linjc16/ctgov huggingface dataset:
Nexavar Dosing in Renal Cancer Patients in Real-life Setting

Study Overview
=================
Brief Summary
-----------------
This study is a registry of renal cancer patients treated with Nexavar. It aims to evaluate the actual dosing of Nexavar in real-life setting vs. the prescribed dose.

Official Title
-----------------
Nexavar Dose Evaluation Study in Patients With Advanced Renal Cell Carcinoma

Conditions
-----------------
Carcinoma, Renal Cell

Intervention / Treatment
-----------------
* Drug: Sorafenib (Nexavar, BAY43-9006)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >/= 18 years Diagnosis of renal cell carcinoma Failure of prior therapy with interferon-alfa (IFN) or interleukine-2 (IL-2) or disqualified from therapy with IFN/IL-2 Patients in whom the oncologist has decide to start therapy with sorafenib. Exclusion Criteria: Synonymous with contraindications to Nexavar.

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 |
| --- | --- |
| Group 1<br> | Drug: Sorafenib (Nexavar, BAY43-9006)<br>* Patients scheduled for treatment with sorafenib given in regular daily dose i.e. 800mg (400mg bid)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients in whom the actual dose of sorafenib equaled the planned dose |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall tolerability of treatment as measured by rate of adverse events |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Renal cell carcinoma,, Sorafenib, Dosing
Diabetic Under 70 (Diabetics Below 70)

Study Overview
=================
Brief Summary
-----------------
A screening project of diabetics with a very high cardiovascular risk (e.g. diabetes plus coronary heart disease) who already receive cholesterol-lowering therapy. Lipid profile and rate of patients who are treated to target (which is <70mg/dl for such patients with very high risk) are screened. The doctors therapy decisions after the screening will be documented and 8-10 weeks later the lipid profile of each patient will be evaluated again. Our aim is to evaluate dosing habits, to evaluate how many patients are treated to their LDL-C target and to underline the importance of treating patients to their cholesterol targets.

Official Title
-----------------
Diabetic Under 70 (Diabetics Below 70)

Conditions
-----------------
Diabetes, Hyperlipidemia, Atherosclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetics with hyperlipidemia and atherosclerosis (coronary heart disease, carotid stenosis, PAVK, etc.) who already receive cholesterol-lowering therapy Exclusion Criteria: Diabetics w/o CVD; diabetics who do not receive cholesterol-lowering therapy

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 |
| --- | --- |
| Patients at very high risk<br> | |
| Patients at high risk<br> | |
| Patients at medium risk<br> | |
| Patients at low risk<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cholesterol levels | Cholesterol levels from high risk patients after 4 weeks of cholesterol-lowering drug therapy under target values | After 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hyperlipidemia, Diabetics, NIS, Diabetics with hyperlipidemia and atherosclerosis (coronary heart disease, carotid stenosis, PAVK, etc.)
Group Cognitive Behavioral Therapy to Treat Depression in an Epilepsy Clinic Setting

Study Overview
=================
Brief Summary
-----------------
This study involves a form of group therapy called Cognitive Behavioral Therapy or CBT for depressed patients with Epilepsy. The CBT groups will be tailored for an epilepsy clinic population. There are 12 sessions of therapy in the study held once a week for 12 weeks.

Detailed Description
-----------------
Depression is frequent in PWE and often missed for unclear reasons. Busy neurology clinics and their overworked physicians often lack psychiatric backup that may make inquiring about psychological issues problematic. In the psychiatric community, awareness of the need for depression intervention in the primary care clinic has been recognized for many years and several treatment models exist. This study will attempt to use one such model, i.e. Cognitive-Behavioral Therapy (CBT) using a group format and tailoring its use for an epilepsy clinic population.

Conditions
-----------------
Epilepsy, Depressive Disorder

Intervention / Treatment
-----------------
* Behavioral: Cognitive Behavioral Therapy (CBT) in a Group Format


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria::- Patients will be screened with the Beck Depression Inventory. Those reaching the positive cut-off score of 11 (indicating at least a mild depression) will be entered into the study. Patients entered on antidepressants will be held at a stable dosage. Anti-epileptic drugs will also be maintained on the same dosage at entry into the study when possible clinically, after consultation with their neurologist. Exclusion Criteria:- Patients will be excluded if there is any active serious medical conditions, Standard Score<70 as assessed via the Wide Range Achievement Test, psychotic or substance abuse issues, those who are unable to maintain a stable dose of medications for the duration of study.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Cognitive Behavioral Therapy (CBT) in a Group Format|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beck Depression Inventory |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NDDI |  |  |
Preparing the Personal Physician for Practice (P4)

Study Overview
=================
Brief Summary
-----------------
We would like to better understand how different educational strategies may influence the practice of family medicine. More specifically, we are interested in participant satisfaction with the educational program, participant retainment in this career, and to see if the curricular change better prepares participants for contemporary clinical practice.

Detailed Description
-----------------
In 2004, the Future of Family Medicine report called for implementation of innovative strategies in residency education, allowing translational key insights from the national demonstration project toward new approaches to family medicine training. Taking full advantage of the P4 Project will require careful evaluation planning and implementation. A comprehensive evaluation plan for the P4 Project will be implemented by a core evaluation team that will interact with site-specific evaluators. The P4 evaluation program represents an observational case series assessment of selected residency programs. It is not an intervention trial; rather each residency program will systematically enroll cohorts of learners who will be exposed to curricular content and learning approaches that will likely be innovative and unique. In the absence of a rigorous study design, core data elements should be obtained from each program including: learner characteristics, program characteristics, and both nationally available data and targeted validated instruments that can link specific educational interventions to learners knowledge, attitudes and skills.

Official Title
-----------------
Preparing the Personal Physician for Practice (P4)

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

Intervention / Treatment
-----------------
* Other: Evaluating Educational Models


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Medical Residents at Christiana Care's Residency Program

Ages Eligible for Study
-----------------
Minimum Age: 26 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Evaluating Educational Models|Evaluating various forms of educational models for physicians.|

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Outpatient continuity training, Relevant, Patient-centered curriculum, Evaluation, New graduation requirements
Bioequivalence Of A Test Alprazolam Sublingual Formulation Compared To A Commercial Sublingual Formulation

Study Overview
=================
Brief Summary
-----------------
This study tests the assumption that the bioavailability of alprazolam from a new sublingual formulation is the same as that from sublingual formulation expected to be used commercially in Brazil.

Official Title
-----------------
Open-label, Randomized, Single-dose, 2-way Crossover Bioequivalence Study Comparing A New Alprazolam Sublingual Tablet Formulation To A Reference Alprazolam Sublingual Tablet

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

Intervention / Treatment
-----------------
* Drug: alprazolam sublingual tablet commercial
* Drug: alprazolam sublingual tablet test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male or female subjects BMI 17.5 - 30.5 Must provide informed consent Exclusion Criteria: Clinically significant disease Narrow angle glaucoma Positive drug screen

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: alprazolam sublingual tablet reference<br> | Drug: alprazolam sublingual tablet commercial<br>* 0.5 mg sublingual tablet, single dose<br>|
| Experimental: alprazolam sublingual tablet test<br> | Drug: alprazolam sublingual tablet test<br>* 0.5 mg tablet, single dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alprazolam bioavailability assessed as area under the concentration-time curve (AUC) and maximum concentration (Cmax) |  | 11 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alprazolam time of maximum concentration (Tmax) and half life |  | 11 days | 
| Adverse events, clinical laboratory tests, vital signs |  | 11 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bioequivalence, pharmacokinetic, alprazolam, sublingual
A Thorough Corrected QT Interval Trial

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effects of K-877 on ECG parameters with a focus on cardiac repolarization compared with placebo in healthy adult subjects.

Conditions
-----------------
Dyslipidemia

Intervention / Treatment
-----------------
* Drug: K-877 Low Dose
* Drug: Moxifloxacin
* Other: Placebo
* Drug: K-877 High Dose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject provides written informed consent before any study specific evaluation is performed. Subject is a healthy adult male or female volunteer, of any race and ethnicity, between the ages of 18 and 45 years, inclusive. Subject has a body mass index of 18 to 30 kg/m2, inclusive. Exclusion Criteria: Subject has clinically relevant abnormalities in the screening or check in assessments. Subject has a supine blood pressure after resting for at least 5 minutes that is higher than 140 mm Hg systolic or 90 mm Hg diastolic, or lower than 90 mm Hg systolic or 60 mm Hg diastolic. Subject has a supine Heart Rate (HR) (as measured at Screening or Check-in during collection of vital signs) after resting for at least 5 minutes that is outside the range of 40 to 90 beats per minute.

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Sequence A<br>Sequence A | Drug: K-877 Low Dose<br>* K-877 Low Dose<br>Drug: Moxifloxacin<br> <br> Other: Placebo<br> <br> Drug: K-877 High Dose<br>* K-877 High Dose<br>|
| Other: Sequence B<br>Sequence B | Drug: K-877 Low Dose<br>* K-877 Low Dose<br>Drug: Moxifloxacin<br> <br> Other: Placebo<br> <br> Drug: K-877 High Dose<br>* K-877 High Dose<br>|
| Other: Sequence C<br>Sequence C | Drug: K-877 Low Dose<br>* K-877 Low Dose<br>Drug: Moxifloxacin<br> <br> Other: Placebo<br> <br> Drug: K-877 High Dose<br>* K-877 High Dose<br>|
| Other: Sequence D<br>Sequence D | Drug: K-877 Low Dose<br>* K-877 Low Dose<br>Drug: Moxifloxacin<br> <br> Other: Placebo<br> <br> Drug: K-877 High Dose<br>* K-877 High Dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QTcI (QT interval corrected) duration |  | 24 hrs |
Study to Assess the Safety and Tolerability of AZD1152 in Combination With Low Dose Cytosine Arabinoside (LDAC)

Study Overview
=================
Brief Summary
-----------------
A study to assess the safety and tolerability of AZD1152 in combination with low dose cytosine arabinoside (LDAC) in patients with acute myeloid leukaemia (AML). The first three patients to complete a 28 day cycle in the cohort, before the second three patients start treatment.

Official Title
-----------------
A Phase I, Open-label, Multi-centre, Multiple Ascending Dose Study to Assess the Safety and Tolerability of AZD1152 in Combination With Low Dose Cytosine Arabinoside (LDAC) in Patients With Acute Myeloid Leukaemia (AML)

Conditions
-----------------
Acute Myeloid Leukemia

Intervention / Treatment
-----------------
* Drug: AZD1152
* Drug: LDAC (low dose cytosine arabinoside)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosed patient. Provision of written informed consent. De Novo (primary) or Secondary AML. Not eligible for intensive induction chemotherapy because of medical, social or psychological reasons. Exclusion Criteria: Patients with AML of FAB M3 classification Acute Promyelocytic Leukaemia (APL). Patients with blast crisis of chronic myeloid leukaemia. Persistent, chronic, clinically significant toxicities from any prior anti- cancer therapy greater than CTCAE Grade 1 (except alopecia).

Ages Eligible for Study
-----------------
Minimum Age: 60 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>AZD1152 variable dose in combination with 20 mg of LDAC. (The LDAC is given twice daily.) | Drug: AZD1152<br>* Variable dose via a 7-day continuous infusion<br>Drug: LDAC (low dose cytosine arabinoside)<br>* 20 mg subcutaneous injection given twice daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety as measured by Adverse Events, Vital Signs, ECGs, Clinical Chemistry, Haematology and Urinalysis |  | Information on these will be collected from the time of informed consent is signed, throughout the study. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the pharmacokinetics of AZD1152, its active moiety AZD1152 hQPA, and LDAC. |  | During the first treatment cycle for AZD1152, pre-dose and Days 2, 3,7, 8, 9, 10, 15 and 22. For LDAC, Days 7 and 10. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute Myeloid Leukaemia (AML)
Evaluation of Inflammatory Cytokines During COVID-19

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate pro-inflammatory cytokines as well as microvesicles during the course of SARS-CoV2 infection in the context of clinical parameters.

Detailed Description
-----------------
In this prospective trial, 100 patients with an acute SARS-CoV2 infection are enrolled. After confirmation of COVID-19, blood samples are taken for evaluation of various inflammatory cyokines and microvesicles at day 1, 5, 9 and 13 during hospitalisation and are interpreted in the context of clinical parameters.

Official Title
-----------------
Evaluation of Inflammatory Cytokines During COVID-19

Conditions
-----------------
Covid19

Intervention / Treatment
-----------------
* Diagnostic Test: Blood sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years Confirmation of acute SARS-CoV2 infection Ability to provide informed consent

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with acute COVID-19<br> | Diagnostic Test: Blood sample<br>* Blood samples at different timepoints during SARS-CoV2 infection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cytokine level in context with clinical parameters |  | 2 weeks |
Evaluating the Infant Complex Congenital Heart Disease by Multidetector Computed Tomography

Study Overview
=================
Brief Summary
-----------------
To test the ability of multi-detector spiral CT in evalting the infant complex congenital heart disease.

Detailed Description
-----------------
To test the ability of multi-detector spiral CT in evalting the infant complex congenital heart disease.

Official Title
-----------------
Integrated Evaluating the Infant Complex Congenital Heart Disease by Multidetector(16)Spiral Computed Tomography

Conditions
-----------------
Heart Diseases

Intervention / Treatment
-----------------
* Procedure: computed tomography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: complex congenital heart disease Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 20 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: computed tomography|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sensitivity, specificity |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
heart diseases, congenital
Bone, Endocrine and Lifestyle Longitudinal Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this proposal is to determine the long-terms effects of hormone and lifestyle factors on bone health in young women over a 20-year time period. It is our primary hypothesis that premenopausal women with irregular periods or endocrine issues related to estrogen will have significantly poorer low back and hip bone health when compared to regularly menstruating women. It is our secondary hypothesis that long-term assessment of changes in endocrine function and lifestyle behaviors will assist in establishing risk factors for osteoporosis in young women. This study will include 1000 premenopausal women. The women will participate in the collection of a blood sample, bone scan, body fat measures, and lifestyle questionnaires. In addition, we hope to use this initial study to develop a group of women to follow throughout menopause, with additional visits occurring every 5 years over the course of their life.

Official Title
-----------------
Bone, Endocrine and Lifestyle Longitudinal Study

Conditions
-----------------
Osteoporosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women at least 18 years of age free from any uncontrolled chronic disease that may affect bone mass Not pregnant Exclusion Criteria: Women recently diagnosed with uncontrolled chronic disease(s) at time of enrollment known to affect bone mass, including but not limited to metabolic and endocrine diseases (specifically, diseases of the thyroid and parathyroid glands), osteoporosis, and those women who have taken prophylactic bone density agents, such as Fosamax.

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

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

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 |
| --- | --- | --- |
| Bone mineral density |  | 5 years |