linjc16/ctgov huggingface dataset:
Periodontal Disease Treatment of a Physically Challenged Population

Study Overview
=================
Brief Summary
-----------------
Many physically handicapped patients at the dental department, Toronto Rehabilitation Institute(TRI) have considerable gingival inflammation and breath odour because of the inability to effectively handle a toothbrush. These patients have considerable periodontal disease. There is a concern that these pathogens may have a detrimental effect on wound healing in other areas of the body. Hypothesis: Patients attending the dental department at TRI that are treated with the antibiotic-antifungal rinse containing metronidazole and nystatin will show substantial decrease in periodontal disease as measured by bleeding points and pocket depth when compared to the group that continues to use their regular oral hygiene methods (control group).

Official Title
-----------------
The Effect of an Antibiotic-antifungal Rinse on Periodontal Disease

Conditions
-----------------
Periodontal Disease

Intervention / Treatment
-----------------
* Drug: metronidazole-nystatin oral rinse


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants must be between the ages of 18 to 65 years Participants must have at least 6 teeth. Participants must have some indication of gingivitis and periodontal breakdown. - Exclusion Criteria: Patients who are taking Warfarin/Coumadin Patients who are allergic to Metronidazole or chlorhexidine. Edentulous patients will be excluded by those who have at least 6 teeth can be a participant -

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Metronidazole-nystatin oral rinse, regular oral hygiene<br>Week 1: daily brushing with suction brush. Week two: daily brushing with a mixture of metronidazole-nystatin suspension. | Drug: metronidazole-nystatin oral rinse<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of healing of periodontal tissues as shown by a reduction of bleeding | Evidence of healing of periodontal tissues is assessed by measuring bleeding points and periodontal pocket depth using a dental probe. | two weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
periodontal pockets, disabled, periodontal disease, bleeding on probing
Safety and Efficacy of Combigan® Ophthalmic Solution in Korea

Study Overview
=================
Brief Summary
-----------------
This study is a Post-Marketing Surveillance study in Korea to evaluate the safety and efficacy of Combigan® (brimonidine tartrate/timolol maleate) Ophthalmic Solution in patients with Open Angle Glaucoma or Ocular hypertension with insufficient response to local beta blockers treated as per standard of care in clinical practice.

Conditions
-----------------
Glaucoma, Open-Angle, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: brimonidine tartrate/timolol maleate Ophthalmic Solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Open Angle Glaucoma or Ocular Hypertension treated with Combigan® Ophthalmic Solution as standard of care in clinical practice. Exclusion Criteria: None.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Combigan® Ophthalmic Solution<br>Patients treated with Combigan® Ophthalmic Solution as per local standard of care in clinical practice. | Drug: brimonidine tartrate/timolol maleate Ophthalmic Solution<br>* brimonidine tartrate/timolol maleate (Combigan®) Ophthalmic Solution as per local standard of care in clinical practice.<br>* Other names: Combigan®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Reporting Adverse Events | An adverse event was any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. | Up to 2.6 Years | 
| Percentage of Participants With Overall Improvement From Baseline in Intraocular Pressure (IOP) | IOP is a measurement of the fluid pressure inside the eye. The study doctor classified the overall improvement of the IOP change from Baseline into 3 categories: Improvement (effective), No Change or Exacerbation (ineffective). The percentage of participants with Improvement is reported. | Baseline, Week 4 |
Effect of Goal-directed Fluid Therapy Using Stroke Volume Variation in Patients Undergoing Free Flap Reconstruction After Head and Neck Cancer Resection

Study Overview
=================
Brief Summary
-----------------
Investigators hypothesized that goal-directed fluid therapy using stroke volume variation will improve postoperative recovery in patients undergoing free flap reconstruction after head and neck cancer resection. Investigators will compare the effect of goal-directed fluid therapy using stroke volume variation on recovery in patients undergoing free flap reconstruction after head and neck cancer resection.

Conditions
-----------------
General Anesthesia

Intervention / Treatment
-----------------
* Procedure: Standard fluid therapy
* Procedure: Conservative fluid therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients of age over 20 years scheduled for free flap reconstruction after head and neck cancer resection Exclusion Criteria: valvular heart disease congestive heart failure liver failure renal failure pregnant woman allergy to hydroxyethyl starch solutions coagulation abnormalities

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard<br> | Procedure: Standard fluid therapy<br>* In Standard fluid therapy group, the administration of fluid will be guided to maintain mean blood pressure more than 65 mmHg, urine output more than 0.5 ml/kg/hr, and central venous pressure less than 14 mmHg.<br>|
| Active Comparator: Conservative<br> | Procedure: Conservative fluid therapy<br>* In Goal directed fluid therapy group, the administration of fluid will be guided by stroke volume variation. The anesthesiologist will infuse volulyte (Fresenius Kabi, Bad Homburg, Germany) 200 ml if stroke volume variation is over 12%. If cardiac index is below 2.5 l/min/m2 and stroke volume variation is below 12%, start dobutamine.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay |  | 1 month after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fluid Therapy, Head and Neck Neoplasms, Surgical Flaps
Feeding After Neonate Surgery Review

Study Overview
=================
Brief Summary
-----------------
The purpose is to determine what factors, if any, lead to delayed feeding, discharge with a NG tube, G-tube placement or Nissen fundoplication.

Detailed Description
-----------------
The purpose is to determine what factors, if any, lead to delayed feeding, discharge with a NG tube, G-tube placement or Nissen fundoplication. Will review the newborn database (Lumedx as most interested in those children who have never been fed prior to their cardiac surgery. The medical charts will be reviewed at Children's Healthcare of Atlanta at Egleston Hospital. Approximately 90 charts will be reviewed for newborns undergoing surgery in the 2003 calendar year. The factors that will be reviewed are pre-op feeding regimen, diagnosis, single vs two ventricle, open vs closed heart procedure, length of bypass, level of hypothermia, circulatory arrest, presence of TEE probe and post-op ventilation.

Official Title
-----------------
Feeding After Neonatal Surgery Chart Review

Conditions
-----------------
Congenital Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Neonates who undergo cardiac surgery Exclusion Criteria: -
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
-----------------
newborn, pediatric health, Feeding difficulty, discharge with a NG tube, G-tube placement, Nissen fundoplication
A Study of the Safety and Efficacy of Synvisc in Patients With Symptomatic Ankle Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
This clinical study is to evaluate the safety and efficacy of Synvisc in patients with symptomatic ankle osteoarthritis (OA). Patients will be given Synvisc, with the possible administration of a second injection where insufficient symptomatic pain relief was experienced during the initial 3 months follow up period.

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Device: Synvisc (hylan G-F 20)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with symptomatic OA pain of ankle (talo-crural) Exclusion Criteria: Patients with current or prior conditions or treatments that would impede measurements of efficacy or safety

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Synvisc (hylan G-F 20)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain relief |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
osteoarthritis of the ankle, musculoskeletal
Inspiratory Resistive Loading and Diaphragm Fatigue

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to clarify whether specific loading of the inspiratory muscles induces contractile fatigue of the diaphragm muscle in healthy individuals and individuals with recurrent low back pain.

Official Title
-----------------
Inspiratory Resistive Loading and Diaphragm Fatigue in Healthy Individuals and Individuals With Recurrent Low Back Pain

Conditions
-----------------
Diaphragm Fatigue, Healthy, Low Back Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria individuals with low back pain: Age: 18-35 years old At least 1 year of low back pain with/without referred pain in buttock/thigh At least 3 episodes of disabling low back pain At least a score of 20% on the Oswestry Disability Index Willingness to sign the informed consent Inclusion Criteria healthy individuals: Age: 18-35 years old No history of low back pain A score of 0% on the Oswestry Disability Index Willingness to sign the informed consent Exclusion Criteria: History of major trauma and/or major orthopedic surgery of the spine, the pelvis or the lower quadrant One of the following conditions: Parkinson, multiple sclerosis, stroke, history of vestibular disorder, respiratory disease, pregnancy Radicular symptoms Not Dutch-speaking Strong opioids Neck pain Smoking history

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 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 |
| --- | --- |
| individuals with low back pain<br> | |
| healthy controls<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| transdiaphragmatic pressure | transdiaphragmatic pressure measurement in response to bilateral anterior magnetic phrenic nerve stimulation before and after an inspiratory resistive loading protocol | 18 months |
Indirect Comparison Between Eltrombopag & Romiplostim

Study Overview
=================
Brief Summary
-----------------
An indirect comparison to compare the efficacy of eltrombopag versus romiplostim

Detailed Description
-----------------
An indirect analysis was conducted to evaluate the relative efficacy of eltrombopag and romiplostim using placebo as a common comparator

Official Title
-----------------
Indirect Comparison of Efficacy of Treatments for Idiopathic Immune Thrombocytopenic Purpura - Review of Platelet Responses and Bleeding Events

Conditions
-----------------
Thrombocytopaenia

Intervention / Treatment
-----------------
* Drug: Eltrombopag
* Drug: Romiplostim
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults with ITP Pre-specified treatment Prospective clinical studies with at least 10 patients Exclusion Criteria: Adults with ITP for other reasons

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 |
| --- | --- |
| Eltrombopag & standard of care<br> | Drug: Eltrombopag<br>* Eltrombopag & standard of care<br>|
| Romiplostim & standard of care<br> | Drug: Romiplostim<br>* Romiplostim & standard of care<br>|
| Standard of care<br> | Drug: Placebo<br>* Placebo & standard of care<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Durable response: platelet count of >=50 and <400 Gi/L |  | 6 months | 
| Overall response: either a durable response or a transient platelet response |  | 6 months |
Changes in Optic Nerve Sheath Diameter in Patients Undergoing Spinal Surgery in the Prone Position

Study Overview
=================
Brief Summary
-----------------
Long standing prone position could affect vision or optic nerve. To measure the optic nerve sheath diameter using ultrasound is quick and useful assessments of patients. This study will look at the change of optic nerve sheath diameters of patients undergoing surgery in prone position

Official Title
-----------------
Changes in Optic Nerve Sheath Diameter in Patients Undergoing Spinal Surgery in the Prone Position

Conditions
-----------------
Optic Nerve Sheath Diameter

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing surgery in prone position Exclusion Criteria: Patients who did not agree to participate in the study Patients has ophthalmic diseases Patients has previous history of ophthalmic surgery. Patients has neurological disorders. Patients has history of head surgery. Severe anaphylactic allergy to ultrasound gel or Tegaderm

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Prone position<br>Patients undergoing surgery in prone position | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change optic nerve sheath diameter | Change in Optic nerve sheathe diameter from baseline, before surgery, immediate after surgery (prone, supine), 1,3,6,24 and 48 hours after completion of surgery | 0,1,3,6,24 and 48 hours |
The Role of Impact Activity in Peripubertal Bone Accrual

Study Overview
=================
Brief Summary
-----------------
Osteoporosis has been established as a major public health problem, primarily effecting women. The attainment of maximal peak bone mass is crucial in the prevention of osteoporosis, yet little is known about the specifics of bone accrual. Physical activity has been identified as an important modifiable factor controlling bone accrual. It is has been shown that increased activity during peri-pubertal years increase bone mineral content during adulthood. Thus, strategies designed to increase peak bone mass should target the peri-pubertal years of critical bone acquisition. Hypothesis 1a: The amount of bone mineral accrued during the peri-pubertal years is greater in girls who engage in impact activity than in those who do not. Hypothesis 1b: The positive effects of impact activity on bone accrual are maintained after cessation of the activity, resulting in greater bone mineral density in girls who participate in impact activity during a portion of the peri-pubertal years than in those who never participated in impact activity.

Detailed Description
-----------------
As above

Official Title
-----------------
The Role of Impact Activity in Peripubertal Bone Accrual

Conditions
-----------------
Bone Mineral Density

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects between the ages of 10-12 will be asked to participate

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 12 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 |
| --- | --- |
| Observation<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Efficacy of 308-nm Excimer Laser for Primary Localized Cutaneous Amyloidosis Treatment in Asians

Study Overview
=================
Brief Summary
-----------------
Efficacy of 308-nm excimer laser for primary localized cutaneous amyloidosis treatment in Asians, pilot study.

Official Title
-----------------
Efficacy of 308-nm Excimer Laser for Primary Localized Cutaneous Amyloidosis Treatment in Asians: Pilot Study

Conditions
-----------------
Lichen Amyloidosis

Intervention / Treatment
-----------------
* Radiation: 308-nm excimer laser


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients, aged >18 years old with lichen amyloidosis diagnosed by using clinical presentation and pathologic features Exclusion Criteria: Those with cutaneous amyloidosis associated systemic diseases Pregnancy or lactating woman Those who are allergic to urea, olive oil Those who are photosensitive to ultraviolet radiation Those who had been previously treated with medications/ radiation/ laser within 3 months for systemic and 1 month for topical therapy

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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: excimer laser<br> | Radiation: 308-nm excimer laser<br>* monochromator UVB laser (308nm)<br>|
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Roughness evaluation by using Visioscan® VC98 | The improvement of roughness evaluation | Change from baseline roughness at every 2 weeks up to 16 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
308-nm excimer laser, primary localized cutaneous amyloidosis, lichen amyloidosis, Asians