linjc16/ctgov huggingface dataset:
Comparison of Fenofibric Acid Bioavailability From ABT-335 Capsules

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and compare the bioavailability of fenofibric acid from 2 different dosage strengths of ABT-335.

Official Title
-----------------
Comparison of Fenofibric Acid Bioavailability From 45 mg and 135 mg Strength ABT-335 Capsules

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: ABT-335


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A condition of general good health BMI 18 to 29 Exclusion Criteria: Currently enrolled in another clinical study Females who are pregnant or breast-feeding

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>ABT -335 capsules 135mg | Drug: ABT-335<br>* Once, see arm description for more information<br>* Other names: Trilipix;|
| Experimental: B<br>ABT-335 capsules 45mg | Drug: ABT-335<br>* Once, see arm description for more information<br>* Other names: Trilipix;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the bioavailability of ABT-335 in healthy subjects as measured by timed pharmacokinetic blood draws from pre-dose (0 hour) to 120 hours post dose |  | 14 Days | 
| To evaluate the safety and tolerability of ABT-335 in healthy adults after single dosage |  | 14 Days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bioavailability
A Study of MK0359 in Patients With Chronic Asthma (0359-013)

Study Overview
=================
Brief Summary
-----------------
A study to test the effect of MK0359 in lessening the symptoms of asthma as compared to placebo.

Official Title
-----------------
A Multicenter, Randomized, Double-Blind, Crossover Study Comparing the Effect of MK0359 and Placebo in Adult Patients With Chronic Asthma

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: MK0359


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: You are between the ages of 18 and 45 You have had a history for at least a year of COPD symptoms Your current asthma treatment is limited to short-acting beta-agonists(such as albuterol) You have a history of smoking one pack of cigarettes per day for 7 years You will not be away from home for more than 5 days during the study Exclusion Criteria: You are unwilling to limit your alcohol use to less than 5 drinks per week You have been in a research study with an investigational drug or vaccine in the last 4 weeks You have donated blood in the last 4 weeks You have been hospitalized or had major surgery in the last 4 weeks You have been treated in the emergency room within the last 4 weeks or hospitalized within the last 3 months for your asthma You have a history of heart problems in the last 6 months You have a history of stomach problems You are unwilling to avoid grapefruit juice throughout the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0359|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Change of Lumbar Symptom After Surgical Treatment for Patients With Cervical Stenosis

Study Overview
=================
Brief Summary
-----------------
Low back pain may be reduced after cervical spinal surgery

Detailed Description
-----------------
The improved back pain score after cervical spinal surgery would be higher than that after non-surgical treatment.

Official Title
-----------------
Change of Lumbar Symptom After Surgical Treatment for Patients With Cervical Stenosis

Conditions
-----------------
Cervical Myelopathy Spondylosis, Low Back Pain

Intervention / Treatment
-----------------
* Procedure: Cervical spinal surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients with cervical myelopathy and low back pain Exclusion Criteria: previous surgery at the lumbar spine malignancy previous surgery at the cervical spine

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Cervical spinal surgery|Cervical laminoplasty or anterior discectomy and fusion|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Low back pain | improve visual analogue pain score (VAS) more than 1.2/10 | postoperative 6 months | 
| functional outcome | improve Oswestry diability index (ODI) more than 6.2/45 | postoperative 6 months |
Genetic Abnormalities and Oxidative Stress in Sperm as Cause of Recurrent Miscarriage.

Study Overview
=================
Brief Summary
-----------------
In recurrent miscarriage, the male factor has been poorly evaluated. In fact, in the vast majority of clinical protocols of recurrent miscarriage, the sperm is not considered or assessed. Recently, some studies have suggested the presence of genetic and metabolic sperm anomalies in couples suffering from repeated miscarriages. Specifically, DNA fragmentation and altered oxidative stress in the sperm and Y microdeletions from blood samples have been related to an increased risk of miscarriage.The aim of the present study is to compare these three parameters in: couples with recurrent miscarriage; oligozoospermic men with or without recurrent miscarriages; and healthy sperm donors, in order to determine their actual impact on this reproductive problem.

Official Title
-----------------
Genetic Abnormalities and Oxidative Stress in Sperm as Cause of Recurrent Miscarriage.

Conditions
-----------------
Recurrent Miscarriage

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 4 groups Recurrent miscarriage, <40 year-old-men, < 38 year-old-women, normal or mild affected sperm, normal parents karyotype, no thrombophilia, normal uterus, no endocrinopathy The same criteria than in group A, but oligozoospermia (1-5 mill/ml) Oligozoospermia (1-5 mill/ml), < 40 year-old-men, no recurrent miscarriages Healthy young sperm donors

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| GROUP 1<br>Recurrent miscarriage, <40 year-old-men, < 38 year-old-women, normal or mild affected sperm, normal parents karyotype, no thrombophilia, normal uterus, no endocrinopathy | |
| GROUP 2<br>•Recurrent miscarriage, <40 year-old-men, < 38 year-old-women, oligozoospermia (1-5 mill/ml), normal parents karyotype, no thrombophilia, normal uterus, no endocrinopathy | |
| GROUP 3<br>•Oligozoospermia (1-5 mill/ml), < 40 year-old-men, no recurrent miscarriages | |
| GROUP 4<br>•Healthy young sperm donors | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Hereditary Colorectal and Associated Tumor Registry Study

Study Overview
=================
Brief Summary
-----------------
After informed consent, participants will be asked to complete a medical/family history questionnaire and provide a blood sample. Participants will also be asked for their permission for study investigators to access medical records and/or recontact them for updates to their medical and family histories. Data and biospecimens will be stored for potential future research projects.

Official Title
-----------------
Hereditary Colorectal and Associated Tumor Registry Study

Conditions
-----------------
Lynch Syndrome, FAP, Hereditary Diffuse Gastric Cancer, Juvenile Polyposis Syndrome, Peutz-Jeghers Syndrome

Intervention / Treatment
-----------------
* Other: Research Registry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Identified gene mutation Personal history of colorectal cancer diagnosed ≤ 50 Personal history of cancer with tumor studies suggestive of Lynch syndrome Personal history of multiple primary tumors associated with a hereditary cancer syndrome (colorectal, uterus, stomach, ovary, small bowel, hepatobiliary tract, transitional cell carcinoma of the renal pelvis/ureter, brain) Personal history of one of the above cancers and a family history of one or more of the above cancers Personal or family history of diffuse gastric cancer From a known genetic predisposition family Personal history of > 10 colon adenomas (cumulative over a lifetime) Personal history of any number of hamartomatous polyps Personal history of multiple large (> 1cm) serrated polyps to right of sigmoid Exclusion critera: Individuals under the age of 8 Individuals who cannot travel to Pittsburgh for in-person enrollment Individuals who cannot provide informed consent

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 100 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Research Registry|Information regarding medical and family history is stored in the registry to be used for potential future studies|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Establish a Hereditary Colorectal Tumor Registry to facilitate development and implementation of epidemiological, clinical and cancer control research. |  | 1-N/A (up to 8 years) |
Asthma in the Elderly: The Role of Vitamin D

Study Overview
=================
Brief Summary
-----------------
We will study whether taking vitamin D improves asthma control and spirometric values in elderly asthmatics.

Official Title
-----------------
Asthma in the Elderly: The Role of Vitamin D

Conditions
-----------------
Asthma in the Elderly

Intervention / Treatment
-----------------
* Dietary Supplement: Vitamin D 2,000 I.U.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Asthma, age of 65 years old or older Exclusion Criteria: Current smokers, subjects who smoked more than 10 pack/year, subjects taking digoxin, subjects with liver disease

Ages Eligible for Study
-----------------
Minimum Age: 65 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: Vitamin D 2,000 I.U. daily<br>Study subjects will take 2,000 I.U. vitamin D daily for three months | Dietary Supplement: Vitamin D 2,000 I.U.<br> <br> * Other names: Vitamin Shoppe;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Asthma Control Test (ACT) score |  | Three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in pulmonary function tests values (FEV1%, etc.) |  | Three months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
asthma, elderly, vitamin D
Comparison of Treatment Success of Botox Injection in the Internal Sphincter Versus Isosorbidedinitrate Ointment in Patients With an Anal Fissure

Study Overview
=================
Brief Summary
-----------------
The standard treatment of anal fissure in the netherlands (ISDN ointment) is being compared to a relatively new treatment (injection of Botox in the internal anal sphincter). The study hypothesis is that after 4 months, Botox has healed more patients than ISDN. The comparison is done blinded for the surgeon and the patient.

Official Title
-----------------
Botulin Toxin Versus Isosorbidedinitrate Ointment in Treatment Anal Fissure; A Prospective, Blinded, Randomized Trial

Conditions
-----------------
Anal Fissure

Intervention / Treatment
-----------------
* Procedure: Botox
* Drug: ISDN ointment
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all consecutive patients over the age of 18 with a chronic anal fissure presenting to our surgical outpatient clinic Exclusion Criteria: pregnancy previous anal surgery Crohn's disease systemic causes of an anal fissure

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Botox injection<br>injection of 10U of BT (Botox®; Allergan, Irvine, California, USA) in the IAS on each side of the anterior midline. In addition, a placebo ointment has to be applied to the anoderm six times a day | Procedure: Botox<br>* injection of 10U of BT (Botox®; Allergan, Irvine, California, USA) in the IAS on each side of the anterior midline.<br>|
| Active Comparator: ISDN ointment<br>application of ISDN 1% ointment 6 times a day. injection of placebo into internal anal sphincter | Procedure: Botox<br>* injection of 10U of BT (Botox®; Allergan, Irvine, California, USA) in the IAS on each side of the anterior midline.<br>Drug: ISDN ointment<br>* application of ISDN 1% ointment 6 times a day<br>Drug: Placebo<br>* Injection of placebo into internal anal sphincter (ISDN ointment arm) Applied to the anoderm six times a day (Botox injection arm)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| macroscopic healing of the fissure |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complications |  | 12 months | 
| fissure recurrence |  | 12 months | 
| fissure related pain |  | 12 months | 
| costs |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anal fissure, fissura ani, botox, ISDN, Nitric oxide donor
Back Pain Prevalence in Wheelchair Users and Associated Risk Factors

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to determine the prevalence of back pain in permanent wheelchair users (excludes transitory users) in different regions of Spain. Another study objective is the identification of risk factors for back pain in this population. Data collection will be by means of a structured questionnaire which will be validated in a previous pilot study.

Official Title
-----------------
Back Pain Prevalence in Wheelchair Users and Associated Risk Factors

Conditions
-----------------
Back Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults with established disability; Permanent wheelchair users; Having physical and intellectual ability to answer questionnaire. Exclusion Criteria: Transitory wheelchair users; Diagnosis of inflammatory rheumatic disease, cancer, systemic infection; Red flags for systemic disease.

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Wheelchair users, Back pain, Prevalence, Risk factors
Prognostic Assessment of Different Pattern of Bifurcation Restenosis

Study Overview
=================
Brief Summary
-----------------
The LATINA registry aims at assessing a new classification of bifurcation restenosis in the prediction of major adverse cardiac events in patients who have previously undergone a succesful percutaneous bifurcation intervention.

Official Title
-----------------
Classification of Bifurcation Restenosis: a Prognostic Assessment

Conditions
-----------------
In-stent Coronary Artery Restenosis

Intervention / Treatment
-----------------
* Other: Bifurcation restenosis classification


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age >18 years restenosis involving a coronary bifurcation previously treated percutaneously Exclusion Criteria: life expectancy >1 year

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Bifurcation restenosis<br>Patients with either a main vessel or a side branch restenosis following succesful percutaneous coronary intervention | Other: Bifurcation restenosis classification<br>* Classification of restenosis involving coronary bifurcation according to their pattern<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiac events | Number of patients experiencing any of the following events: cardiac death, non-fatal miocardial infarction, target vessel revascularization | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac death | Number of patients experiencing a cardiac death event | 12 | 
| Non-fatal myocardial infarction | Number of patients experiencing a non-fatal myocardial infarction event | 12 months | 
| Target vessel revascularization | Number of patients experiencing a target vessel revascularization event | 12 month |
Colombia Epidemiologic Surveillance Study

Study Overview
=================
Brief Summary
-----------------
The study will determine the reduction in invasive pneumococcal disease (IPD) after the introduction of a National Immunization Program with PCV-7 in Bogota. The original LEAP study determine incidence of IPD prior to introduction of PCV-7 in Brazil, Costa Rica and Colombia. LEAP II is the continuation of the study in Colombia only.

Detailed Description
-----------------
The study was stopped based on a decision to include PCV 10 in the National Immunization Program in Colombia. The study was designed to measure the impact of PCV 7 and 13 and is no longer feasible.

Official Title
-----------------
Multinational Latin American Epidemiologic Surveillance For Invasive Pneumococcal Disease

Conditions
-----------------
Pneumonia, Meningitis, Bacteremia, Sepsis

Intervention / Treatment
-----------------
* Other: Surveillance


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children 28 days to 36 months of age Presenting to a participating facility with a measured temperature of 39 degrees C or higher within 24 hours prior to screening, or with clinical suspicion of pneumonia, meningitis, bacteremia, sepsis, or other invasive pneumococcal disease Exclusion Criteria: Any patient hat based on the clinical impression of the treating physician should not participate in the study: examples such as those with suspected dengue or urinary tract infection

Ages Eligible for Study
-----------------
Minimum Age: 28 Days
Maximum Age: 36 Months

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All eligible patients<br> | Other: Surveillance<br>* No study drug, only interventions are blood draws and Chest X-rays<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Annual age specific incidence rate of invasive pneumococcal disease based on the number of identified cases from the study sites and the size of the population at risk for children 28 days to 36 months of age |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Epidemiology, Surveillance, Streptococcal Pneumonia
Tissue and Serum Collection From Colorectal Cancer Patients

Study Overview
=================
Brief Summary
-----------------
To establish a serum and tissue bank with specimens form patients with colorectal cancer, for subsequent immunological and biochemical analysis.

Official Title
-----------------
Tissue and Serum Collection From Colorectal Cancer Patients

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must be undergoing surgery for resection of their primary tumor, resection of hepatic metastases, or hepatic artery catheter and pump implant for unresectable hepatic metastases. For and tumor specimen removed at surgery ,the lesion must be large enough to allow for routine pathological analysis, with excision from residual otherwise discarded material for the tumor bank. Exclusion Criteria: N/A
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 |
| --- | --- | --- |
| establish a serum and tissue bank |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
colorectal cancer, tissue collection