linjc16/ctgov huggingface dataset:
Natural History Study of Patients With Leber Congenital Amaurosis Associated With Mutations in RPE65

Study Overview
=================
Brief Summary
-----------------
MGT005 is a natural history study to collect longitudinal prospective data from patients with Leber Congenital Amaurosis associated with defects in RPE65.

Detailed Description
-----------------
Leber Congenital Amaurosis (LCA) is a diagnosis for a group of severe, autosomal recessively inherited rod - cone dystrophies that typically result in complete visual loss in the third or fourth decade of life. One form, LCA2, is caused by a mutation in the gene encoding RPE56, an RPE-specific 65-kDa isomerase. Non-functional RPE65 results in photoreceptor cells that are unable to respond to light resulting in these patients being visually impaired. In preparation for human clinical trials, a detailed prospective phenotypic study will be undertaken to investigate the natural history of RPE65-LCA. Such a study will help identify suitable patients for therapeutic intervention. Furthermore through greater phenotyping an optimal window for intervention and specific parameters to help quantify effect and identify clinical end points may have been ascertained .

Official Title
-----------------
Natural History Study of Patients With Leber Congenital Amaurosis Associated With Mutations in RPE65

Conditions
-----------------
Leber Congenital Amaurosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with RPE65 associated retinal dystrophy Minimum subject age of 3 years Able to give consent/parent or guardian able to give consent Exclusion Criteria: Patients unable or unwilling to undertake consent or clinical testing Have received a gene therapy treatment in both eyes

Ages Eligible for Study
-----------------
Minimum Age: 3 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 |
| --- | --- | --- |
| Analysis of retinal structure and function | Retinal structure will be analysed using Adaptive optics and SD-OCT and Fundal autofluorescence. This will be correlated with assessment of visual acuity, psychophysical visual assessment, visual mobility, retinal sensitivity and visual fields | 6 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life Questionnaires | Assessment of Visual impairment using appropriate, validated questionnaires | 6 years | 
| Retinal Sensitivity | To be assessed in Microperimetry | 6 years | 
| Retinal Structural analysis | Retinal Structure analysis with Adaptive Optics | 6 years | 
| Fundal Autofluorescence | Presence or Absence | 6 years | 
| Assessment of Visual Fields | Assessment of Visual Fields with analysis of hill of vision | 6 years |
Clinical Pharmacology Study of MRA in Patient With Rheumatoid Arthritis (RA) With Renal Impairment

Study Overview
=================
Brief Summary
-----------------
This is an open-label, clinical pharmacology study to evaluate the safety and PK of MRA in patients with RA with Renal Impairment.

Official Title
-----------------
An Open-Label, Clinical Pharmacology Study to Evaluate the Safety and PK of MRA in Patients With RA With Renal Impairment

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: MRA(Tocilizumab)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Patients who are diagnosed with RA according to the 1987 ACR (American College of Rheumatology) classification criteria Patients with RA at least 6 months prior to enrollment Patients with a creatinine clearance not less than 10 mL/min but no higher than 80 mL/min Exclusion criteria Patients with Class IV Steinbrocker functional impairment at enrollment Patients who are undergoing dialysis Patients who have been treated for the underlying disease with a biological agent, such as infliximab or etanercept, and have been receiving treatment with leflunomide, within 12 weeks before treatment with the investigational product

Ages Eligible for Study
-----------------
Minimum Age: 20 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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MRA(Tocilizumab)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 20% improvement based on the ACR criteria compared with the baseline value. |  | throughout study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time courses taken from baseline values for DAS28, for ACR20%, 50%, and 70% improvement, and for each ACR core set variable. |  | Week 0, Week 4 |
The Effect of Oral Polymeric Diet Enriched With TGF-beta 2 (Modulen) on Clinical Response and Mucosal Healing in Adult Patients With Newly Diagnosed Crohn's Disease

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate prospectively a possible effect of an oral polymeric diet enriched with TGF-beta 2 (Modulen) as compared to Budesonide (one of the commonly accepted treatments for Crohn's disease) on clinical response, mucosal healing and intestinal microbiota in adult patients with newly diagnosed Crohn's disease using a capsule endoscopy.

Official Title
-----------------
The Effect of Oral Polymeric Diet Enriched With TGF-beta 2 (Modulen) on Clinical Response and Mucosal Healing in Adult Patients With Newly Diagnosed Crohn's Disease: a Prospective, Randomized Study

Conditions
-----------------
Crohn Disease

Intervention / Treatment
-----------------
* Dietary Supplement: Modulen
* Drug: Budesonide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosed Crohn's Disease Mild to moderate severity Exclusion Criteria: Patients who received systemic steroid or Budesonide or biological treatment Recent bowel surgery Colostomy, ileostomy Short bowel syndrome Obstructive symptoms Pregnancy, lactation Cardiac pacemaker or defibrillator Swallowing problems Uncontrolled metabolic diseases or any other condition that can be exacerbated by steroids

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Modulen Diet<br>Crohn patients will be given Modulen, an oral polymeric diet enriched with TGF-beta 2, along with a tailored diet | Dietary Supplement: Modulen<br>* Crohn patients will be given Modulen, an oral polymeric diet enriched with TGF-beta 2, along with a tailored diet<br>|
| Active Comparator: Budesonide Treatment<br>Crohn patients will be given Budesonide treatment | Drug: Budesonide<br>* Standard treatment for mild Crohn Disease patients<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of Modulen Diet | Patients will undergo capsular endoscopy before and after dietary intervention and mucosal healing will be accessed using standard Lewis Score. Outcome will be compared to efficacy of Budesonide treatment. | 8 weeks |
Auricular Acupuncture for The Treatment of Post-Tonsillectomy Pain

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to assess the role of battlefield acupuncture in the reduction of pain scores status post adult tonsillectomy. Secondary goals of this study include reduction in narcotic usage, decreased nausea and vomiting, and evaluating patient factors that lend an increased risk of worsening pain or improved response with acupuncture.

Official Title
-----------------
Auricular Acupuncture for The Treatment of Post-Tonsillectomy Pain

Conditions
-----------------
Recurrent Tonsillitis, Peritonsillar Abscess, Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Procedure: Auricular Acupuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any adult patient who meets criteria and is scheduled for tonsillectomy Exclusion Criteria: Any patient with prior use of acupuncture Individuals under age 18 Tonsillectomy performed with other surgical procedures, i.e UPPP, adenoidectomy, Patients with a known personal or family history of a bleeding disorder will be excluded. Patients with a history of kidney or liver problems will also be excluded. Patients found to be pregnant will be excluded from participation. Patients unwilling to enroll in the study will have the tonsillectomy with or without adenoidectomy performed according to current practice standards.

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Auricular Acupuncture<br>Use of auricular acupuncture in bilateral ears | Procedure: Auricular Acupuncture<br>* Application of auricular acupuncture to 5 points on the ear<br>|
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in VAS scores between experimental and control group |  | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tonsillectomy, Acupuncture
Effects of Brassica or Indole-3-carbinol on Prostatectomy Patients With PSA Recurrence

Study Overview
=================
Brief Summary
-----------------
Pilot and feasibility diet and phyto-agent intervention among healthy men at risk for prostate cancer progression.

Official Title
-----------------
Effects of Brassica or Indole-3-Carbinol on Prostatectomy Patients With PSA Recurrenc

Conditions
-----------------
Biochemical Failure

Intervention / Treatment
-----------------
* Dietary Supplement: brassica intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men with PSA recurrence following prostatectomy Exclusion Criteria: Not using exogenous hormones

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>one a day placebo | Dietary Supplement: brassica intervention<br>* diet and phyto-chemical intervention<br>|
| Experimental: 2<br>Brassica intake | Dietary Supplement: brassica intervention<br>* diet and phyto-chemical intervention<br>|
| Experimental: 3<br>indole-3-carbinol supplement | Dietary Supplement: brassica intervention<br>* diet and phyto-chemical intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in blood PSA levels |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| monitor for health events |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PSA, biochemical failure
Safety, Fatigue, and Continuity in the Intensive Care Unit (ICU)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to describe the features of continuity and quantify fatigue in three ICU resident work schedules, estimate the frequency of preventable adverse events, and inform the design and demonstrate the feasibility of a future multi-centre study.

Detailed Description
-----------------
The overall goal of our research is to describe the optimal scheduling pattern for frontline physicians working in ICUs. Our hypothesis is that call schedule associated reductions in fatigue are counterbalanced by reductions in continuity, resulting in no change in the safety of patients. This is a prospective before-after, two-centre study using a mixed-methods design. We will apply 3 work schedules, each for a period of 2 months over a 6 month period in the adult medical-surgical ICUs at two university affiliated hospitals in Toronto. In this mixed methods approach, quantitative and qualitative data will be collected concurrently, analysed separately, and their results compared, to produce an integrated interpretation of the impact of work schedule on the relationship between continuity and fatigue. This will evaluate healthcare continuity and fatigue, describe adverse events in ICUs, identify the two best resident schedules for subsequent comparison, and demonstrate the feasibility of a future multi-centre study of physician scheduling.

Official Title
-----------------
Safety, Fatigue, and Continuity in the ICU: a Pragmatic Mixed-methods Study

Conditions
-----------------
Fatigue

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All residents at participating ICUs starting a rotation in Fall 2008 Staff members supervising and/or working with participating residents Patients/family members under the care of the participating residents Patients admitted to participating ICUs Exclusion Criteria: Lack of informed consent
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 |
| --- | --- | --- |
| Fatigue |  | 6 months | 
| Continuity of patient care |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | 6 months | 
| Preventable adverse events |  | 6 months | 
| Feasibility |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Resident, Safety, Fatigue, Continuity, ICU
Investigation of Coagulation Parameters in Hereditary Haemorrhagic Telangiectasia

Study Overview
=================
Brief Summary
-----------------
We will address coagulation parameters in hereditary haemorrhagic telangiectasia (HHT) compared to controls.

Detailed Description
-----------------
The inherited disease hereditary haemorrhagic telangiectasia (HHT) causes bleeding from dilated fragile vessels, particularly in the nose and gut. However, many HHT patients develop deep venous thromboses and/or pulmonary embolism, necessitating treatments with anticoagulants that further impair control of their haemorrhagic state. Our initial observations using general coagulation tests suggest that the blood of HHT patients is intrinsically hypercoagulable. We hypothesize that the genetically-determined abnormality in the blood vessels of HHT patients leads to alteration in the concentrations or activity of one or several of the proteins which affect blood clotting leading to a hypercoagulable state. We propose to study levels and activity of blood coagulation factors in people with hereditary haemorrhagic telangiectasia and in normal volunteers. This should define the significance and basis for our initial observations, and will have significant implications for the clinical management of HHT patients.

Official Title
-----------------
Investigation of Coagulation Parameters in Hereditary Haemorrhagic

Conditions
-----------------
Telangiectasia, Hereditary Hemorrhagic

Intervention / Treatment
-----------------
* Other: Blood sample to be taken.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with HHT and normal controls Exclusion Criteria: Previous thrombosis, recent ill health
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 |
| --- | --- |
| HHT patients<br>Patients with hereditary haemorrhagic telangiectasia. Blood sample to be taken. | Other: Blood sample to be taken.<br>* Blood sample to be taken.<br>|
| Controls<br>People without hereditary haemorrhagic telangiectasia. Blood sample to be taken. | Other: Blood sample to be taken.<br>* Blood sample to be taken.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Effect of Drug Targeting Nebulization on Lung Deposition

Study Overview
=================
Brief Summary
-----------------
To compare deposition between two modalities of nebulization

Official Title
-----------------
Effect of Drug Targeting Nebulization on Lung Deposition

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Device: AKITA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Free of respiratory disease Exclusion Criteria: Smokers

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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: AKITA with program central deposition<br>Nebulization for central deposition | Device: AKITA<br> <br> |
| Active Comparator: AKITA with program for peripheral deposition<br>Nebulization for peripheral deposition | Device: AKITA<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung deposition by scintigraphy |  | After 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Regional deposition by scintigraphy |  | After 15 minutes |
Hepatitis B in Cystic Fibrosis and Latent Tuberculosis Respectively

Study Overview
=================
Brief Summary
-----------------
CF patients are at risk for hepatic disease. Vaccination is recommended to all CF patients according to European consensus. The aim of the study is to vaccinate as many patients as possible and to follow up whether immunization has been complete.

Detailed Description
-----------------
Initially, healthy volunteers will be vaccinated to be compared with patients' antibody response to hepatitis A and B vaccine. The connected part of this study is to vaccinate children suffering from latent tuberculosis against hepatitis B and to measure whether the immunization is related to specific interferon gamma response against Mycobacterium tuberculosis.

Official Title
-----------------
Hepatitis B in Cystic Fibrosis and Latent Tuberculosis Respectively

Conditions
-----------------
Cystic Fibrosis, Hepatitis A, Hepatitis B, Tuberculosis

Intervention / Treatment
-----------------
* Biological: Vaccination with vaccine against hepatitis A and B


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CF patients not previously immunized against hepatitis A or B Healthy volunteers not previously immunized against hepatitis A or B Age over 1 year Exclusion Criteria: Previously transplanted patients Previous vaccination with hepatitis vaccine Known allergy against components in Twinrix (TM)

Ages Eligible for Study
-----------------
Minimum Age: 1 Year

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cystic Fibrosis<br>Vaccination with Twinrix (TM), 3 doses within 6 months according to the manufacturer's instruction. The response will be studied in a time frame of 6 months. | Biological: Vaccination with vaccine against hepatitis A and B<br>* Vaccination against hepatitis A and B<br>* Other names: Twinrix (TM);|
| Active Comparator: Healthy volunteers<br>Vaccination with Twinrix (TM), 3 doses within 6 months according to the manufacturer's instruction. The response will be studied in a time frame of 6 months. | Biological: Vaccination with vaccine against hepatitis A and B<br>* Vaccination against hepatitis A and B<br>* Other names: Twinrix (TM);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive antibody response to vaccination with Twinrix(TM) in CF patients compared to healthy volunteers |  | 6 months for vaccination |