linjc16/ctgov huggingface dataset:
NAC in Preventing CIN in CRF Patients Who Need Enhanced CT Scan in ED

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of NAC or sodium bicarbonate in preventing the aggravation of renal function in chronic renal failure when enhanced computed tomography scan is checked in emergency room.

Detailed Description
-----------------
CIN is frequent in CRF patients. However most studies about CIN has been focusing on elective PCI patients. There is no study that the NAC nor sodium bicarbonate would help in preventing CIN in CRF patients who need enhanced CT scan in ED. Our intention was to investigate the effect of NAC or sodium bicarbonate in preventing the aggravation of renal function in chronic renal failure when enhanced computed tomography scan is checked in emergency room.

Conditions
-----------------
Chronic Renal Failure

Intervention / Treatment
-----------------
* Drug: NAC Bicarbonate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CRF patients who need enhanced CT scan Exclusion Criteria: less than 15 years old hypersensitivity to NAC on dialysis no consent from patient or next of kin

Ages Eligible for Study
-----------------
Minimum Age: 15 Years

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: NAC Bicarbonate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the rate of CIN |  | 3 days after CT scan | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality |  | 30 days after CT scan | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
N-acetylcysteine, nephropathy, bicarbonate
Assessment of Ability Related to Vision

Study Overview
=================
Brief Summary
-----------------
To determine the clinical usefulness of a refined third-generation instrument - The Assessment of Ability Related to Vision (AARV) in establishing the amount of disability, charting the detrimental effects of progressive disease and establishing the beneficial effects of treatment

Detailed Description
-----------------
This research study is designed to test the usefulness and repeatability of testing how much disability is caused by vision loss due to glaucoma. We are recruiting 100 patients with glaucoma and 20 healthy (have no eye disease) individuals to be enrolled in this study. The healthy study participants will be enrolled in order to describe how a healthy individual will perform on the test designed to assess one's performance when completing ten activities of daily living. Clinical testing will be conducted by binocular and monocular visual fields, contrast sensitivity and visual acuity. The NEI-VFQ 15 Quality of Life Questionnaire will be used to measure patients perception of how well they are doing.

Official Title
-----------------
Reproducibility and Clinical Usefulness of AARV (Assessment of Ability Related to Vision)

Conditions
-----------------
Glaucoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients 18 yrs of age and older must understand and respond to spoken English and be fully literate. Exclusion Criteria: Patients with significant neurological problems (like Parkinson's disease), motor problems (like arthritis) or other significant illnesses that may prevent them from completing the testing involved in the study (like advanced heart failure). Patients who have received training related to low vision.

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Glaucoma Patients<br>Glaucoma patients covering the entire range of visual field loss from none to advanced. | |
| Control Group<br>Aged matched people with no eye diseases. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the reproducibility of AARV, and its relationship to standard clinical tests |  | Day 1, 1 week, 6 months, 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A better estimate of the reproducibility of standard clinical tests. |  | Day 1, 1 week, 6 months, 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glaucoma, quality of life, daily living activities, visual fields, contrast sensitivity
SynchroMed II Post-Approval Study

Study Overview
=================
Brief Summary
-----------------
This FDA Condition of Approval study will include up to 100 subjects at up to 13 US centers. Subjects are selected from those evaluated and planning to receive a SynchroMed II drug infusion system for treatment of severe spasticity or chronic pain. Subjects must return for refill visits at 1, 6, and 12 months. In addition, subjects return for any other medically necessary refills. Information is collected on all refills and adverse events.

Official Title
-----------------
SynchroMed II Programmable Drug Infusion System Post-Approval Study

Conditions
-----------------
Severe Spasticity, Chronic Pain

Intervention / Treatment
-----------------
* Device: Refills (SynchroMed® II Programmable Drug Infusion Pump)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have chronic intractable severe spasticity or chronic pain requiring intrathecal delivery of medication Have undergone a pre-implant assessment and determined to be an appropriate candidate for implantation of an infusion system Be geographically stable and willing to return to the study center for follow-up visits Subject, or subject's legal representative, has signed informed consent form prior to any study-related procedures Age is at least 18 years of age at time of enrollment Exclusion Criteria: Have a condition in which the pump cannot be implanted 2.5 cm or less from the surface of the skin Have an ongoing infection prior to implant Have insufficient body mass to accept the pump bulk and weight Are unable or unwilling to adhere to the study protocol Have an estimated life expectancy of less than twelve months

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

| Intervention/Treatment |
| --- |
|Device: Refills (SynchroMed® II Programmable Drug Infusion Pump)|Refill information at 1, 6, and 12 months post-implant, as well as any additional refills required from implant through end of study. Amount removed from the pump (taken from syringe), Amount placed in the pump (from syringe),Pump predicted amount remaining in the pump.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the observed volume of drug dispensed by the pump to the programmer's calculated volume of drug dispensed |  | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterize adverse events experienced with the drug infusion system |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
infusion pump, implantable, performance
Heart Transplant Registry of Városmajor

Study Overview
=================
Brief Summary
-----------------
The purpose of this registry is to determine the long term outcomes of heart transplantations performed at the Semmelweis University Heart and Vascular Center. All eventual interventional and non-interventional procedures will be accounted for and summarized.

Official Title
-----------------
Follow-up Registry of Heart Transplant Recipients, to Determine Long Term Outcome and Need for Further Interventional and Non-interventional Procedures

Conditions
-----------------
Disorder Related to Cardiac Transplantation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Heart transplant recipient >18 years old Signed informed consent Cared for at the Semmelweis University Heart and Vascular Center Exclusion Criteria: Denies consent to registry

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 |
| --- | --- | --- |
| Outcome of heart transplantation as measured by all-cause mortality | All-cause mortality will be assessed after transplantation in all participating subjects. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity after heart transplantation | All invasive procedures that are required after initial surgery will be tracked and accounted for. | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart transplant, Cardiac allograft vasculopathy, Chronic rejection, Immunosuppressant therapy
Rate of Microbial Colonization Over Native Calcified Cardiac Valves

Study Overview
=================
Brief Summary
-----------------
The purpose of this observational, exploratory study in patients undergoing any cardiac valve replacement or repair is to assess the rate of bacterial colonization over native degenerative calcified cardiac valves.

Official Title
-----------------
Observational, Prospective, Exploratory Study to Evaluate the Rate of Microbial Colonization Over Native Calcified Cardiac Valves

Conditions
-----------------
Degenerative Cardiac Valve Disease, Coronary Artery Bypass Surgery Patients

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent must be obtained from the subject or his/her legal guardian before any assessment is performed Male or Female subject, 50 years or older Subjects are scheduled to go through any cardiac valve replacement or repair due to degenerative calcified process. For control, subjects with no evidence of valve disease Exclusion Criteria: Subjects have an established or indicated history of IE. Subjects have complaint that might indicate IE- intermittent fever and physical finding according to IE diagnosis criteria (not including a heart murmur) Subjects are current users or have a close history of drug abuse

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- |
| cardiac surgery patients<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To asses the rate of bacterial colonization over degenerative cardiac valves and to discover whether there is a link to a specific micro-organism. |  | Patients will be followed for the duration of their hospitalization, average of 5 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between baseline demographic, clinical and laboratory parameters to degenerative cardiac valve disease | Baseline demographic, clinical and laboratory parameters such as age, gender, medical history, complete blood count and biochemistry profile will be compared between research group (degenerative cardiac valve disease) and control group (Isolated coronary artery bypass graft surgery patients) by means of multivariate analysis and pattern recognition techniques. | Patients will be followed for the duration of their hospitalization, average of 5 days. |
Sutures Versus Glue in Laparoscopic Port Site Closure.

Study Overview
=================
Brief Summary
-----------------
Cosmesis postoperatively is an important consideration for both patients and surgeons and consequently surgeons have become increasingly interested in replacing conventional sutures by means of adhesive bonds for the closure of skin wounds. Therefore the investigators are using two different close techniques for laparoscopic wounds. These are; 1. sutures with steri-strips and 2. adhesive bond.

Official Title
-----------------
The Use of Absorbable Suture Versus Tissue Glue in Laparoscopic Port Skin Closure. A Prospective, Randomised Control Trial. The STILS Trial.

Conditions
-----------------
Cosmetic Outcome, Infection, Cost

Intervention / Treatment
-----------------
* Other: 4-0 Monocryl
* Other: Adhesive Glue


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective Laparoscopic surgeries. Emergency Laparoscopic surgeries. Exclusion Criteria: Contaminated wounds. immunocompromised patients. diabetic patients. history of Keloid scarring.

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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Suture & steri-strips<br> | Other: 4-0 Monocryl<br>* sutures and steri-strips<br>* Other names: sutures and steri strips;|
| Active Comparator: Adhesive Glue<br> | Other: Adhesive Glue<br>* Adhesive Glue<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cosmesis | Cosmetic outcome being graded by patient and clinician via questionnaire. Observer scar assessment form (1-10) 1 = worst result possible, 10 being the best result possible. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical site infection (SSI). | Any superficial site infection which requires antibiotic use or wound complication such as dehisence. This information will be obtained from clinic. | 6 months |
Evaluation of Covid 19 Anxiety in Endometriosis Patients

Study Overview
=================
Brief Summary
-----------------
It is aimed to measure the general anxiety and lifestyle information of endometriosis patients about covid 19 pandemic, to evaluate anxiety levels in this period.

Official Title
-----------------
Endometriosis Patients Covid 19 Anxiety

Conditions
-----------------
Endometriosis, Covid19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: endometriosis patients no psychiatric illness no antidepressant use Exclusion Criteria: women who had not endometriosis no extra health conditions women younger than 18 and older than 45

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

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

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 |
| --- | --- | --- |
| Covid 19 Anxiety levels in Endometriosis Patients | The Beck Anxiety Inventory (BAI); it measures the frequency of anxiety symptoms experienced by the patient. It consists of 21 questions in total. Each item gets an increasing score between 0-3. The total score ranges from 0 - 63. The following guidelines are recommended for the interpretation of scores: 0 -9, normal or no anxiety; 10 -18, mild to moderate anxiety; 19 -29, moderate to severe anxiety; and 30 - 63, severe anxiety. | 20 days |
Investigation of Potential Retinal Toxicity Associated With Hair Dye Products Containing pPD Type Aromatic Amines

Study Overview
=================
Brief Summary
-----------------
Hair dye products could induce minimal forms of MEKAR retinopathies (Mitogen-activated Extracellular signal-regulated Kinase - inhibitors associated retinopathies). These minimal forms of MEKAR are likely to be underdiagnosed, since the associated visual loss is usually mild and so this condition should be considered when patients report blurred vision. The aim of the study is to analyze whether in the current population that dyes the hair, minimal forms that go unnoticed by MEKAR retinopathies can be induced.

Official Title
-----------------
Investigation of Potential Retinal Toxicity Associated With Hair Dye Products Containing pPD (Para-phenylenediamine) Type Aromatic Amines

Conditions
-----------------
MEK Inhibitor-Associated Serous Retinopathy

Intervention / Treatment
-----------------
* Device: OCT-B scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hair dye up to one month before the inclusion Hair dye product containing aromatic amines Exclusion Criteria: Pregnant or lactating woman Retinal pathology already known, or central serous choroiditis

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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants with hair dye<br>Hair dye product with pPD Type Aromatic Amines used up to 1 month before | Device: OCT-B scan<br>* OCT-B scan (Optical coherence tomography)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % of patients with MEKAR retinopathy detected on OCT-B scan | Physiological parameter : Serous retinal detachment at the posterior pole, detected on OCT-B scan | Day of inclusion, up to one month month after the last hair dye | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MEK Inhibitor-Associated Serous Retinopathy, Hair dye, Aromatic amines
Diagnostic of Human Immunodeficiency Virus (HIV) and Other Sexual Transmission Diseases (STD) in High Risk Populations: Men Who Have Sex With Men (MSM) Users of Chemsex

Study Overview
=================
Brief Summary
-----------------
The main objective is to offer diagnostic tests for HIV, HCV and other STD in the risk group of men having sex with men (MSM) users of Chemsex

Detailed Description
-----------------
The main objective is to offer diagnostic tests for HIV, HCV and other STD in the risk group (MSM users of Chemsex) with the purpose of conduct diagnosis, early treatment and monitoring of this infections and reduce the incidence rate of the same ones

Official Title
-----------------
Diagnostic of Human Immunodeficiency Virus (HIV) and Other Sexual Transmission Diseases (STD) in High Risk Populations: Men Who Have Sex With Men (MSM) Users of Chemsex

Conditions
-----------------
HIV

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults (≥ 18 years) Men MSM/transgender referred from PEP office Men MSM/transgender referred from urgency service attended for acute intoxication or an STD Men MSM/transgender referred from STD office Men MSM/transgender referred from a local ONG attended for chemsex use Specifically drug use for having sexual relations, at least once in a month in the lasts 6 months or more than 10 times the last year Reading and understanding ability Patients should be given written informed consent Negative HIV and HCV men HIV positive men but HIC negative referred from HIV daily hospital Disposal of sanitary card from CatSalut Exclusion Criteria: Men that not accomplish inclusion criteria Drug use for another purposes not sexual Drug use for having occasional sexual relations, least than once in the past 6 months

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Number of HIV, | HIV positive serology | 2 years | 
| number of HCV seroconversion | HCV positive serology | 2 years | 
| number STD seroconversion | positive serology | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| type of consumer drug | number and name ( Visual Analog Score for drug) | 2 years | 
| clinical outcomes | number of hospital admissions for acute intoxications | 2 years | 
| analytical outcomes | VDRL serology | 2 years | 
| analytical outcomes | PCR CT/GN(pharynx / urethra / anus) | 2 years | 
| weight | in kilograms | 2 years |
Treatment With Ziprasidone for Schizophrenia Patients With Obsessive Compulsive Disorder (OCD)

Study Overview
=================
Brief Summary
-----------------
Comparing schizophrenic patients with comorbid OCD and schizophrenic patients without OCD in response to Ziprasidone and in cognitive functioning as compared with OCD patients

Official Title
-----------------
Treatment With Ziprasidone for Schizophrenia Patients With Obsessive Compulsive Disorder (OCD)

Conditions
-----------------
Schizophrenia, Obsessive Compulsive Disorder

Intervention / Treatment
-----------------
* Drug: Ziprasidone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Schizophrenia and OCD for at least 6 months Minimum score of 14 on YBOCS Minimum score of 60 on PANSS Diagnosis of Schizophrenia without OC symptoms Exclusion Criteria: Patients who are already being treated with ziprasidone Diagnosis of schizophreniform disorder Organic brain syndrome, mental retardation and pervasive developmental disorder Patients having any significantly cardiovascular illness or electrolyte imbalance

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: Ziprasidone<br>* 40-80 mg BID<br>|
| Active Comparator: 2<br> | Drug: Ziprasidone<br>* 40-80 mg BID<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| YBOCS |  | 8 weeks |