linjc16/ctgov huggingface dataset:
An Observational Study of Adjuvant Treatment With Capecitabine (Xeloda) in Combination With Oxaliplatin in Participants With Stage III Colon Cancer

Study Overview
=================
Brief Summary
-----------------
This observational study evaluates the efficacy and safety of capecitabine in combination with oxaliplatin in the adjuvant setting in participants with Stage III colon cancer. Data were collected from each participant for up to 36 months or until disease recurrence.

Official Title
-----------------
An Open Label Study of the Effect of Adjuvant Treatment With Capecitabine in Combination With Oxaliplatin on Disease-Free Survival in Patients With Stage III Colon Cancer

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Drug: Capecitabine
* Biological: Oxaliplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult participants, >/= 18 years of age Treatment in line with the currently approved indication in the Summary of Product Characteristics Exclusion Criteria: Contraindications according to the current Summary of Product 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Capecitabine + Oxaliplatin<br>Participants with stage lll colon cancer, who were starting adjuvant chemotherapy with capecitabine in combination with oxaliplatin according to standard of care. | Drug: Capecitabine<br>* Administered according to the Summary of Product Characteristics.<br>* Other names: Xeloda;Biological: Oxaliplatin<br>* Administered according to the Summary of Product Characteristics.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-Free Survival (Time to Event) | Disease free survival was measured as the time from the date of randomization until the date of first event (recurrence of colon cancer, or death due to any cause). | Up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Percentage of Participants With Adverse Events | An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. | Up to 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colorectal cancer, Adjuvant setting, Capecitabine, Oxaliplatin
Study of TRU-015 in Subjects With Membranous Nephropathy Secondary to Systemic Lupus Erythematosus

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine how the body absorbs and chemically changes a single infusion of TRU-015 in subjects with kidney disease caused by lupus.

Official Title
-----------------
A Randomized, Two-Arm, Parallel Group Study of the Safety, Pharmacokinetics, and Pharmacodynamics of TRU-015 Added to Standard Therapy in Subjects With Membranous Nephropathy Secondary to Systemic Lupus Erythematosus

Conditions
-----------------
Systemic Lupus Erythematosus

Intervention / Treatment
-----------------
* Drug: TRU-015


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Man or nonlactating and nonpregnant woman, aged 18 to 70 years, inclusive, at the screening visit. Diagnosis of systemic lupus erythematosus more than 6 months before study day 1. History of positive antinuclear antibody titer of >1:160 or equivalent. Biopsy-proven class V lupus nephritis within the last 2 years. Have been on a stable dose of oral corticosteroids (<20 mg/day prednisone or equivalent) for 2 months before study day 1.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: 1<br> | Drug: TRU-015<br>* Arm 1 = 800 mg Arm 2 = 2000 mg<br>|
| Experimental: 2<br> | Drug: TRU-015<br>* Arm 1 = 800 mg Arm 2 = 2000 mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the pharmacokinetics of TRU-015 after a single administration in subjects with membranous nephropathy secondary to systemic lupus erythematosus. |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety, immunogenicity, and pharmacokinetic/pharmacodynamic relationship of TRU-015 in subjects with membranous nephropathy secondary to systemic lupus erythematosus. |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Membranous Nephropathy, Systemic Lupus Erythematosus
Tolerance and Efficiency of Paracetamol Subcutaneous Injection

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the tolerance and the efficiency of subcutaneous administration of Paracetamol for patients in palliative care.

Detailed Description
-----------------
Subcutaneous administration is the most commonly used way for palliative care and geriatric service. A lot of drugs are recommended with subcutaneous administration, but their use is performed out of the Marketing Authorization, and fewer data exist about this practice in literature. Paracetamol is a grade 1 analgesic not currently recommended for subcutaneous injection, because of the lack of validated references. However this kind of administration is usually performed for Paracetamol in the French palliative care services related with its advantages for patients, as analgesic or antipyretic. The assumption of the study is that the use of paracetamol subcutaneously is possible with a good tolerance for hospitalized patients in palliative care service.

Official Title
-----------------
Tolerance and Efficiency of Paracetamol bu Subcutaneous Releasing in Patients Hospitalized Into Palliative Care

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: older than 18 years old indication of paracetamol by subcutaneous injection, as an analgesic or an antipyretic Exclusion Criteria: opposition to gather data patient subcutaneous administration of paracetamol during the last week before the inclusion of the patient

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 |
| --- | --- | --- |
| Occurrence of the severe or not adverse effects on the injection site |  | 8 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| as antipyretic, a feedback of tympanic temperature below 38°C during the two hours after injection |  | 8 days | 
| as analgesic, the decrease of pain (decrease of 30 in the numerical scale score, or a Algo+ scale score lower than 2/5) |  | 8 days |
Factors Association With Poor Physical Function in Older Adults With Schizophrenia

Study Overview
=================
Brief Summary
-----------------
Older adults with schizophrenia are a growing segment of the population yet their physical health status is poor. In order to design effective interventions, the contributing factors must be understood. Current data suggest the side effects of psychiatric medications, sociodemographic factors, and health care disparities are a few of the reasons for the poor physical health. There are only limited data on the impact of psychiatric symptomatology and neurocognition on the physical health of this population. These limited data indicate that worse symptomatology and poorer neurocognition may negatively impact physical functioning, a critical component to optimal physical health. The purpose of this pilot study is to begin to fill this knowledge gap by: 1. examining the relationship between neurocognitive function and physical function and 2. Examining the relationship between schizophrenia symptoms and physical function. 3. Examining the relationship between serum Brain Derived Neurotrophic Factor (BDNF) and physical function. Using a descriptive correlational design, 50 older adults (55+) with schizophrenia or schizoaffective disorder will be assessed. Bivariate associations will be used to examine the relationship between key variables including schizophrenia symptoms as measured by the Positive and Negative Syndrome Scale (PANSS), neurocognitive function as measured with the MATRICS Consensus Cognitive Battery (MCCB), Physical Function as measured objectively by the Timed Get Up and Go (TGUG) test and subjectively with the physical component summary subscale of the 12-item short form health survey (SF-12), and serum BDNF. These pilot data will lay the foundation for a future health promoting intervention.

Official Title
-----------------
The Impact of Neurocognition and Symptomatology on Physical Function Among Older Adults With Schizophrenia

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: English speaking adults older than or equal to 55 with a DSM-IV diagnosis of schizophrenia or schizoaffective disorder that pass a capacity to consent test based on comprehension of the consent form. Exclusion Criteria: Non-English speaking, Adults younger than 55, No diagnosis of schizophrenia of schizoaffective disorder, and/or Not passing a capacity to consent test.

Ages Eligible for Study
-----------------
Minimum 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 |
| --- | --- | --- |
| Physical Function |  | enrollment |
WISER After Ovarian Cancer - Exercise Pilot Study

Study Overview
=================
Brief Summary
-----------------
One in four deaths in the United States is due to cancer, and one in three women will develop cancer in her lifetime. Despite improvements in survival among other forms of cancer, ovarian cancer prognosis remains poor. Eighty percent of women with ovarian cancer will present with advanced disease (stage 3 or 4) where 5-year survival ranges from 18-34%.2 Among patients with stage III and IV epithelial ovarian cancer (EOC), recurrence rates are high.4 Therefore, interventions focused on preventing recurrence or slowing progression of EOC is a critical problem in the field. The investigators have submitted an R21 to NCI for a dose response exercise intervention trial to examine the dose response effects of aerobic exercise on biomarkers relevant to ovarian cancer progression and recurrence. The reviewers would like assurance that the investigators can recruit ovarian cancer patients into an exercise study and that these women will do the exercise protocol we plan to prescribe in our high dose of exercise.

Official Title
-----------------
WISER After Ovarian Cancer - Exercise Pilot Study

Conditions
-----------------
Ovarian Cancer

Intervention / Treatment
-----------------
* Behavioral: Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of stage III-IV EOC, completed surgery, > 12 months life expectancy (physician estimate), able to walk 15 minutes at a time (use of a cane is acceptable). Exclusion Criteria: medical or psychiatric conditions (beyond ovarian cancer, its treatment, and its symptoms) that would impair our ability to test study hypotheses (e.g. cardiac, pulmonary, or orthopedic history that would prohibit a program of walking for exercise; psychotic disorders, dementia, inability to give informed consent

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

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

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

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

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: exercise<br> | Behavioral: Exercise<br>* This is an exercise intervention study. All 10 participants will complete 26 weeks high dose exercise (60% of peak aerobic capacity 45 min/session, 5 sessions per week).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events |  | 26 weeks |
Evaluation of Corneal Temperature by Infrared Thermography in Glaucoma Patients

Study Overview
=================
Brief Summary
-----------------
Measurement of corneal temperature gives indirect information about the ocular blood flow. For this reason corneal temperature can be used as a surrogate to quantify ocular blood flow. It can be measured by means of infrared thermography. This test, however, is not used in an everyday clinical routine so far. In this study is investigated if ocular blood flow disturbances in glaucoma patients can be diagnosed by means of infrared thermography. Corneal temperature are measured in normal tension glaucoma patients and healthy controls before and after cold provocation test. In the group of patients and the group of controls, subjects with and without a primary vascular dysregulation (PVD) are included. This will allow to analyze and compare the influence of cold provocation on corneal temperature (and indirectly ocular blood flow) in these study Groups.

Official Title
-----------------
Evaluation of Corneal Temperature by Infrared Thermography in Glaucoma Patients

Conditions
-----------------
Glaucoma

Intervention / Treatment
-----------------
* Device: infrared thermography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria for Patients: Glaucoma Age 18-65 Exclusion Criteria for patients: No Glaucoma Alcohol consumption Smoking Inclusion Criteria for Control: No Glaucoma Age 18-65 Exclusion Criteria for control: Alcohol consumption Smoking

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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: measurement of corneal temperature by infrared thermography<br> | Device: infrared thermography<br>* measurement of corneal temperature by infrared thermography before and after cold provocation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal temperature measurement by infrared thermography | measurement of change in corneal temperature starting with first measurement at Baseline and second measurement after 5 minutes | 2 measurements with interval of 5 minutes starting at baseline |
Reducing Disparities in Medication Adherence in SLE

Study Overview
=================
Brief Summary
-----------------
This is a pilot study to assess the feasibility of using Surescripts refill data during the clinical encounter to improve medication adherence in patients with systemic lupus erythematosus

Official Title
-----------------
Reducing Disparities in Medication Adherence of Patients With Systemic Lupus Erythematosus (SLE)

Conditions
-----------------
Systemic Lupus Erythematosus

Intervention / Treatment
-----------------
* Behavioral: Behavioral Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria - All followup patients seen at the Duke Lupus clinic Exclusion Criteria Patients not seen at the Duke Lupus Clinic New patients seen for the first time at the Duke Lupus Clinic Patients who are not prescribed any lupus medications

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention arm<br>Lupus clinic providers will use Surescripts refill information to assess adherence level and address adherence barriers. We will assess the feasibility and acceptability of the intervention. | Behavioral: Behavioral Intervention<br>* Lupus clinic providers will be prompted to assess adherence level using Surescripts refill information and address any adherence barriers that arise during the clinical encounter.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility as Measured by Number of Participants With EMR (Electronic Medical Record) Documentation of Adherence | Feasibility as measured by documentation of adherence assessment made by provider. | 12 weeks | 
| Acceptability as Measured by Provider Survey | Acceptability as measured by provider survey, score range 1-5, with a higher score indicating that the intervention was more acceptable. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication Adherence as Determined by Self Report |  | 12 weeks | 
| Percentage of Adherent Participants as Determined by Medication Possession Ratio (MPR) | Medication Possession Ratio (MPR) = days with medication/total days. This will be determined by pharmacy refill data and calculated for 3 months (90 days). An MPR > or = 80% indicates adherence. | Baseline, 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
medication adherence
Metabolomics and Breast Cancer Risk in a Nested Case-control Study of the Cancer Prevention Study-II Nutrition Cohort

Study Overview
=================
Brief Summary
-----------------
This study aims to investigate diet, lifestyles, serum metabolomics in relation to breast cancer risk in a nested case-control study including 1,547 postmenopausal women from the Cancer Prevention Study II (CPS-II) Nutrition Cohort. The CPS-II Nutrition Cohort is a prospective cohort study of cancer incidence and mortality among 184,185 men and women, established by the American Cancer Society in 1992. Participants completed a self-administered baseline questionnaire in 1992/1993 including demographic, medical, and lifestyle information. Follow-up questionnaires were sent to living participants in 1997 and every other year to update exposure information and ascertain newly diagnosed cancers. From June 1998 through May 2001, blood specimens were collected from 21,963 women. All participants completed a short questionnaire and provided informed consent at the time of blood draw. Non-fasting whole blood collected from each participant was shipped chilled overnight to a central repository, processed, and frozen in liquid nitrogen at approximately -130 °C for long-term storage. Of the 21,963 women who provided a blood sample, investigators identified 782 postmenopausal women diagnosed with invasive breast cancer between blood draw date and June 2011 who had not been diagnosed with cancer (other than nonmelanoma skin cancer) before blood draw or prior to their breast cancer diagnosis. Controls were 1:1 matched to cases on date of birth, date of blood draw, and race and were cancer free at the date of case diagnosis. Seventeen women who were selected as controls were later diagnosed with breast cancer, at which time they became a case. A total of 1,547 postmenopausal women were included in the breast cancer nested case-control study.

Official Title
-----------------
Cancer Prevention Study-II Nutrition Cohort

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: blood sample cancer free at blood draw Exclusion Criteria: unverified breast cancer non-invasive breast cancer

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| cases<br> | |
| controls<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incident invasive breast cancer | Identified through medical record or linkage with state cancer registry | Blood draw through June 30, 2011 |