linjc16/ctgov huggingface dataset:
Temozolomide in Concomitant Radiochemotherapy Followed by Sequential Temozolomide Chemotherapy - Observational Program (Study P04816)

Study Overview
=================
Brief Summary
-----------------
The purpose of this program is to evaluate the safety, tolerability, and efficacy of the new concomitant and sequential temozolomide regimen in newly diagnosed Glioblastoma patients in a routine care setting.

Detailed Description
-----------------
Participant sampling method: consecutive patient sampling.

Official Title
-----------------
Temodal (TMZ) in Concomitant Radiochemotherapy Followed by Sequential TMZ Chemotherapy in Newly Diagnosed Glioblastoma Multiforme Patients - an Observational Program

Conditions
-----------------
Glioblastoma

Intervention / Treatment
-----------------
* Drug: Temozolomide
* Radiation: Radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosed Glioblastoma multiforme Exclusion Criteria: History of hypersensitivity to temozolomide or its components, or to dacarbazine. Women who are pregnant or breast-feeding. Patients with severe myelosuppression.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>Participants with newly diagnosed Glioblastoma multiforme who were prescribed temozolomide and radiotherapy as standard care. | Drug: Temozolomide<br>* Temozolomide will be administered orally at 75 mg/m^2 with radiotherapy during the concomitant treatment phase. After four weeks, temozolomide will be administered at 150 mg/m^2 to 200 mg/m^2 from Day 1 to Day 5 of six therapy cycles during the monotherapy phase.<br>* Other names: SCH 052365;Radiation: Radiotherapy<br>* Radiotherapy will consist of fractionated focal irradiation at a dose of 2 Gy per fraction given Monday through Friday for a total dose of 60 Gy, administered with temozolomide during the concomitant treatment phase.<br>* Other names: Irradiation;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Number of Adverse Events in the Indicated Categories |  | Weekly during the concomitant treatment phase, and then monthly during the monotherapy phase | 
| Number of Participants Who Discontinued Due to Toxicity |  | Weekly during the concomitant treatment phase, and then monthly during the monotherapy phase |
Anterior Shoulder Dislocation

Study Overview
=================
Brief Summary
-----------------
To compare and validate the two clinical algorithms

Detailed Description
-----------------
Clinical Decision rules have safely and successfully allowed clinicians to reduce the total number of radiographs ordered, while detecting patients with important pathology or injuries. The Ottawa Ankle and Knee Rules were developed from a series of studies, and have successfully reduced the number of radiographs ordered by physicians without missing serious ankle fractures (1-4). Likewise, the NEXUS group developed a clinical decision rule for the selection of blunt trauma patients who are appropriate for imaging, based on clinical features (5). Drs. Hendey and Emond have separately developed similar algorithms for selective radiography in patients with a suspected shoulder dislocation (6-10). The goal of the current study is to compare and validate the two clinical algorithms. Both approaches examine clinical features that are readily accessible to the physician at the time of ED evaluation. In the pre-reduction assessment, both algorithms included the mechanism of injury and whether the patient had experienced a previous shoulder dislocation. Hendey additionally assessed whether the physician was clinically confident of the dislocation (8). Emond additionally included the age of the patient, and the presence or absence of humeral ecchymosis (9). In the post-reduction assessment, both algorithms emphasize the importance of clinical certainty of reduction, as well as the presence of a fracture dislocation.

Official Title
-----------------
Selective Radiography in Anterior Shoulder Dislocation: Prospective Validation Rule of Decision Rules Derived in Fresno and Quebec

Conditions
-----------------
Shoulder Dislocation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients 18 years and older patient with a suspected acute anterior shoulder dislocation Exclusion Criteria: patients under 18 years of age prisoners

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prospective validation of clinical decision rules |  | to be measured at study conclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anterior Shoulder Dislocation, Shoulder Dislocation, Shoulder Pain, Shoulder Deformity
Performance Evaluation of the Biological Diagnosis of HIT

Study Overview
=================
Brief Summary
-----------------
Heparin-induced thrombocytopenia (HIT) is a severe complication of heparin therapy with a non-negligible incidence (estimated at 2.6% of unfractionated heparin treatments and 0.2% of low molecular weight heparin treatments). It is generally secondary to the appearance of IgG antibodies directed against the platelet factor 4 (PF4) - heparin complex. These antibodies, once bound to this complex, are likely to activate platelets: the thrombotic risk generated can be potentially fatal.

Official Title
-----------------
Performance Evaluation of the Biological Diagnosis of Heparin-induced Thrombocytopenia (HIT)

Conditions
-----------------
Heparin-induced Thrombocytopenia (HIT)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria : Adult patient (≥ 18 years of age) Hospitalized at HUS between 01/01/2009 and 31/12/2019 Specimen sent to the HUS Hematology Laboratory for biological diagnosis of HIT between 01/01/2009 and 31/12/2019 Data collected by the CRPV and analyzed by the HIT multidisciplinary group in order to reach a consensus decision on the presence or absence of HIT Patient does not object to the reuse of his medical data for scientific research purposes. Exclusion criteria: Patient for whom no test has been performed at the HUS Hematology Laboratory Patient for whom no data has been collected by the CRPV Patient for whom the HIT group could not confirm or deny the presence of HIT

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retrospective description of the biological diagnosis approach for heparin-induced thrombocytopenia (HIT) in the Hematology laboratory of the University Hospitals of Strasbourg |  | through study completion, an average of 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heparin-induced thrombocytopenia, HIT, heparin therapy, heparin treatments, molecular weight heparin, IgG antibodies, platelet factor 4 (PF4), heparin complex, thrombotic risk
Comparison of Two Biphasic Insulin Aspart 30 Formulations (Current and New Formulation) in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in the United states of America (USA). The aim of this trial is to compare two formulations of biphasic insulin aspart 30 in healthy volunteers.

Official Title
-----------------
Bioequivalence of Two Biphasic Insulin Aspart 30 (NovoLog® Mix 70/30) Formulations (Current and New Formulation With Glycerol): A Randomized, Double-Blind, Two-Period Crossover Study in Healthy Volunteers

Conditions
-----------------
Diabetes, Healthy

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI (body mass index) between 18 and 28 kg/m^2, both inclusive Subject is a nonsmoker for at least 3 months Subject is judged to be in good health on the basis of their medical history, physical examination, ECG (electrocardiogram), and routine laboratory data Fasting plasma glucose between 80 and 110 mg/dl Exclusion Criteria: •Any clinically significant disease history of systemic or organ disease •Clinically significant abnormalities on pre-study clinical examination or any laboratory measurements during screening (any abnormality should be discussed with the clinical monitor) •In females of child bearing potential: Pregnancy, lactating, breastfeeding, intent to become pregnant within the next 6-months or judged to be using inadequate contraceptive measures (adequate contraceptive measures include: condom, intrauterine devices). ß-hCG pregnancy test must be negative

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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Formulation 1<br> | Drug: biphasic insulin aspart 30<br>* Single dose administrated subcutaneously (s.c., under the skin)<br>|
| Active Comparator: Formulation 2<br> | Drug: biphasic insulin aspart 30<br>* Single dose administrated subcutaneously (s.c., under the skin)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the concentration curve (AUC) of the two formulations from time 0 hours to infinity |  |  | 
| Maximum drug concentration of the two formulations (Cmax) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the concentration curve for insulin aspart from time 0 hours to 16 hours |  |  | 
| Mean residence time (MRT) |  |  | 
| Frequency of adverse events |  |  |
Epidemiology of Acute Phase Protein and CHD

Study Overview
=================
Brief Summary
-----------------
To use the Multiple Risk Factor Intervention Trial (MRFIT) stored serum bank to do nested case-control studies of various serum risk factors in coronary heart disease incidence and mortality.

Detailed Description
-----------------
BACKGROUND: The use of stored serum from the MRFIT cohort contributed additional information on how various lipid fractions and other serum constituents interact to produce atherosclerotic disease. The cost of performing such studies on a new cohort would be many times greater. DESIGN NARRATIVE: The case-control study evaluated: 1) the relationship between acute phase reactants, albumin, alpha 1 glycoprotein c-reactive protein and sialic acid; 2) oxidized low density lipoprotein cholesterol (LDLC) measured by thiobarbituric acid reactive substances (TBARS), and risk of myocardial infarction or coronary heart disease death; 3) Lp(a); 4) antioxidized vitamin E and carotene. The study was done in one year because of the need to analyze the specimens shortly after they were thawed. The statistical analysis was done in collaboration with University of Minnesota Coordinating Center. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Coronary Disease, Heart Diseases, Atherosclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 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 |
| --- | --- | --- |
Surface Electrocardiogram (ECG) Signal Recording for Implantable Subcutaneous String Defibrillator (ISSD) Development

Study Overview
=================
Brief Summary
-----------------
Record cutaneous Electrocardiogram (ECG) data from positions corresponding to the expected subcutaneous locations of the Implantable Subcutaneous String Defibrillator (ISSD) using existing, approved ECG recording devices.

Detailed Description
-----------------
2 electrodes places near the sternum and 2 near the midaxillary line, simulating the expected positions of Implantable Subcutaneous String Defibrillator (ISSD) sense electrodes. reference ECG electrodes are also attached (in most cases). Approved ECG recording devices are used to record the signal continuously: During an EP session (different types) a bedside recorder, and a holter monitor is used during holter recordings. Ep session recordings are performed in order to capture different types of arrhythmia, and holter recordings are performed to observe changes in ECG morphology due to activity, position changes, circadian cycles etc. The data is saved and used in the development of the ISSD.

Official Title
-----------------
Surface Electrocardiogram (ECG) Signal Recording for Implantable Subcutaneous String Defibrillator (ISSD) Development

Conditions
-----------------
Arrhythmia, Cardiac

Intervention / Treatment
-----------------
* Other: recorded patients


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Candidate for ICD implantation Candidate for EP study Candidate for 24 hour holter monitor recording Exclusion Criteria: age<18

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Recorded patients<br>Patients requiring Intracradiac Defibrillator (ICD) implantation, Electrophysiology (EP) study or a holter monitor recording, mainly due to suspected ventricular tachy - arrhythmias | Other: recorded patients<br>* No intervention applied, only recording of cutaneous ECG signal from specific points on the torsi<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| successful recording of Electrocardiogram (ECG) from a patient containing arrhythmia | recorded Electrocardiogram (ECG) of patients with as many arrhythmia events as possible, preferably tachy-arrhythmia events such as fast VT, flutter or VF | immediate |
Quadratus Lumborum Block for Postoperative Analgesia After Colostomy Closure

Study Overview
=================
Brief Summary
-----------------
Patients undergoing abdominal procedures often require multimodal postoperative pain controls. Truncal blocks such as quadratus lumborum (QL) block may be used adjunctively as a part of it. The investigators hypothesized that the ultrasound-guided QL block with transmuscular approach can provide adequate pain relief for colostomy closure as part of a multimodal pain control.

Official Title
-----------------
Ultrasound-guided Quadratus Lumborum Block for Postoperative Analgesia After Colostomy: A Randomized Controlled Trial

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Drug: levo-bupivacaine
* Drug: normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A physical status between ASA I and III 20 - 75 years of age Patient has signed an informed consent Without contraindication of QL block Exclusion Criteria American Society of Anesthesiologists (ASA) Physical Status ≥ 4 Any contraindication to nerve blocks (including coagulopathy, abnormal anatomy, infection at the planned QL injection site, and amide-type local anesthetic allergy) pregnancy or breast-feeding Severe obesity (body mass index≥ 35 kg/m2) Patients with a history of significant neurological, psychiatric, neuromuscular, cardiovascular, pulmonary, renal or hepatic disease Allergy to NSAIDs Infection at the QL injection site Patients with major psychosis or drug and alcohol abuse Patient unable to comprehend or use the verbal rating pain scoring system or patient-controlled analgesia pump

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Placebo QL block<br>30 ml single shot QL block with saline 0.9% | Drug: normal saline<br> <br> |
| Active Comparator: Active QL block<br>30 ml single shot QL block with 0.25% levo-bupivacaine | Drug: levo-bupivacaine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cumulative morphine consumption |  | 1 hour |
FGF-23 (Fibroblast Growth Factor 23) Regulation in Chronic Kidney Disease

Study Overview
=================
Brief Summary
-----------------
FGF-23 is a newly described protein that is an important regulator of phosphorus in the body. This protein increases in people with kidney disease and people who need dialysis have very high levels of FGF-23 in the blood. However, although some studies have indicated that FGF-23 levels go up with increased intake of phosphorus, no one knows if FGF-23 levels can be lowered in patients with kidney disease by preventing them from absorbing phosphorus from food. This study is designed to see what happens to levels of FGF-23 in the blood when patients with chronic kidney disease take medications to prevent phosphorus absorption. Since high levels of FGF-23 have been linked with increased rates of death in patients with advanced kidney disease, controlling the levels may, in the future, be a way to decrease heart disease in patients with kidney disease.

Official Title
-----------------
FGF-23 (Fibroblast Growth Factor 23) Regulation in Chronic Kidney Disease

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

Intervention / Treatment
-----------------
* Drug: Sevelamer Carbonate
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inclusion criteria include pediatric patients, between the ages of 2 and 21 years, with CKD stages 2-4 (GFR 15-90 ml/min/1.73m2). Exclusion Criteria: Exclusion criteria include: the use of phosphate binder therapy within the past 3 months, treatment with 25(OH)vitamin D or 1,25dihydroxyvitamin D, underlying metabolic bone disease, or underlying renal phosphate wasting disorder.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 21 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Renvela<br>Daily renvela with meals for 12 weeks | Drug: Sevelamer Carbonate<br>* Daily renvela (800 mg tid with meals) x 12 weeks<br>* Other names: Renvela;|
| Placebo Comparator: placebo<br> | Other: Placebo<br>* 1 inert tablet tid x 12 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in FGF-23 Level | Change in FGF23 value from baseline in response to Renvela at 12 weeks in comparison to placebo. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1,25(OH)2vitamin D Value | Percentage change in 1,25(OH)2vitamin D level from baseline at 12 weeks. | 12 week | 
| Serum Phosphate Concentration | Change in serum phosphate at 12 weeks from baseline | 12 weeks |
Effects of A Standardized Treatment Approach on Kidney Transplant Recipients With Antibody-Mediated Rejection

Study Overview
=================
Brief Summary
-----------------
Antibody-mediated rejection (ABMR) is one of the leading causes of graft loss in kidney transplant recipients (KTRs). Although it is a well characterized entity, there is limited data regarding effective treatment options for preserving graft functions. Moreover, results from different studies have been contradictory. Therefore, we conducted a study using our registry data to evaluate the effects of a standardized treatment approach consisting of therapeutic plasma exchange (regular plasmapheresis, double filtration plasmapheresis or immunoadsorption), intravenous immunoglobulin and rituximab on KTRs with acute or chronic ABMR.

Official Title
-----------------
Effects of A Standardized Treatment Approach Comprising Plasma Exchange, Intravenous Immunoglobulin and Rituximab on Kidney Transplant Recipients With Acute or Chronic Antibody-Mediated Rejection

Conditions
-----------------
Antibody-mediated Rejection, Kidney Transplant Rejection, Graft Loss

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Being a kidney transplant recipient with biopsy-proven acute or chronic antibody-mediated rejection who were treated using 6 sessions of therapeutic plasma exchange, 2 g/kg of intravenous immunoglobulin and 1-2 weekly doses of 375 mg/m2 rituximab. Exclusion Criteria: Not providing or withdrawing consent.

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 |
| --- | --- |
| Study Group<br>Kidney transplant recipients with biopsy-proven acute or chronic antibody-mediated rejection who were treated using 6 sessions of therapeutic plasma exchange, 2 g/kg of intravenous immunoglobulin and 1-2 weekly doses of 375 mg/m2 rituximab. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft Loss | Returning to dialysis due to graft failure or death with a functioning graft. | 2-5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
antibody-mediated rejection, kidney transplantation