linjc16/ctgov huggingface dataset:
Lenalidomide Plus ICE in the Treatment of Refractory and Relapsed DLBCL

Study Overview
=================
Brief Summary
-----------------
This study is to evaluate the efficacy and safety of Lenalidomide plus ICE in the treatment of Refractory and Relapsed DLBCL patients.

Official Title
-----------------
A Phase II Study of the Efficacy and Safety of Lenalidomide Plus ICE in the Treatment of Refractory and Relapsed Diffuse Large B-cell Lymphoma

Conditions
-----------------
Diffuse Large B-Cell Lymphoma Refractory

Intervention / Treatment
-----------------
* Drug: Lenalidomide
* Drug: Ifosfamide
* Drug: Carboplatin
* Drug: Etoposide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically proven diffuse large B-cell lymphoma. Previously treated with 1, and only 1, chemotherapy regimen including rituximab and anthracycline. Relapse after CR, less than PR or PR to previous treatment. No history of stem cell transplantation. Age between 16-75. ECOG<3. At least 1 measurable tumor mass. Minimum life expectancy of 3 months. Written informed consent. No history of using Lenalidomide, ifosfamide, carboplatin and etoposide. No uncontrolled CNS involvement by lymphoma:No CNS disease at time of relapse;CNS disease diagnosed at initial presentation allowed provided a complete response for CNS disease was achieved and maintained. Exclusion Criteria: Chemotherapy or large field radiotherapy within 3 weeks prior to entering the study. Clinically significant active infection. Impaired liver, renal or other organ function not caused by lymphoma, which will interfere with the treatment schedule. Any significant medical or psychiatric condition that might prevent the patient from complying with all study procedures. Subject has ≥grade 2 peripheral neuropathy or grade 1 with pain within 14 days before enrollment. Patients who are pregnant or breast-feeding. HIV infection.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 75 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: L-ICE<br>Lenalidomide 25mg/d po d1-10, Ifosfamide 1500mg/m2/d iv d1-3, Carboplatin 5*[GFR(ml/min)+25]mg/d iv d2, Etoposide 100mg/m2/d iv d1-3, Frequency every 21 days, Total cycles 4 | Drug: Lenalidomide<br> <br> Drug: Ifosfamide<br> <br> Drug: Carboplatin<br> <br> Drug: Etoposide<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete response rate |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival rate |  | 1 year | 
| Overall survival rate |  | 1 year | 
| Overall response rate |  | 12 weeks | 
| Safety as assessed using CTCAE v4.0 |  | 1 year |
Circulating microRNAs for Discriminating Obese Preschoolers at Risk of Diabetes

Study Overview
=================
Brief Summary
-----------------
Childhood obesity certainly increases susceptibility to type 2 diabetes (T2D) in adulthood. Recently, microRNAs (miRNAs) are closely related to various diseases and have been suggested as valuable biomarkers. Here, we sought to identify potential miRNAs to discriminate obese children at risk for diabetes in future.

Detailed Description
-----------------
This study was designed to screen the circulating miRNAs in association with progression from children obesity to type 2 diabetes (T2D) in adulthood. Serum samples were evaluated in a 3 step procedure: 1) discovery study, in which samples from obese children and healthy controls were pooled for miRNA sequecing experiment; 2) cross-sectional validation study, in which miRNAs of interest were validated in all individuals (obese children, overweight children and normal controls); 3) longitudinal validation study, in which the candidate miRNAs were estimated in newly diagnosed diabetes patients and normal glucose tolerance controls (NGT). The final determined miRNAs were further confirmed though primary function studies.

Official Title
-----------------
Circulating microRNAs as Novel Prognostic Biomarkers in Obese Preschoolers at Risk for Type 2 Diabetes in Adulthood

Conditions
-----------------
Discriminate Obese Children at Risk for Diabetes.

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Obese preschoolers; Adults with type 2 diabetes; Age-matched healthy controls. Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 48 Months
Maximum Age: 72 Months

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 |
| --- | --- |
| Children group<br>Children recruiters were categorized into three groups: obesity, overweight and normal control based on World Health Organization child growth standards. | |
| Adults group<br>Adults with type 2 diabetes were defined if the individual had a fasting plasma glucose (FPG) level ≥ 7.0 mmol/L. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| It is expected that the identification of circulating miRNAs as potential biomarkers may facilitate to the diagnosis of obese preschoolers at high risk for developing diabetes. |  | 50-70 month old | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Circulating microRNA, Childhood obesity, Adulthood diabetes
Competing Risk of Death and ESRD in Incident CKD Patients

Study Overview
=================
Brief Summary
-----------------
Although chronic kidney disease (CKD) affects a growing number of people, epidemiologic data on incident CKD in the general population are scarce. Screening strategies to increase early CKD detection have been developed. Methods: From a community-based sample of 4,409 individuals residing in a well-defined geographical area, investigators determined the number of patients having a first serum creatinine value ≥1.7 mg/dL and present for at least 3 months that allowed us to calculate an annual incidence rate of CKD (stages 3 to 5). CKD (stages 3 to 5) was defined by estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2. Investigators also described the primary care, outcomes and risk factors associated with outcomes using competing risks analyses for these CKD patients.

Official Title
-----------------
Competing Risk of Death and End-stage Renal Disease in Incident Chronic Kidney Disease (Stages 3 to 5): the EPIRAN Community-based Study

Conditions
-----------------
Chronic Kidney Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >= 18 years first serum creatinine value ≥1.7 mg/dL reached after January 1st, 2004 and present for at least 3 months residing in the given geographical area (the Urban Community of Greater Nancy (UCGN)) Exclusion Criteria: <18 years prevalent CKD patient : CKD diagnosis before January 1st, 2004 patients on dialysis or renal transplanted refusal of participation

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| annual incidence rate of CKD | number of patients residing in a well-defined geographical area having a first serum creatinine value ≥1.7 mg/dL after January 1st, 2004 and still present for at least 3 months | inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dialysis initiation | number of dialysis initiation. | through study completion, 6 year after study start | 
| death | number of death | through study completion, 6 year after study start | 
| management of CKD patients | %patients referred to a nephrologist, decline of the renal function | through study completion, 6 year after study start | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic kidney disease, Competing-risk analysis, Epidemiological study, Incidence, Outcomes, Risk factors
Personal Values, Interpersonal Needs, and Suicidal Ideation in a Veteran Population

Study Overview
=================
Brief Summary
-----------------
The primary aim of this study is to examine the relationship between personal values and suicidal thoughts in a sample of U.S. Veterans.

Official Title
-----------------
Examining the Relationship Between Personal Values, Interpersonal Needs, and Suicidal Ideation in a Veteran Population

Conditions
-----------------
Suicide Prevention

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Currently receiving care through the Denver VA Medical Center Behavioral Health Interdisciplinary Team Over the age of 18 Willing to travel to the Denver VAMC to complete assessment measures. Provide informed consent to participate Exclusion Criteria: Inability to adequately respond to questions regarding the informed consent procedure

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 |
| --- | --- |
| Veterans<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beck Scale for Suicide Ideation | Questionnaire that assesses suicidal thoughts | One time | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Personal values, Suicidal thoughts
Biliary Hilar Drainage Managed by Endoscopy

Study Overview
=================
Brief Summary
-----------------
The management of hilar biliary strictures remains difficult. These strictures are classified in 4 types (I,II,III and IV). In palliative cases, an endoscopic drainage should be performed in types I and II while a percutaneous drainage is performed in type IV. There is controversy as to whether partial or complete liver drainage should be done. Furthermore there are no standards for drainage types (metallic stents, plastic stents). Morbidity remains high and a multistage procedure can be required. This study aims at evaluating the clinical practices in the investigators' center in order to determine the key factors that contribute to the drainage success or failure.

Conditions
-----------------
Hilar Biliary Strictures

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18 years Biliary strictures requiring a drainage Exclusion Criteria: Contraindication to hilar biliary drainage

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 |
| --- | --- |
| Patients with a hilar biliary stricture requiring a drainage<br>Drainage performed by endoscopy, echo-endoscopy or percutaneously | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy evaluated by the need for re-interventions | Number of re-interventions | up to 2 years | 
| Efficacy evaluated by the need for re-hospitalization | Number of re-hospitalization | up to 2 years | 
| Efficacy evaluated by complete or partial liver drainage | realization of complete or partial liver drainage | up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity: Occurrence of drainage complications (sepsis, hemorrhage) | Occurrence of drainage complications (sepsis, hemorrhage) | up to 2 years |
Post-Market Registry of the ACIST CPM System and Navvus Catheter in Clinical Practice

Study Overview
=================
Brief Summary
-----------------
This registry will collect real-world clinical evidence on the performance, safety, and usability of the ACIST CPM System and NAVVUS Catheter when used in accordance with approved labeling in a European commercial setting. Up to 60 subjects will have Fractional Flow Reserve (FFR) measurements of coronary lesions attempted with the CPM System and NAVVUS Catheter. All subjects will receive diagnostic treatment according to clinical indications and center standard practice.

Detailed Description
-----------------
There are no protocol-specific procedural requirements for this registry. Enrolled subjects will undergo a diagnostic angiography procedure including an FFR measurement with the CPM System and NAVVUS Catheter according to the center standard of care and the Instructions for Use of the CPM System and Navvus Catheter. Participants will be followed for the duration of hospital stay, an expected average of 1 day.

Official Title
-----------------
Post-Market Registry of the ACIST Cardiovascular Pressure Measurement (CPM) System and Navvus Catheter in Clinical Practice-ADVANCE-EU

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Device: Navvus Catheter FFR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects 18 years of age or older in whom FFR measurement is indicated to guide percutaneous coronary intervention (PCI) strategy and use of the ACIST CPM System and Navvus Catheter is attempted. Exclusion Criteria: -

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 |
| --- | --- |
| Navvus Catheter FFR<br>The Navvus Catheter is a rapid exchange microcatheter with a pressure sensor at the distal tip that measures Fractional Flow Reserve measurements to guide PCI treatment strategy. | Device: Navvus Catheter FFR<br>* Navvus Catheter provides Fractional Flow Reserve (FFR) measurement for each lesion identified according to standard of care of the center and the Instructions for Use (IFU).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural Success | Procedural success is defined as the ability of the ACIST CPM System and NAVVUS Catheter to acquire FFR measurement without adverse device effect or device malfunction. | From enrollment through hospital discharge, an expected average of 1 day. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fractional Flow Reserve, Rapid Exchange, Catheter
Large Overuse of Post-polypectomy Surveillance Colonoscopy

Study Overview
=================
Brief Summary
-----------------
In colorectal cancer screening era a huge burden of medical resources has been applied to surveillance. Although the adherence to post-polipectomy recommendations is a advocated as a mainstay for quality assurance colonoscopy programs, prospective data on appropriateness of surveillance are lacking. The aim of present study was to evaluate the percentage of subjects in which timing of surveillance colonoscopy in practice agrees with that recommended by guidelines and to identify factors associated to the appropriateness of surveillance.

Official Title
-----------------
Large Overuse of Post-polypectomy Surveillance Colonoscopy: a Prospective Nation-wide Study

Conditions
-----------------
Colonic Polyps, Surveillance, Colonoscopy

Intervention / Treatment
-----------------
* Other: colonoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: consecutive colonoscopy outpatients adults (18-80 yrs) Exclusion Criteria: Subjects with missing data on polyp findings at previous colonoscopy (number, endoscopic or histological features) Subjects with unsatisfactory quality standards of previous examination (no cecal intubation, inadequate bowel preparation, incomplete polyp resection) patients with a medical history of inflammatory bowel disease, inherited or other polyposis syndrome and colorectal cancer.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Colonoscopy patients<br>Consecutive colonoscopy outpatients referred to one of 29 endoscopy units in Italy | Other: colonoscopy<br>* evaluation of surveillance timing adequacy as compared to the guidelines<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to post-polypectomy surveillance guidelines | Time interval between index and surveillance colonoscopies for patients undergoing post-polypectomy surveillance was calculated and compared to that suggested by the guidelines according to endoscopic findings at previous examination. For each patiens, surveillance time interval was regarded as correct if coherent with the recommended interval +/- 6 months, thus allowing to calculate the proportion of correct prescriptions | up to one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Factors associated to surveillance appropriateness | The presence of factors associated to appropriate surveillance prescriptions was investigated by multivariate analysis (odds ratio and 95% confidence interval for each factor) | up to one year |
Changes in Oxygen Saturation in Two Exercise Modalities

Study Overview
=================
Brief Summary
-----------------
The investigator will proceed to assess changes in oxygenation of muscle tissue, electromyographic activation and strength in healthy subjects. For this, a measurement of all demographic variables on the first day of the study as well as a familiarity with the equipment will be performed. Participants will start the intervention 48 hours later to proceed with the first intervention with one of the exercises in this research (inertial pulley or regular machine). Later on, 48 hours later participants will perform the latest intervention that has not yet done, thus generating a crossover study.

Official Title
-----------------
Comparison of Changes in Oxygen Saturation in Flywheel Exercise Versus Conventional Strength Machine

Conditions
-----------------
Muscle Oxigenation, Strength

Intervention / Treatment
-----------------
* Device: Iso inertial
* Device: Conventional machine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sedentary No pain Non disease Exclusion Criteria: Exercise experience

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Iso inertial<br>Subjects should do 12 exercise repetition with Iso inertial machine | Device: Iso inertial<br> <br> |
| Experimental: Conventional machine<br>Subjects should do 12 exercise repetition with conventional machine | Device: Conventional machine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Oxygen saturation of Vastus lateralis muscle during the exercise of each participant | physiological parameter (Percentage of local oxygen consume will be record in every stage of the investigation) | one second |
Study of Metabolic Effects of Pregnancy in Women With Cystic Fibrosis

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Compare the clinical status of pregnant vs non-pregnant women with cystic fibrosis. II. Determine glucose tolerance during each trimester of pregnancy in these women. III. Evaluate peripheral insulin sensitivity in these women. IV. Evaluate whole body protein turnover and hepatic glucose production in these women. V. Determine resting energy expenditure in these women.

Detailed Description
-----------------
PROTOCOL OUTLINE: Patients undergo a glucose tolerance test over 3 hours and a potassium body scan on day 1. Patients undergo an indirect calorimetry over 20 minutes on day 2. Patients receive stable-labeled leucine and stable-labeled glucose IV over 3 hours followed by insulin and glucose IV over 4-4.5 hours on day 2 using the hyperinsulinemic euglycemic clamp technique. Blood and breath samples are collected to measure glucose tolerance, peripheral insulin sensitivity, and whole body protein turnover. Hepatic glucose production is measured by mass spectrophotometry. Patients maintain a 3-day food journal before pregnancy, during each trimester, and after pregnancy. Patients undergo each study during the final 2 weeks of each trimester of pregnancy and then at 6 months post-partum.

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Drug: glucose
* Drug: insulin
* Drug: leucine


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of cystic fibrosis (CF) and pregnant OR Age, weight, and body mass index matched non-pregnant CF woman or pregnant non-CF woman No infection with Burkholderia cepacia FEV1 at least 60% --Prior/Concurrent Therapy-- At least 3 weeks since prior corticosteroids --Patient Characteristics-- Hepatic: No more than one transaminase level greater than 10% above normal Other: Pregnant non-CF controls: No cigarette smokers No history of gestational diabetes mellitus No type 1 or 2 diabetes No other chronic illness

Ages Eligible for Study
-----------------
Minimum Age: 0 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: glucose|nan|
|Drug: insulin|nan|
|Drug: leucine|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
-----------------
cardiovascular and respiratory diseases, cystic fibrosis, genetic diseases and dysmorphic syndromes, rare disease