linjc16/ctgov huggingface dataset:
Comparison of Pain Sensation During Single Use of Two Topical Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

Study Overview
=================
Brief Summary
-----------------
Different case reports are showing that depending on the drug used for eye drops, it might provoke a painful sensation. Actually two leading NSAIDs are used in ophthalmology. This study is intended to provide information about this parameter concerning these two drugs.

Official Title
-----------------
Phase 4 Study of Topical NSAID for Ophthalmologic Use: Pain Measurement After First Drop.

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: Nevanac
* Drug: Acular LS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient over 21 years old No ocular surface pathology Eligible for cataract surgery Exclusion Criteria: Any other eye pathology other than cataract

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nevanac<br> | Drug: Nevanac<br>* 1 drop of NEVANAC at random eye<br>|
| Active Comparator: Acular LS<br> | Drug: Acular LS<br>* One drop of Acular LS<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain after instilation |  | 5 min | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pain, Pain after eyedrops
Impact of Rheumatoid Arthritis on the Course of Type 2 Diabetes During a Longitudinal Follow-up of 5 Years

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether patients with rheumatoid arthritis and type 2 diabetes experience a more severe disease course compared to control patients with osteoarthritis and type 2 diabetes

Official Title
-----------------
Impact of Rheumatoid Arthritis on Type 2 Diabetes Mellitus

Conditions
-----------------
Type 2 Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients Adults (>18 years) Rheumatoid arthritis fulfilling American College of Rheumatology (ACR )1987 or European League Against Rheumatism (ACR/EULAR) 2010 classification criteria Type 2 diabetes (HbA1c ≥6.5% OR fasting glycemia≥7 mmol/l OR glycemia 120 min after 75 mg glucose ingestion ≥ 11.1 mmol/l OR symptoms of hyperglycemia with glycemia ≥11.1 mmol/l) Affiliated to social security system Controls Adults (>18 years) matched for age, sex and BMI with patients with rheumatoid arthritis Osteoarthritis (knee, hip, spine and hand) Type 2 diabetes with disease duration matched with patients with rheumatoid arthritis Affiliated to social security system Exclusion Criteria: Patient not able to understand study implication and rules Patient opposed to participate to the study Transient diabetes Gestational diabetes Secondary diabetes

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| rheumatoid arthritis and type 2 diabetes<br> | |
| osteoarthritis and type 2 diabetes<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to the addition of a new treatment for type 2 diabetes in months | addition of a new treatment includes insulin requirement | five years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycated haemoglobin (HbA1c) levels in % |  | two years | 
| Insulin resistance (HOMA-IR), absolute value |  | two years | 
| Proportion of patients requesting insulin in % |  | two years | 
| Proportion of patients with type 2 diabetes-related acute complications in % |  | two years | 
| Proportion of patients requiring the addition of a new treatment for type 2 diabetes in % |  | five years | 
| Proportion of patients with increased glycated haemoglobin (HbA1c) levels between 2 visits in % |  | five years | 
| Proportion of patients with increased HOMA-IR between 2 visits in % |  | five years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
type 2 diabetes mellitus, Rheumatoid arthritis
Follow-up Study of the RAI-Treated Hyperthyroid Patients

Study Overview
=================
Brief Summary
-----------------
Previous studies of hyperthyroid patients suggest that they remain at increased risk of cardiovascular morbidity after restoring euthyroidism. The study objective is to compare the rate and causes of hospitalization of hyperthyroid patients treated with radioactive iodine (RAI) with those of an age- and gender-matched reference population in a long-term follow-up study.

Detailed Description
-----------------
A population-based cohort study was conducted among 2611 hyperthyroid patients treated with RAI between 1969 and 2002 in Tampere University Hospital, and among 2611 reference subjects. A reference group was randomly selected, with an age- and gender-matched control subject identified for each patient from the Population Register Centre. The control subject had to be alive at the time when the patient received the first RAI treatment. The causes of hospitalization as well as the diagnosis and date of hospital admission were obtained from the nationwide Hospital Discharge Register (HILMO) maintained by the Research and Development Centre for Welfare and Health (STAKES) using a computerized record linkage, with the personal identification number as the key. The HILMO database covers all dates and causes of hospitalization (hospital admission requiring an overnight stay) of the Finnish citizens since January 1969. New events were analyzed as the main outcome, including only the first hospitalization due to a given indication. The special focus was on the cardiovascular morbidity.

Official Title
-----------------
Follow-up Study of Hyperthyroid Patients Treated With RAI in 1965-2002: Morbidity in Long-Term Follow-up

Conditions
-----------------
Hyperthyroidism, Cardiovascular Diseases, Atrial Fibrillation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients: Radioiodine treatment for hyperthyroidism given in the Tampere University Hospital between January 1969 and June 2002 Controls: age- and gender-matched control subject identified for each patient from the Population Register Centre. The control subject had to be alive at the time when the patient received the first RAI treatment
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
-----------------
Radioiodine, Hyperthyroidism, Morbidity, Cardiovascular diseases
PRognOstiC valuE of rEd Density in Ulcerative Colitis

Study Overview
=================
Brief Summary
-----------------
Observational prospective multicenter study: baseline assessement of the disease activity by an automated endoscopic tool and follow up of 52 weeks to evaluate sustained clinical remission.

Official Title
-----------------
PRognOstiC valuE of rEd Density in Ulcerative Colitis: PROCEED-UC STUDY

Conditions
-----------------
Ulcerative Colitis

Intervention / Treatment
-----------------
* Diagnostic Test: Red Density


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed diagnosis of UC for at least 3 months Clinical remission with SCCAI <3 at baseline and stable remission for the last 3 months Ability to give informed consent by the patient or legal representative in case of minority. Exclusion Criteria: Any contraindication for sigmoidoscopy or undergoing biopsies of the rectosigmoid. Uncontrolled coagulopathy. Any planned change in UC related treatment (both escalation and de-escalation) after the baseline endoscopy Planned UC related surgery Previous subtotal or total colectomy Short bowel, ileostomy or colostomy Pregnancy at baseline Age younger than 16 years

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- |
| Ulcerative colitis in clinical remission<br>Clinical remission with SCCAI <3 at baseline and stable remission for the last 3 months | Diagnostic Test: Red Density<br>* Image analysis of endoscopic images in patients with ulcerative colitis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sustained clinical remission | Number of patients with sustained clinical remission at week 52, defined as simple clinical colitis activity index (SCCAI) <3 AND no need for initiation of new treatment, escalation of therapy, UC related hospitalization or colectomy correlated to the RD score at baseline. | week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| endoscopic remission Mayo | Number of patients with Mayo endoscopic subscore of 0 after 52 weeks correlated to the RD score at baseline. | week 52 | 
| endoscopic remission UCEIS | Number of patients with UCEIS of 0 after 52 weeks correlated to the RD score at baseline. | week 52 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endoscopy, Artificial intelligence, Image analysis, Precision medicine, Inflammatory bowel disease
Study of a New Anticoagulant Drug in Patients With Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study (CLN-504) is to determine the safety and develop a dosing regimen of an investigational anticoagulant drug (ATI-5923) in patients with atrial fibrillation.

Detailed Description
-----------------
ATI-5923 is a structural analog of warfarin that is being developed as an oral anticoagulant. It has a similar pharmacological profile to warfarin but was designed to provide more uniform and stable anticoagulation. ATI-5923 is a selective, non-competitive inhibitor of vitamin K epoxide reductase. ATI-5923 is metabolized by esterase to a single inactive metabolite and thus is expected to have less variable metabolism, drug-drug interactions and reduced instances of under/over coagulation, making the response safer and more predictable. The primary purpose of this study is to develop a dosing regimen and INR monitoring schedule that can be applied in an outpatient setting to safely and conveniently anticoagulate patients with atrial fibrillation to a therapeutic INR. Patients with atrial fibrillation (AF) were chosen for the study population of this trial because they require anticoagulation if they have risk factors for stroke.

Official Title
-----------------
An Open-Label Multi-Center Study of ATI-5923 for Anticoagulation in Patients With Atrial Fibrillation

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Drug: ATI-5923


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented atrial fibrillation Candidate for anticoagulation or currently receiving warfarin at screening Males or females greater than 18 years of age Males or females with a CHADS2 score of 0 to 2 Exclusion Criteria: Contraindications to anticoagulation e.g., active bleeding Taking other anticoagulant or antiplatelet agents other than low-dose aspirin History of myocardial infarction, acute coronary syndrome, or coronary revascularization procedure within the past 3 months prior to Day 1 History of laboratory values suggestive of anemia (i.e., Hb <10 gm/dL) Women of childbearing potential

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: ATI-5923|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| INR, Coagulation Factors II, VII, IX and X. Safety Measures: ECG, Laboratory and Adverse Events |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atrial fibrillation, Anticoagulation
Proper Dosage of Ketamine in Intravenous Regional Anesthesia

Study Overview
=================
Brief Summary
-----------------
Ketamine added to Lidocaine can increase duration of pain relief following intraveonous regional anesthesia (IVRA). The purpose of this dose response study is to determine the minimum effective dosage of intravenous Ketamine, added to 3 mg/kg of Lidocaine. We anticipate that one dosage will provide us with the proper balance between sufficient anesthesia and minimal side effects.

Official Title
-----------------
Proper Dosage of Intravenous Ketamine When Used as an Adjuvant to Lidocaine in Intravenous Regional Anesthesia (IVRA).

Conditions
-----------------
Pain.

Intervention / Treatment
-----------------
* Drug: Different dosages of Ketamine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 18-70 Weight: 50-100 kg ASA: I, II, III Carpal tunnel syndrome surgery, tenolysis, ganglion removal or any peripheral hand surgery that can be done by IVRA. Exclusion Criteria: Contraindication to IVRA such as sickle cell disease. Any known hypersensitivity reaction to Ketamine. History of chronic pain or regular medication with analgesics. History of opioid dependence. Drug of alcohol abuse. Psychiatric disorder. Allergy to acetaminophen or codeine

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: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Different dosages of Ketamine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Renal Function Post Cardioversion for Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
Atrial fibrillation is a common arrhythmia which requires electrical cardioversion in many patients in order to regain sinus rhythm. In a previous retrospective study a complication of acute renal failure was found in 17% of the patients after cardioversion.(The incidence and prognosis of renal dysfunction following cardioversion of atrial fibrillation. Helman Y,...Gilon D et al:Cardiology 2013;124(3);184-9.) Another complication previously described after cardioversion is pulmonary edema. In this prospective study the investigators aim to evaluate the risk of acute renal failure post cardioversion. In addition the investigators would like to evaluate hemodynamic changes, fluid balance and sodium levels in patients post cardioversion as a potential mechanism for both acute renal failure and pulmonary edema post cardioversion. In order to assess hemodynamic changes the investigators will use a non-invasive FDA approved device called NICaS (Non-Invasive Cardiac System). This system calculates cardiac output, cardiac index and peripheral vascular resistance in a non-invasive, fast and accurate way.

Official Title
-----------------
Evaluation of Renal Function and Fluid Balance of Patient Undergoing Electrical Cardioversion for Atrial Fibrillation

Conditions
-----------------
Atrial Fibrillation, Renal Insufficiency, Cardioversion

Intervention / Treatment
-----------------
* Other: Electrical atrial fibrillation Cardioversion
* Other: Cardioversion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with new onset atrial fibrillation Exclusion Criteria: Pregnant

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational<br>All comers with Atrial fibrillation | Other: Electrical atrial fibrillation Cardioversion<br>* Electrical cardioversion for patients admitted for Atrial Fibrillation<br>* Other names: Cardioversion;Other: Cardioversion<br>* Electrical cardioversion for patients admitted for Atrial Fibrillation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal dysfunction | Creatinine Clearance less 25 percent. | Short term - One month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Death | One year |
Medical and Surgical Treatment of Esophageal Reflux

Study Overview
=================
Brief Summary
-----------------
The purpose of this project is to lay the groundwork for a proposed clinical trial to compare the effectiveness of two approaches to gastroesophageal reflux disease: treatment with medications and treatment with anti-reflux surgery. This project includes a non-interventional pilot study to test ways of measuring outcomes of treatment, and to gauge potential participants' willingness to enroll in the proposed clinical trial.

Conditions
-----------------
Gastroesophageal Reflux

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: age 18-80 diagnosis of gastroesophageal reflux disease have taken proton pump inhibitor medications Exclusion criteria: prior esophageal surgery other serious medical conditions

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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
-----------------
Esophageal, Reflux
A Randomized Trial of Buccal Compared to Oral Misoprostol Following Mifepristone for Medical Abortion up to 63 Days LMP

Study Overview
=================
Brief Summary
-----------------
This open-label, randomized study will compare the efficacy, safety, and acceptability of mifepristone 200 mg followed in 24-36 hours either by buccal (i.e., in the cheeks) or oral misoprostol 800 mcg for termination of pregnancy in women up to 63 days L.M.P.

Conditions
-----------------
Abortion, Induced

Intervention / Treatment
-----------------
* Drug: 800 mcg misoprostol via oral or buccal administration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: be willing and able to sign consent forms; be eligible for medical abortion according to clinician's assessment; be willing to undergo a surgical completion if necessary; have ready and easy access to a telephone and emergency transportation; speak English, Spanish, or have a translator available to translate for all study procedures; and, agree to comply with the study procedures and visit schedule. Exclusion Criteria: Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass; IUD in place; Chronic renal failure; Concurrent long-term corticosteroid therapy; History of allergy to mifepristone, misoprostol or other prostaglandin; Hemorrhagic disorders or concurrent anticoagulant therapy; Inherited porphyrias; or Other serious physical or mental health conditions.

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: 800 mcg misoprostol via oral or buccal administration|nan|

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

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

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
medical abortion, mifepristone, misoprostol, buccal administration