linjc16/ctgov huggingface dataset:
Focusing Implementation to Bring Effective Reminders (FIBER)

Study Overview
=================
Brief Summary
-----------------
FIBER is 4-year study that will evaluate the implementation of a large-scale population-based colorectal cancer screening patient reminder and coordinated follow-up program. The CRC screening program began in 2007 with Kaiser Permanente Northwest (KPNW),a not-for- profit, integrated health system in Oregon and Washington. FIBER consists of 1)a practical randomized controlled trial at the start of the program, followed by 2) a longer-term cohort study as all remaining eligible patients receive the program, and 3)a qualitative evaluation. FIBER will evaluate the factors that are associated with implementation success across multiple levels: patient, primary care provider (PCP) team, specialists (gastroenterologists, general surgeons, pathologists), and other health plan staff and systems.

Official Title
-----------------
Focusing Implementation to Bring Effective Reminders (FIBER)

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

Intervention / Treatment
-----------------
* Behavioral: Patients receives letter, phone call, office visit, educational materials


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: KPNW members since 2005 Men and women, aged 50-80 who were due for CRC screening during a 24-month period of time. Exclusion Criteria: KPNW members who were part of a previous quantitative study.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Patient has had PCP contact (letter, phone call, office visit, educational materials). | Behavioral: Patients receives letter, phone call, office visit, educational materials<br>* Behavioral<br>|
| No Intervention: 2<br>Usual Care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the effectiveness and maintenance of a colon-rectal cancer screening patient reminder program.Identify patient, primary care team, and system factors important to implementation success. |  | Year 2, 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Create, refine, and disseminate an implementation guide for colon-rectal cancer screening reminder programs by combining the findings from the primary aim. |  | Years 3, 4 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
colon, rectal, cancer, screening
Aspirin in Asymmetrically Intrauterine Growth

Study Overview
=================
Brief Summary
-----------------
Intrauterine growth restriction refers to a fetus that has failed to get a specific measures by a gestational age. Asymmetric type of Intrauterine growth restriction is known by normal sized head with smaller abdomen.It is important to recognize the growth restricted fetuses, because these fetuses may have fetal or neonatal complications. When blood flow is increased, the oxygen and nutrients will deliver good to the fetus. The role of low-dose aspirin therapy in management of intrauterine growth restriction is controversial. It has been used, in many studies, in prevention of intrauterine growth restriction especially in women at high risk of pre-eclampsia or obstetrical antiphospholipid syndrome.

Official Title
-----------------
Effect of Low-dose Aspirin on Fetal Weight of Idiopathic Asymmetrically Intrauterine Growth Restricted Fetuses With Abnormal Umbilical Doppler Indices

Conditions
-----------------
Intrauterine Growth Restriction Asymmetrical

Intervention / Treatment
-----------------
* Drug: Aspirin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The pregnant women 28-30 weeks Idiopathic asymmetrically intrauterine growth restriction Middle aged women (20-35 years) Women with abnormal umbilical artery Doppler flow indices ( > +2 standard deviation above mean for gestational age) Exclusion Criteria: Women less than 20 and more than 35 years hypertensive or diabetic women any type of smoking multiple pregnancies amniotic fluid index <5 cm premature pre-labor rupture of membranes abnormal placenta any fetal congenital malformations. women had absent diastolic flow or reversed flow in umbilical artery at the time of recruitment.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 Years

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

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 |
| --- | --- |
| Active Comparator: Aspirin group<br> | Drug: Aspirin<br>* This group were subjected to aspirin 75 mg once daily for 6 weeks.<br>|
| No Intervention: No intervention<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimated fetal weight |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Birth weight |  | 6 weeks | 
| Changes in Doppler blood flow indices in umbilical artery |  | 6 weeks |
Venous Thromboembolism in Pregnant and Puerperal Women in Denmark 1995-2005

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to describe the incidence of thromboembolic events in relation to pregnancy and when in pregnancy and the puerperal period.

Detailed Description
-----------------
Venous thromboembolism (VTE) still causes maternal death in the western world. The purpose of this study is to estimate the relative and absolute risk of VTE at different gestational ages in pregnant women compared to non-pregnant women. All Danish Women 15 to 49 years old in the period January 1995 through December 2005, free of previous VTE and current use of oral contraceptives are included.Non-pregnant women are controls.

Official Title
-----------------
Venous Thromboembolism in Pregnant and Puerperal Women in Denmark 1995-2005

Conditions
-----------------
Venous Thromboembolism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Danish woman at 15 to 49 years old in the period January 1995 through December 2005. Free of previous VTE and current use of oral contraceptives. Exclusion Criteria: Previous VTE or current use of oral contraceptives.

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 50 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Danish Women 15 to 49 years old.<br>Free of previous VTE and current use of oral contraceptives. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute incidence of thromboembolic event |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Thromboembolic event
Smoking Cessation Treatment With Transdermal Nicotine Replacement Therapy - 1

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to look at how feasible it is to incorporate a state-of-the-art smoking cessation treatment program into community substance abuse treatment programs and its impact on substance abuse and cigarette smoking.

Official Title
-----------------
Smoking Cessation Treatment With Transdermal Nicotine Replacement Therapy

Conditions
-----------------
Tobacco Use Disorder

Intervention / Treatment
-----------------
* Drug: nicotine transdermal system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is alcohol or drug dependent, in Outpatient Drug-Free or Opiate Substitute program and is interested in quitting smoking Exclusion Criteria: Patient is psychotic Use of smokeless tobacco Use of other smoking cessasation product Pregnancy Patient has hyper-tension, heart problems, or skin condition

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: nicotine transdermal system|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug use |  |  | 
| Smoking Cessation |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nicotine dependence
The Incidence of Occult Hepatitis C Virus Infection in Hemodialysed Patients With Liver Enzymes Disturbances

Study Overview
=================
Brief Summary
-----------------
To assess the incidence of occult hepatitis C virus in hemodialysed patients with mild impairment of liver enzymes

Detailed Description
-----------------
occult hepatitis C virus will be checked in monocytes of hemodialyzed patients with permanent mild impairment of liver enzymes This population has no evidence of hepatitis B or C according to standard laboratory tests (HVC antibodies,HCV PCR, hepatitis B antibodies) Hepatitis C virus RNA will be performed in peripheral blood mononuclear cells of hemodialysed patients

Conditions
-----------------
Hemodialysed Patients With Impaired Liver Enzymes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hemodialysed patients with impaired liver enzymes Exclusion Criteria: hepatitis B and C positive

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 |
| --- | --- |
| impaired liver enzymes<br> | |
| normal liver enzymes<br> | |
| hepatitis C antibodies positive<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
-----------------
liver enzymes, peripheral mononuclear blood cells, hemodialysis, hepatitis C, RNA
DC Vaccine Combined With CIK Cells in Patients With Renal Cell Carcinoma

Study Overview
=================
Brief Summary
-----------------
The aim of this Phase I/II study is to evaluate the safety and efficacy of dendritic cells (DC) vaccine combined with cytokine-induced killer (CIK) cells in patients with renal cell carcinoma. Experimental recombinant adenovirus-transfected DC, which engineered to express MUC1 and Survivin are used for DC-based immunotherapy. Based on the results of our previously performed preclinical study with DC vaccine combined with CIK cells, the investigators plan to perform the clinical trial.

Official Title
-----------------
Safety and Therapeutic Efficacy of DC Vaccine Combined With Cytokine-induced Killer Cells in Patients With Renal Cell Carcinoma: a Phase I/II Study

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

Intervention / Treatment
-----------------
* Biological: adenovirus-transfected DC + CIK


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18 years at time of consent Histopathologically confirmed diagnosis of renal cell carcinoma Received standardized treatment of renal cell carcinoma Interval between the last standardized treatment and DC/CIK treatment ≥ 4weeks KPS (Karnofsky performance scale) >60 Patient's written informed consent Predicted survival >3 months No severe viral or bacterial infections Exclusion Criteria: Receiving chemotherapy, radiotherapy or other therapy Patients with other malignancies and infectious diseases Pregnant and breast-feeding patient Currently participating in another clinical trial Unfit for participating in this clinical trial in investigators' opinions

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: adenovirus-transfected DC + CIK<br>adenovirus-transfected autologous DC vaccine plus CIK cells | Biological: adenovirus-transfected DC + CIK<br>* adenovirus-transfected DC vaccine plus CIK cells<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| objective tumor response (CR+PR) as measured by RECIST criteria |  | 4 weeks after DC/CIK treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of participants with adverse events |  | 3 days within DC/CIK treatment |
Umbilical Cord Serum Eye Drops

Study Overview
=================
Brief Summary
-----------------
In the present study, the investigators investigated the efficacy of umbilical cord serum eye drops for the treatment of patients with recurrent corneal erosions. Group A were treated with 20% umbilical cord serum eye drops 3 to 4 times a day in addition to artificial tears, and group B were treated with artificial tears only. Ophthalmic examinations including visual acuity measurement and slit lamp biomicroscopy were performed before and every month after treatment. Recurrence was defined as the presence of clinical symptoms accompanied by epithelial defects in the cornea.

Conditions
-----------------
Recurrent Corneal Erosion

Intervention / Treatment
-----------------
* Drug: Umbilical cord serum eyedrops


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with recurrent corneal erosions 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: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: umbilical cord serum eyedrops<br>patients with recurrent corneal erosions were treated with 20% umbilical cord serum eye drops 3 to 4 times a day in addition to artificial tears | Drug: Umbilical cord serum eyedrops<br>* 20% umbilical cord serum eye drops 3 to 4 times a day<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
-----------------
Umbilical cord serum, Recurrent corneal erosion
Open Label Arimidex in Gynecomastia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety, effectiveness, pharmacokinetics and pharmacodynamics of anastrozole (ARIMIDEX™) in the treatment of boys with gynecomastia.

Official Title
-----------------
An Open-Label Pharmacokinetic and Pharmacodynamic Study of Anastrozole (Arimidex™) Used to Treat Pubertal Boys With Gynecomastia of Recent Onset

Conditions
-----------------
Gynecomastia

Intervention / Treatment
-----------------
* Drug: Anastrozole (ARIMIDEX™)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent/assent (as per local requirements), males aged 11-18 yrs. (after his 10th and prior to 19th birthday), gynecomastia, one breast measuring ≥ 2 cm in diameter (by ultrasound or caliper measurement) that has not decreased during the prior 3 month period by medical history and has been present for 12 months or less (date of onset based on best estimate of treating physician after discussion with patient and or patient's parent/guardian), normal renal liver and thyroid function, no evidence of hormone producing tumor, no evidence of hypogonadism or androgen resistance. Exclusion Criteria: Patients who have been given medications known to cause gynecomastia within the previous 6 months, involvement in the planning and conduct of the study (includes AZ staff and investigative site staff), previous enrollment in the present study, investigators opinion patient would be unable to comply with study protocol.

Ages Eligible for Study
-----------------
Minimum Age: 11 Years
Maximum Age: 18 Years

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

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

| Intervention/Treatment |
| --- |
|Drug: Anastrozole (ARIMIDEX™)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess anastrazole PK in boys aged 11-18 yrs. in pubertal boys with gynecomastia of less than 12 months duration |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine efficacy by the response rate following 6 months of treatment |  |  |
Oral Peptones Load in Normocalcemic and Hypercalcemic Primary Hyperparathyroidism and Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess if subjects with hyperparathyroidism with normal serum calcium levels have different responses in the calcium regulating hormonal handling compared to a) patients with primary hyperparathyroidism and high serum calcium levels; b) healthy subjects. The differences will be evaluated with oral peptones load and subsequent blood samples collected every 15 minutes for two hours. Ionized calcium, phosphate, gastrin and PTH levels will be evaluated.

Official Title
-----------------
Dissimilar PTH, Gastrin, and Ionized Calcium Response to Oral Peptones in Normocalcemic Primary Hyperparathyroidism, Hypercalcemic Primary Hyperparathyroidism and Healthy Subjects

Conditions
-----------------
Hyperparathyroidism, Hypercalcemia

Intervention / Treatment
-----------------
* Other: Oral peptones load


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: normocalcemic hyperparathyroidism presence of high serum levels of intact PTH serum ionized calcium levels in the high normality range hypercalcemic hyperparathyroidism presence of high serum levels of intact PTH high serum ionized calcium levels Exclusion Criteria: potential causes of secondary hyperparathyroidism like renal insufficiency, liver disease, malabsorption, hypercalciuria, Paget's disease, thiazide diuretic or lithium use. bone disease of any origin

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Normocalcemic Hyperparathyroidism<br> | Other: Oral peptones load<br>* Enrolled subjects will receive 10 g Liebig meat extract diluted in 250ml of 0.9% saline<br>|
| Experimental: Hypercalcemic Hyperparathyroidism<br> | Other: Oral peptones load<br>* Enrolled subjects will receive 10 g Liebig meat extract diluted in 250ml of 0.9% saline<br>|
| Active Comparator: Healthy subjects<br> | Other: Oral peptones load<br>* Enrolled subjects will receive 10 g Liebig meat extract diluted in 250ml of 0.9% saline<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTH levels variations |  | 2 hours | 
| Ionized serum calcium variations |  | 2 hours | 
| Serum phosphate variations |  | 2 hours | 
| Serum gastrin variations |  | 2 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Receptors, Calcium sensing, Parathyroid Hormone
Efficacy and Safety of Insulin Aspart in MDI or CSII in Children Below 7 Years of Age With Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this trial is to investigate the efficacy of insulin aspart compared to soluble human insulin on blood glucose control in children below 7 years of age with type 1 diabetes.

Official Title
-----------------
Efficacy and Safety of Insulin Aspart in MDI or CSII in Children Below 7 Years of Age With Type 1 Diabetes Mellitus

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1

Intervention / Treatment
-----------------
* Drug: insulin aspart
* Drug: soluble human insulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 diabetes for at least 1 year HbA1c below 12.0% Treatment with regular human insulin and insulin NPH for at least 1 month Receive more than 2 injections daily Exclusion Criteria: Receipt of investigational product within 6 months prior to trial participation Known or suspected allergy to investigational product Receipt of of insulin aspart within 3 months prior to trial participation

Ages Eligible for Study
-----------------
Maximum Age: 7 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

| Intervention/Treatment |
| --- |
|Drug: insulin aspart|nan|
|Drug: soluble human insulin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | after 26 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall glycaemic control |  |  | 
| Occurrence of adverse events |  |  | 
| Occurrence of serious adverse events |  |  | 
| Frequency of hypoglycaemia episodes |  |  | 
| Quality of Life (QoL) |  |  |