linjc16/ctgov huggingface dataset:
Evaluation and Comparison of the Efficacy of Triphala Mouthwash and 0.2% Chlorhexidine

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the usefulness of triphala mouthwash in comparison with the gold standard chlorhexidine in hospitalized and periodontally diseased patients.

Official Title
-----------------
A Randomized Clinical Trial to Evaluate and Compare the Efficacy of Triphala Mouthwash With 0.2% Chlorhexidine in Hospitalized Patients With Periodontal Diseases

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age group of 20-65 years having periodontal diseases according to American Academy of Periodontology (AAP) classification 1999 Exclusion Criteria: patients seeking any periodontal treatment during the course of study

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- | --- |
| plaque index |  | 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gingival index |  | 15 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chlorhexidine, gingivitis, periodontitis
Musculoskeletal Ultrasound in Asymptomatic Hyperuricemia

Study Overview
=================
Brief Summary
-----------------
An observational study to evaluate the prevalence of US changes of gout in the joints and tendons of patients with different degrees of asymptomatic hyperuricemia. The investigators' findings may support the extension of the spectrum of urate disease, and define a subset of patients that may benefit from early urate-lowering therapy.

Official Title
-----------------
Musculoskeletal Ultrasound in Asymptomatic Hyperuricemia: Redefining Early Urate Disease

Conditions
-----------------
Hyperuricemia

Intervention / Treatment
-----------------
* Other: Uric acid level


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have at least one serum uric acid level l ≥ 7.0 mg/dL within the last two years without a clinical diagnosis of gout per American College of Rheumatology criteria30 (appendix A). Patients, of matched gender and age, with normal uric acid levels will serve as controls. Exclusion Criteria: Patients who meet or have met the ACR criteria for Gout, unable to read English, and/or have terminal illness will not be eligible to participate in the study. Patients with a diagnosis of skin psoriasis31, rheumatoid arthritis, or spondyloarthropathies will not be eligible to participate. Patients who are on urate-lowering therapy. Patients with 1 or 2 total knee replacements.

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 |
| --- | --- |
| Uric Acid Level<br> | Other: Uric acid level<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Urate Depositions Detected in Ultrasound |  | 2 years |
Efficacy and Safety of FTY720 Versus Mycophenolate Mofetil (MMF, Roche Brand) in de Novo Adult Renal Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety and efficacy of FTY720 versus mycophenolate mofetil (MMF, Roche brand) combined with cyclosporine and corticosteroids in patients receiving a kidney transplant.

Official Title
-----------------
A Two-year Extension to a One-year, Multicenter, Partially Blinded, Double-dummy, Randomized Study to Evaluate the Efficacy and Safety of FTY720 Combined With Reduced-dose or Full-dose Cyclosporine, USP [Modified] (Novartis Brand) and Corticosteroids Versus Mycophenolate Mofetil Combined With Full-dose Cyclosporine, USP [Modified] (Novartis Brand) and Corticosteroids, in de Novo Adult Renal Transplant Recipients.

Conditions
-----------------
Renal Transplantation

Intervention / Treatment
-----------------
* Drug: FTY720


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Completion of core study Exclusion Criteria Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

| Intervention/Treatment |
| --- |
|Drug: FTY720|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IA, IB, IIA, IIB, III, or humoral rejection diagnosed by biopsy according to Banff 97 criteria within 36 months post transplant |  |  | 
| Permanent resumption of dialysis within 36 months post transplant |  |  | 
| Surgical removal of graft within 36 months post transplant |  |  | 
| Death within 36 months post transplant |  |  | 
| Withdrawal of consent, death, or lost to follow up within 36 months post transplant |  |  | 
| Serum creatinine, calculated creatinine clearance and urine-protein/creatinine rati at Months 18, 24, 30 and 36 o |  |  | 
| FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% at Months 18, 24, 30 and 36 |  |  | 
| Absolute lymphocyte count at Month 18, 24, 30 and 36. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical examinations at Months 18, 24, 30 and 36 |  |  | 
| Vital signs at Months 18, 24, 30 and 36 |  |  | 
| Electrocardiogram at Months 24 and 36 |  |  | 
| Chest X-ray Months 24 and 36 |  |  | 
| Safety laboratory tests 18, 24, 30 and 36 |  |  | 
| Ophthalmic evaluations 18, 24, 30 and 36 |  |  | 
| AEs and SAEs |  |  | 
| FTY720/CsA levels at Months 18, 24, 30 and 36 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Transplantation, kidney,organ transplant
A Study of Preferences for the First-Line Treatment of Advanced/Metastatic Non-Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this observational study is to determine participants' preferences for outcomes associated with first-line treatment of advanced/metastatic Non-Small Cell Lung Cancer (NSCLC) using a discrete-choice experiment (DCE).

Official Title
-----------------
Preferences for the First-Line Treatment of Advanced/Metastatic Non-Small Cell Lung Cancer

Conditions
-----------------
Carcinoma, Non-Small-Cell Lung

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The following is the inclusion criteria for pretest interviews and final online survey. Participants: Must be 18 years of age or older Must be a US resident. Lung cancer participants with a physician diagnosis of NSCLC. Global Perspectives will be involved to suggest alternative strategies to a physician-confirmed diagnosis to ensure that actual cancer participants are recruited. Exclusion Criteria: Not applicable Other protocol-defined inclusion/exclusion criteria apply

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 |
| --- | --- |
| Cohort 1<br>Participants with early stage and advanced/metastatic non-small cell lung cancer (NSCLC) | |
| Cohort 2<br>Participants from the general population | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Set of relative preference weights for all attribute levels included in the Discrete Choice Experiment (DCE) |  | At Baseline | 
| Respondents' baseline understanding of attribute descriptions |  | At Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Preference, Advanced/Metastatic NSCLC, Discrete choice experiment (DCE)
Selective Neurectomy and Mesh Removal for Chronic Postherniotomy Pain

Study Overview
=================
Brief Summary
-----------------
Chronic postherniotomy pain affects every day activities in 5-8% of patients. However, no established treatment for this pain syndrome exists and previous reports on the effect of surgical intervention suffer from methodological problems. The neurophysiological characteristics suggest that pain arises from deeper neuronal structures injured during surgery or by ongoing inflammation from the mesh. This study investigates the effect of removing inserted mesh and compressed nerves on pain related daily impairment of activities assessed by the validated AAS questionnaire before and 6 months after surgery

Official Title
-----------------
The Effect of Selective Neurectomy and Mesh Removal on Chronic Postherniotomy Pain

Conditions
-----------------
Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult ( more than 18 years old) patients with chronic pain after groin hernia surgery, and pain related impairment of everyday function. The pain should have occurred after previous open surgery. The patient should be able to locate to a specific area with maximum pain. Patients should be able to understand and use pain scales, and the AAS-scale. Exclusion Criteria: All that contradicts the above

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 |
| --- | --- |
| 1<br>patients with chronic postherniotomy pain (>1 year), affecting everyday activities severely | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in AAS scores before and six months after operation |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in sensory function assessed by quantitative sensory testing |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic pain, groin hernia, neuropathic pain, chronic postoperative pain, Postherniotomy pain, Neuroplastic changes
Safety and Efficacy Study of BETAXON 0.5% and AZOPT 1.0% in Pediatric Patients With Glaucoma or Ocular Hypertension

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of both BETAXON and AZOPT in pediatric patients. Patients will dose with study drug at 8 am and 8 pm daily for twelve weeks. Patients will have vision tested, slit lamp exam, blood pressure and pulse checks at each visit. Patients will have a dilated fundus exam and corneal measurements taken at first and last visit.

Official Title
-----------------
Safety and Efficacy Study of BETAXON 0.5% and AZOPT 1.0% in Pediatric Patients With Glaucoma or Ocular Hypertension

Conditions
-----------------
Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: BETAXON (levobetaxolol HCl)
* Drug: AZOPT (brinzolamide)


Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION: Children 5 years old and younger require treatment for glaucoma or ocular hypertension vision is 20/80 or better cup-to-disc ratio of 0.8 or less EXCLUSION: do not have abnormal fixation IOP greater than 36 mm Hg significant retinal disease penetrating keratoplasty severe ocular pathology optic atrophy eye surgery in the past 30 days cardiovascular abnormalities hypersensitivity to beta blockers, carbonic anhydrase inhibitors or sulfa drugs

Ages Eligible for Study
-----------------
Minimum Age: 1 Week
Maximum Age: 5 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: Brinzolamide suspension, 1%<br>Dosed twice daily for 12 weeks | Drug: AZOPT (brinzolamide)<br>* brinzolamide suspension, 1%<br>|
| Experimental: Levobetaxolol suspension, 0.5%<br>Dosed twice daily for 12 weeks | Drug: BETAXON (levobetaxolol HCl)<br>* levobetaxolol suspension, 0.5%<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change from Baseline IOP |  | Up to Week 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glaucoma, Ocular Hypertension
How Long Must the MRI Follow-up Last to Safely Identify Middle Ear Residual Cholesteatoma

Study Overview
=================
Brief Summary
-----------------
Previous studies demonstrated the high diagnostic value of non-echoplanar diffusion weighted magnetic resonance imaging (non-EP DWI) for residual cholesteatoma. However, limited data are available regarding a suitable length of imaging follow-up. The present study aimed to determine the optimal duration of non-EP DWI follow-up for residual cholesteatoma

Detailed Description
-----------------
A retrospective, monocentric study was performed between 2013 and 2019 and included all patients regularly followed-up after canal wall-up tympanoplasty with at least two non-EP DWI performed on the same 1.5T MRI scanner. MR images were reviewed independently by two radiologists. Sensitivity and specificity values were calculated as a function of time after the surgery. Receiver operating characteristics (ROC) curves were analyzed to determine the optimal follow-up duration.

Official Title
-----------------
Optimal Duration of Magnetic Resonance Imaging (MRI) Follow-up to Safely Identify Middle Ear Residual Cholesteatoma

Conditions
-----------------
Middle Ear Cholesteatoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: - patients regularly followed-up for middle ear cholesteatoma, who underwent two or more non-EP DWI performed on the same 1.5 Tesla MRI scanner Exclusion criteria: - congenital cholesteatomas, tympanoplasty with canal wall-down technique, or suspicion of residual cholesteatoma on the first MRI follow-up
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 |
| --- | --- | --- |
| MRI sensitivity and specificity values as a function of the duration of the follow-up | MRI sensitivity and specificity values as a function of the duration of the follow-up. Since no official recommendations are available in the literature, the decision regarding the number of MRIs and the time lapse between any two was left to the discretion of the surgeon | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Receiver operating characteristics (ROC) curves | the receiver operating characteristics (ROC) curves | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
residual cholesteatoma, imaging follow-up, canal wall-up tympanoplasty, non-EP DWI
Study to Assess BMD and Bone Turnover Response to 5 mg Daily Risedronate Treatment in Women With PMO

Study Overview
=================
Brief Summary
-----------------
A 2-year, Multicenter, Open-label, Phase IIIb Extension Study to Assess Bone Mineral Density and Bone Turnover Response to 5 mg Daily Risedronate Treatment in Women with Postmenopausal Osteoporosis Who Sequentially Completed Clinical Studies RVE009093, RVE1996077, RVE1998080, and RVE2001079 (NCT01249261)

Detailed Description
-----------------
A 2-year, Multicenter, Open-label, Phase IIIb Extension Study to Assess Bone Mineral Density and Bone Turnover Response to 5 mg Daily Risedronate Treatment in Women with Postmenopausal Osteoporosis Who Sequentially Completed Clinical Studies RVE009093, RVE1996077, RVE1998080, and RVE2001079 (NCT01249261)

Official Title
-----------------
An Extension Study to Assess BMD and Bone Turnover Response to 5 mg Daily Risedronate Treatment in Women With PMO

Conditions
-----------------
Postmenopausal Osteoporosis

Intervention / Treatment
-----------------
* Drug: risedronate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: have satisfactorily completed Clinical Study RVE2001079 (Year 8 extension study) Exclusion Criteria: Can not use any bone modifying substances except risedronate

Ages Eligible for Study
-----------------
Minimum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>5 mg/day risedronate | Drug: risedronate<br>* 5 mg tablet of risedronate once a day for 2 years<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety and tolerability profile of 5 mg daily oral risedronate therapy administered for 2 years in patients with post-menopausal osteoporosis, who had received risedronate for 2 or 7 years and then had a risedronate-free year. |  | 2 years |
Assessment of Exposures of the Mother-infant Pair to the Air Pollution of São Paulo

Study Overview
=================
Brief Summary
-----------------
A single group of pregnant women who was analyzed in the first and in the third trimesters of pregnancy

Detailed Description
-----------------
A single group of 120 pregnant women separated in smokers (n = 17) and nonsmokers (n = 103) and first pregnancy (n = 54) or multiparous (n = 66) who underwent pulmonary function test and used the individual passive sampler in the first and third trimesters of pregnancy

Official Title
-----------------
Longitudinal Study of the Pulmonary Function Testing of Pregnant Women Exposed to Air Pollution in São Paulo

Conditions
-----------------
Lung Diseases

Intervention / Treatment
-----------------
* Procedure: Lung function test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: prior informed consent; single pregnancy; topical and feasible; gestational age of less than 13.86 weeks at the first evaluation; absence of preexisting maternal diseases Exclusion Criteria: withdrawal from the project; abortion; inadequate pulmonary function test

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 41 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lung function test<br>Pregnant women performed one spirometry at each trimester of pregnancy | Procedure: Lung function test<br>* Pregnant woman use the individual passive sampler 15 days before the spirometry test at each trimester<br>* Other names: Spirometry;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of air pollution in the spirometry of 120 pregnants, evaluated by individual passive samplers in the first (T1) and third (T3) trimesters of pregnancy, using the non-parametric analysis for repeated measures |  | Through study completion, an average of 3 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the influence of smoking and parity and the results of spirometry of all pregnants exposed to pollution comparing the frequency of events held by Wilcoxon and the Mann Witney test |  | Through study completion, an average of 3 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Respiratory Function Tests, Air pollution, Pregnancy, Spirometry
Biomarker and DNA Collection in Subjects Participating in Protocol 22003

Study Overview
=================
Brief Summary
-----------------
The subjects that meet the inclusion and exclusion criteria and consent to participate in protocol 22003 will be offered participation in 22003A which will evaluate secreted protein before and after treatment with STX209 and placebo to determine if they correlate with effectiveness of treatment or susceptibility to treatment with STX209. These same subjects will also be asked to contribute a blood sample for DNA (deoxyribonucleic acid) collection. The investigators will study the DNA to determine if STX209 works better in people with specific gene variations, or to find new gene variations that predict how well STX209 works.

Official Title
-----------------
Biomarker Testing and DNA Collection in Subjects Participating in an Open-Label, Flexible-Dose Evaluation of the Efficacy, Safety, and Tolerability of STX209 in the Treatment of Irritability in Subjects With Autism Spectrum Disorders

Conditions
-----------------
Fragile X Syndrome

Intervention / Treatment
-----------------
* Drug: STX209


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The Autism Spectrum Disorder subjects that meet the inclusion and exclusion criteria and consent to participate in protocol 22003 Exclusion Criteria: The Autism Spectrum Disorder subjects that meet the inclusion and exclusion criteria and consent to participate in protocol 22003

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 17 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: STX209|collection of serum for DNA to elucidate a potential biomarker for patients with ASD|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarker | evaluation of DNA for ASD to elucidate a potential biomaker | june 2013 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fragile X syndrome, biomarkers