linjc16/ctgov huggingface dataset:
Dispervise Ophthalmic Viscoelastic as an Agent to Ensure Watertight Wound Closure After Clear Corneal Cataract Incisions

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to look at the ability of Viscoat to ensure proper wound closure.

Official Title
-----------------
Dispervise Ophthalmic Viscoelastic as an Agent to Ensure Watertight Wound Closure After Clear Corneal Cataract Incisions

Conditions
-----------------
Cataracts

Intervention / Treatment
-----------------
* Drug: Viscoat
* Drug: Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ability to provide informed consent, complete questionnaires, and likely to complete all visits Subject must be male or female, of any race, and at least 21 years old Undergoing uncomplicated cataract surgery with clear corneal incisions Exclusion Criteria: Subjects with known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course Acute or chronic disease or illness that would increase risk or confound study results (e.g., uncontrolled diabetes mellitus, immunocompromised,etc.) Uncontrolled systemic disease Corneal abnormalities (e.g., stromal, epithelial or endothelial dystrophies) Subjects who use concurrent topical or systemic medications that may impair healing, including but not limited to:antimetabolites,isotretinoin (Accutane) within 6 months of treatment, and amiodarone hydrochloride (Cordarone) within 12 months of treatment Subjects with a history of any of the following medical conditions, or any other condition that could affect wound healing: collagen vascular disease, autoimmune disease, immunodeficiency diseases, ocular herpes zoster or simplex, endocrine disorders (including but not limited to unstable thyroid disorders and diabetes), lupus, and rheumatoid arthritis Concurrent participation or participation in the last 30 days in any other clinical trial

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- |
| Experimental: Saline<br>One group will receive Saline to irrigate the wound | Drug: Saline<br>* One group will receive Saline to irrigate the wound<br>|
| Experimental: Viscoat<br>One group will receive Viscoat to close the surgical wound | Drug: Viscoat<br>* One group will receive Viscoat for incision closure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ensure watertight, patient wound closure after clear corneal cataract incisions |  | 1 year |
Comparison of Anesthetic Modalities on Hemodynamic Stability and Postoperative Pain in Diabetic Foot Patients Undergoing Minor Lower Extremity Amputation

Study Overview
=================
Brief Summary
-----------------
Diabetic foot ulcer is the most common cause of non traumatic lower extremity amputations (LEA) associated with diabetes. Traditionally general and spinal anesthesia were the preferred modality of anesthesia. The use of sciatic nerve block has recently gained popularity, however, without the supporting evidence of any benefits. This study was to evaluate the comparison of anesthesia modalities for hemodynamic stability and postoperative pain in diabetic foot patients undergoing minor LEA.

Conditions
-----------------
Diabetic Foot Ulcer, Lower Extremity Amputation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diabetic foot patients who underwent minor LEA Exclusion Criteria: emergency cases patients who underwent major upper or lower extremity amputations patients who received general anesthesia following fail regional or spinal anesthesia patients who underwent LEA within 1year, and patients who underwent other concomitant surgeries

Ages Eligible for Study
-----------------
Minimum Age: 29 Years
Maximum Age: 88 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 |
| --- | --- |
| Group A<br>patients undergo general anesthesia | |
| Group B<br>spinal anesthesia | |
| Group C<br>ultrasound-guided sciatic nerve block | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean blood pressure |  | every ten minutes from preinduction to 30minutes after sugery | 
| Mean blood pressure |  | from arrival at recovery room until 20miutes after surgery at recovery room | 
| Heart rate |  | every ten minutes from preinduction to 30minutes after sugery | 
| Heart rate |  | from arrival at recovery room until 20miutes after surgery at recovery room | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
patients
Hormonal Effects on Pain Perception

Study Overview
=================
Brief Summary
-----------------
To investigate if labor pain is affected by mother's hormone levels. The hormonal effects of pregnancy are well documented. Although differences in pain sensitivity between women and men are partly attributable to social conditioning and to psychosocial factors, many laboratory studies of humans have described sex differences in sensitivity to noxious stimuli, suggesting that biological mechanisms underlie such differences. Some animal studies have suggested that sensitivity to pain decreases during pregnancy because of the progressive activation of endogenous pain inhibitory systems. This effect may be mediated by pregnancy-associated hormones, in particular progesterone.

Official Title
-----------------
Hormonal Effects on Pain Perception

Conditions
-----------------
Pregnancy, Progesterone Levels, Pregnancy Associated Analgesia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy pregnant women at term (>37GA) Exclusion Criteria: chronic pain regular analgesic medication severe cardiopulmonary problems very difficult intravenous access advanced labor precipitous delivery

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Term pregnant women<br>Healthy women scheduled for elective Cesarean section. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in heat pain threshold and tolerance |  | 1 month |
Continued Use of Effective Contraception After Use of Emergency Contraception

Study Overview
=================
Brief Summary
-----------------
Women using an emergency contraceptive method must use back up protection for 1-2 weeks depending on method. The Copper-IUD is the most effective emergency contraceptive method. The investigators wish to explore if women choosing the Cooper IUD have a higher frequency of use of an effective contraceptive method 3 months and 6 months after the use of an emergency contraceptive method than women who choose to use the emergency contraceptive pill EllaOne (ulipristal acetate).

Conditions
-----------------
Emergency Contraception, Contraception, Reproductive Health

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women over 18 years eligible for all emergency contraception Exclusion Criteria: previous conisation known stenosis of the cervix signs of ongoing genital infection known uterine anomaly Known bleeding disorder

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ulipristal acetate<br>Women choosing EllaOne as emergency contraception | |
| Copper IUD<br>Women choosing copper IUD as emergency contraception | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of an effective contraceptive method | Use of pill, patch, ring, IUD, IUS, or injection 6 months after use of emergency contraceptive method | 6 months after emergency contraceptive use |
Health Promotion in the Elderly--Prevention of Cardiovascular Disorders

Study Overview
=================
Brief Summary
-----------------
To develop an epidemiologic model to estimate the benefits, costs and risks of disease prevention in the elderly.

Detailed Description
-----------------
DESIGN NARRATIVE: The investigators extended work they had done in modeling the health benefit of reducing risk factors for cardiovascular disease. Their new model incorporating risks of importance in the elderly, including cerebrovascular disease, estimated both morbidity and mortality averted by risk reduction, and estimated the costs and risks of the interventions used to modify risk factors. The model was designed for the counseling of elderly individuals free of cardiovascular disease, and evaluated strategies for remaining disease free. It was implemented as software running on personal computers, and marketed to physicians and other health professionals who advised the elderly on medical issues. Accompanying documentation was also developed to explain the assumptions and non-quantifiable aspects of the decision to adopt major lifestyle changes to reduce risk. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Cerebrovascular Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 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 |
| --- | --- | --- |
Community-Based Interventions for Infant Health in Nepal

Study Overview
=================
Brief Summary
-----------------
An Evaluation of the Cost-Effectiveness of Community-Based Participatory Interventions for Pregnant Women in Nepal to Reduce Fetal & Infant Mortality and to Improve Fetal Growth & Cognitive Development in Infancy

Official Title
-----------------
An Evaluation of the Cost-Effectiveness of Community-Based Participatory Interventions for Pregnant Women in Nepal to Reduce Fetal and Infant Mortality, and to Improve Fetal Growth and Cognitive Development in Infancy.

Conditions
-----------------
Child Mortality

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: mothers, community health volunteers Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Methotrexate|Methotrexate|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neonatal mortality rates |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Child mortality, Nepal, Community, care practices
GDF-15 Levels in Risk Stratification in Acute Pulmonary Embolism

Study Overview
=================
Brief Summary
-----------------
Prospective observational study evaluating serum GDF-15 levels in patients with acute pulmonary embolism.

Detailed Description
-----------------
Prospective observational study evaluating serum GDF-15 levels in patients with acute pulmonary embolism (APE). In APE right ventricle failure developing due to ischemia and myocarditis is considered the primary cause of death, however, its pathomechanism has not been fully established yet. Growth differentiation factor 15 (GDF-15) is a chemokine secreted by activated macrophages in response to oxidative stress. It has now been shown that ischemic injury, mechanical stretch, and pro-inflammatory cytokines also stimulate the expression of GDF-15 in cardiac myocytes. The objective of this project is to describe the role of GDF-15 in the pathomechanism of acute right ventricle failure in the setting of acute pulmonary embolism and to verify the hypothesis that higher serum concentrations of GDF-15 are associated with more advanced right ventricle dysfunction and failure.

Official Title
-----------------
GDF-15 Levels in Risk Stratification in Acute Pulmonary Embolism

Conditions
-----------------
Pulmonary Embolism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients with APE hospitalized who give written consent. Exclusion Criteria: lack of informed consent APE with symptoms lasting above 14 days before the admission acute coronary syndrome, diagnosed pulmonary hypertension severe valve disease sepsis active malignancy diagnosed mitochondrial diseases chronic kidney disease at least stage 4 (KDIGO) 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| APE with RVD<br>RVD (right ventricle disfunction) defined according to ESC (European Society of Cardiology) criteria | |
| APE without RVD<br>RVD defined according to ESC criteria | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hemodynamic deterioration | Hemodynamic deterioration defined according to ESC criteria as: change in blood pressure defined as: drop in systolic arterial blood pressure < 90 mmHg or at least 40 mmHg, lasting ≤ than 15 minutes | assessed daily through study completion, average of 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemorrhagic complications | Major bleeding defined according to ISTH (International Society on Thrombosis and Haemostasis) criteria. | assessed daily through study completion, average of 10 days |
Multicenter, Post-marketing, Non-interventional, Observational Study in RA Patients Treated With RoActemra/Actemra (Tocilizumab)

Study Overview
=================
Brief Summary
-----------------
This non-interventional study will observe the usage and efficacy of RoActemra/Actemra in patients with rheumatoid arthritis (RA) who have recently begun treatment. The treatment regimen will be directed by the treating physician according to clinical practice. Patients are expected to be observed for approximately 6 months after beginning treatment.

Official Title
-----------------
A Multi-center Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients at least 18 years of age Patients with a diagnosis of moderate to severe RA according to the revised (1987) ACR criteria Patient in whom the treating physician has made the decision to commence RoActemra/Actemra treatment (in accordance with the local label). This can include patients who have received RoActemra/Actemra treatment within 8 weeks prior to the enrolment visit Patient has given informed consent Exclusion Criteria: Patients who have received RoActemra/Actemra more than 8 weeks prior to the enrolment visit Patients who have previously received RoActemra/Actemra in a clinical trial or for compassionate use Patients who have received treatment with any investigational agent within 4 weeks (or 5 half-lives of investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra Patients with a history of autoimmune disease or of any joint inflammatory disease other than RA

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 |
| --- | --- |
| RA Patients on RoActemra/Actemra treatment<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients on RoActemra/Actemra treatment 6 months after treatment initiation |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with systemic manifestation of RA |  | At Baseline | 
| Record of RA treatment history |  | 6 months | 
| Treatment patterns during observation period, assessed by alteration in dosing regimen |  | 6 months | 
| Efficacy as assessed by total joint count evaluation |  | 6 months | 
| Incidence of adverse events |  | 6 months | 
| Health-related quality of life as assessed by questionnaire |  | 6 months |
Patient Satisfaction With Contoura Vision Topography-Guided LASIK

Study Overview
=================
Brief Summary
-----------------
To evaluate patient reported outcomes associated with quality of vision before and after treatment with Contoura Vision Topography-Guided LASIK.

Official Title
-----------------
Patient Satisfaction With Contoura Vision Topography-Guided LASIK

Conditions
-----------------
Myopia, Astigmatism

Intervention / Treatment
-----------------
* Procedure: Contoura Vision LASIK


Participation Criteria
=================
Eligibility Criteria
-----------------
Eligibility criteria: The study enrollment will include all willing patients with: pre-operative BCVA 20/20 for each eye individually, myopic refractive error up to -8.00 diopters, refractive astigmatism that ranges from 0 to 3 diopters, maximum spherical equivalent of -9.00 diopters, the designated age requirements, and only patients that have signed the informed consent document. Exclusion criteria: Patients are excluded that are not willing to participate in a research trial, are unable to cooperate well enough to safely perform the procedure, fail to meet inclusion criteria, have ocular disease (including but not limited to keratoconus, macular degeneration, glaucoma, corneal dystrophy, dry eye syndrome and corneal scarring), and patients that have had previous ocular surgery. Any patients with known allergies to the post-operative medications or preservatives in the medications will also be excluded.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 35 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Group<br>Contoura Vision LASIK using Phorcides Analytic Software | Procedure: Contoura Vision LASIK<br>* Topography-Guided LASIK using Phorcides Analytic Software<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Vision Satisfaction Index | Analog Score from Adapted from PROWL Survey | 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vision | Uncorrected Visual Acuity using ETDRS | 26 weeks | 
| Objective Scatter Index | HD Analyzer | 26 weeks | 
| Higher Order Corneal Aberrations | Galilei Topography | 26 weeks |
Evaluation of Interferon-gamma Responses to HCMV Infection in HIV Positive Individuals

Study Overview
=================
Brief Summary
-----------------
The study is designed to evaluate interferon responses to CMV in HIV positive individuals and a component will look at interferon responses to CMV in HIV positive individuals over time after commencement of antiretroviral therapy. We will also look at the correlation between CD4 T cell numbers and HLA type with the interferon response.

Official Title
-----------------
Evaluation of Interferon-gamma Responses to HCMV Infection in HIV Positive Individuals

Conditions
-----------------
HIV Infection, CMV Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV positive with history of documented HCV infection Over 18 years old HIV positive Antiretroviral naive, starting on antiretroviral therapy

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Treatment Naive, HIV