linjc16/ctgov huggingface dataset:
Clinical Study With Axitinib In Advanced Kidney Cancer, Who Have Failed First Line Treatment

Study Overview
=================
Brief Summary
-----------------
This is a single arm study with axitinib in patients with advanced kidney cancer (clear cell variant), who have failed first line therapy. The study will recruit a maximum of 30 patients from 2 countries including Australia and Canada. Patients will be followed up for efficacy, safety and health related outcomes.

Official Title
-----------------
Clinical Study With Axitinib (AG 013736) In Patients With Metastatic Renal Cell Carcinoma After Failure Of One Prior Systemic First-Line Therapy

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

Intervention / Treatment
-----------------
* Drug: Axitinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Metastatic renal cell carcinoma with a component of clear cell subtype. Prior first line systemic therapy At least 1 measurable lesion as per Response Evaluation Criterion in Solid Tumors [RECIST 1.1]. Adequate hematology, liver and kidney functions Eastern Cooperative Oncology Group [ECOG] performance status of 0 or 1. Life expectancy of ≥12 weeks. Normotensive or well controlled hypertension (less than/equal to 140/90 mm Hg.) Negative pregnancy test Adequate recovery time from prior systemic therapy, surgery or radiation Willing and able subjects who have signed consent Exclusion Criteria: More than one prior systemic therapy regimen Major bowel-penetrating surgery <4 weeks Active gastro intestinal bleed in past 3 months Active peptic ulcer disease in the past 6 months Current or anticipated use of potent CYP3A4/5 inhibitors Current or anticipated use of known CYP3A4/5 or CYP1A2 inducers Requirement for therapeutic warfarin or high dose steroids Symptomatic or untreated brain metastases A serious uncontrolled medical disorder or active infection Pregnant or breastfeeding females History of another active malignancy Dementia

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 |
| --- |
|Drug: Axitinib|5mg twice daily [BD] daily dosing until progression or prohibitive toxicity Dose titration by 2 levels upwards (7mg and 10mg) and downwards (3mg and 2mg) allowed per protocol|

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
-----------------
Axitinib, metastatic renal cell carcinoma
Analysis of In-hospital Emergency Team Calls in a German Tertiary Care University Hospital From 2013 to 2016

Study Overview
=================
Brief Summary
-----------------
A retrospective analysis of 1,664 emergency forms from MET activities, ranging from January 2013 to December 2016. Every MET activation call via the emergency telephone number (5555) and following emergency treatment was recorded by a standardized documentation form.

Detailed Description
-----------------
Recent studies demonstrated that in-hospital emergencies are linked to a higher mortality in patients. In total, 1 out of 10 patients is suffering from an unexpected incident during the hospital stay. Therefore, establishing and developing medical emergency teams (MET) is getting more important in the future. Aim of the present study was an analysis of medical documentation, operational tactics and procedures taken by MET in a 4-year-period, ranging from 2013 to 2016. A retrospective analysis of 1,664 emergency forms from MET activities, ranging from January 2013 to December 2016. Every MET activation call via the emergency telephone number (5555) and following emergency treatment was recorded by a standardized documentation form.

Official Title
-----------------
Analysis of In-hospital Emergency Team Calls in a German Tertiary Care University Hospital From 2013 to 2016

Conditions
-----------------
Emergencies

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients treated with emergencies Exclusion Criteria: none
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 |
| --- | --- | --- |
| Death | Patients having in in-Hospital emergency. | 2013 to 2016 |
Pennsylvania Idiopathic Pulmonary Fibrosis Research Registry

Study Overview
=================
Brief Summary
-----------------
The Pennsylvania Idiopathic Pulmonary Fibrosis State-wide Research Registry (PA-IPF) is a cooperative project between five medical centers to coordinate a team of investigators. The aim of this registry will be: 1) To assess the extent of lung fibrosis in the commonwealth of Pennsylvania 2) To provide better access of patients with pulmonary fibrosis in all regions of Pennsylvania to standard of care and diagnosis 3) To facilitate the translation of new therapeutic interventions from the bench to the bedside.

Detailed Description
-----------------
The University of Pittsburgh Medical Center, Dorothy P. & Richard P. Simmons Center for Interstitial Lung Disease is the coordination center for the Pennsylvania Idiopathic Pulmonary Fibrosis Statewide Research Registry, the collaborative institutions include: the University of Pennsylvania Health System, Geisinger Health System, and Penn State Milton S. Hershey Medical Center. The PA-IPF Registry developed into a web site that contains information for patients, health professionals, and families, as well as an Internet-based database that will store information about patients to provide them with guidance about care, research, and support groups close to the area in which they live. Benefits for membership in the PA-IPF Registry include: Staying informed about IPF research news, both nationally and locally. Having advance notice of any IPF research in which patients may be eligible to participate.

Official Title
-----------------
The Pennsylvania Idiopathic Pulmonary Fibrosis State-wide Research Registry

Conditions
-----------------
Idiopathic Pulmonary Fibrosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: IPF diagnosis Sufficient testing results completed for an IPF Diagnosis (screening script) Adults (age > 18 years old) Participants who read and comprehend English language Exclusion Criteria: Children Prisoner-patients

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 |
| --- | --- | --- |
| IPF Disease Course | Monitor IPF disease course | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease
Randomized Controlled Trial of the Effects of Electroacupuncture Preconditioning in Children Undergoing Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether electroacupuncture preconditioning would provide protection against myocardial Ischemic-Reperfusion injury and systemic inflammation in children undergoing CPB for repair of congenital heart defects.

Detailed Description
-----------------
2-12 years old children undergoing repair of congenital heart defects were included, except for those with server pulmonary arterial hypertension, chromosomal defects, airway and parenchymal lung disease, immunodeficiency, or blood disorders were excluded. Children were equal randomized to EAPC(electroacupuncture preconditioning)or control group. Electroacupuncture was administered on the bilateral P6 acupoint after anesthesia induction, but prior to surgery in EAPC group. Control patients underwent sham placement of the electrode the arm without stimulation. The duration of cardiopulmonary bypass and aortic cross-clamp time was recorded. Myocardial injury was assessed by cardiac heart-type fatty acid-binding protein (HFAP) and cardiac troponin I (cTnI>0.40 ng/mL). 8-isoprostane , C-reactive protein, cytokines were measured pre- and postoperatively.

Official Title
-----------------
National Natural Science Foundation of China

Conditions
-----------------
Congenital Heart Defects

Intervention / Treatment
-----------------
* Device: Electrical acupuncture stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 2-12 years children undergoing repair of congenital heart defects without server pulmonary arterial hypertension or systematic disease. Get an informed consent from parental. Exclusion Criteria: Patient's age is less than 2 years or more than 12 years. Patient with isolated atrial septal defect undergoing repair via thoracoscope completion. Patients with chromosomal defects, airway and parenchymal lung disease, immunodeficiency, or blood disorders. Patients without an informed consent from parental.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 12 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 |
| --- | --- |
| Electro-acupuncture, Control<br> | Device: Electrical acupuncture stimulation<br>* electroacupuncture would be administered on the bilateral P6 acupoint after anesthesia induction, but prior to surgery.<br>* Other names: Suzhou Hua Tuo Medical Instruments Co, Ltd, Suzhou, China;|
| Preconditioning, No preconditioning<br> | |

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
-----------------
electroacupuncture pediatric cardioprotection
Study of Muromonab-CD3 and Cyclosporine in Patients With Giant Cell Myocarditis

Study Overview
=================
Brief Summary
-----------------
This is a study to determine the efficacy of muromonab-CD3 and cyclosporine as treatment in patients with giant cell myocarditis (GCM). T lymphocytes appear to be involved in GCM. Muromonab-CD3 has been shown to reduce the number of lymphocytes and cyclosporine inhibits lymphocyte activation. This treatment may prolong patient survival until transplantation or ventricular assist device placement is possible.

Detailed Description
-----------------
Each patient will be randomized to receive either standard care and immunosuppression therapy (treatment group) or standard care alone (control group). To prevent bias, randomization will be stratified by recency of symptom onset to ensure that both the treatment and control groups are balanced with respect to it. Within each of these 2 strata, permuted-block randomization will be done to keep the number of treatment and control patients balanced. Due to the necessary monitoring of the patients randomized to receive immunosuppression therapy, treatment cannot be blinded. Approximately 1 year after the last patient has been randomized, the observed times from randomization to the composite endpoint (death, transplantation, or LVD placement) will be compared in the treatment and control groups. Completion date provided represents the completion date of the grant per OOPD records

Official Title
-----------------
Giant Cell Myocarditis Treatment Trial Pilot Study

Conditions
-----------------
Myocarditis

Intervention / Treatment
-----------------
* Drug: Muromonab-CD3
* Drug: Cyclosporine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Idiopathic heart failure and/or arrhythmia of less than 3 months duration Endomyocardial biopsy diagnostic of idiopathic giant cell myocarditis Negative pregnancy test Exclusion criteria: Clinical evidence of sepsis or active infection (e.g., meningitis or osteomyelitis) Pregnant Any contraindication to immunosuppression Allergy to cyclosporine or muromonab-CD3 Creatinine greater than 2.5 mg/dL AST or ALT greater than 3 times upper limit of normal Other severe concurrent disease that would preclude study Unreliable or uncooperative subject
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Muromonab-CD3|nan|
|Drug: Cyclosporine|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
-----------------
Giant Cell Myocarditis
Degenerative Nigrostriatal Dysfunction in Drug-induced Parkinsonism

Study Overview
=================
Brief Summary
-----------------
Parkinson's disease (PD) and Drug-induced Parkinsonism (DIP) can be clinically indistinguishable and DIP sometimes represents unmasking of underlying PD. The objective of this study is to determine the relationship of underlying Parkinson's disease (PD) to the incidence and clinical outcome in DIP using non-motor assessments as a marker for nigrostriatal degeneration. Research Design: This is a nested case-control design to investigate risk factors associated with the development of DIP and persistent Parkinsonism after antipsychotic (AP) withdrawal (a potential clinical marker of underlying PD). Target enrollment is 45 subjects. Methodology: We will examine objective olfactory function (via objective olfactory testing), other non-motor symptoms of PD (via standardized validated questionnaires), and motor findings (via clinical exam and quantitative gait analysis) in: 1) DIP patients (30 subjects) compared to AP-treated patients without Parkinsonism (15 subjects) and 2) patients with persistent Parkinsonism compared to those whose symptoms resolve in the DIP cohort followed prospectively after a change in AP treatment. Additionally, in patients where it was performed clinically, we will evaluate dopamine transporter SPECT imaging (DaTI) as a marker of nigrostriatal integrity examining the ability of qualitative and semi-quantitative analysis to distinguish between pharmacologic and degenerative Parkinsonism. We will also measure serum uric acid and Apolipoprotein A1, two putative biomarkers in early PD, and examine their relationship with clinical and radiologic status.

Official Title
-----------------
Degenerative Nigrostriatal Dysfunction in Drug-induced Parkinsonism

Conditions
-----------------
Secondary Parkinsonism, Parkinson's Disease

Intervention / Treatment
-----------------
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: antipsychotic treated patients with or without parkinsonism Exclusion Criteria: parkinson's disease, dementia

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 89 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 |
| --- | --- |
| Drug-induced parkinsonism<br>subjects with drug-induced parkinsonism | Other: no intervention<br> <br> |
| antipsychotic treated non-parkinsonian control<br>subjects treated with antipsychotic but without parkinsonism | Other: no intervention<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| normal or abnormal DAT SPECT |  | baseline |
Far Infrared Treatment for Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
Alzheimer's disease is a progressive and fatal brain disease. This study will investigate the use of far infrared radiation treatment for the disease.

Detailed Description
-----------------
Alzheimer's destroys brain cells, causing problems with memory, thinking and behaviour severe enough to affect work, lifelong hobbies or social life. Alzheimer's gets worse over time and it is fatal. Alzheimer's, which has no current cure, is the most common form of dementia. It is hereby postulated that far infrared radiation of the central nervous and endocrine systems will help with the management of the disease and possibly cure the disease.

Official Title
-----------------
Phase 1 Study to Determine the Efficacy of Using Far Infrared Radiation for the Treatment of Alzheimer's Disease.

Conditions
-----------------
Alzheimer Disease

Intervention / Treatment
-----------------
* Radiation: Far Infrared Radiation (5μm to 20μm wavelength)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: People with Alzheimer's disease Exclusion Criteria: None
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 |
| --- | --- |
| Other: 1<br>Far Infrared Radiation | Radiation: Far Infrared Radiation (5μm to 20μm wavelength)<br>* Far Infrared radiation for 30 to 40 minutes per treatment session.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Management and Cure of Alzheimer's Disease |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Management and Cure of Dementia |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute Confusional Senile Dementia, Alzheimer Type Senile Dementia, SENILE PLAQUES, NEUROFIBRILLARY TANGLES, NEUROPIL THREADS
The Effects of Arixtra on Wound Drainage Following Total Joint Arthroplasty

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize that Arixtra patients will be less likely to experience wound infection than patients who have received low-molecular weight heparin, coumadin or aspirin with mechanical compression.

Official Title
-----------------
The Effects of Arixtra on Wound Drainage Following Total Joint Arthroplasty

Conditions
-----------------
Total Knee Replacement

Intervention / Treatment
-----------------
* Drug: Fondaparinux Sodium (Arixtra)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All primary unilateral TKA and THA cases will be included. Exclusion Criteria: Patients less than 50 kg, Patients with CrCl<30ml/min. Revision and bilateral procedures will be excluded.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arixtra<br>Effect of Arixtra on would drainage and length of stay for the patients with hip and knee replacement | Drug: Fondaparinux Sodium (Arixtra)<br>* 2.5 mg once per day to begin 6-8 hours after surgery and continued for 10 days.<br>* Other names: Arixtra;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Days Until a Dry Wound | Days from day of surgery to stoppage of leakage from the wound | Up to 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Days in Hospital. | Days after surgery to dischage | Up to 10 days | 
| Incidence of Wound Infection | Incidence of Cellulitis in patients undergoing Arixtra treatment | Up to 10 days |
Lifestyle Modification for Weight Loss in Schizophrenia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find out how effective lifestyle modification group therapy is on reducing body weight when compared to usual care in individuals with schizophrenia and/or schizoaffective disorder.

Official Title
-----------------
Lifestyle Modification for Weight Loss in Schizophrenia

Conditions
-----------------
Obesity, Schizophrenia, Schizoaffective Disorder

Intervention / Treatment
-----------------
* Behavioral: Nutritional Lifestyle Modification Group
* Other: Usual Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects will be between 18 and 65 years of age. Have a BMI of 28 or greater. Meet DSM-IV criteria for schizophrenia or schizoaffective disorder. Be on a stable dose of antipsychotic medication for at least one month, with positive symptoms stability as judged by the clinical team and investigator. Exclusion Criteria: A history of dementia or mental retardation. Not capable of giving informed consent for participation in this study. Ongoing pregnancy. Living in a structured environment where the meals are provided as part of the program, e.g., a group home, nursing home, etc.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Weight Loss Education Group<br>Involvement in weekly manualized, educational group on nutrition and lifestyle modifications to help with weight loss. | Behavioral: Nutritional Lifestyle Modification Group<br>* Manualized group treatment to educate about basic nutritional concepts to help improve eating choices with the goal of losing weight.<br>|
| Other: Usual Care<br>Treatment as usual | Other: Usual Care<br>* Care as usual<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome measure is change in body weight from baseline. |  | 16 weeks, 6 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in lab values from baseline (fasting serum glucose, glycosylated hemoglobin, insulin, LDL cholesterol, triglyceride levels) |  | 16 weeks, 6 month follow-up | 
| Change in questionnaires and assessments (Q-LES-Q, QLS, PANSS, Food craving scales, Food frequency scales, Food preference scales) |  | 16 weeks, 6 month follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity, Schizophrenia, Schizoaffective disorder, weight loss