linjc16/ctgov huggingface dataset:
Autonomic Phenotype Before and After Akt Inhibition

Study Overview
=================
Brief Summary
-----------------
Some Akt inhibitors have produced functional cardiovascular effects such as marked hypotension that may limit their clinical benefit. There are no current data on whether this autonomic failure presents in humans at clinically used doses. We will test the hypothesis that Akt inhibition causes an acute decrease in sympathetic tone and lowers blood pressure.

Official Title
-----------------
Autonomic Phenotype Before and After Akt Inhibition: Akt Therapy for Melanoma Sub-study

Conditions
-----------------
Diagnosis of Melanoma

Intervention / Treatment
-----------------
* Behavioral: Autonomic Function Tests
* Other: supine and standing catecholamines


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with melanoma with a BRAF mutation and relapse following therapy with a BRAF inhibitor Enrolled in a clinical trial through the Vanderbilt Ingram Cancer Center (VICC) including an arm with an oral Akt inhibitor Able and willing to provide informed consent Exclusion Criteria: Factors which in the investigator's opinion would prevent the participant from completing the protocol, including poor compliance during previous studies or an unpredictable schedule Unable to give informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 Melanoma<br>Patients with Melanoma that are enrolled in a clinical trial at the Vanderbilt Ingram Cancer Center (VICC) including an arm with an oral Akt inhibitor | Behavioral: Autonomic Function Tests<br>* Patients will undergo Autonomic Function testing (AFT) before and 8 hours after Akt Inhibition therapy. AFT includes: Supine & standing heart rate & blood pressure, 10 minute head up tilt, cardiac output, sinus arrhythmia, hyperventilation, sustained handgrip, valsalva manuever, and cold pressor test.<br>Other: supine and standing catecholamines<br>* patients will have blood drawn from supine and standing catecholamines.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drop in systolic blood pressure before and after Akt treatment |  | 8 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
melanoma, autonomic failure, hypotension, akt therapy
Kidney Function in Diabetics During CPB (Cardio Pulmonary Bypass)

Study Overview
=================
Brief Summary
-----------------
Filtration of urine in the kidney requires sufficient oxygen supply. The filtration of urine is greater in patents with diabetes. Our theory is that the diabetic kidney has a higher oxygen demand than the non diabetic kidney thereby making the diabetic kidney more sensitive to decreased oxygen delivery following reduced blood flow. With a catheter inserted into the kidney vein we will monitor the blood flow and oxygen saturation before and during CPB, in patient with diabetes.

Official Title
-----------------
The Effect of the CPB on Kidney Blood Flow, Function and Oxygen Uptake During Open Heart Surgery in Patients With Diabetes Mellitus

Conditions
-----------------
Diabetes Mellitus, Kidney, CPB

Intervention / Treatment
-----------------
* Diagnostic Test: DM-ECC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with diabetes mellitus Serum creatinine < 150 micromol/L preoperative Heart surgery requiring CPB LV (left ventricle) EF >40 % Normal hemoglobin Exclusion Criteria: -
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: DM-ECC|Diabetes mellitus CPB|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal O2 extraction | Renal O2 extraction measured by sampling blood from a catheter inserted into the kidney vein. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GFR | GFR (Glomerular filtration rate), measured with CrEDTA- and PAH- clearance. | 2 years | 
| Renal blood flow | Change in renal blood flow measured by sampling blood from a catheter inserted into the kidney vein | 2 years |
Study of [S,S]-Reboxetine in Patients With Postherpetic Neuralgia, Who Are Gabapentin Treatment Failures

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effectiveness of [S,S]-Reboxetine in the treatment of chronic pain following a shingles infection in patients who are Gabapentin treatment failures.

Official Title
-----------------
A 5-Week, Randomized, Double-Blind, Placebo-Controlled Multi-Center Study Of [S,S]-Reboxetine In Patients With Postherpetic Neuralgia (PHN), Who Are Gabapentin Treatment Failures.

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: [S,S]-Reboxetine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have pain present for more than 3 months after the healing of shingles skin rash. Patients at screening must have a score > or = 40 mm on the pain visual analogue scale. Exclusion Criteria: Patients with poor renal function. Patients with other severe pain, that may impair the self-assessment of the pain due to shingles. Patients with abnormal electrocardiogram.

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: [S,S]-Reboxetine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The numerical pain intensity rating scale is used to assess pain and a change from baseline in pain score for week 5 will be calculated. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - The mean endpoint (week 5) sleep interference score change from baseline - Analysis of the Patient Global Impression of Change - Analysis of the Clinical Global Impression of Change - Analysis of the SF-McGill questionnaire |  |  |
Impact of Thermocoagulation During Invasive EEG Monitoring in Children With Focal Drug-resistant Epilepsies

Study Overview
=================
Brief Summary
-----------------
When focal epilepsies become drug-resistant, it could be eligible for cortical surgical resection. Therefore, an invasive EEG monitoring with depth electrodes is often needed during presurgical evaluation. Some of these children can have access to thermocoagulation inside the ictal onset zone, at the end of the monitoring and before to remove the electrodes. These thermocoagulations can disorganize the epileptogenic network thanks to millimetric cortical lesions around the electrodes. The aim is to stop or at least, to reduce the seizure frequency for few weeks or months. This could be a benefit for the child, and also a confirmation of the ictal onset zone and guide the surgeon. This technique is currently used in adult population for years, but remains very rare in children.

Conditions
-----------------
Epilepsy

Intervention / Treatment
-----------------
* Procedure: Thermocoagulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18 month to 17 years old focal drug-resistant epilepsy small size lesion (1 or 2 gyri) or cryptogenic epilepsy indication for EEG monitoring with depth electrodes during presurgical evaluation Exclusion Criteria: formal contraindication to surgery or anaesthesia functional area or potentially large epileptic area refusal to participate in the study no health insurance coverage

Ages Eligible for Study
-----------------
Minimum Age: 18 Months
Maximum Age: 17 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thermocoagulation<br> | Procedure: Thermocoagulation<br>* Thermocoagulation During pre-surgical Invasive EEG Monitoring<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of children with a decrease of at least 50% of the seizure frequency |  | one month after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Paediatrics, epilepsy surgery, genetic mutation, focal seizures
Dependence of LV Hemodynamics on Pacing Site

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effects of epicardial and endocardial pacing at each side of the left ventricular (LV) segments on cardiac hemodynamics in patients with impaired LV function undergoing epicardial ablation and mapping procedure. Hemodynamic function will be assessed during a pacing protocol with a pressure catheter inserted in the LV.

Official Title
-----------------
Characterization of LV Hemodynamics During Epicardial and Endocardial Pacing

Conditions
-----------------
Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is already indicated for epicardial mapping and ablation of arrhythmia(s) utilizing a transcutaneous subxiphoid approach Be in sinus rhythm Have LVEF < 40% Have the ability to provide informed consent for study participation and be willing and able to comply with the CIP (Clinical Investigational Plan) described evaluations Exclusion Criteria: Have permanent AF Have pericardial disease Have a recent myocardial infarction within 40 days prior to enrollment Have undergone cardiac surgery or coronary revascularization procedure within 3 months prior to enrollment or be scheduled for such procedures Have had a recent CVA or TIA within 3 months prior to enrollment Be less than 18 years of age Be pregnant

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 |
| --- | --- |
| VT Ablation<br>Patients undergoing epicardial mapping and ablation procedure for a ventricular tachycardia | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Invasive Dp/dt Max | Variation on invasive Dp/dt max during dedicated pacing site | Acute E.P. Procedure |
Association of Low Vitamin D Levels With Mortality in Patients With Reduced Left Ventricular Function Referred to Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
This study investigates if reduced serum levels of vitamin D concentration are a typical feature in patient group with low left ventricular function admitted for cardiac surgery interventions. and also the necessity of more preventive strategies for adequate nutrition of these patients with more focus on intake of vitamin D before admission to cardiac surgery.

Official Title
-----------------
Association of Low Vitamin D Levels With Mortality in Patients With Reduced Left Ventricular Function Referred to Cardiac Surgery

Conditions
-----------------
Malnutrition

Intervention / Treatment
-----------------
* Procedure: Cardiac Surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All routinely cardiac procedures Exclusion Criteria: dialysis, cancer

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| A<br>Patients referred for cardiac surgery intervention | Procedure: Cardiac Surgery<br>* Cardiac Surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative mortality |  | 90day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vitamin D, malnutrition, cardiac surgery, study, emphasize, importance, significant, high risk patient
Modes of Ventilation During Laparoscopic Bariatric Surgery

Study Overview
=================
Brief Summary
-----------------
During minimally invasive surgery, a pneumoperitoneum is created to facilitate surgical visualization. Although effective in facilitating the procedure, there are respiratory consequences of the pneumoperitoneum, which significantly increases intra-abdominal pressure (IAP) up to 20 cmH2O. The increased IAP can decrease functional residual capacity and increase closing capacity resulting in increased resistance, decreased compliance, and increased ventilation-perfusion mismatch. In a randomized, cross-over design, this study will evaluate in sequential order, 3 modes of ventilation during laparoscopic bariatric surgery to determine which is better able to support oxygenation and ventilation while limiting the peak inflating pressure (PIP).

Conditions
-----------------
Bariatric Surgery

Intervention / Treatment
-----------------
* Other: Pressure controlled ventilation
* Other: Volume controlled ventilation
* Other: PRVC ventilation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Laparoscopic bariatric surgery requiring intra-arterial blood pressure monitoring, age 14-20 years. Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 20 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 |
| --- | --- |
| Bariatric surgery<br>Patients undergoing bariatric surgery. | Other: Pressure controlled ventilation<br>* For pressure controlled ventilation, the peak inflating pressure (PIP) is set for each tidal breath.<br>Other: Volume controlled ventilation<br>* For volume controlled ventilation, the tidal volume is set.<br>Other: PRVC ventilation<br>* Pressure-regulated, volume-controlled (PRVC) is an auto-regulated pressure-controlled mode of mechanical ventilation with a user-selected tidal volume target.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in heart rate | Heart rate will be assessed every 5 mins. during each 30 minute mode of ventilation. | Baseline to 30 mins. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in blood pressure | Blood pressure will be recorded every 5 mins. during each 30 minute mode of ventilation. | Baseline to 30 mins. | 
| Blood gas | Blood gas will be obtained at the end of each 30 minute mode of ventilation. | 30 mins. |
Study to Assess the Potential for Adrenal Suppression Following Treatment With DSXS in Patients With Plaque Psoriasis

Study Overview
=================
Brief Summary
-----------------
An open label, safety study to assess the potential for adrenal suppression following maximal use treatment with DSXS administered twice daily for 28 days in patients with moderate to severe plaque psoriasis.

Detailed Description
-----------------
The objective of this study is to evaluate the potential of DSXS to suppress HPA axis function in patients with moderate to severe plaque psoriasis To evaluate the efficacy parameters, pharmacokinetics and adverse event (AE) profile of DSXS

Official Title
-----------------
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment With DSXS (Taro Pharmaceuticals U.S.A., Inc.) in Patients With Plaque Psoriasis.

Conditions
-----------------
Plaque Psoriasis

Intervention / Treatment
-----------------
* Drug: DSXS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a confirmed diagnosis of plaque psoriasis, patients 2-17 years of age with ≥ 10% BSA affected and patients age 18 years of age or older with ≥ 20% BSA affected Investigator Global Assessment (IGA) score of 3 (moderate) or 4 (severe) at baseline for the overall disease severity. Results from a cortisol response test that are considered normal and show no evidence of any abnormal HPA function or adrenal response Exclusion Criteria: Patients under 2 years of age. Investigator Global Assessment (IGA) of less than 3 (moderate) or greater than 4 (severe) at baseline. Current diagnosis of types of psoriasis other than stable plaque psoriasis (i.e., erythrodermic, exfoliative or pustular psoriasis). Results from a cortisol response test that show evidence of any abnormal HPA function or adrenal response

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DSXS1503<br>administered twice daily for 28 days in patients with moderate to severe plaque psoriasis. | Drug: DSXS<br>* twice daily for 28 days<br>* Other names: Active;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With HPA Axis Suppression | Hypothalamic Pituitary Adrenal (HPA) Axis Response to Cosyntropin demonstrating the absence or presence of adrenal suppression at the end of treatment. HPA Axis suppression is defined as a 30 minute post CortrosynTM injection level cortisol level of ≤ 18 mcg/100ml. | 28 days |
Bioavailability of BI 144807 Given Alone and in Combination With Ketoconazole in Healthy Male Volunteers

Study Overview
=================
Brief Summary
-----------------
This trial investigates the influence of oral ketoconazole on the pharmacokinetics and safety of BI 144807.

Official Title
-----------------
Relative Bioavailability of a Single Oral Dose of BI 144807 (Oral Solution) When Administered Alone or in Combination With Multiple Oral Doses of Ketoconazole (200 mg Tablet) in Healthy Male Subjects (an Open-label, Two-period, Fixed-sequence Trial)

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

Intervention / Treatment
-----------------
* Drug: Ketoconazole
* Drug: BI 144807
* Drug: BI 144807


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: 1. healthy male subjects Exclusion criteria: 1. any relevant deviation from healthy conditions

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

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

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

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: BI 144807<br>subjects receive an oral single dose of BI 144807 | Drug: BI 144807<br>* BI144807 oral solution, intermediate dose<br>|
| Experimental: BI 144807 plus Ketoconazole<br>subjects receive bid ketoconazole plus an oral single dose of BI 144807 | Drug: Ketoconazole<br>* Ketoconazole 400 mg / day<br>Drug: BI 144807<br>* BI144807 oral solution, intermediate dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity |  | 0 to 48 hours after administration | 
| Maximum measured concentration of the analyte in plasma |  | 0 to 48 hours after administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point |  | 0 to 48 hours after administration |