linjc16/ctgov huggingface dataset:
Evaluation of Amphotericin B in Optisol-GS for Prevention of Post-Keratoplasty Fungal Infections.

Study Overview
=================
Brief Summary
-----------------
With the increasing popularity of endothelial keratoplasty, a coincident increase in the rate of fungal infections post-keratoplasty has been seen in the United States. In this study, the eye bank will harvest pairs of donor corneas and randomize one cornea from each pair to be stored in Optisol-GS per Eye Bank Association of America guidelines. The eye bank will add amphotericin B 0.255 μg/mL (antifungal) to the storage solution for the mate cornea. The study donor corneas will be assigned to participants who are scheduled to undergo Descemet membrane endothelial keratoplasty. The surgeons, participants, and evaluators will remain masked regarding the donor cornea storage solution assignment. The participants will be followed for 6 months.

Official Title
-----------------
A Randomized, Double-masked, Placebo-controlled Study of the Safety of Amphotericin 0.255 μg/mL in Optisol-GS

Conditions
-----------------
Fuchs' Endothelial Dystrophy

Intervention / Treatment
-----------------
* Drug: Amphotericin B


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female at least 18 years of age and any race or ethnicity Scheduled to have Descemet membrane endothelial keratoplasty Exclusion Criteria: History of glaucoma surgery in operative eye Known allergy or intolerance to amphotericin B Presence of anterior chamber intraocular lens Corneal stromal or epithelial dysfunction Presence of glaucoma defined as optic nerve damage as confirmed on Humphrey visual field testing or retinal nerve fiber layer analysis Presence of peripheral anterior synechiae

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Amphotericin B<br>The eye bank will add amphotericin B 0.255 μg/mL to the Optisol-GS donor cornea storage solution. | Drug: Amphotericin B<br>* Drug concentration: 0.255 μg/mL<br>|
| No Intervention: Control<br>The donor cornea will be stored in Optisol-GS per the eye bank's standard procedure. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial cell density | Central corneal endothelial cell density will be assessed by specular microscopy | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of post-keratoplasty fungal keratitis | The incidence of post-keratoplasty fungal keratitis will be assessed. | 6 months |
Prevalence of Hospital Malnutrition in Afghanistan

Study Overview
=================
Brief Summary
-----------------
This study aims to determine the prevalence of malnutrition among adult patients in hospitals across Afghanistan.

Detailed Description
-----------------
Malnutrition is associated with negative patient outcomes and increased healthcare costs. The purpose of this cross-sectional study is to determine the prevalence of malnutrition at admission or discharge in adult patients in hospitals across Afghanistan. The secondary outcome is to assess risk factors for malnutrition.

Official Title
-----------------
A Multi-Centre Survey on Hospital Malnutrition in Afghanistan

Conditions
-----------------
Malnutrition

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All admitted or discharged patients age 18-65 Males and females Conscious Informed consent provided Exclusion Criteria: Patients undergoing surgery on the data collection day Outpatients Pregnant females Pediatric patients Patients with psychiatric or eating disorders Patients on dialysis

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of Malnutrition | Nutrition status will be measured with the subjective global assessment (SGA).The SGA tool categorizes nutritional status as: well-nourished (SGA-A), moderately malnourished (SGA-B), and severely malnourished (SGA-C). | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Malnutrition, Nutrition Disorders
Long-term Follow-up on Immunogenicity & Safety of Measles-Mumps-Rubella-Varicella (MMRV) Combined Vaccine

Study Overview
=================
Brief Summary
-----------------
Follow-up to evaluate the immunogenicity and safety of three production lots of GSK Biologicals' MMRV vaccine given as a two-dose schedule to healthy children in their second year of life, as compared to separate administration of GSK Biologicals' measles-mumps-rubella (MMR) vaccine (Priorix®) and varicella vaccine (Varilrix®) in Germany & Austria. Blood samples were collected at three time points during the follow-up period (Year 1, 2 & 3). No new subjects will be enrolled in these follow-up phases of the study.

Official Title
-----------------
Follow-up to Evaluate the the Immunogenicity & Safety of GSK Biologicals' MMRV Vaccine Given as a Two-dose Schedule in the Second Year of Life, as Compared to Separate Administration of GSK Biologicals' Priorix® & Varilrix®.

Conditions
-----------------
Rubella, Varicella, Mumps, Measles

Intervention / Treatment
-----------------
* Biological: MMRV
* Biological: MMR (Priorix®)
* Biological: Varicella (Varilrix®)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent from the parents/guardians of the child before participating in the long-term follow-up. Subjects must have received their complete vaccination course according to the group allocation (i.e. subjects must have received either two doses of MMRV combined vaccine, or two doses of Priorix vaccine and one dose of Varilrix vaccine as separate injections in the primary vaccination study. Subjects were aged between 12 to 18 months of age at the time of the first vaccination in the primary study. Exclusion Criteria: Subjects must not have received an additional dose of measles, mumps, rubella or varicella containing vaccines.

Ages Eligible for Study
-----------------
Minimum Age: 12 Months
Maximum Age: 18 Months

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: MMRV|nan|
|Biological: MMR (Priorix®)|nan|
|Biological: Varicella (Varilrix®)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seropositivity rate & antibody titers for MMRV at 1, 2 & 3 year |  |  | 
| Occurrence of breakthrough cases & contacts with MMRV disease(s) for 3 years after vaccination |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rubella, Varicella, Measles, Mumps, Germany, Austria
Efficiency of Tadalafil for Management of Female Sexual Dysfunction

Study Overview
=================
Brief Summary
-----------------
comparative study between tadalafil versus placebo effect for the management of circumsized female

Detailed Description
-----------------
the group of patient will be randomly divided into 2 groups, half of the patients will receive tadalafil and the other half will receive placebo

Official Title
-----------------
Efficiency of Tadalafil for Management of Female Sexual Dysfunction in Females With Genital Mutilation

Conditions
-----------------
Sexual Dysfunction

Intervention / Treatment
-----------------
* Drug: Tadalafil 5mg
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female with history of female genital mutilation female with history of sexual dysfunction Exclusion Criteria: any medical disorder

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 35 Years

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

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: tadalafil group<br>5 mg of Tadalafil on daily bases for one month duration | Drug: Tadalafil 5mg<br>* oral tablets for one month duration<br>|
| Placebo Comparator: placebo group<br>the patients will receive oral tablets without any active substance for one month | Drug: Placebo<br>* oral tablets for one month duration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clitorial Artery Doppler | Pulsatile index | after one month duration of drug use | 
| Clitorial artery doppler | Resistance index | after one month duration of drug use | 
| Clitorial artery doppler | Peak systolic velosity | after one month duration of drug use | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| score of sexual function | arousal orgasm frequency | after on month of the drug use | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
female genital mutilation, Sexual dysfunction, Clitoral artery Doppler
Lung Function and Inflammatory Markers in Cement Dust Exposed Workers: A Cross-shifts Study

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to examine possible changes in lung function, nitric oxide levels and systemic inflammatory markers in cement dust exposed workers, during one shift (6-8 hours).

Detailed Description
-----------------
OBJECTIVE: Cement dust is suspected to be one of the main factors causing increased mortality among workers not only in the cement production industry, but also in the construction industry worldwide. Our aim is to examine possible changes in lung function, nitric oxide levels and systemic inflammatory markers in cement dust exposed workers, during one shift (6-8 hours). METHODS: All employees from Norwegian cement plants, are invited to participate. The workers will perform spirometry, single-breath determination of carbon monoxide uptake, blood samples before and after a working shift of 6-8 hours, and again after 24 hours. Information on respiratory symptoms, allergy and former respiratory disease as well as exposure information will be given on a self-reported questionnaire. Changes in lung function indices, nitric oxide levels and serum inflammatory markers will be calculated. Nitric oxide will only be measured in non-smokers. We will compare cement dust exposed workers with low-level or non-exposed workers (controls).

Official Title
-----------------
Circulating Inflammatory Markers, Exhaled NO and Lung Function in Cement Production Workers; a Cross-shifts Study

Conditions
-----------------
Airway Obstruction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Employees from a Norwegian cement production plant Exclusion Criteria: Exhaled nitric oxide measurements: smokers Substantial previous work in quarry or as a miner

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- | --- |
| Changes in Lung Function Measurements During One Work Shift (6-8h) | Changes in lung function measurements during one work shift (6-8h), spirometry and gass diffusion capacity | baseline and 6-8h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in FeNO Measurements During One Shift (6-8h) |  | baseline and 6-8h | 
| Changes in Serum/Plasma Inflammatory Markers During One Shift (6-8h) |  | Baseline and 6-8h | 
| Changes in FeNO Measurements Between Baseline (0h) and 32 h |  | 0-32h | 
| Changes in Serum/Plasma Inflammatory Markers Between Baseline and 32 h |  | 0-32h | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cement dust exposure, Cross-shift study, Lung function indices, Exhaled nitric oxide, Serum inflammatory markers
Effect of Stretching on Visco-elastic Behaviour of the Fascia Plantaris in a Healthy Population

Study Overview
=================
Brief Summary
-----------------
RCT with two arms: (1) stretch fascia plantaris (6 weeks, n=30) (2) control (n=30); Outcome parameters: ROM ankle and first toe; visco-elastic behaviour of the fascia plantaris determined by means of myotonometry Study protocol: Outcome parameters were evaluated before and after the intervention/control with a 6 weeks interval. All participants were screened bilaterally and for the participants assigned to the intervention group stretching was only performed on the dominant side

Official Title
-----------------
Effect of Stretching on Visco-elastic Behaviour of the Fascia Plantaris in a Healthy Population

Conditions
-----------------
Fasciitis, Plantar, Stretch, Rehabilitation, Stiffness of Unspecified Foot, Not Elsewhere Classified

Intervention / Treatment
-----------------
* Other: Fascia stretch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers Exclusion Criteria: Lower extremity injury
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 |
| --- | --- |
| Experimental: Stretch fascia plantaris<br> | Other: Fascia stretch<br>* Stretch of the fascia plantaris during 3x30, 5x/week, 6 weeks<br>|
| No Intervention: Control group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visco-elastic behaviour using myotonometry | By means of the MyotonPro device | within 20 minutes before and after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of Motion of ankle joint and first metatarsalphalangeal joint | By means of goniometry | within 20 minutes before and after intervention |
Korean Coronary Bifurcation Stenting (COBIS) Registry II

Study Overview
=================
Brief Summary
-----------------
The COBIS II registry is a multi-center, real-world registry of drug-eluting stenting in coronary bifurcation lesions in South Korea. From 18 major coronary intervention centers in Korea, a total of 2,873 patients were enrolled in this database between January 2003 and December 2009. The aim of the study was to investigate long-term clinical results and predictors of adverse outcomes after percutaneous coronary intervention with drug-eluting stents for coronary bifurcation lesions in South Korea.

Official Title
-----------------
Korean Coronary Bifurcation Stenting (COBIS) Registry II

Conditions
-----------------
Coronary Bifurcation Lesion

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >= 18 years Any type of bifurcation lesion in major epicardial artery Side branch reference diameter >= 2.3 mm and at least stentable with 2.5 mm stent Treated with drug-eluting stent Exclusion Criteria: Protected left main disease previous CABG for LAD or LCX territory Cardiogenic Shock History of CPR in the same hospitalization

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 |
| --- | --- |
| Coronary bifurcation lesion<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of the composite outcomes of cardiac death, target vessel-related myocardial infarction, or target-lesion revascularization |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac death |  | 3 years | 
| Myocardial infarction |  | 3 years | 
| Target lesion revascularization |  | 3 years | 
| Stent thrombosis |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronary bifurcation lesion, Drug-eluting stent
Lighting and Human Response in Motor Time, Autonomic Nervous System, and Emotion

Study Overview
=================
Brief Summary
-----------------
Light influences on human movement, autonomic nervous system, and emotion. It is inconclusive whether illuminance (Ev) and colour temperature (Tc) is appropriate to human movement, autonomic nervous systme, and emotion. Effect of Ev and Tc on responses of movement, autonomic nervous system, and emotion in human is investigated.

Detailed Description
-----------------
The adult and elderly sign informed consent form. They sit in a room where Ev and Tc is adjusted. During sitting they are measured response of movement, autonomic nervous system, and emotion.

Official Title
-----------------
Lnfluence of Light Conditions on Brain Activity, Response Time, Autonomic Nervous Response, and Emotion in the Elderly and Young Adults

Conditions
-----------------
Emotions, Physical Activity, Autonomic Nervous System Imbalance

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age between 18 - 79 years old Normal visual acuity with or without own glasses or contact lens Normal visual field Normal visual color perception Able to following commands Able to read, write, and understand in Thai language Able to sit independently with or without support Able to move dominant upper limb No pain in dominant Shoulder, Elbow, Wrist, and Hand during movement Exclusion Criteria: Aggravated pain at trunk and lower limb during movement of dominant upper limb Having Neurological disorders Having uncontrolled diseases Having psychological problems

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 79 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 |
| --- | --- |
| elderly , young adults<br>Participants are in 9 light conditions, 5 minute for each condition. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| motor response time | ms | 1 minute | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain activity | microvolt | 5 minutes | 
| Heart rate variability | millisecond | 2 minutes | 
| emotion | score | 2 minutes | 
| skin conductance level | microsiemens | 2 minute |
Efficacy of Oral Colchicine in Prevention of Proliferative Vitreoretinopathy in Rhegmatogenous Retinal Detachment

Study Overview
=================
Brief Summary
-----------------
This clinical trial will test the efficacy and safety of oral colchicine in prevention of proliferative vitreoretinopathy (PVR) in cases of rhegmatogenous retinal detachment

Conditions
-----------------
Rhegmatogenous Retinal Detachment

Intervention / Treatment
-----------------
* Drug: colchicine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Rhegmatogenous retinal detachment Exclusion Criteria: PVR grade C Duration of retinal detachment ≥ one month History of cataract surgery History of RD surgery

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proliferative vitreoretinopathy |  |  | 
| retinal reattachment rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual acuity |  |  | 
| reoperation |  |  | 
| macular pucker |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
retinal detachment, proliferative vitreoretinopathy