linjc16/ctgov huggingface dataset:
Polydextrose for Patients With Chronic Kidney Disease

Study Overview
=================
Brief Summary
-----------------
Constipation is a common complication in patients with chronic kidney disease (CKD), especially in hemodialysis (HD) patients. Reduced intake of fibre-rich food is among the most important causes of constipation. The study aims to investigate the possible influence of polydextrose (PDX) supplementation on constipation in patients with CKD on HD.

Official Title
-----------------
Effects of Polydextrose Supplementation on Constipation in Patients Undergoing Hemodialysis

Conditions
-----------------
Chronic Kidney Diseases, Constipation

Intervention / Treatment
-----------------
* Dietary Supplement: Polydextrose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of Chronic Kidney Disease Hemodialysis patients for more than 6 months Aged 18 years or older Exclusion Criteria: Patients pregnant Smokers Using antibiotics in the last 3 months Autoimmune diseases Clinical diagnosis of infectious diseases Clinical diagnosis of Cancer Clinical diagnosis of AIDS

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Group<br>Administration of corn starch daily for 2 months | Dietary Supplement: Polydextrose<br>* Administration of 3g polydextrose per day, for 2 months<br>|
| Experimental: polydextrose<br>Administration of 12g polydextrose daily for 2 months | Dietary Supplement: Polydextrose<br>* Administration of 3g polydextrose per day, for 2 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change constipation status after supplementation with polydextrose | Stool frequency and Bristol Stool Form | 2 months | 
| Change in cytokines plasma levels measured by ELISA after supplementation with polydextrose | cytokines levels | 2 months |
The Effect of MK0633 in Patients With Chronic Asthma (0633-007)

Study Overview
=================
Brief Summary
-----------------
A clinical study to evaluate the efficacy and safety of MK0633 in adult patients with chronic asthma.

Official Title
-----------------
A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Parallel-Group, Dose-Ranging Study of MK0633 in Adult Patients With Chronic Asthma

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

Intervention / Treatment
-----------------
* Drug: MK0633
* Drug: Comparator: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented clinical history of symptoms of chronic asthma, including dyspnea, wheezing, chest tightness, cough, and/or sputum production Males and females 18-70 years of age Exclusion Criteria: History of kidney or chronic liver disease Recent history of heart problems within the past 3 months Evidence of another clinically significant, active lung disorder such as bronchiectasis or COPD

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>MK0633 10 mg | Drug: MK0633<br>* Patients will receive 10 mg, 50 mg, or 100 mg MK0633 tablets once daily for 6 weeks. There will be 2 week period during which all patients will receive placebo to MK0633<br>|
| Experimental: 2<br>MK0633 50 mg | Drug: MK0633<br>* Patients will receive 10 mg, 50 mg, or 100 mg MK0633 tablets once daily for 6 weeks. There will be 2 week period during which all patients will receive placebo to MK0633<br>|
| Experimental: 3<br>MK0633 100 mg | Drug: MK0633<br>* Patients will receive 10 mg, 50 mg, or 100 mg MK0633 tablets once daily for 6 weeks. There will be 2 week period during which all patients will receive placebo to MK0633<br>|
| Placebo Comparator: 4<br>placebo | Drug: Comparator: placebo<br>* Placebo to MK0633 10 mg, 50 mg, or 100 mg tablets once daily for 6 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary function test data measured over 6 weeks |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall daytime and nighttime symptoms score, beta-agonist use, asthma exacerbations, asthma-specific quality of life questionnaire score, measured over 6 weeks |  | 6 weeks |
Cardiovascular Disease (CVD) in Haemophilia

Study Overview
=================
Brief Summary
-----------------
Life expectancy of hemophilia patients has improved considerably during the past decades and is approaching that of the general population. Hemophilia patients are therefore likely to be confronted with age-related disorders in addition to their primary illness and related diseases. Little is known about the occurrence of age-related co-morbidity, especially cardiovascular disease (CVD), in these patients. Low clotting factor levels are hypothesized to protect against both atherosclerosis and thrombus formation, resulting in a reduced risk of ischemic CVD. CVD mortality has been reported to be lower in haemophilia patients than in the general population, but data on non-fatal CVD are lacking, and no adjustment for CVD risk factors has been made so far. The aim of our study is to assess the occurrence of CVD and its risk factors in a large cohort of haemophilia patients. In this prospective multicenter cohort study in a group of 700-800 male patients with haemophilia A or B aged 30 years or older from The Netherlands and the UK, data on CVD history and CVD risk factors will be collected at baseline and compared with the general age-matched male population. Overall QRISK2 cardiovascular risk scores will be calculated and also compared with the general population. During a follow-up period of 5 and 10 years the occurrence of CVD events will be recorded and compared with the expected occurrence based on the QRISK2 scores and with data from the general population.

Official Title
-----------------
Cardiovascular Disease in Adult Haemophilia Patients

Conditions
-----------------
Haemophilia, Cardiovascular Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Haemophilia A or B (mild, moderate or severe) Male gender Age 30 years or older Treated at participating haemophilia treatment center Exclusion Criteria: No specific exclusion criteria

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

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

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 |
| --- | --- | --- |
| Ischemic cardiovascular disease |  | After 5 and 10 years | 
| Cardiovascular disease risk factors |  | At baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association between clotting factor concentrate administration and cardiovascular events |  | 5-10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Haemophilia, Cardiovascular disease, Cardiovascular disease risk factors, Prospective, QRISK2, Hypertension, Hypercholesterolaemia, Diabetes, Obesity
The Effect of Low Oxygen Tension on the Early Development of Human Embryo in IVF/ICSI

Study Overview
=================
Brief Summary
-----------------
To investigate the effect of low oxygen tension during in vitro culture in terms of embryo quality and outcomes of pregnancy in vitro fertilization/ Intracytoplasmic sperm injection

Detailed Description
-----------------
The oocytes will be divided into two parts(two groups) form one patient. The two groups of oocytes will be cultured seperately in the incubator with the concentrations of 5% CO2,6%O2,89% N2(low oxygen concentration) verse 6% CO2,20% O2,74% N2(in atmosphere). A series of observational measurement(embryo quality and outcomes of pregnancy) will be performed.

Official Title
-----------------
The Effect of Low Oxygen Tension on the Early Development of Human Embryo in IVF/ICSI

Conditions
-----------------
Embryo Hypoxia

Intervention / Treatment
-----------------
* Other: 5% oxygen concentration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fresh cycles of in vitro fertilization/intracytoplasmic sperm injection and emrbyo transfer (IVF/ICSI-ET) ≥ 10 oocytes after oocyte retrieval Exclusion Criteria: ≥ 3 transfer or oocyte retrieval cycles PGD/PGS cycles half-ICSI/rescure ICSI fluid in the uterine cavity, abnormal endometrium, uterine abnormalities,pelvic inflammation acute maternal problems. One or both spouses have an abnormal karyotype (including polymorphism)
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 5% oxygen<br>the oocytes and embryos are cultured in 5% oxygen concentration after oocytes retrieval until Day 6 (counting from fertilization) | Other: 5% oxygen concentration<br>* the oocytes and embryos are cultured in the incubator with concentrations of 6% CO2,5%O2, and 89% N2<br>* Other names: low oxygen concentration;|
| No Intervention: 20% oxygen<br>the oocytes and embryos are cultured in 20% oxygen concentration (in atmosphere) after oocytes retrieval until Day 6(counting from fertilization) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| embryo quality | Embryo morphology was assessed on day 2, day 3 day 4 day 5 day and 6 by considering the number of blastomeres, symmetry and granularity of blastomeres, type and percentage of fragmentation, presence of multinucleated blastomeres, and degree of compaction. Gardner's blastocyst scoring system is used for blastocyst assessment | up to 6 days after fertilization | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
low oxygen tension, embryo quality
Pictographic Education Handout on Tracheostomy Care

Study Overview
=================
Brief Summary
-----------------
The goal of the study is to address the clinical problem of poor education outcome from the current practice of teaching tracheostomy care by providing them with a pictographic education handout to assist their learning. The study seeks to establish face validity and preliminary efficacy of a pictographic education handout with patients and identify factors associated with lower self-efficacy level on tracheostomy care.

Official Title
-----------------
Develop a Pictographic Educational Handouts and Validate Its Preliminary Efficacy on Tracheostomy Care

Conditions
-----------------
Health Literacy

Intervention / Treatment
-----------------
* Other: Pictographic tracheostomy care handouts


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older Had a tracheostomy as part of head and neck cancer treatment, and who is not on mechanical ventilation His or her date of the related tracheostomy surgery was within the past 6 months Have received the discharge tracheostomy care education from the clinical nurse Exclusion Criteria: Documented major physical or cognitive disabilities that would limit the ability to give informed consent or answer survey questions

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pictographic group<br>Participants received the pictographic handouts on tracheostomy care | Other: Pictographic tracheostomy care handouts<br>* The handouts were developed and validated by Clinical and inter-professional experts based on the hospital's text-based tracheostomy home care instructions.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Author-developed self-efficacy on tracheostomy care scale | Participants' self-reported confidence on tracheostomy care from 0 to 10 (0=not confident, 10=very confident) | immediately after consenting and post intervention (up to 2 weeks) on study survey | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tracheostomy care, participatory action research
Prospective Multicenter Study to Characterize the REAL-WORLD EVIDENCE Regarding Safety and Performance of the PTCA NC Catheters Family

Study Overview
=================
Brief Summary
-----------------
The purpose of this post market study is to collect clinical data of the Arthesys PTCA NC catheters family during angioplasty intervention of coronary vessels or coronary bypass graft stenosis to support MDR submission.

Official Title
-----------------
Prospective Multicenter Study to Characterize the REAL-WORLD EVIDENCE Regarding Safety and Performance of the PTCA NC Catheters Family

Conditions
-----------------
Coronary Artery Stenosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients will be included as per Instructions for Use (IFU), Hospital standard of care and Good Clinical Practice (GCP): Patient with a Percutaneous intervention to a native coronary or coronary bypass graft indication Patient >18 years Patient who understands the trial requirements and the treatment procedures and provides written informed consent Exclusion Criteria: Patients will be excluded as per IFU, Hospital standard of care and GCP. Patients will not be included if they are under judicial protection, guardianship or curatorship or if they are deprived of their liberty by judicial or administrative decision.
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 |
| --- | --- | --- |
| Efficacy endpoint | Balloon successfully reaching and crossing target location, successful inflation, deflation, and retrieval in the guiding catheter | up to end of procedure | 
| Safety endpoint | Successful balloon dilatation without device related adverse event during the dilatation procedure | up to end of procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance - Pre-dilatation | Residual stenosis < 50% and TIMI flow grade 3 (corelab assessment) | up to end of procedure | 
| Performance - post-dilatation | Angiographic success of the device defined as < 30% residual stenosis after angiography (corelab assessment) | up to end of procedure |
Short Peptide Formula for Bowel Preparation

Study Overview
=================
Brief Summary
-----------------
Video capsule endoscopy (VCE) is a noninvasive diagnostic tool used to assess the small bowel pathology. The diagnostic value of VCE is mostly dependent on the cleanliness of the colon. Investigators are aimed to prospectively assess the quality of bowel preparation in pediatric patients receiving short peptide diet versus those receiving liquid diet.

Official Title
-----------------
Evaluation of Short Peptide Formula for Bowel Preparation in Video Capsule Endoscopy

Conditions
-----------------
Capsule Endoscopy, Pediatric Disorder

Intervention / Treatment
-----------------
* Other: Short peptide
* Other: Liquid diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Indications of capsule endoscopy; Informed consent form obtained. Exclusion Criteria: Contraindication of capsule endoscopy; Unwilling to participate; Formula allergy; Unable to swallow the capsule.

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 18 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Formula group<br>short peptide formula prior to capsule endoscopy | Other: Short peptide<br>* Short peptide formula during bowel preparation<br>|
| Other: Control group<br>regular liquid diet | Other: Liquid diet<br>* Liquid diet during bowel preparation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cleansing score | Cleansing scores were recorded according to a predetermined criterion | assessed through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic yield | Percentage of positive cases | assessed through study completion, an average of 1 year | 
| Completion rate | CE was considered complete when the cecum was reached within recording time | assessed through study completion, an average of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bowel preparation
Positive Angle Kappa

Study Overview
=================
Brief Summary
-----------------
Patients with aniridia have positive angle kappas.

Official Title
-----------------
Positive Angle Kappa: a Sign in Aniridia

Conditions
-----------------
Aniridia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with aniridia only Exclusion Criteria: poor va PK, K-pro

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 85 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 |
| --- | --- |
| eye examinations<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
-----------------
aniridia, positive angle kappa
Evaluation of Saliva IL-6 Levels and Periodontitis

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to analyze the association between salivary IL-6 levels in patients with periodontitis. Furthermore, the objective was to determine if the periodontitis influenced salivary IL-6 levels

Detailed Description
-----------------
Forty-nine patients with periodontitis and 47 healthy subjects (HS) were enrolled in the present study. Enrolled patients were examined and characterized for clinical and blood samples analysis, and salivary IL-6 levels. The Spearman Correlation Test and Jonckheere-Terpstra Test were applied in order to assess the interdependence between salivary IL-6 levels and clinical periodontal parameters.

Official Title
-----------------
Association Between Salivary IL-6 and Extent of Periodontitis

Conditions
-----------------
Periodontal Diseases

Intervention / Treatment
-----------------
* Other: Observation of salivary IL-6 levels


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presence of at least 16 teeth CP with a minimum of 40% of sites with a clinical attachment level (CAL) ≥2mm and probing depth (PD) ≥4mm; Presence of at least ≥2 mm of crestal alveolar bone loss verified on digital periapical radiographs Presence of ≥40% sites with bleeding on probing (BOP) Exclusion Criteria: Intake of contraceptives Intake of immunosuppressive or anti-inflammatory drugs throughout the last three months prior to the study Status of pregnancy or lactation Previous history of excessive drinking Allergy to local anaesthetic Intake of drugs that may potentially determine gingival hyperplasia such as Hydantoin, Nifedipine, Cyclosporin A or similar drugs.

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 65 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control<br>observation of salivary IL-6 levels | Other: Observation of salivary IL-6 levels<br>* Observation of salivary IL-6 levels and correlation of salivary IL-6 levels with periodontal disease<br>|
| Periodontitis<br>observation of salivary IL-6 levels | Other: Observation of salivary IL-6 levels<br>* Observation of salivary IL-6 levels and correlation of salivary IL-6 levels with periodontal disease<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Attachment Level | evaluation of changes in clinical attachment level | 1-year |
Comparison of Fecal Ribonucleic Acid (RNA) Test With Fecal Occult Blood Test (FOBT) for Detecting Colorectal Cancer and Adenoma

Study Overview
=================
Brief Summary
-----------------
Colorectal cancer (CRC) is the second common cause of death in the Western world, and is very increasing in Japan. Fecal occult blood test (FOBT) is used routinely for CRC screening, which has been shown to reduce the incidence, morbidity, and mortality of CRC. However, there is a need to develop a novel method to improve sensitivity. The investigators reported that Fecal COX-2 assay, one of fecal RNA test, is potentially useful for colorectal cancer screening (Gastroenterology 127; 422-427, 2004). So the investigators planed to compare fecal RNA test with FOBT for detecting colorectal cancer and adenoma.

Official Title
-----------------
Comparative Study of Fecal RNA Test With Immunochemical Fecal Occult Blood Test for Detecting Colorectal Cancer and Adenoma

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of colorectal cancer or adenoma Subjects with no abnormal findings of colon

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |