinal tract, Biological availability, Pharmacokinetics, Lercanidipine
Association Between Systemic Exposure of Atorvastatin and Metabolites and Atorvastatin-induced Myotoxicity

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate whether the pharmacokinetics of atorvastatin and/or its metabolites is altered in patients with confirmed atorvastatin-induced myopathy compared to healthy controls.

Detailed Description
-----------------
A 24 hour pharmacokinetic investigation of atorvastatin and metabolites will be performed in 15 patients with a history of atorvastatin -induced myotoxicity. The possible link to relevant mutations in SLCO1B1, CYP3A5 and MDR1 will be also be investigated

Conditions
-----------------
Myopathy

Intervention / Treatment
-----------------
* Drug: Atorvastatin (Lipitor)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: above 18 years previous history of atorvastatin-associated myotoxicity Exclusion Criteria: current treatment with drugs or herbal remedies with known pharmacokinetic interaction potential with atorvastatin previous CK levels above ten times the upper limit of normal range pregnancy and persistent muscular complaints after a four week wash-out period of statin treatment

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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Atorvastatin (Lipitor)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Statin toxicity | Rechallenge test of statin induce toxicity | 1 year |
Prospective and Randomized Study to Evaluate Interest of Ultracision Use in Inguinal Lymph Nodes Curage

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the decrease of post-operative morbidity in inguinal lymphadenectomies realised for vulvar tumors and inferior limb skin tumors by use of Ultracision with regard to classical operative techniques.

Official Title
-----------------
Prospective and Randomized Study to Evaluate Interest of Ultracision Use in Inguinal Lymph Nodes Curage.

Conditions
-----------------
Vulvar Neoplasms, Skin Neoplasms

Intervention / Treatment
-----------------
* Device: ultracision
* Device: classical lymphadenectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Vulvar neoplasm, inferior limb's skin malignant tumours, with an inguinal curage indication. Age ≥ 18 years Hematological functions : leucocytes > 1500/mm3, hemoglobin > 8 g/dl, blood platelets > 150000/mm3. Well informed written consent signed by the patient Negative pregnancy test for female patient of child-bearing potential. Exclusion Criteria: Preliminary surgery of inguinal cavity (sentinel lymph node removal accepted) Massive lymph node invasion with femoro-vessels attack Inclusion in another study (excepted study turned to inguinal lymph node) Pregnant or nursing women Patient under guardianship or trusteeship

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Classical surgical Inguinal curage<br>Classical Inguinal curage | Device: classical lymphadenectomy<br>* classical lymphadenectomy<br>|
| Experimental: Ultracision surgical Inguinal curage<br> | Device: ultracision<br>* Surgery by Ultracision<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the decrease of post-operative morbidity. |  | 2012 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To study differences between the two techniques according to : operative duration ; operative difficulties ; quantity of drainage ; hospitalization's duration ; necessity of local care ; number of consultations ; medical and economical assessment. |  | 2012 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vulvar Neoplasms, Skin Neoplasms, Ultracision, Lymphadenectomy
A Study of the Combination of Electrical Stimulation and Dysport® in Myofascial Pain Syndrome.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether electrical stimulation enhances the effect of botulinum toxin type A (Dysport®) on myofascial pain syndrome.

Official Title
-----------------
A 16-week Prospective Randomised Double-blind Study on Facilitation of DYSPORT® Effect on Myofascial Pain Syndrome (MPS) by Electrical Stimulation.

Conditions
-----------------
Myofascial Pain Syndromes

Intervention / Treatment
-----------------
* Biological: Botulinum toxin type A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic neck and shoulder pain for at least 6 months, refractory with other conservative treatments Presents at baseline with pain score greater than 50mm on 100mm length VAS. Pain score will be measured as overall pain over the 7 days preceding the visit during activities Active trigger point (TrP) defined as a tender spot localised in a taut band of muscle fibres associated with tenderness AND referred pain recognised by the patient into well-defined areas that are remote from the TrP area at palpation AND preferably local twitch response at palpation AND/OR jump sign at palpation Exclusion Criteria: Disc/bone disease History of surgery on neck Neurological deficits, neuromuscular junction disorder, Motor Neuron disease Patient has received anesthetic injections to the target trigger point within 4 weeks of study enrolment, or corticosteroid injections within 3 months Systemic inflammatory disease Hypersensitivity to Dysport® Diffuse tender points, or diagnosed with fibromyalgia Previous electrical stimulation Previous injection of Dysport® within 6 months of study enrolment

Ages Eligible for Study
-----------------
Minimum Age: 21 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

| Intervention/Treatment |
| --- |
|Biological: Botulinum toxin type A|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in mean pain measured by Visual Analogue Scale (VAS) will be assessed. |  | Comparison of VAS will be performed before Dysport® injection and at 16 weeks after injection | 
| Number of patients in percentage whose pain intensity measured by VAS decreases to less than 50% of baseline. |  | Before Dysport® injection and at 16 weeks after injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain threshold measured by pressure algometer. |  | At each visit | 
| Neck Pain and Disability scale (NPAD) and Global Assessment of Impairment Scale (GAS) will be assessed. |  | At each visit |