linjc16/ctgov huggingface dataset:
Study of Autoimmune Disease Complications Following Ipilimumab Treatment Among Melanoma Patients With Underlying Autoimmune Diseases

Study Overview
=================
Brief Summary
-----------------
The research questions to be addressed by this study are as follows: What is the prevalence of ipilimumab use among adults with a history of autoimmune disease that received treatment with ipilimumab for advanced melanoma? Do melanoma patients with a history of autoimmune disease experience complications that require hospitalization related to their underlying autoimmune disease following treatment with ipilimumab?

Official Title
-----------------
Evaluation of Hospitalization for Complications of Autoimmune Disease Following Ipilimumab Treatment Among Melanoma Patients With Underlying Autoimmune Diseases Treated in Routine Clinical Practices in the US

Conditions
-----------------
Melanoma

Intervention / Treatment
-----------------
* Biological: Ipilimumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Received ipilimumab therapy between 03/01/2011 and 6/30/2014 Aged 18 years or older at index date (initiation of ipilimumab) Diagnosed with melanoma before index Documented history of an autoimmune disease Have at least 6 months of continuous pharmaceutical and medical benefit enrollment prior to the index Have at least 3 months of continuous pharmaceutical and medical benefit enrollment following and including the index date Exclusion Criteria: Diagnosed with melanoma but NO record of exposure to ipilimumab No exposure to nivolumab (Opdivo ®) at any time

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 |
| --- | --- |
| Cohort Population<br>Individuals included in a large US-based administrative medical claims database with underlying autoimmune disorder exposed to ipilimumab for the treatment of melanoma. | Biological: Ipilimumab<br>* Intravenous monoclonal antibody injection<br>* Other names: Yervoy®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of ipilimumab treatment among adult melanoma patients with a prior or existing autoimmune disease/condition |  | Approximately 40 months | 
| Incidence of hospitalizations related to the pre-existing autoimmune disease/condition following treatment with ipilimumab |  | Approximately 40 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rate of hospitalization related to a complication of the underlying autoimmune condition before exposure to ipilimumab treatment |  | Approximately 40 months | 
| Incidence rate of hospitalization related to a complication of the underlying autoimmune condition after exposure to ipilimumab treatment |  | Approximately 40 months |
Granulocyte Colony Stimulating Factor (G-CSF) in Acute Liver Failure and Alcoholic Hepatitis

Study Overview
=================
Brief Summary
-----------------
Granulocyte colony stimulating factor in acute liver failure and alcoholic hepatitis

Detailed Description
-----------------
In this study 4 groups have been taken. Two groups of cases including Alcoholic patients and acute liver failure which are given G-CSF therapy and two groups of controls given standard therapy. Primary end point is to see the mobilization of CD-34 hematopoietic cells and survival. Secondary end point is to see the clinical and biochemical improvement in liver functions.

Official Title
-----------------
G-CSF in Acute Liver Failure and Alcoholic Hepatitis - A Pilot Study

Conditions
-----------------
Liver Failure, Acute

Intervention / Treatment
-----------------
* Drug: Granulocyte colony stimulating factor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Acute Liver failure as defined by AASLD.65 Patients with Alcoholic hepatitis defined as follows: decades of heavy alcohol use (mean intake, approximately 100 g per day).The combination of an aspartate aminotransferase level that is elevated (but <300 IU per milliliter) and a ratio of the aspartate aminotransferase level to the alanine aminotransferase level that is more than 2, a total serum bilirubin level of more than 5 mg per deciliter (86 μmol per liter), an elevated INR, and neutrophilia. Exclusion Criteria: • Known hypersensitivity to filgrastim creatinine > 150 µmol/L infection or hemorrhage within the last 10 days documented hepatocellular carcinoma hepatitis B,C or human immunodeficiency virus seropositivity and pregnancy

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: G-CSF therapy in acute liver failure and alcoholic hepatitis<br>G-CSF therapy given in cases with acute liver failure and alcoholic hepatitis | Drug: Granulocyte colony stimulating factor<br>* 300 I.U twice daily for 5 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • Mobilization of CD34 cells in the peripheral blood, a surrogate marker for hematopoietic stem cell mobilization |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical and biochemical improvement in liver functions |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
liver failure, Acute
Carotid Risk Prediction (CRISP) Consortium

Study Overview
=================
Brief Summary
-----------------
Develop adverse event prediction and plaque phenotype classification models for patients with known or suspected carotid artery disease.

Detailed Description
-----------------
Develop adverse event prediction and plaque phenotype classification models using plaque morphology and composition assessment of CTA which has been validated by histology, applied to representative cohort of patients. Generalizability of models is enhanced by using validated rather than only raw image inputs. Demographic, clinical, and outcome data is collected for enrolled patients as well as information on events and interventions.

Official Title
-----------------
Carotid Risk Prediction (CRISP) Consortium

Conditions
-----------------
Carotid Atherosclerosis

Intervention / Treatment
-----------------
* Diagnostic Test: vascuCAP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must have two (or more) neck CTAs at least 6 months apart of sufficient quality as documented in the vascuCAP Reading Manual. Atherosclerotic plaque must be visualized within the carotid artery. Exclusion Criteria: Subjects without visible plaque within the carotid artery Subject with insufficient CTA image quality (defined strictly as documented in the vascuCAP Reading Manual)

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Development / training<br>Selected by stratified partitioning | Diagnostic Test: vascuCAP<br>* adverse event and phenotype classification model<br>|
| Sequestered / test<br>Selected by stratified partitioning | Diagnostic Test: vascuCAP<br>* adverse event and phenotype classification model<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse outcome model performance | Develop adverse event model for major adverse neurological events (MANE) prediction on large retrospective cohort (and enable a prospective collection subsequent to this study). Consistent with this primary endpoint is the evaluation of all imaging-derived data that has a bearing on the diagnosis and prognosis of the subject. | 2 years |
SWOG-8947 Collecting and Storing Blood Samples From Patients With Previously Untreated Non-Hodgkin Lymphoma

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Collecting and storing samples of blood from patients with cancer to test in the laboratory may help the study of cancer in the future. PURPOSE: This research study is collecting and storing blood samples from patients with previously untreated non-Hodgkin lymphoma.

Detailed Description
-----------------
OBJECTIVES: To establish a central lymphoma serum repository that will serve as a resource to provide specimens for current and future scientific studies. To utilize the Southwest Oncology Group clinical database to perform clinicopathologic correlations with the results of those studies. OUTLINE: Serum is collected and stored for future correlative studies.

Official Title
-----------------
Central Lymphoma Serum Repository Protocol

Conditions
-----------------
Lymphoma

Intervention / Treatment
-----------------
* Other: biologic sample preservation procedure


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Diagnosis of non-Hodgkin lymphoma Previously untreated disease Patients must meet the eligibility criteria and be registered to a currently active Southwest Oncology Group-coordinated treatment protocol for previously untreated non-Hodgkin lymphoma PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: See Disease Characteristics

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

| Intervention/Treatment |
| --- |
|Other: biologic sample preservation procedure|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Establishment of a Centralized Lymphoma Serum Repository for the Southwest Oncology Group |  | July 2011 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
non-Hodgkin lymphoma
EBUS Guided Cryo Biopsy of Solitary Pulmonary Nodules

Study Overview
=================
Brief Summary
-----------------
To proof the feasibility and safety of EBUS guided transbronchial cryo biopsies in peripheral lung lesions

Detailed Description
-----------------
Solitary pulmonary nodule are a diagnostic dilemma. Nowadays not only the basic tissue diagnosis is necessary, molecular signals are state of the art. Therefore more tissue is necessary. With a cryoprobe the amount of tissue is increased compared to the classical forceps biopsy. Until now, the use of the cryoprobe ism´t show in peripheral lung tissue.

Conditions
-----------------
Yield of Cryo Biopsy in Lung Cancer, Solitary Pulmonary Nodule

Intervention / Treatment
-----------------
* Procedure: Cryo biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: solitary pulmonary nodule < 4 cm no endobronchial lesion indication for bronchoscopy Exclusion Criteria: coagulopathy pulmonary hypertension pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cryo biospy<br> | Procedure: Cryo biopsy<br>* Cryoprobe, Erbe Company<br>* Other names: Cryo biopsy probe 20416-032, ERBE company, Germany;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Number of Participants with Adverse Events as a Measure of Safety Detailed analysis of number of Pneumothoraces and number of bleeding complication | 24 h after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy | Diagnostic yield of the different biopsy techniques in establishing a specific diagnosis of the lesion | 48 h after intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
solitary pulmonary nodules, transbronchial lung biopsy, endobronchial ultrasound
LEVITRA® 20mg Special Drug Use Investigation (Long-term)

Study Overview
=================
Brief Summary
-----------------
This investigation targets either the patients of 18 years-old or older and under 65 years-old with organic or mixed erectile dysfunction (ED) who cannot obtain sufficient efficacy by dose 10mg of Levitra, and the target patients dose is increased to Levitra 20mg. This investigation will be limited to the patients whose tolerability of Levitra 10mg is judged to be no problem.

Official Title
-----------------
LEVITRA® 20mg Special Drug Use Investigation (Long-term)

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

Intervention / Treatment
-----------------
* Drug: Vardenafil, (Levitra, BAY38-9456)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: This investigation targets either the patients of 18 years-old or older and under 65 years-old with organic or mixed erectile dysfunction who cannot obtain sufficient efficacy by dose 10mg of Levitra, and the target patients dose is increased to Levitra 20mg. This investigation will be limited to the patients whose tolerability of Levitra 10mg is judged to be no problem.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br> | Drug: Vardenafil, (Levitra, BAY38-9456)<br>* Patients under daily life treatment receiving Levitra according to local drug information.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of patients with LEVITRA treatment |  | After 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LEVITRA treatment improved the patient's erection |  | After 6 months | 
| LEVITRA improved the patient's erection after Minimum and Maximum Intervals between LEVITRA intake and the start of intercourse |  | After 6 months | 
| Reporting a second successful intercourse within 24 hours of dosing |  | After 6 months | 
| Patients prefer LEVITRA over last Erectile Dysfunction treatment |  | After 6 months | 
| Tolerability of patients with LEVITRA treatment |  | After 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Erectile dysfunction,, Phosphodiesterase Inhibitors
Tele-diagnostics for Remote Parkinson's Monitoring

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to design, implement, and clinically assess a portable, user worn system for monitoring Parkinson's disease (PD) motor symptoms. The current standard in evaluating symptoms is the Unified Parkinson's Disease Rating Scale (UPDRS), a subjective, qualitative ranking system. The main goal of this research is to develop a quantitative system, Kinesia HomeView, to assess tremor as well as different features of bradykinesia in a home based system which can capture those symptom changes over the course of a day and aid in evaluating treatment protocol efficacy.

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Device: Kinesia HomeView


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of Parkinson's disease Exclusion Criteria: Inability to follow the required clinical instruction Subjects with cognitive impairments that would prohibit them from properly using the Kinesia HomeView system Subjects without the cognitive ability to respond to researchers and let them know when any parameters of the study may become uncomfortable Subjects found on examination by our clinicians to have any physical limitations which would be counter productive to participation in this study.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Kinesia HomeView Monitoring<br>Uses Kinesia HomeView at home once per week | Device: Kinesia HomeView<br>* Quantifies motor symptom severity in the home<br>|
| Control<br>Assessed in the clinic every 4 weeks using traditional methods | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| UPDRS |  | Every 4 weeks | 
| PDQ-39 |  | Every 4 weeks |
The Relation Between Preoperative ScO2 and the Postoperative Course of Humoral Organ Dysfunction Markers.

Study Overview
=================
Brief Summary
-----------------
Cerebral oxygen saturation (ScO2) is a measure of cerebral and systemic oxygen delivery to demand ratio. An observational trial in a heterogeneous cohort of 1078 patients patients revealed that a ScO2 below 50% absolute during oxygen insufflation is an independent predictor of short and long term mortality in patients undergoing on-pump cardiac surgery. Comparably, a low ScO2 was a predictor of postoperative morbidity determined as a combined endpoint of a high dependency unit stay of more than 9 days and/or at least 2 of the major postoperative complications. low cardiac output syndrome, stroke, need of renal replacement therapy or reintubation. The primary objectives of the present prospective observational study is to determine, if there is an association between preoperative ScO2 and postoperative organ dysfunction determined by sensitive markers of organ dysfunction (N-Terminal pro B-type natriuretic peptide, high sensitive troponin T, growth-differentiation factor 15, soluble -FLT1, and placental growth factor)

Official Title
-----------------
The Prognostic Relevance of N-terminal Pro B-type Natriuretic Peptide(NTproBNP), Cerebral Oxygen Saturation (ScO2), and Preoperative Creatinine Clearance in Cardiac Surgery Patients - Amendment 2: the Role of NTproBNP and ScO2 in Predicting Mortality and Postoperative Organ Dysfunction.

Conditions
-----------------
Patients Undergoing Cardiac Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients scheduled for cardiac surgery Exclusion Criteria: age less than 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity |  | Within hospital | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cerebral oxygen saturation,, NTproBNP, hsTNT, GDF-15
IGEL Laryngeal Mask Airway Device Effectiveness in Irradiated Necks

Study Overview
=================
Brief Summary
-----------------
It is known that patients with head and neck cancer who have had radiation therapy to the structures of the neck are at a greater risk of difficult mask ventilation and tracheal intubation than the majority of patients undergoing general anaesthesia. Failure to maintain oxygenation can lead to catastrophic consequences for any patient undergoing general anaesthesia, such as severe hypoxic brain injury and death. As such, the current guidelines from the Difficult Airway Society promote the use of a second generation laryngeal mask airway to maintain oxygenation in the event of failed mask ventilation or tracheal intubation, a rescue technique that has in most patient groups a very high chance of success. Unfortunately these guidelines are by necessity generic guidance and do not take into account the clinical performance of these devices in specific patient groups. While there is evidence of the effectiveness of the IGEL device as the primary method of airway maintenance in many studies there are none that describe its clinical performance in a group of patients in whom the rate of failed mask ventilation and tracheal intubation are significantly higher than the general population of patients. It is therefore of great interest to have an idea of the likelihood of success of rescue ventilation with this device in a group of high risk patients.

Official Title
-----------------
Effectiveness of Airway Control Using the IGEL Laryngeal Mask Airway Device in Patients With Previous Radiotherapy to the Neck

Conditions
-----------------
Laryngeal Masks

Intervention / Treatment
-----------------
* Device: IGEL Laryngeal mask


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older Attending for an elective procedure requiring general anaesthesia Prior radiotherapy to the neck Exclusion Criteria: General anaesthesia is not the primary airway plan Previously known difficult intubation Patient refusal

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IGEL arm<br> | Device: IGEL Laryngeal mask<br>* Insertion of an IGEL device in anaesthetised patients<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful insertion of the device and ventilation of the patient | Time to successful ventilation as evidenced by 5 consecutive square wave end tidal carbon dioxide waveforms. | 10 minutes |