linjc16/ctgov huggingface dataset:
Post Transjugular Intrahepatic Portosystemic Shunt (Tips) Albumine Infusion to Prevent Hepatic Encephalopathy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy of albumin infusion to prevent post tips hepatic encephalopathy'

Detailed Description
-----------------
The outcome is the prevention of post tips hepatic encephalopathy

Official Title
-----------------
Effect of Albumine Infusion in the Prevention of Hepatic Encephalopathy After Transjugular Intrahepatic Portosystemic Shunt

Conditions
-----------------
Hepatic Encephalopathy

Intervention / Treatment
-----------------
* Drug: Albumin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cirrhotic patients TIPS placement Absence of Hepatic Encephalopathy at the enrolement Age > 18 years No pregnancy Exclusion Criteria: Non-cirrhotic portal hypertension Previous liver transplantation Impossibility to attend the scheduled follow-up including the weekly visit as outpatients during the first month after TIPS (see the description of follow-up below) Sings of overt hepatic encephalopathy as well as a history of persistent HE at entry. The latter as a contraindication for TIPS placement

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: albumin<br>cirrhotic patients who underwent tips placement | Drug: Albumin<br>* albumin 20% 1 g/Kg body weight for the first two days after TIPS followed by 0,5 g/Kg body weight at day 4 and then 0,5 g/Kg body weight once a week for three weeks.<br>* Other names: human albumin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| one or more episodes of hepatic encephalopathy (> grade 2 according to West Heven criteria)after TIPS placement | evaluate the efficacy of albumin infusion to prevent the occurrence of hepatic encephalopathy (> grade 2 according to West Heven criteria)one months after tips placement | one month post tips | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| arterial blood pressure >120/80 mmHg and natremia >130 mg/dl in cirrhotic patients one month after TIPS placement | improving the hypovolemia, evaluated by the arterial blood pressure value, and hyponatremia (<130 mg/dl)after albumine infusion for one month after tips placement | one month after tips placement | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TIPS, albumin, hepatic encephalopathy, hyponatremia, hypovolemia, cirrhosis
Effects of Pain on Driving Performance and Cognition.

Study Overview
=================
Brief Summary
-----------------
It has been suggested that cognitive functioning is impaired in chronic pain patients. Since most of these pain patients engage in daily activities including driving, it was hypothezised that they may have an increased risk of becoming involved in traffic accidents.

Detailed Description
-----------------
Most chronic pain patients engage in daily activities including driving. Driving a car is a complex task requiring mental alertness and a variety of cognitive functions such as perception, attention, learning, memory and decision making.Several studies have demonstrated cognitive impairments on laboratory tasks in patients with chronic pain, particularly on measures assessing attentional capacity, processing speed and psychomotor speed. These findings suggest that car driving performance might be impaired, and that chronic pain patients may therefore have an increased traffic accident risk. Unfortunately, no studies have investigated the impact of chronic pain on actual driving ability. The present study was designed to investigate the effects of chronic pain on actual driving performance during normal traffic. In addition to the on-the-road driving test, psychomotor, and memory tests measuring driving-related skills were conducted in the laboratory. Moreover, effects of pain on an attentional capacity test were tested using event-related potentials.

Official Title
-----------------
Effects of Pain on Driving Performance, Attentional Capacity and Psychomotor Performances: a Comparative Study Between Healthy Controls and Chronic Pain Patients.

Conditions
-----------------
Chronic Pain

Intervention / Treatment
-----------------
* Behavioral: driving and laboratory tests


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age driving licence driving experience normal vision right-handed fluently Dutch speaking Exclusion Criteria: psychological or physical disorder drug or alcohol abuse psychotropic medication use excessive smoking, drinking

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 60 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: driving and laboratory tests|nan|

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
-----------------
driving, chronic pain, attention
Ablation of Ventricular Fibrillation by Accurate Targeting of Arrhythmogenic Regions (AVATAR)

Study Overview
=================
Brief Summary
-----------------
This study will test the hypothesis that many human heart rhythm disorders are caused by small localized sources, where brief ablation may successfully eliminate the heart rhythm disorder.

Detailed Description
-----------------
The investigators will enroll patients with documented rapid heart rates from the bottom chambers of the heart (ventricular tachyarrhythmias). During electrophysiological study, the investigators will map the localized sources of these heart rhythm disorders. The 'active' group will prospectively receive brief ablation at localized sources (Focal Impulse and Rotor Modulation, FIRM). The control group will be a historical cohort who have received traditional ablation for this disorder. All patients will be followed for up to 1 year to ensure that they have no recurrent arrhythmias.

Official Title
-----------------
Ablation of Ventricular Fibrillation by Accurate Targeting of Arrhythmogenic Regions (AVATAR)

Conditions
-----------------
Ventricular Tachyarrhythmias

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented ventricular tachyarrhythmias. Undergoing clinically indicated EP study with ablation. Exclusion Criteria: 1. Unwillingness or inability to provide informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 90 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 |
| --- | --- |
| Active Group<br>This group will receive brief ablation at localized sources (Focal Impulse and Rotor Modulation, FIRM) | |
| Control Group<br>This group receives traditional ablation for this disorder | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction in ventricular tachyarrhythmias events | Using careful clinical monitoring, we will compare the burden of VT/VF after ablation (including FIRM) to the burden preceding ablation. | 3 months | 
| safety of ventricular basket mapping in patients undergoing ablation | To assess the incidence of adverse events arising from ablation using basket mapping in the ventricles. These include but are not limited to stroke, systemic thromboembolism, MI or acute coronary syndrome, groin complications, or death. | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ventricular Tachyarrhythmia, Ablation, Electrophysiology, Human, Mapping
Observational Study Gemigliptin in Patients Aged ≥ 65 Years With Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate safety and effectiveness of treatment with gemigliptin for 24 weeks in Korean patients aged ≥ 65 years with type 2 diabetes mellitus in routine clinical settings

Official Title
-----------------
A Multicenter, Single-arm, Prospective Observational Study to Evaluate the Safety and Effectiveness of Gemigliptin (as Monotherapy or as Single Pill Combinations) in Patients Aged ≥ 65 Years With Type 2 Diabetes Mellitus

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have been started on gemigliptin in accordance with the approved label and who have signed on the consent form Exclusion Criteria: Patients with previous exposure to gemigliptin and current participation in clinical trials

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- | --- |
| Change from Baseline of HbA1c at 24 weeks |  | Baseline, 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline of HbA1c at 12 weeks |  | Baseline, 12 weeks | 
| The rate of subjects who reached the target value of less than 7% (reasonable HbA1c goal) of HbA1c. |  | 24 weeks |
A Compassionate Treatment Protocol for the Use of Trimetrexate Glucuronate With Leucovorin Protection for Patients With Pneumocystis Carinii Pneumonia.

Study Overview
=================
Brief Summary
-----------------
To provide trimetrexate glucuronate to immunosuppressed patients with Pneumocystis carinii pneumonia (PCP) for whom this investigational compound could provide significant medical benefit.

Detailed Description
-----------------
Patients receive intravenous infusions of trimetrexate glucuronate and leucovorin for 21 days. Leucovorin is continued for 3 additional days after discontinuation of trimetrexate glucuronate.

Official Title
-----------------
A Compassionate Treatment Protocol for the Use of Trimetrexate Glucuronate With Leucovorin Protection for Patients With Pneumocystis Carinii Pneumonia.

Conditions
-----------------
Pneumonia, Pneumocystis Carinii, HIV Infections

Intervention / Treatment
-----------------
* Drug: Trimetrexate glucuronate
* Drug: Leucovorin calcium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Concurrent Medication: Allowed: Antiretroviral therapy (at the discretion of the treating physician and/or medical monitor). Patients must have: Presumptive or definitive diagnosis of Pneumocystis carinii pneumonia (PCP). HIV positivity or be otherwise immunosuppressed. Demonstrated intolerance and/or resistance to trimethoprim/sulfamethoxazole during the course of therapy for the current episode and not candidates for parenteral pentamidine, OR a documented history of such intolerance during a prior episode. Consent of parent or guardian if less than 18 years of age. NOTE: In general, patients who meet the eligibility criteria for other U.S. Bioscience-sponsored clinical trials for trimetrexate would not be eligible for this Compassionate Use protocol. Exclusion Criteria Patients with the following prior conditions are excluded: History of Type I hypersensitivity (i.e., urticaria, angioedema, or anaphylaxis), exfoliative dermatitis, or other life-threatening reactions to trimetrexate.

Ages Eligible for Study
-----------------
Minimum Age: 1 Day

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

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

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

Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Trimetrexate glucuronate|nan|
|Drug: Leucovorin calcium|nan|

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
-----------------
Trimetrexate, Pneumonia, Pneumocystis carinii, Leucovorin, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome
An Investigational Study of Cyclosporine on Experimental Medication BMS-986165 in Healthy Male Participants

Study Overview
=================
Brief Summary
-----------------
This is an investigational study of Cyclosporine on the experimental medication BMS-986165 in healthy male participants.

Official Title
-----------------
An Open-Label, Single-Sequence Study to Investigate the Effects of Cyclosporine on the Pharmacokinetics of BMS-986165 at Steady State in Healthy Male Participants

Conditions
-----------------
Psoriasis

Intervention / Treatment
-----------------
* Drug: BMS-986165
* Drug: Cyclosporine


Participation Criteria
=================
Eligibility Criteria
-----------------
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations Body mass index 18.0 to 32.0 kg/m2 Weight ≥ 50 kg Exclusion Criteria: Any medical condition that presents a potential risk to the subject and/or may compromise the objectives of the study, including a history of or active liver disease History or presence of acute or chronic bacterial, fungal, or viral infection (eg, pneumonia, septicemia) within the 3 months prior to screening Known or suspected autoimmune disorder, or any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status History of administration of live vaccines within 60 days before screening Any history or risk for tuberculosis (TB) Other protocol defined inclusion/exclusion criteria could apply

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMS-986165 and cyclosporine<br>BMS-986165 and cyclosporine administered orally | Drug: BMS-986165<br>* Specified dose on specified days<br>Drug: Cyclosporine<br>* Specified dose on specified days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum concentration (Cmax) |  | 24 hours | 
| Area under the concentration vs time curve from time zero to 24 hours post dose (AUC[0-24]) |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events (AEs) |  | Up to 20 days |
HBRN: Immune Regulation and Costimulation in Natural History of Chronic Hepatitis B

Study Overview
=================
Brief Summary
-----------------
This is an ancillary to the NIDDK-sponsored Hepatitis B Research Network (HBRN) Study Cohort Study NCT01263587. This study will examine the balance between immune regulatory and effector responses in hepatitis B-infected participants enrolled in the HBRN study (NCT01263587).

Detailed Description
-----------------
Aim 1: The clinical and virological status of chronic Hepatitis B (HBV) infection is defined by distinct patterns of immune effector and regulatory responses: The investigators propose that one or more immune regulatory are induced during chronic hepatitis B that define the extent of immune tolerance vs. activation with associated disease activity and viremia. Towards this end, the immune effector and regulatory responses relative to serum HBV DNA, alanine aminotransferase (ALT), Hepatitis B e antigen (HBeAg), Hepatitis B surface antigen (HBsAg) and liver histology will be examined in a cross-sectional manner in patients with chronic HBV and control groups. Aim 2: Clinical hepatitis flares during chronic hepatitis B reflect altered balance between immune regulatory and effector responses.

Official Title
-----------------
HBRN: Immune Regulation and Costimulation in Natural History of Chronic Hepatitis B

Conditions
-----------------
Hepatitis B

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Providing informed consent for this ancillary study. Exclusion Criteria: Children under 18 years of age, participants with anemia Hgb<10 or Hct<30, congestive heart failure or chronic lung disease requiring oxygen, active coronary artery disease with unstable angina, sepsis or renal failure, other significant medical conditions, autoimmune disease or immunosuppression.

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 |
| --- | --- | --- |
| Immune regulatory and activation measures | Immune regulatory and effector responses relative to HBV DNA, ALT and clinical outcome. HBV-specific lymphoproliferative, IFN-gamma and IL 10 responses, T cell activation and costimulatory markers (PD1, CTLA4, CD28, CD127), FoxP3+ Treg frequency, and NK frequency and expression of activating/inhibitory receptors and Dendritic cell frequency. | 240 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Immunology, Hepatitis B, HBV
Correlation of Right-left Shunt Detection in Cardioembolism Etiology in Stroke Patient.

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to compare correlation for right to left shunts (mainly patent foramen ovale) detection for three methods-transesophageal echo as a gold standard, transcranial doppler with contrast agent (microbubbles) and new method- Flow detection system ( Cardiox TM) in young stoke patients ( age under 55 years).

Detailed Description
-----------------
The aim of the study is to compare correlation for right to left shunts (mainly patent foramen ovale) detection for three methods-transesophageal echo as a gold standard, transcranial doppler with contrast agent (microbubbles) and new method- Flow detection system ( Cardiox TM) in young stoke patients ( age under 55 years). Flow detection systém is a new method for right to left shunt detection comfortable for patients, not dependent on experienced examinator and only one method with exact valsalve maneuver measurement. Right to left shunt could be important etiology of cardioembolization in young stroke patient population, therefore screening for this condition is recommended in all young patient after ischemic stroke especially with unclear etiology. Flow detection systes seams to be ideal screening method for this patients.

Official Title
-----------------
Correlation of Right-left Shunt Detection in Cardioembolism Etiology in Stroke Patient. Pilot Study.

Conditions
-----------------
Foramen Ovale Patent

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:ischemic stroke / TIA, signed informed consent - Exclusion Criteria:imposibillity to undergo transesophageal echo, transcranial doppler with contrast or Cardiox flow detection system -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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 |
| --- | --- | --- |
| detection of right-to-left shunt | Correletation of right-to-left shunt detection by 3 methods: transesophageal echocardiography, transcranial Doppler with contrast agent (microbubbles) and Flow detection system (Cardiox TM) | 1 week |