linjc16/ctgov huggingface dataset:
Colon Investigation - Factors Determining Choice of Procedure

Study Overview
=================
Brief Summary
-----------------
Registration of patients referred for colon investigation by barium enema, CT colonography and colonoscopy in two hospitals and one radiology centre in Telemark, Norway, for a period of minimum six months. Indications, delay and results of procedure will be recorded.Hypothesis: Choice of procedure for colon investigation is not based solely on clinical indication, but factors like delay, patient preference, lack of knowledge about the the procedures by the referring physician may have a decisive influence. The study will also analyse the correlation between patients symptoms, clinical findings and laboratory results and major pathology findings by colon investigation. Further, delay from patient´s first symptoms to finally diagnosis by colon investigation will also be registered and analysed.

Detailed Description
-----------------
see extensive protocol in Norwegian

Official Title
-----------------
Colon Investigation With Barium Enema, CT Colonography and Colonoscopy: A Prospective Registration of Indications, Delay and Procedure Results.

Conditions
-----------------
Irritable Colon, Colorectal Cancer, Inflammatory Bowel Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients referred to colon investigation Patients must be 18 years or older Exclusion Criteria: Patients not able to give a written consent

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 |
| --- | --- | --- |
| findings compared across investigation modes | Findings by one investigation compared to other | events by dec 2014 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delayed diagnosis of CRC | Waiting times depending on accessibility of diagnostic methods | events by dec 2014 |
Safety, Tolerability and Efficacy of MBS2320 in Patients With Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
Rheumatoid arthritis (RA) affects 1 percent of the population worldwide and up to 40 percent of patients don't respond to current treatments. MBS2320, the drug being tested in this trial, represents a new approach to treating RA, with the potential not only to reduce levels of inflammation but to also directly prevent bone damage.The aim of this project is to test the safety, tolerability and efficacy of MBS2320 in patients with RA in combination with an existing treatment, methotrexate.

Detailed Description
-----------------
Rheumatoid Arthritis is a chronic autoimmune disease characterised by synovial inflammation and cartilage and bone degradation, leading to joint destruction and progressive disability. The aim of the study is to evaluate the safety and tolerability of MBS2320 in patients with RA following chronic administration. In addition, the study aims to evaluate the effects of MBS2320 on measures of disease activity.

Official Title
-----------------
A 12-Week, Double-Blind, Placebo-Controlled, Phase 2a Study to Investigate the Safety, Tolerability and Efficacy of MBS2320 in Patients With Active Rheumatoid Arthritis Receiving Methotrexate

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

Intervention / Treatment
-----------------
* Drug: MBS2320
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients of childbearing or non-childbearing potential with with active RA, receiving stable once-weekly methotrexate between 18 and 75 years of age, inclusive. Exclusion Criteria: Patients who are currently pregnant or breastfeeding. Patients who are being treated with biological or non-biological disease-modifying anti-rheumatic drug therapy. Patients with a history of any other inflammatory or arthritic disease in addition to RA that may interfere with the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MBS2320<br> | Drug: MBS2320<br>* As described in the arm descriptions<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* As described in the arm descriptions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment-emergent adverse events (safety and tolerability) | Incidence of all grade adverse events | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Activity Score 28 (DAS28) | Disease Activity Score according to the EULAR response criteria | 12 weeks |
A Follow up Safety Study of Patients Who Participated in Previous Studies of the Drug Org 24448 (Study P05719)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
This is a safety study evaluating the subjects who participated in previous Organon trials of the drug Org 24448. Patients will undergo a Screening visit, 1 or 2 Evaluation visits, and a possible Follow-Up period. During the visits, study tests, including echocardiograms, will be performed to summarize cardiac functioning.

Detailed Description
-----------------
All subjects who participated in previous Org 24448 trials and who do not meet any of the exclusion criteria are eligible.

Official Title
-----------------
A Multi-center Cardiac Safety Study of Subjects Who Participated in Organon Sponsored Phase 1 and Phase 2 Completed and Discontinued Trials With Org 24448

Conditions
-----------------
Psychosis

Intervention / Treatment
-----------------
* Drug: SCH 900460


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must: be verified by the investigator to have participated in a previous Organon sponsored Org 24448 trial. sign an affirmative informed consent before evaluations are conducted; Exclusion Criteria: Subjects must not have: a concurrent acute condition that could interfere with the conduct or interpretation of the evaluations (e.g. acute psychosis; respiratory illness; current experimental medications). If possible, evaluation of such subjects is deferred until resolution of such conditions.
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 |
| --- | --- |
| 1<br>Subjects who participated in previous Org 24448 trials | Drug: SCH 900460<br>* Subjects who participated in previous trials of Org 24448 (SCH 900460)<br>* Other names: Org 24448;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall cardiac function by cardiologist evaluation including echocardiogram. |  | During the Evaluation Period (Visit 1 or 2 and 3 if applicable). |
Efficacy and Safety of Oral BT-11 in Moderate to Severe Crohn's Disease

Study Overview
=================
Brief Summary
-----------------
This is a phase 2 randomized, placebo-controlled, double-blind, parallel-group multicenter induction study.

Official Title
-----------------
A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Moderate to Severe Crohn's Disease

Conditions
-----------------
Crohn's Disease

Intervention / Treatment
-----------------
* Drug: BT-11 880 mg
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Subjects aged 18 to 75 years with a diagnosis of CD for at least 3 months; Moderately to severely active CD as defined by: a CDAI score of 220 450, and an SES-CD scored ≥ 6 ( ≥ 4 for isolated ileitis) (centrally read); Key exclusion criteria: Ulcerative colitis; Known current bacterial or parasitic pathogenic enteric infection; live virus vaccination within 12 weeks of screening.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a phase 2 randomized, placebo-controlled, double-blind, parallel-group multicenter induction study. The purpose of this study is to evaluate the efficacy and safety of oral BT-11 induction compared to placebo in subjects with moderate to severe CD. Approximately 100 sites will participate from Europe and the USA. A total of 150 subjects with moderate to severe CD (CDAI Score 220-450 and a Simplified Endoscopic Index of Severity of Crohn's Disease (SES-CD) SCORED ≥ 6 (≥ 4 for isolated ileitis) will be randomized in a 1:1 ratio to receive BT-11 1,000 mg or placebo. Each of the treatment arms will comprise 75 subjects. The randomization will be stratified by prior exposure to biologic therapy for CD (yes/no) and corticosteroid use at baseline (yes/no). The study consists of a 28-day screening period, a 12-week induction phase, and a 2-week post-treatment safety follow-up period.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BT-11 880 mg<br>Oral once daily tablet | Drug: BT-11 880 mg<br>* Oral once daily tablet<br>|
| Placebo Comparator: Placebo<br>Oral once daily tablet | Drug: Placebo<br>* Oral once daily tablet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Remission Rate | Clinical remission defined by CDAI score <150. | 12 weeks |
Tamsulosin Phase III Clinical Trial -Double-Blind, Placebo Controlled Study in Male Patients With Lower Urinary Tract Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether Tamusulosin is effective in the treatment of lower urinary tract syndrome with male patients.

Conditions
-----------------
Urinary Tract Diseases

Intervention / Treatment
-----------------
* Drug: Tamusulosin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with urination disorder not accompanied by apparent organic or neurologic abnormality(lower urinary tract syndrome: LUTs). Exclusion Criteria: Patients with urination disorder accompanied by apparent organic(benign prostatic hyperplasia: BPH) or neurologic abnormality, active urinary tract infections, severe cardiovascular, hepatic and/or kidney complications.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 Years

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

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

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

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tamsulosin, urinary tract diseases, male
Expression of VEGF-C and VEGF-CR in Oral Cancers and Premalignant Lesions

Study Overview
=================
Brief Summary
-----------------
The role of vascular endothelial growth factor-C (VEGF-C) and its receptors induced lymphangiogenesis and host inflammatory responses on the carcinogenesis of oral cancers and premalignant lesions

Detailed Description
-----------------
The role of vascular endothelial growth factor-C (VEGF-C) and its receptors induced lymphangiogenesis and host inflammatory responses on the carcinogenesis of oral cancers and premalignant lesions

Official Title
-----------------
The Role of Vascular Endothelial Growth Factor-C (VEGF-C) and Its Receptors Induced Lymphangiogenesis on the Carcinogenesis of Oral Cancers and Premalignant Lesions

Conditions
-----------------
Oral Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: oral cancer and oral precancer specimens Exclusion Criteria: other diseases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vascular endothelial growth factor-C, VEGF-CR, lymphangiogenesis, host inflammatory responses, oral carcinogenesis, oral cancers, oral premalignant lesions
A Dose Evaluation Study for the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension or Open-Angle Glaucoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy, safety and duration of the L-PPDS (latanoprost punctal plug delivery system) at different dose levels.

Official Title
-----------------
PPL GLAU 12: A Phase 2 Dose Evaluation Study for the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension (OH) or Open-Angle Glaucoma (OAG)

Conditions
-----------------
Glaucoma, Ocular Hypertension (OH)

Intervention / Treatment
-----------------
* Drug: Latanoprost-PPDS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female at least 18 years old Diagnosis of bilateral open angle glaucoma or ocular hypertension Unmedicated IOP must be ≥22mm Hg Exclusion Criteria: Any significant vision loss in the last year No contact lens use for the length of the study Abnormal eye lids, eye infection, or diseases to the eye Recent eye surgery Uncontrolled medication conditions

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

| Intervention/Treatment |
| --- |
|Drug: Latanoprost-PPDS|Sustained delivery for 12 weeks|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IOP change from baseline |  | 12 weeks to baseline |
Balance Impairment and Falls Risk in People With Lower Limb Arthritis, and Can These be Improved With Exercise?

Study Overview
=================
Brief Summary
-----------------
Arthritis has been reported as a risk factor for falls. Few studies have investigated the effect of balance training on balance performance in women with lower limb arthritis. The aim of this study was to evaluate the effectiveness of a four-month individualised home exercise programme in improving gait stability and balance for women with arthritis.

Official Title
-----------------
Which Measures of Balance Best Discriminate Balance Impairment and Falls Risk in People With Lower Limb Arthritis, and Can These be Improved With Exercise?

Conditions
-----------------
Arthritis

Intervention / Treatment
-----------------
* Behavioral: Balance Exercises


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Lower limb osteoarthritis or lower limb rheumatoid arthritis Exclusion Criteria: Participants were excluded if they: Did not have lower limb arthritis, Were bed bound, Had additional co-morbidities that confer risk of falls (such as Parkinson's disease, stroke, multiple sclerosis, history of cardiac syncope, epilepsy), Had undergone lower limb surgery within the previous twelve months, and/or Had synvisc or a corticosteroid injection within the last six months.
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Balance Exercises|Home based balance exercises based on Otago Exercise programme|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Falls Risk Human Activity Profile Confidence Balance Measures Gait Measures |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Arthritis, Exercise, Balance - Postural Control
Tofacitinib Versus Methotrexate as the First Line DMARD in the Treatment of Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
It is a randomized controlled study

Detailed Description
-----------------
Randomization controlled study on Rheumatoid arthritis patients whos disease activity is high, controlled subjects will be given methotrexate and study subjects will get tofacitinib

Official Title
-----------------
Tofacitinib Versus Methotrexate as the First Line DMARD in the Treatment of Rheumatoid Arthritis

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

Intervention / Treatment
-----------------
* Drug: Methotrexate
* Drug: Tofacitinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:1. age greater than 18 years 2. patients fulfill the ACR-EULAR classification criteria for RA 3.DAS-28 CRP more than 5.1 - Exclusion Criteria: systemic infection hemoglobin less than 9 mg/dl WBC <4000, neutrophil <1000, platelet <100000/mm live vaccine within 3 months GFR < 50 ml/min ALT > 2 times ULN pregnancy

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
Interventional Model Description: open label Randomization controlled clinical study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group A<br>group A is a control arm who will get conventional drug (methotrexate). 25 mg subcutaneous weekly . at 3 months if DAS-28 not fall by at least 1.2, drug is to be changed and regarded as therapy failure. if at least 1.2 improvement of DAS-28 occur,then therapy is continued for 6 monyhs | Drug: Methotrexate<br>* Methotrexate 25 mg subcutaneous is given in group A<br>* Other names: injection trexonate;|
| Experimental: group B<br>group B will get tofacitinib 10 mg weekly. if DAS-28 not improved at least 1.2 at 3 months, it is regarded as therapy failure. if improved at least 1.2, then therapy continued for 6 months | Drug: Tofacitinib<br>* tofacitinib 10 mg given in group B<br>* Other names: tofacit;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DAS-28 CRP at 6 month | disease activity score in 28 joints has to measured at 6 months | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SDAI at 6 months | simplified disease activity index at 6 months | 6 months | 
| HAQ-DI at 6 months | health assesment by HAQ-DI at 6 months | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rheumatoid arthritis tofacitinib methotrexate
Evaluation of Wear Experience With a Daily Disposable Contact Lens

Study Overview
=================
Brief Summary
-----------------
To evaluate the wear experience of current two-week contact lens wearers after they have been fit into a daily disposable contact lens. This is a single arm, non-comparative study.

Detailed Description
-----------------
This is a single arm, non-comparative study. All participants were habitual lens wearers of the same brand of lenses, and were re-fit with the study lenses.

Official Title
-----------------
Evaluation of Wear Experience With PRECISION1® Contact Lenses in Previous Acuvue® Oasys® Lens Wearers

Conditions
-----------------
Contact Lens

Intervention / Treatment
-----------------
* Device: Daily Disposable Contact Lens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be current Acuvue® Oasys® spherical contact lens wearers. Distance visual acuity of 20/25 or better with current contact lenses. Good general health (defined by medication use that has not changed within the last month and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the PI). Ability to give informed consent. Willing to spend time for the study, which includes attending two study visits and wearing contact lenses on days between study visits. Either gender. Any racial or ethnic origin. Exclusion Criteria: No current ocular inflammation or infection. Not currently pregnant or lactating.

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
Intervention Model: Single Group Assignment
Interventional Model Description: This is a single arm, non-comparative study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All study participants<br>All subjects are fit into daily disposable contact lenses after wearing their optimized habitual contact lenses for   1 week. Subjects are requested to wear the lenses for two weeks, for a minimum of at least 6 hours per day for 10 days. | Device: Daily Disposable Contact Lens<br>* Soft, daily disposable spherical contact lens used to correct distance vision.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contact Lens Dry Eye Questionnaire (CLDEQ-8) Survey | Participants complete the Contact Lens Dry Eye Questionnaire (CLDEQ-8) survey. This is an 8 question survey assesses symptoms while wearing contact lenses with possible scores from 0 (no symptoms) to 37 (maximum symptoms). Higher scores indicate worsening symptoms of dry eye while wearing lenses. | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Daily Disposable Contact Lens, Soft Contact Lens, Spherical Contact Lens