linjc16/ctgov huggingface dataset:
Study Evaluating The Potential Effect Of Multiple Doses Of Neratinib On The Pharmacokinetics Of A Single Dose Of Digoxin

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the potential effect of multiple doses of neratinib on the pharmacokinetics (how the body absorbs, distributes, metabolizes and/or excretes) of a single dose of digoxin.

Official Title
-----------------
An Open-Label, Nonrandomized, Crossover Study to Evaluate the Potential Effect of Multiple Doses of Neratinib on the Pharmacokinetics of a Single Dose of Digoxin When Administered Orally to Healthy Adult Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Digoxin
* Drug: Neratinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Healthy men and women of non-childbearing potential, age 18-50

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Digoxin alone | Drug: Digoxin<br> <br> |
| Experimental: 2<br>Digoxin plus neratinib | Drug: Digoxin<br> <br> Drug: Neratinib<br>* HKI-272<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameters: concentration of digoxin in blood and urine |  | 5 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy Subjects
First in Human Study of an Anti-IFN Gamma Monoclonal Antibody in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety, pharmacodynamic and pharmacokinetic profiles of a novel therapeutic drug when administered to healthy volunteers.

Official Title
-----------------
A Randomized Double-blinded Placebo Controlled Single Center Phase I Study of Escalating Single Intravenous Doses of NI-0501 in Healthy Volunteers

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: NI-0501
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy adults between 18 and 50 years old non smokers able to adhere to study protocol requirements Exclusion Criteria: any abnormal clinical safety laboratory parameters

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NI-0501<br> | Drug: NI-0501<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of escalating single IV doses of NI-0501. |  | AEs at: Study Day (SD) 1 pre-infusion, SD1 at 1, 2, 4, 8, 10, 12 hrs post infusion start, SD 2, SD 3, SD 5, SD 8, Wk 2, Wk 4, Wk 6, Wk 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics parameters, Determination of any pharmacodynamic effects, Immunogenicity of NI-0501 |  | PK/PD at: Study Day (SD) 1 pre-infusion, SD1 at 1, 2, 4, 8, 10 hrs post infusion start, SD 2, SD 3, SD 5, SD 8, Wk 2, Wk 4, Wk 6, Wk 8, Immunogenicity: SD1 pre-infusion, Wk 8 |
Impact of Self-Monitoring Blood Glucose Frequency on Glycemic Control in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
To determine if the frequency of blood glucose testing in patients with type 2 diabetes who are being treated with diet and exercise alone or diet and exercise plus oral agents will impact the HbA1c level.

Detailed Description
-----------------
To determine the impact of SMBG frequency on blood glucose control in patients receiving systematic diabetes management education through Type 2 Diabetes BASICS at International Diabetes Center.

Official Title
-----------------
Impact of Self-Monitoring Blood Glucose Frequency on Glycemic Control in Patients With Type 2 Diabetes

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Behavioral: frequency of self monitoring blood glucose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes Treatment with diet and exercise alone or with the addition of 1 or 2 oral agents Enrolled in Type 2 BASICS program A1c between 7.0 and 11%, inclusive Able to understand spoken English Exclusion Criteria: Insulin therapy Unable/unwilling to perform SMBG Participating in another research study Currently performing SMBG >3 times/week

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 79 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 |
| --- | --- |
| Experimental: 1<br>self monitor blood glucose 3 times a day per usual diabetes class curriculum | Behavioral: frequency of self monitoring blood glucose<br>* Evaluate the impact of self monitoring blood glucose frequency on glycemic control in patients with type 2 diabetes.<br>|
| Experimental: 2<br>only self monitor blood glucose when fasting | Behavioral: frequency of self monitoring blood glucose<br>* Evaluate the impact of self monitoring blood glucose frequency on glycemic control in patients with type 2 diabetes.<br>|
| Experimental: 3<br>no self monitoring of blood glucose | Behavioral: frequency of self monitoring blood glucose<br>* Evaluate the impact of self monitoring blood glucose frequency on glycemic control in patients with type 2 diabetes.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood glucose testing frequency |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
referred to, comprehensive, diabetes, education, program
Exploratory Study to Assess Delivery of LMN-201 Components Via Enteric Capsules in the Gut of Individuals With Ostomies

Study Overview
=================
Brief Summary
-----------------
This is a Phase 1, single-site, open label, exploratory study to assess delivery of LMN-201 components via enteric capsules in the gut of individuals with ostomies.

Official Title
-----------------
Exploratory Study to Assess Delivery of LMN-201 Components Via Enteric Capsules in the Gut of Individuals With Ostomies

Conditions
-----------------
C. Diff. Infections

Intervention / Treatment
-----------------
* Biological: LMN-201


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Willing to participate in the clinical trial Able and willing to provide informed consent Stable ostomy (no revisions in the last 6 months) At least 19 years old Medically stable, but may be on medications for chronic conditions Exclusion Criteria: Unable or unwilling to provide adequate informed consent Non-English speakers Clinically significant disease Women who are pregnant, intending to become pregnant, or breastfeeding Use of anti-diarrheal medicine Suffer gastroparesis Opioid use

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: LMN-201|Components of LMN-201|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence or absence of capsules and/or transit markers in ostomy fluid by visual observation | Presence or absence of capsules and/or transit markers in ostomy fluid by visual observation | Up to 12 hours after dose |
Preclinical Study Towards an Immunotherapy in Adrenocortical Carcinoma

Study Overview
=================
Brief Summary
-----------------
Adrenocortical carcinoma (ACC) is a rare and heterogeneous malignancy with poor prognosis. Surgical resection of the tumor is the treatment of choice. However, even after complete resection more than 80 % of patients will experience recurrence of disease. Therefore, new treatment options are urgently needed. This pre-clinical study try to lay the foundations for a successful immunotherapy in patients with ACC.

Official Title
-----------------
Präklinische Studie Zur Etablierung Einer Immuntherapie für Das Nebennierenrindenkarzinom - Preclinical Study Towards an Immunotherapy in Adrenocortical Carcinoma

Conditions
-----------------
Adrenocortical Carcinoma, Cushing's Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with histological proven adrenocortical carcinoma healthy persons as control group Life expectancy > 6 months Exclusion Criteria: autoimmune diseases severe clinical condition

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To find reasonable antigens for a vaccination therapy in ACC |  | day of blood sampling | 
| To investigate the role of tumor-induced suppression in ACC |  | NA, in vitro study |
Heart Function in Patients Assessed for Sleep Apnoea

Study Overview
=================
Brief Summary
-----------------
This study aims to determine the prevalence and prognosis of heart failure with preserved ejection function (HFpEF) among patients being assessed for sleep disordered breathing (SDB).

Detailed Description
-----------------
Patients with sleep disordered breathing (SDB) and those with heart failure with preserved ejection fraction (HFpEF) share similar characteristics. Increasing age, hypertension, obesity, diabetes mellitus and atrial fibrillation are well recognised links in both groups. It also known that SDB is common in patients with heart failure, both with reduced and preserved ejection fraction. It is therefore hypothesised that among patients being referred for SDB assessment, we can identify a group with unrecognised HFpEF.

Official Title
-----------------
Heart Function in Patients Assessed for Sleep Disordered Breathing (SDB)

Conditions
-----------------
Heart Failure With Preserved Ejection Fraction, Sleep Disordered Breathing, Heart Failure With Normal Ejection Fraction, Obstructive Sleep Apnea, Central Sleep Apnea, Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged ≥40 years and referred for respiratory polygraphy Exclusion Criteria: Previous diagnosis of Heart Failure Treated sleep disordered breathing

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- |
| Patients with clinically suspected sleep disordered breathing (SDB)<br>Patients referred for Sleep disordered breathing assessment. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Unrecognised Heart Failure With Preserved Ejection Fraction (HFpEF) in Cohort With Clinically Suspected Sleep Disordered Breathing (SDB) | The diagnosis of HFpEF was established using criteria set out in the European Society for Cardiology (ESC) guidelines based on clinical symptoms and/or signs, biomarker analysis (NT-proBNP) and evidence of structural cardiac remodeling or diastolic dysfunction on transthoracic echocardiography. | Baseline |
A Study to Evaluate the Effectiveness of Aranesp® for Cancer Patients With Anemia

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to assess the effectiveness of Aranesp® administered at 300 mcg every 3 weeks (q3w) in achieving therapeutic objectives of anemia treatment (achieving and maintaining hemoglobin levels consistent with the National Comprehensive Cancer Network (NCCN) guidelines).

Official Title
-----------------
SYNCHRONICITY: A Study to Evaluate the Effectiveness of Aranesp® at 300 Mcg Q3W on Clinical Outcomes in Cancer Patients With Anemia Due to Chemotherapy

Conditions
-----------------
Anemia, Neoplasms

Intervention / Treatment
-----------------
* Drug: Aranesp®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Subjects with non-myeloid malignancy - Anemia (Hgb less than 11.0 g/dL) due to cancer chemotherapy - Receiving chemotherapy and expected to receive at least 8 additional weeks of chemotherapy - Adequate renal function - Adequate liver function Exclusion Criteria: - Subjects with acute myelogenous leukemia (AML), chronic myelogenous leukemia (CML), or myelodysplastic syndromes (MDS) - Unstable cardiac disease - Active bleeding - Active systemic or chronic infection - Severe active chronic inflammatory disease - Other hematologic disorder associated with anemia - Uncontrolled hypertension - Known iron or nutritional deficiency - Known positive test for human immunodeficiency virus (HIV) infection - History of pure red cell aplasia - History of positive antibody response to any erythropoietic agent - Erythropoietin therapy within 4 weeks before screening - RBC transfusions within 2 weeks prior to screening

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Aranesp®|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin maintenance |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life |  |  | 
| Changes in measures of work productivity and anemia treatment convenience |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anemia, fatigue, Aranesp®, clinical trial
Thromboelastometry in Assessment of Sepsis Coagulopathy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to analyze occurence of bleeding complications during invasive procedures in septic patients with normal tromboelastometry results despite prolonged standard coagulation tests results

Official Title
-----------------
Evaluation of Thromboelastometry in Sepsis in Correlation to Bleeding During Invasive Procedures

Conditions
-----------------
Thrombelastography, Sepsis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: sepsis/septic shock prolonged PT-INR (international normalized ratio) ≥ 1.3 normal ROTEM-EXTEM results. Exclusion Criteria: patients on antiplatelet drugs or anticoagulant therapy (heparin, vitamin K antagonists…) patients with cirrhosis

Ages Eligible for Study
-----------------
Minimum Age: 24 Years
Maximum Age: 89 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 |
| --- | --- | --- |
| incidence of bleeding complications | In our group of 76 septic patients who had normal values of EXTEM despite prolonged INR/PR invasive procedures were performed without severe bleeding. | 2013 - 2016 |
Register of Autoimmune Bullous Dermatoses

Study Overview
=================
Brief Summary
-----------------
Autoimmune bullous dermatoses are a group of diseases with chronic course. They are provoked by the production of autoantibodies against the dermal-epidermal junction or against the inter-keratinocyte junctions, resulting in the formation of intra-epidermal or sub-epidermal blisters. The diagnosis of autoimmune bullous dermatoses is based on clinical and immunopathological findings, including skin direct immunofluorescence. Systemic corticosteroid therapy is generally considered as the mainstay of treatment for many years both for bullous pemphigoid and pemphigus which are the most frequent diseases.

Detailed Description
-----------------
The aim of the study is the creation of a register of patients suffering from autoimmune bullous dermatoses to quickly identify patients who can be included in clinical trials or retrospective epidemiological studies

Official Title
-----------------
Register of Autoimmune Bullous Dermatoses

Conditions
-----------------
Autoimmune Bullous Dermatoses

Intervention / Treatment
-----------------
* Other: Data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with autoimmune bullous dermatosis patients cared for in dermatology referral center of Reims, Rouen or Limoges patient consenting to participate to the study Exclusion Criteria: - patient <18 years

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 |
| --- | --- |
| Autoimmune bullous dermatoses<br>Patients with autoimmune bullous dermatoses | Other: Data collection<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| autoimmune bullous dermatosis according to physical examination, skin biopsy and autoantibodies detection in blood sample | Each autoimmune bullous dermatosis is classified according one of the following diagnoses : 1/ bullous pemphigoid, 2/ Mucous membrane pemphigoid, 3/ Pemphigoid gestationis, 4/ Epidermolysis bullosa acquisita, 5/ Linear IgA bullous dermatosis, 6/ pemphigus (vulgaris or foliaceus) This classification will be performed according : clinical characteristics including location, clinical aspect and number of cutaneous and/or mucosal blisters skin biopsy for routine histology (subepidermal blister or intra-epidermal blister) and direct immunofluorescence (IgG and/or I gA and/or C3 deposits along the epidermal basement membrane zone or on the cell surface of keratinocytes) blood sample for serum autoantibodies detection against epidermal autoantigens using ELISA or indirect immunofluorescence techniques | Day 0 |
Comparison Endotracheal Cardiac Output Monitor (ECOM) to a Standard Device in Measuring Heart Blood Volume

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate a new monitor that measures cardiac output (amount of blood pumped by the heart). The system that is being tested in this study, called Endotracheal Cardiac Output Monitor (ECOM), uses electricity (impedance cardiography) to measure cardiac output and is not harmful to the patient. This study will test the accuracy and efficacy of the ECOM system in anesthetized and sedated patients who, in the normal course of clinical care in the OR or ICU, are having cardiac output measured. The investigators propose that unlike the standard system for cardiac output measurement, the ConMed ECOM System should result in a simplified, inexpensive, continuous, less-invasive, and accurate method of measuring cardiac output. Such a technique could allow the rapid diagnosis of instability in the cardiovascular system for critically ill patients.

Official Title
-----------------
Comparison Endotracheal Cardiac Output Monitor (ECOM) to a Standard Device in Measuring Heart Blood Volume

Conditions
-----------------
Heart Disease, Cardiac Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to give informed consent Patients requiring all of the following: an oral ET tube an arterial catheter measurement of CO Exclusion Criteria: Patients not competent to give informed 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |