linjc16/ctgov huggingface dataset:
Folic Acid Supplementation in Phenytoin Induced Gingival Overgrowth

Study Overview
=================
Brief Summary
-----------------
Phenytoin, a common anti-seizure drug, leads to cosmetically unacceptable side effect of gingival overgrowth in a significant number of patients. There is some evidence of therapeutic effect of folic acid in cases of established phenytoin induced gingival overgrowth. In this study, the aim is to study the prospective preventive effect of low dose oral folic acid supplementation on phenytoin induced gingival overgrowth in epileptic children.

Official Title
-----------------
Effect of Low Dose Oral Folic Acid Supplementation on Phenytoin Induced Gingival Overgrowth: A Randomized Double Blind Controlled Trial.

Conditions
-----------------
Gingival Overgrowth

Intervention / Treatment
-----------------
* Drug: folic acid
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 6-15 yr Started on phenytoin within 1 mo of enrollment Exclusion Criteria: Not willing to participate On other folic acid antagonists e.g. anti-neoplastic drugs for >/= 2 wks during last 3 months Pre-existing gingival over-growth due to other cause

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 15 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: 1<br>Oral folic acid | Drug: folic acid<br>* capsule 0.5 mg once a day<br>|
| Placebo Comparator: 2<br>placebo | Drug: placebo<br>* capsule, once a day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of any grade of overgrowth in 2 groups after 6 mo of phenytoin therapy |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of grade > 2 hyperplasia at the end of 6 mo |  | 6 months | 
| Time to occurrence of grade > 2 overgrowth |  | open | 
| Correlation between following and occurrence of grade > 2 overgrowth *phenytoin dose (in mg/kg/d) *serum phenytoin levels *plaque index |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
phenytoin, gum hyperplasia, phenytoin induced gingival overgrowth, plaque index, gingival overgrowth grade
Thermographic Images as an Objective Method for Assessing the Efficacy of Steroidal Epidural Injections

Study Overview
=================
Brief Summary
-----------------
Spinal stenosis is a prevalent diagnosis, which is handled in a heterogeneous manner by clinicians. Moreover, when using steroidal epidural injections, successful treatment is currently defined as the satisfaction of the patient from the treatments, a subjective and non-quantifiable indicator. In this experiment, the investigators aim to evaluate thermographic images as an objective method for assessing the efficacy of steroidal epidural injections, the most common invasive treatment for pain associated with spinal stenosis

Official Title
-----------------
Thermographic Images as an Objective Method for Assessing the Efficacy of Steroidal Epidural Injections

Conditions
-----------------
Spinal Stenosis

Intervention / Treatment
-----------------
* Device: Therm-AppTM TH, thermographic camera
* Drug: epidural injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed a valid, IRB/EC-approved informed consent form 18 years of age or older when written informed consent is obtained Diagnosis of spinal stenosis by MRI or CT imaging Exclusion Criteria: Sensitivity to local anesthetics Skin infection at the site of needle insertion Had evidence of a peripheral neuropathy Had clinical signs of peripheral vascular disease Patient is pregnant Clinical diagnosis of blood clotting disorder Tumor or infection at spine as demonstrate at MRI Unbalanced Cardiac Insufficiency, hypertension & Diabetes cataract Stomach Ulcer

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subject after epidural injection<br>Subjects are patients from the clinic who have been diagnosed with Lumbar spinal stenosis and determined eligible for receiving steroidal epidural injection for pain management | Device: Therm-AppTM TH, thermographic camera<br> <br> Drug: epidural injection<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Ts (Skin Temperature) will be determined at image taken by Therm-AppTM TH camera at the same region |  | Baseline and 30 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain Intensity by a 0 - 10 numerical rating scale (NRS), where 0 indicates no pain and 10 indicates pain as bad as you can imagine. |  | Baseline, 1 month, 3 months |
Dysfunctional Lens Index Serves as a Novel Surgery Decision Maker for Age-related Cataracts

Study Overview
=================
Brief Summary
-----------------
To study the correlations among the dysfunctional lens index (DLI), Lens Opacities Classification System III (LOCS III) nuclear opalescence grading score, preoperative corrected distance visual acuity (CDVA), the objective scatter index (OSI) and Scheimpflug based average lens density in age-related cataracts. To investigate the potential of the DLI as a novel surgery decision maker via the Operating Characteristic (ROC) curve analysis.

Detailed Description
-----------------
Each patient received a comprehensive eye examination, including corrected distance visual acuity (CDVA) preoperatively and the day after surgery, subjective refraction, slit-lamp evaluation, noncontact tonometry (TX-F; Cannon, Tokyo, Japan), and dilated fundus examination. According to the surgery decision made by the three surgeons based on the slit lamp biomicroscopy and CDVA, patients were divided into two groups: Surgical and Non-Surgical. The results of the DLI, OSI and average lens density (ALD) were masked to the surgeons. The DLI, OSI, average lens density, LOCS III nuclear opalescence grading, and preoperative CDVA were obtained. Correlations among these parameters were analyzed. ROC curves were used to analyze DLI values to determine a value to separate between surgical and non-surgical cataracts.

Official Title
-----------------
Dysfunctional Lens Index Serves as a Novel Surgery Decision Maker for Age-related Cataracts

Conditions
-----------------
Age-related Cataract

Intervention / Treatment
-----------------
* Procedure: a ray-tracing aberrometry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with age-related cataracts Exclusion Criteria: any corneal opacity, corneal dystrophies, retinal anomalies, a history of ocular surgery or laser treatment, a LOCS III grade of cortical opacity ≥ 3.0 or posterior subcapsular cataract ≥ 2.0.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cataract surgery<br>cataract extraction and intraocular implantation | Procedure: a ray-tracing aberrometry<br>* The Dysfunctional Lens Index is obtained by a ray-tracing aberrometry<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dysfunctional lens index | The DLI is an objective lens performance metric derived from internal higher order aberrations (HOAs), pupil size, and contrast sensitivity data | 6 months |
Amoxicillin-clavulanate in Treating Acute Otitis Media Evaluated by Daily Tympanometry

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to assess the efficacy of amoxicillin-clavulanate in treating acute otitis media in children. The primary end point is time to disappearance of middle ear effusion which monitored by daily tympanometry performed by families and study physicians.

Official Title
-----------------
Oral Amoxicillin-clavulanate in Treating Acute Otitis Media in Children: Randomized Double-blind Placebo-controlled Study Including Daily Monitoring With Tympanometry

Conditions
-----------------
Otitis Media, Suppurative

Intervention / Treatment
-----------------
* Drug: Amoxicillin-clavulanate
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children with acute otitis media Exclusion Criteria: Amoxicillin allergy Tympanic membrane perforation Tympanostomy tubes (current) Complication of acute otitis media such as mastoiditis

Ages Eligible for Study
-----------------
Maximum Age: 16 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Amoxicillin-clavulanate<br>Oral amoxicillin-clavulanate 40 mg/kg/day divided in two daily doses for 7 days | Drug: Amoxicillin-clavulanate<br>* Amoxicillin-clavulanate 40 mg/kg/day in two daily doses for 7 days<br>* Other names: Clavurion;|
| Placebo Comparator: Placebo<br> | Drug: Amoxicillin-clavulanate<br>* Amoxicillin-clavulanate 40 mg/kg/day in two daily doses for 7 days<br>* Other names: Clavurion;Drug: Placebo<br>* Placebo mixture in two daily doses for 7 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time (days) to disappearance of middle ear effusion | Disappearance of middle ear effusion is defined as the first day of receiving a normal tympanogram (A-curve) in tympanometry. | Within 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time (days) to disappearance of pain |  | Within 60 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
middle ear effusion, amoxicillin-clavulanate, tympanometry
Photodynamic Therapy for Oral Leukoplakia and Erythroleukoplakia

Study Overview
=================
Brief Summary
-----------------
Photodynamic therapy for oral leukoplakia and erythroleukoplakia

Detailed Description
-----------------
Photodynamic therapy for oral leukoplakia and erythroleukoplakia

Official Title
-----------------
Photodynamic Therapy for Oral Leukoplakia and Erythroleukoplakia

Conditions
-----------------
Oral Leukoplakia

Intervention / Treatment
-----------------
* Procedure: photodynamic therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with leukoplakia or erythroleukoplakia Exclusion Criteria: oral cancers

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: photodynamic therapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| End of 8 treatments |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Regression of lesions |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
leukoplakia, erythroleukoplakia, photodynamic therapy
Open Versus Endoscopic Surgical Management Of Posterior Calcaneal Deformity.

Study Overview
=================
Brief Summary
-----------------
Patients with posterior calcaneal deformity may presented by many clinical data associated with retrocalcaneal bursitis which occurs due to the deformity this clinical complaining include pain and swelling in the back of the heel. Many treatment choices available of this deformity with low level of response to conservative treatment which includes medical treatment , physiotherapy and corticosteroids injection. surgical treatment in cases of HAGLUND deformity is the treatment of choice including either endoscopic or open surgical approach for this deformity .

Official Title
-----------------
Open Versus Endoscopic Surgical Management Of Posterior Calcaneal (HAGLUND) Deformity. A Pilot Non Randomized Trial

Conditions
-----------------
Bone Diseases

Intervention / Treatment
-----------------
* Procedure: open approach
* Procedure: endoscopic approach


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Symptomatic patients. Continued refractory pain despite use of extensive conservative management. Exclusion Criteria: Asymptomatic patients Patients which are unfit for surgery.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: open group<br>patients with posterior calcaneal deformity | Procedure: open approach<br>* open excision of the bursa and deformity then debridement of Achilles tendon<br>|
| Active Comparator: endoscopic group<br>patients with posterior calcaneal deformity | Procedure: endoscopic approach<br>* excision of the bursa and deformity then debridement of Achilles tendon through endoscopy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the mean difference in pain scores postoperative | visual analog scale | 3 months |
Reliability and Validity of The Turkish Version of the Functional Assessment of Chronic Illness Therapy - Treatment Satisfaction - General Questionnaire

Study Overview
=================
Brief Summary
-----------------
In the evaluation of the services provided in hospitals in recent years, importance has been given to the measurements based on the perception of the patients. Today, the most frequently used criteria for this purpose are quality of life and patient satisfaction. The general opinion of the experts is that the information obtained with these criteria is valid and reliable.The researchers pointed out that patients who are dissatisfied with the health service provided comply with the recommendations of the healthcare personnel less and thus the primary and secondary preventive services are adversely affected.Although treatment satisfaction is a very important factor in terms of patient adherence to treatment, there is no valid and reliable scale in Turkish to evaluate this factor. This study was carried out to investigate the validity and reliability of The Turkish version of the Functional Assessment of Chronic Illness Therapy - Treatment Satisfaction - General Questionnaire in the patients receiving health care.

Official Title
-----------------
Reliability and Validity of The Turkish Version of the Functional Assessment of Chronic Illness Therapy - Treatment Satisfaction - General Questionnaire

Conditions
-----------------
Satisfaction, Patient

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Getting at least 3 sessions of physiotherapy and rehabilitation services, To be at the cooperative level to understand and answer the surveys. Volunteering to participate in the study. Exclusion Criteria:

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 |  | 30 July 2020 |
Evaluation of a Handwashing Promotion Program in Chinese Elementary Schools

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effects of a commercial hand washing promotion program on hygiene knowledge, attitudes, and practices, and on health outcomes such as reported infectious illnesses and school absences.

Detailed Description
-----------------
Diarrheal and respiratory diseases cause 3.8 million deaths annually among children in the developing world. Reduced rates of these diseases have been measured during intensive, home-based handwashing interventions. We evaluated a school-based handwashing program for 1st grade students to determine whether a more scalable intervention could also reduce illness rates, and impact hygiene knowledge and attitudes. Thirty schools from each of 3 counties in Fujian Province, China, were randomized to one of the following groups: a) control; b) standard intervention, which included a handwashing program (1 hour of hygiene instruction and 1 soap sample kit per pupil); or c) expanded intervention, which included the handwashing program, soap for school sinks and 1 peer hygiene monitor per class. Teachers collected illness symptom information from students weekly and recorded student absences daily between January and April, 2005. Mean illness and absence rates were calculated for each school. Students were given a knowledge, attitudes, and practices questionnaire before the intervention and again 5 months later.

Official Title
-----------------
Evaluation of a Handwashing Promotion Program in Chinese Elementary Schools

Conditions
-----------------
Communicable Diseases

Intervention / Treatment
-----------------
* Behavioral: handwashing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: school has running water Exclusion Criteria: school has not previously received commercial handwashing promotion program

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 12 Years

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 |
| --- |
|Behavioral: handwashing|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| student illness rates |  |  | 
| student absence rates |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| teacher illness rate |  |  | 
| changes in student hygiene knowledge |  |  | 
| changes in student hygiene attitudes |  |  | 
| changes in school water use |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
handwashing, communicable diseases, health education
Postoperative Quality of Life in Treated Patients With Human Adjuvant Disease

Study Overview
=================
Brief Summary
-----------------
This study aims to describe the quality of life in patients submitted to surgical excision of the adjuvants and injured surrounding tissue. For this purpose, the EuroQol questionnaire (EQ-5d) facilitates to obtain values of health in the physical, psychological, and social dimensions. It is a standardized non-disease specific instrument to describe and value the health-related quality of life. Although there are only five domains, it has been found to cover the most critical dimensions of quality of life.

Official Title
-----------------
Postoperative Quality of Life in Surgically Treated Patients With Human Adjuvant Disease: Case Series

Conditions
-----------------
Quality of Life, Granuloma, Foreign-Body

Intervention / Treatment
-----------------
* Other: EuroQol 5D questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of human adjuvant disease due to foreign substances injection Treated surgically to remove foreign substance In a private practice setting and treated all by plastic surgeon senior author. Exclusion Criteria: History of antidepressant use during the follow up

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: EuroQol 5D questionnaire|EuroQol questionnaire (EQ-5d) facilitates to obtain values of health in the physical, psychological, and social dimensions. It is a standardized non-disease specific instrument to describe and value the health-related quality of life.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life: EuroQuality Of Life-5Dimensions | Each EuroQOL-5Dimensions instrument comprises a short descriptive system questionnaire and a visual analogue scale (EQ VAS) that are cognitively undemanding, taking only a few minutes to complete. The questionnaire provides a simple descriptive profile of a respondent's health state. Values of health in the physical, psychological, and social dimensions are investigated. After surgical removal of foreign substances quality of life should have high values. | 31.09 months (range 6 - 96) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
human adjuvant disease, quality of life, Reconstructive surgery