linjc16/ctgov huggingface dataset:
Safety of Same Day Discharge After Elective Percutaneous Coronary Intervention

Study Overview
=================
Brief Summary
-----------------
Study intends to determine if there is any difference in the occurrence of major adverse cardiology events in patients discharged on the same day as their elective cardiac angioplasty or discharged one day after their angioplasty. Hypothesize that same day discharge is as safe as a day later discharge.

Official Title
-----------------
Feasibility and Safety of Same Day Discharge After Elective Percutaneous Coronary Intervention (PCI) in a Tertiary Care Hospital in Karachi, Pakistan.

Conditions
-----------------
Angioplasty, Coronary

Intervention / Treatment
-----------------
* Other: Same Day Discharge


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: : Low risk lesion (according to the ACC classification) Normal Pre Catheterization laboratory investigation Procedure performed before 3 pm procedure performed with ≤ 6 French guiding Catheter EF ≥ 35% living at a distance of within 15 kilometers from hospital caregiver present at home elective procedure Exclusion Criteria: Acute PCI high risk lesions (according to the ACC classification) deranged Pre Catheterization laboratory investigations Age >70 Severe LV dysfunction, CVA procedure to be performed with a guiding catheter >6F Use of IIb/IIIa inhibitor Creatinine clearance of < 50

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- |
| No Intervention: Next day discharge<br>this group will be discharged as is the standard practice at our facility; i.e. the day after the PCI procedure | |
| Experimental: Same Day Discharge<br>Patients in this arm will be discharged on the same day as their angioplasty. | Other: Same Day Discharge<br>* This group will be discharged home, on the same day after their elective angioplasty<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | Within 30 days post angioplasty | 
| Number of patients who require a 2nd angioplasty |  | within 30 days of 1st angioplasty | 
| Number of patients with bleed from the angioplasty site |  | within 30 days post angioplasty | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of hospital re-admissions |  | within 30 days of initial angioplasty |
A Study to Assess the Effects of DPP-4 Inhibition on Insulin Sensitivity in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
Type 2 diabetes results when the body does not produce enough insulin and/or is unable to properly use the insulin it makes (insulin resistance). This study was undertaken to assess the effects of vildagliptin on insulin sensitivity in people with type 2 diabetes.

Official Title
-----------------
A Study to Assess the Effects of DPP-4 Inhibition on Insulin Sensitivity in Type 2 Diabetes

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: Vildagliptin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with type 2 diabetes at least 3 months prior to screening Blood glucose criteria must be met On stable dose of metformin therapy BMI less than or equal to 39 Exclusion Criteria: Type 1 diabetes, diabetes resulting from pancreatic injury or secondary forms of diabetes Treatment with thiazolidinediones or use of insulin within the previous 3 months Significant illness within 2 weeks prior to dosing High fasting triglycerides as defined by the protocol Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect on insulin sensitivity at 6 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipolysis rate after 6 weeks of treatment |  |  | 
| Plasma free fatty acid concentration after 6 weeks of treatment |  |  | 
| Hepatic glucose production after 6 weeks of treatment |  |  | 
| Glucose disposal after 6 weeks of treatment |  |  | 
| Gluconeogenesis rate after 6 weeks of treatment |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vildagliptin, Type 2 diabetes, Insulin sensitivity, Insulin action
Efficacy of FreshKote and Systane for the Treatment of Dry Eye and Improvement of Osmolarity

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the efficacy of FreshKote and Systane for the reduction of dry eye signs and symptoms.

Official Title
-----------------
Efficacy of FreshKote and Systane for the Treatment of Dry Eye and Improvement of Osmolarity

Conditions
-----------------
Dry Eye

Intervention / Treatment
-----------------
* Drug: FreshKote
* Drug: Systane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Dry eye patients with Level 2 disease or greater as defined by the Delpi Panel Tear osmolarity of at least 308 mosm At least 18 years of age, Male or Female Willing to provide written informed consent Likely to complete all study visits If currently using ocular lubricants, must complete a 10-14 day washout Exclusion Criteria: Presence of any active ocular disease other than dry eye Use of topical ophthalmic medications Use of contact lenses during the trial Pregnant or nursing, or planning a pregnancy. Patients will be asked if they are pregnant or may be pregnant and excluded if they answer in the affirmative. Any known sensitivity to any ingredients of either study drop Oral anti-inflammatory medications, omega 3 supplements, or doxycycline Punctal plugs inserted within the last 6 months or less Uncontrolled systemic disease Subjects with known sensitivity or inappropriate responsiveness to any of the medications used. Acute or chronic disease or illness that would increase risk or confound study results (e.g., uncontrolled diabetes mellitus, immunocompromised, etc.) Corneal abnormalities (e.g., ecstatic diseases, degenerations, or corneal dystrophies of the stroma or endothelium) Concurrent participation or participation in the last 30 days in any other clinical trial

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 |
| --- | --- |
| Active Comparator: FreshKote<br> | Drug: FreshKote<br>* Three times a day for three months<br>|
| Placebo Comparator: Systane<br> | Drug: Systane<br>* three times a day for three months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TBUT | Test that measures how long it takes for the tears to break up | Three months | 
| Best Corrected Visual Acuity | Vision obtained with the best possible lens correction (glasses or contact lenses) | Three months |
Special Drug Use Investigation for PAXIL Tablet (Long-term)

Study Overview
=================
Brief Summary
-----------------
This surveillance study is designed to detect adverse events (particularly clinically significant adverse drug reactions) occurring in clinical settings and to examine factors likely to affect the safety and efficacy of paroxetine in long-term use (1 year).

Official Title
-----------------
Special Drug Use Investigation for PAXIL Tablet (Long-term)

Conditions
-----------------
Mental Disorders

Intervention / Treatment
-----------------
* Drug: Paroxetine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with depression/depressed state or panic disorder PAXIL must be used for long-term Exclusion Criteria: Patients who had been taking PAXIL since before the start of the survey Patients with hypersensitivity to paroxetine Patients taking monoamine oxidase inhibitors (MAOIs) or within 2 weeks of stopping treatment with MAOIs Concomitant use in patients taking pimozide
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients prescribed PAXIL for long-term use<br>Patients with depression/depressed state or panic disorder prescribed PAXIL during study period | Drug: Paroxetine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events in Japanese subjects treated with paroxetine tablet based on prescribing information under the conditions of general clinical practice |  | 1 year | 
| Presence/absence of concomitant use of drugs metabolized by CYP2D6 | PAXIL inhibits drug-metabolizing enzyme CYP2D6, and it takes about 1 week following discontinuation of PAXIL for this CYP2D6 function to recover from the inhibiting effect. Since it requires attention if drugs that are metabolized by CYP2D6 are administered during this recovery period, it was decided to investigate the presence/absence of use of drugs metabolized by CYP2D6 within 2 weeks after discontinuation of treatment in patients for whom treatment with PAXIL was discontinued, as well as the safety thereof. | Within 2 weeks after discontinuation or completion of treatment | 
| Presence/absence of concomitant use of products containing Saint John's Wort (Hypericum perforatum; SJW, hereinafter) | Although the action mechanism for this is not clear, SJW has been reported to have the action of inhibiting reuptake of serotonin, noradrenaline and dopamine, and to exhibit an antidepressant effect. Since PAXIL also acts to inhibit serotonin reuptake, concomitant use of products containing SJW is thought to have an effect upon the serotonin reuptake inhibiting action of PAXIL, so it was decided to check for concomitant use of products containing SJW and investigate the safety of such concomitant use. | 1 year |
First Presentation of Parkinson Disease Patients to Neurologist

Study Overview
=================
Brief Summary
-----------------
In this study information is gathered about the treatment of Parkinson patients who present themselves in a neurological practice for the first time

Official Title
-----------------
CEE PMSS (Central Eastern European Post-Marketing Surveillance Study) First Presentation of Mirapexin in Parkinson Patients

Conditions
-----------------
Parkinson Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Parkinson Disease patients presenting to neurologist for first time Exclusion Criteria: - Hypersensitivity to the active substance or to any of the excipients

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 |
| --- | --- | --- |
| Number of De-novo Patients in Whom Monotherapy With Mirapexin® Could be Successfully Initiated | Successful initiation was defined as a clinical assessment of efficacy by the neurologist rated at least as good on a 4 point scale after 4-8 weeks Mirapexin® treatment, where:1 = very good; 2 = good; 3 = moderate; and 4 = poor. De-novo patients were identified by: those who were referred: - if 'Reason for Referral' = 'initiation of therapy' or for 'diagnostic reason' and for those not referred: - if initial pharmacotherapy = 'Mirapexin® monotherapy' (i.e., no other anti Parkinson Disease (PD) therapy) | 4 - 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in UPDRS (Unified Parkinson's Disease Rating Scale) Part I | Change in UPDRS Part I score from baseline to final visit. The score ranging from 0-16 (0= no disability, 16= maximum disability) | Baseline and 4 to 8 weeks | 
| Change From Baseline in UPDRS Part III | Change in UPDRS Part III score from baseline to final visit. Score ranging from 0 - 108 (0= no disability, 108 = worst disability). | Baseline and 4 - 8 weeks | 
| Global Clinical Assessments of Efficacy of Mirapexin® for All Patients | Successful initiation was defined as a clinical assessment of efficacy by the neurologist rated at least as good on a 4 point scale after 4-8 weeks Mirapexin® treatment, where:1 = very good; 2 = good; 3 = moderate; and 4 = poor. | 4 - 8 weeks |
Biomolecular Messages Associated With the Differentiation of Human Induced Pluripotent Stem Cells to Skeletal Muscle Progenitor Cells

Study Overview
=================
Brief Summary
-----------------
Female urinary incontinence and pelvic organ prolapse are common diseases especially in aged women that frequently cause urogenital infection, voiding difficulty, urinary retention, pelvic pain, constipation, and coital difficulty, as well as impact the quality of life of women. Risk factors of the above diseases include pregnancy, vaginal delivery, and menopausal status. Despite playing a crucial role in the pathophysiology of the above diseases, the urogenital skeletal muscular dysfunction cannot be fully corrected via the current treatment modalities. The human induced pluripotent stem cells (hiPSCs) represent a prime candidate cell type for current research and future cell therapy because of their significant self-renewal, differentiation potential and the relative lack of ethical conflict. With the advent of efficient technology of reprogramming peripheral blood mononuclear cells (PBMCs) into hiPSCs, researchers can generate personalized lines of cells from which it will be possible to obtain differentiated cells in a less invasive way, introducing opportunities in treating diseases that are now considered incurable. Until very recently, little success has been achieved in terms of skeletal muscle differentiation from hiPSCs. The purpose of this study is to explore the applicability of the differentiation into skeletal muscle progenitor cells from hiPSC cell lines and the associated biomolecular messages. It is anticipated that the derived skeletal muscle progenitor cells can be reprogrammed from PBMCs of female patients with urinary incontinence and/or pelvic organ prolapse and used in preclinical testing for relieving female urogenital problems.

Conditions
-----------------
Female Urinary Incontinence and Pelvic Organ Prolapse

Intervention / Treatment
-----------------
* Other: Differentiation of hiPSCs to skeletal muscle progenitors


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: human induced pluripotent stem cells, hiPSCs Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Differentiation of hiPSCs to skeletal muscle progenitors|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cell count |  | Day 50 |
Eating Disorders in Type 1 Diabetes: Mechanisms of Comorbidity

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to investigate how people with type 1 diabetes experience and manage their diabetes, eating, and weight. Summary of the Study: If you choose to participate, you will complete a set of questionnaires and a structured interview. You will then wear a continuous glucose monitor and use your cell phone to answer study questions for a period of 3 days. The questions come in the form of regular phone calls between the hours of 8:00 a.m. and 10:00 p.m. Each call takes only a minute or two to complete. You will also be asked to call in and answer study questions at other times during the day, especially after eating. The study involves a minimum of 2 clinic visits to Duke. Participants who live greater than 1.5 hours from Duke can be approved to take part in the study by phone/Skype. Participants will receive and return study materials through the mail.

Detailed Description
-----------------
Eating disorders (ED) are far more prevalent among individuals with type 1 diabetes (T1D) than the general population. Yet what accounts for the increased prevalence of ED in T1D, and how to effectively treat these patients is unknown. ED in T1D is dangerous. T1D patients with ED not only engage in behaviors common among non-diabetic ED patients (like binge eating), but also might omit insulin to prevent weight gain. The goal of this study is to understand the psychophysiological precipitants to ED behavior among T1D patients.

Official Title
-----------------
Eating Disorders in Type 1 Diabetes: Mechanisms of Comorbidity

Conditions
-----------------
Type 1 Diabetes, Eating Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult (aged 18-65) Diagnosed with type 1 diabetes Clinically significant eating disorder symptoms Currently monitored by a physician Exclusion: Severe hypoglycemic unawareness Pregnancy Current or history of psychosis or mania Current substance abuse Non-English speaking Significant deficits in intellectual functioning

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- | --- |
| Blood Glucose Values |  | 72 Hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ecological Momentary Assessment of Emotional and Behavioral Outcomes |  | 72 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 1 Diabetes, Type 1 Diabetes Mellitus, Eating Disorders, Insulin Omission
Effect of the Level of Dietary Protein on Infant Growth

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether infants fed a formula with protein levels different than a standard infant formula have similar growth and development.

Official Title
-----------------
Effect of the Level of Dietary Protein on Infant Growth and Body Composition in the First Year of Life

Conditions
-----------------
Infant Nutrition

Intervention / Treatment
-----------------
* Other: Standard infant formula
* Other: Infant formula with different level of proteins


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gestational age at least 37 weeks Singleton birth Birth weight between 2500g and 4500g Weight at enrolment is at or above the 5th percentile (CDC) Infant has been exclusively formula fed for at least the last 14 days Having obtained informed consent of legal representative Exclusion Criteria: Congenital illness or malformation that affects infant feeding and/or growth Significant pre-natal and/or post-natal disease Suspected or confirmed allergy to cow milk protein In the investigators assessment, infant's family cannot be expected to comply with treatment (feeding regimen) Currently participating in another clinical trial

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum Age: 12 Months

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Standard Infant Formula | Other: Standard infant formula<br>* From 3 to 12 months of age. As per standard requirement<br>|
| Experimental: Test Product<br>Infant formula with different level of proteins | Other: Infant formula with different level of proteins<br>* From 3 to 12 months of age. As per standard requirement<br>|
| No Intervention: Breast Milk<br>Breastfeeding reference group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean weight gain |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Infant formula, Protein metabolism