linjc16/ctgov huggingface dataset:
Effectiveness and Safety of the Dexcom™ G6 Continuous Glucose Monitoring System

Study Overview
=================
Brief Summary
-----------------
Effectiveness and Safety of the Dexcom G6 Continuous Glucose Monitoring (CGM) System

Detailed Description
-----------------
The objective of the study is to establish performance of the System compared to a laboratory reference measurement. The effectiveness of the System will be evaluated by comparison of CGM values to a laboratory reference, Yellow Spring Instrument (YSI), using arterialized venous sample measurements. Performance will be evaluated in terms of point and rate accuracy of the System in reference to YSI. The safety profile of the System will be characterized by the incidence of device-related Adverse Events (AEs) experienced by study subjects.

Official Title
-----------------
Effectiveness and Safety of the Dexcom™ G6 Continuous Glucose Monitoring System

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Device: CGM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages 2 or older Diagnosis of Type 1 diabetes or Type 2 diabetes, on intensive insulin therapy Willing to participate in a clinic session involving venous sampling for evaluation of study end point Exclusion Criteria: Use of acetaminophen Known allergy to medical-grade adhesives Pregnancy Hematocrit outside specification of the study-assigned blood glucose meter

Ages Eligible for Study
-----------------
Minimum Age: 2 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: CGM Users<br>Glucose challenge during a clinic sessions to assess performance of CGM compared to reference measurement | Device: CGM<br>* Glucose challenge during a clinic session to assess CGM performance compared to a laboratory reference measurement.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of blood glucose values, compared between CGM and a lab glucose analyzer that are matched relative to a proportion of blood glucose values, compared between CGM and a lab glucose analyzer matched to an accuracy measurement of %20/20 mg/dL |  | 10 Days |
Evaluation of a Gel Sunscreen in Controlled Use Conditions (208/2016)

Study Overview
=================
Brief Summary
-----------------
To explore and quantify potential issues with application of a gel sunscreen in Outdoor Use testing, in a controlled indoor environment

Official Title
-----------------
Evaluation of a Gel Sunscreen in Controlled Use Conditions

Conditions
-----------------
Sunscreening Agents

Intervention / Treatment
-----------------
* Drug: BAY987517
* Drug: BullFrog Gel Sunscreen Land Sport SPF-50


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects may be male or female. Subjects must be adults between 18 and 45 years of age. Subjects must have and have had a consistently active lifestyle for at least the previous few years (exercise outdoors and in direct sun exposure at least 2 times per week for at least 30 minutes-acceptable activities include tennis, running, jogging, walking, golf, etc.), i.e., outdoor activity should not be a new behavior. Subjects must have used a sunscreen with SPF 50 or higher within the previous 9 months. Exclusion Criteria: Subjects who have received or used an Investigational New Drug within the last 30 days. Subjects who have been active participants in another clinical or subjective product performance study within the last 30 days. Subjects who have a known allergy or sensitivity to sunscreen ingredients or test materials. Subjects with respiratory allergies or asthma.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sunscreen Users<br>Subjects will participate in a 2-Day study involving three applications of a single test article each day. The first application will be followed by an exposure of 30 minutes in a hot room. | Drug: BAY987517<br>* Subjects will be instructed to apply the test article in a split-body and face configuration, to the assigned side of the body (face, arms, torso, and legs), as they normally would before going outdoors for a run, walk or other sport related activity. (Formulation: RB# Y73-161)<br>Drug: BullFrog Gel Sunscreen Land Sport SPF-50<br>* Subjects will be instructed to apply the test article in a split-body and face configuration, to the assigned side of the body (face, arms, torso, and legs), as they normally would before going outdoors for a run, walk or other sport related activity.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feeling any discomfort after applying the product assessed by questionnaire |  | 15 minutes after each application |
Proof-of-concept for the Aldosterone Synthase Inhibitor LCI699 in Patients With Primary Hyperaldosteronism

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if LCI699, thorough reductions in aldosterone, can lower BP in patients with Primary hyperaldosteronism.

Official Title
-----------------
A Pilot, Single-blind, Forced-titration Study to Assess the Hemodynamic and Hormonal Effects, Safety and Tolerability of the Aldosterone Synthase Inhibitor LCI699 in Patients With Primary Hyperaldosteronism

Conditions
-----------------
Primary Hyperaldosteronism

Intervention / Treatment
-----------------
* Drug: LCI699


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of primary hyperaldosteronism (PH) within the last 3 years, either with or without an aldosterone producing adenoma (APA). Hypertension at screening Exclusion Criteria: Persistent hypokalemia Renal impairment Significant hepatic disease Any surgical or medical condition which may significantly alter the absorption, distribution, metabolism or excretion of any drug substance Other protocol-defined inclusion/exclusion criteria may apply

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LCI696 1mg bid<br> | Drug: LCI699<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic blood pressure over a 7-week forced titration treatment period |  | 7 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma and urine hormone levels and electrolytes, diastolic blood pressure and drug pharmacokinetics over a 7-week forced titration treatment period |  | 7 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
primary hyperaldosteronism, hypokalemia, hypertension, aldosterone synthase inhibitor
Assessment of Hemodynamic Response in Cardiopulmonary Bypass Graft After Cardiopulmonary Bypass Using Transesophegeal Echocardiography

Study Overview
=================
Brief Summary
-----------------
This is a double blind randomization study, assessing hemodynamic response in patients who underwent a cardiopulmonary bypass graft (CABG) with cardiopulmonary bypass (CPB) using intraoperative trasnesophageal echocardiography (TEE) to know what inotropic drug will be batter to improve the heart function. Epinephrine, milrinone, dobutamine and levosimendan will be assessment.

Official Title
-----------------
Assessment and Hemodynamic Response in CABG After Cardiopulmonary Bypass Using Intraoperative Transesophegeal Echocardiography

Conditions
-----------------
Cardiopulmonary Bypass Graft

Intervention / Treatment
-----------------
* Drug: epinephrine and levosimendan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sinusal ritmus EF > 35% Elective CABG surgery Exclusion Criteria: No accept Severe valvular regurgitation or stenoses Chest pain Cardiogenic shock

Ages Eligible for Study
-----------------
Minimum Age: 45 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 |
| --- | --- |
| Active Comparator: epinephrine<br>Assessment of systolic and diastolic heart function during CABAG with CPB with levosimendan using TEE. | Drug: epinephrine and levosimendan<br>* epinephrine (0,06mcg/kg/min), levosimendan (0,2 mcg/kg/min)<br>|
| Active Comparator: levosimendan<br>Assessment of systolic and diastolic heart function during CABAG with CPB with epinephrine using TEE. | Drug: epinephrine and levosimendan<br>* epinephrine (0,06mcg/kg/min), levosimendan (0,2 mcg/kg/min)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic and diastolic heart function | Assessment the systolic and diastolic heart function | Two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality after CABAG | Assessment mortality after CABAG | Two years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CABG, Echocardiography, Heart Failure, Heart Function
Outcome of Low Energy Ankle Fractures

Study Overview
=================
Brief Summary
-----------------
Ankle fractures are among the most common osseous injuries to the lower extremity, and remain a significant source of morbidity for both the young and the elderly. Recent cross-national studies have shown a significant increase in the incidence and severity of ankle fractures among the elderly population.

Official Title
-----------------
Outcome of Low Energy Ankle Fractures

Conditions
-----------------
Ankle Fractures

Intervention / Treatment
-----------------
* Procedure: Trans-syndesmotic fixation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - all types of trumatic ankle fractures due to low energy amenable to surgical open reduction and internal fixation . Exclusion Criteria: previous surgery. Disorders of bone metabolism other than osteoprosis (ie, Paget disease , renal osteodystrophy , osteomalacia ) Patient with moderate or severe congnitive impairment or patients with Parkinson disease or dementia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Trans-syndesmotic fixation|antromedial approach for medial malleolus fractures, posterolateral or direct lateral approach for fibula fractures, direct fixation of third malleolus by posterior approach, Trans-syndesmotic fixation ,cement augmentation and Tibiotalocalcaneal fusion|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of recovery from the surgery of fractures |  | 4 weeks |
Hypophosphatemic Rickets in Norway

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to do a follow-up survey of all individuals with hereditary hypophosphatemia in Norway, focusing on manifestations in childhood and adolescence. The investigators also want to study phenotype-genotype associations, and look for new genes, in all forms of hereditary hypo and hyperphosphatemia.

Official Title
-----------------
Hypophosphatemic Rickets in Norway

Conditions
-----------------
Hypophosphatemia, Familial, Rickets, Hyperphosphatemia

Intervention / Treatment
-----------------
* Dietary Supplement: Alfacalcidol; phosphate.
* Drug: Sevelamer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients in the Norwegian population with hereditary hypophosphatemia, with or without rickets Patients in the Norwegian population with hereditary hyperphosphatemia Exclusion Criteria: -
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 |
| --- | --- |
| hereditary hypophosphatemia<br>Norwegian patients with hereditary hypophosphatemia. | Dietary Supplement: Alfacalcidol; phosphate.<br>* Individual dosage form and dosage depending on phenotype and underlying cause.<br>|
| Hereditary hyperphosphatemia<br>Norwegian patients with hereditary hyperphosphatemia (hyperphosphatemic familial tumoral calcinosis and hyperphosphatemia hyperostosis syndrome). | Drug: Sevelamer<br>* Pills. Individual dosage depending on clinical symptoms/phenotype.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth | Change i height z-score from time of diagnosis to last registered consultation. | Up to 18 years |
Neoadjuvant Chemotherapy for Pancreatic Cancer Followed by GS and GnP

Study Overview
=================
Brief Summary
-----------------
The effect of neoadjuvant chemotherapy for pancreatic cancer was gradually established. However it has been not clarified which regimen of neoadjuvant treatment for pancreatic cancer is the best.

Detailed Description
-----------------
gemcitabine plus S-1 versus gemcitabine plus nab-paclitaxel

Official Title
-----------------
Neoadjuvant Chemotherapy for Pancreatic Cancer; GS vs. GnP

Conditions
-----------------
Pancreatic Adenocarcinoma

Intervention / Treatment
-----------------
* Drug: GS
* Drug: GnP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elective pancreatectomy for pancreatic cancer Exclusion Criteria: a previous cancer surgery a body weight loss of >10% during the 6 months before surgery the presence of distant metastases seriously impaired function of vital organs because of respiratory, renal, or heart disease.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: GS<br>gemcitabine plus S-1 | Drug: GS<br>* drip infusion of gemcitabine plus oral administration of S-1 S-1 received S-1 orally twice daily at a dose calculated according to body-surface area (BSA) (< 1.25 m2, 60 mg/d; ≥ 1.25 to < 1.5 m2, 80 mg/d; ≥ 1.5 m2, 100 mg/d) on days 1 through 14 of a 21-day cycle gemcitabine received gemcitabine intravenously at a dose of 800 mg/m2 over 30 minutes on days 1 and 8of a 21-day cycle.<br>|
| Active Comparator: GnP<br>gemcitabine plus nab-paclitaxel | Drug: GnP<br>* drip infusion of both gemcitabine and nab-paclitacel gemcitabine received gemcitabine intravenously at a dose of 800 mg/m2 over 30 minutes on days 1, 8, and 15 of a 28-day cycle. nab-paclitaxel received nab-paclitaxel intravenously at a dose of 100 mg/m2 over 30 minutes on days 1, 8, and 15 of a 28-day cycle.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | postoperative survival | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse events | incidence of adverse events for neoadjuvant chemotherapy for pancreatic cancer | up to 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neoadjuvant
A Study to Evaluate the Efficacy and Safety of 2.5mg and 5mg Tadalafil Given Once a Day to Men With Erectile Dysfunction

Study Overview
=================
Brief Summary
-----------------
This is a multicenter, randomized, double blind, placebo-controlled, parallel design study to evaluate the efficacy and safety of 2.5mg and 5mg tadalafil taken once daily in men with erectile dysfunction.

Official Title
-----------------
A Randomized, Double-Blind, Parallel, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tadalafil (2.5mg and 5mg) Administered Once Daily to Men With Erectile Dysfunction

Conditions
-----------------
Erectile Dysfunction

Intervention / Treatment
-----------------
* Drug: tadalafil
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men with erectile dysfunction At least 18 years of age Exclusion Criteria: Certain chronic medical conditions including cardiac disease, congestive heart failure, kidney or liver disease, cancer and HIV A history of certain impotence disorders History of specified pelvic surgery Any significant genital abnormality identified at the start of the study

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

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

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: 1<br>placebo tablet | Drug: placebo<br>* Placebo tablet taken by mouth once a day for 24 weeks. Placebo patient will receive 5 mg tadalafil tablet during the open label extension.<br>|
| Active Comparator: 2<br>2.5 mg tadalafil tablet | Drug: tadalafil<br>* 2.5 mg or 5 mg tadalafil tablet taken by mouth once a day for 24 weeks. Followed by an open label extension where all patients receive 5 mg doses.<br>* Other names: IC351;|
| Active Comparator: 3<br>5 mg tadalafil tablet | Drug: tadalafil<br>* 2.5 mg or 5 mg tadalafil tablet taken by mouth once a day for 24 weeks. Followed by an open label extension where all patients receive 5 mg doses.<br>* Other names: IC351;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in erectile function measured at baseline and after 6 months of treatment with 2.5mg and 5mg tadalafil; assessment of safety after 1 and 2 years of therapy with 5mg tadalafil. |  | 24-128 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in additional aspects of erectile function after 3 and 6 months of treatment; assessment of the pharmacokinetics of tadalafil 2.5mg and 5mg. |  | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Impotence, erectile dysfunction
Studying Genes in Samples From Younger Patients With Adrenocortical Tumor

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This research trial studies genes in samples from younger patients with adrenocortical tumor.

Detailed Description
-----------------
OBJECTIVES: To perform whole-genome sequencing, deep sequencing, micro RNA analysis, methylation status, copy number variation analysis, and single-nucleotide polymorphisms (SNPs) analysis in pediatric adrenocortical tumors and compare those results to those of the same patient's normal cells. OUTLINE: Archived tumor and blood samples are analyzed for whole-genome sequencing, deep sequencing, micro RNA , methylation status, copy variation, and single-nucleotide polymorphisms. Results are then compared with patients' normal cells.

Official Title
-----------------
Using New Approaches for Genomics Studies in Pediatric Adrenocortical Tumors: Whole Genome Sequencing; Deep Sequencing; miRNA; methDNA and SNP 6.0

Conditions
-----------------
Adrenocortical Carcinoma

Intervention / Treatment
-----------------
* Genetic: DNA methylation analysis
* Genetic: RNA analysis
* Genetic: gene expression analysis
* Genetic: nucleic acid sequencing
* Genetic: polymorphism analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Banked tumor and blood samples obtained from patients enrolled on COG-ARAR0332 in North America and Brazil PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: Not specified

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: DNA methylation analysis|nan|
|Genetic: RNA analysis|nan|
|Genetic: gene expression analysis|nan|
|Genetic: nucleic acid sequencing|nan|
|Genetic: polymorphism analysis|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of genetic factors affecting adrenocortical tumors |  |  | 
| Comprehensive catalog of altered genes in adrenocortical samples |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adrenocortical carcinoma