linjc16/ctgov huggingface dataset:
Discontinuation Study Of Citalopram (Antidepressant) in Depressed Adolescents

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate whether it is advantageous for adolescents who have recovered from depression after a 6 to 12 week course of antidepressant treatment to stay on the treatment a further 6 months or is it just as helpful to stop the medication after recovery. The hypothesis is that adolescents with major depression who recover from the 6 to 12 week trial of citalopram will be less likely to have a recurrence of depression over a 6 month period if continued on the citalopram as compared to those who discontinue the medication.

Conditions
-----------------
Major Depression

Intervention / Treatment
-----------------
* Drug: Citalopram


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of major Depression. Age 13-18. A score of > 16 on the 17 item Hamilton Depression Scale or a score of > 12 on the 17 items plus a score of >7 on the atypical items. Males and females. Outpatient at initiation of double blind treatment phase. Ability to give informed consent. Exclusion Criteria: Past or current hypomanic or manic episode. Currently meets criteria for a Conduct Disorder. Current psychotic symptoms. Substance dependence in the last 3 months. Significant medical condition that would contraindicate the use of an antidepressant. Pregnancy Past treatment with Citalopram for major depression

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum 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: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse - subject meets criteria for an episode of major depression for 2 weeks or more. |  |  |
A Retrospective Study of C-kit Mutation Status in Asian Patients With Advanced Gastro-intestinal Stromal Tumors (GIST) Treated With Imatinib.

Study Overview
=================
Brief Summary
-----------------
Imatinib is the current standard treatment for advanced GIST. Previous studies have shown that GIST genotype was associated with treatment outcomes with exon 11 having superior outcome compared with exon 9 or WT.10, 11 In patients with exon 9 kit mutation, the response rate was higher at when imatinib was given at 800mg daily compared with the standard dose of 400mg daily. Although the data linking tyrosine kinase mutation status and imatinib response in metastatic GISTs is intriguing, more information is needed before mutation testing is adopted as part of the routine analysis of high-risk or overtly malignant KIT-expressing GISTs.25 Despite the fact that exon 9 mutations are associated with a lower response rate, overall survival does not appear to be better with high-dose therapy. The investigators propose to conduct a retrospective analysis of mutational analysis on patients with GIST and determine the relationship between patient response and imatinib dose.

Conditions
-----------------
Asian Patients With Advanced Gastro-intestinal Stromal Tumors (GIST) Treated With Imatinib

Intervention / Treatment
-----------------
* Procedure: Tumor biopsies


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologic diagnosis of advanced stage or metastatic GIST Asian patient (as defined by the investigator) First line treatment with imatinib Availability of tumor samples for kit mutation analysis Availability of tumor response rate and or time to progression data Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- |
| Tumor biopsies<br> | Procedure: Tumor biopsies<br> <br> |

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
-----------------
Advanced gastro-intestinal stromal tumors
Pharmacokinetics of Advantage Arrest

Study Overview
=================
Brief Summary
-----------------
The study aim is to characterize the kinetics of silver and fluoride after topical application of silver diamine fluoride.

Detailed Description
-----------------
The purpose of this study is to characterize basic PK parameters (Cmax, t1/2, AUC, and total urinary recovery) to contribute to evidence for the safety of Advantage Arrest, consistent with Guidance for Industry--Exposure--Response Relationships (April 2003).

Official Title
-----------------
Pharmacokinetics of Advantage Arrest

Conditions
-----------------
Dental Caries

Intervention / Treatment
-----------------
* Drug: 38% silver diamine fluoride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older, minimum 20 teeth, healthy, not taking prescription or OTC medications Exclusion Criteria: pregnant, weighed less than 50 kg, had oral mucositis or ulcerative lesions, known sensitivity to silver or fluoride

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
Intervention Model: Single Group Assignment
Interventional Model Description: Open label exposure--response study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 38% silver diamine fluoride<br>38% silver diamine fluoride, topical, 1 drop, single application | Drug: 38% silver diamine fluoride<br>* Topical application of SDF to teeth<br>* Other names: Advantage Arrest;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observed Fluoride Urinary Recovery | 24 hour fluoride urinary recovery (in mg) | baseline to 24 hours | 
| Observed Silver Tmax | Observed silver time to maximum serum concentration in hours | baseline, 30 minutes, and 1, 2, 3, 4, 6, 8, 12, and 24 hours | 
| Observed Silver Cmax | Observed silver maximum serum concentration in ng/mL | baseline, 30 minutes, and 1, 2, 3, 4, 6, 8, 12, and 24 hours | 
| Observed Silver Baseline-Corrected Cmax | Observed silver baseline-corrected maximum serum concentration in ng/mL | baseline, 30 minutes, and 1, 2, 3, 4, 6, 8, 12, and 24 hours | 
| Observed Silver t1/2 | Observed silver serum elimination half-life in hours | baseline, 30 minutes, and 1, 2, 3, 4, 6, 8, 12, and 24 hours | 
| Observed Silver 24 Hour Urinary Concentration | Observed silver 24-hour urinary concentration in ng/mL | baseline to 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adult, fluoride, silver, silver diamine fluoride, pharmacokinetics
SDD for Eradicating CRKP Carriage

Study Overview
=================
Brief Summary
-----------------
There is an urgent need to control the current national outbreak of Carbapenem-resistent Klebsiella pneumonia (CRKP). In Israel, the death rate among CRKP carriers is 3.5 times higher than in Carbapenem-sensitive Klebsiella pneumonia carriers (44% vs. 12.5%, respectively). In the investigators' previous study: A Randomized, Double-Blind, Placebo-Controlled Trial of Selective Digestive Decontamination (SDD) Using Oral Gentamicin and Oral Polymyxin E for Eradication of CRKP Carriage (Infect Control Hosp Epidemiol. 2012;33:14-19) the investigators have shown that the investigators' SDD regimen is effective for decolonization patients colonized with CRKP. The investigators' assumption is that a higher dose of polymyxin E together with gentamicin (SDD drugs) for a prolonged period is needed to overcome the likelihood of a high rate of drug inactivation in the gut, thereby reaching CRKP carriage eradication.

Official Title
-----------------
SELECTIVE DIGESTIVE DECONTAMINATION USING ORAL GENTAMICIN AND ORAL POLYMYXIN E FOR ERADICATION OF CARBAPENEM-RESISTANT KLEBSIELLA PNEUMONIAE CARRIAGE IN HOSPITALIZED PATIENTS

Conditions
-----------------
Carriers of Carbapenem-resistant Klebsiella Pneumonia

Intervention / Treatment
-----------------
* Device: Gentamicin and polymyxin E


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provide a sighed and dated written informed consent document indicating that the subject (or a legally accepted representative) has been informed of all pertinent aspects of the study Hospitalized men or women at least 18 years of age Rectal swab culture positive for CRKP in the last week Will be willing to initiate and remain on treatment, except for adverse events occurring Exclusion Criteria: Age less than 18 years. Pregnant women, lactating women. A know allergy to one of the study drugs. Renal failure with creatinine clearance less than 50mL/min. Current Treatment with IV gentamicin and/or IV polymyxin E Any safety, behavioral, clinical, or administrative reasons that, in the Investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: One arm only - Gentamicin and polymyxin E<br>All subjects will receive:Gentamicin and polymyxin E paste applied on buccal surface four times daily + gentamicin + polymyxin E PO + Strict contact precautions | Device: Gentamicin and polymyxin E<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CRKP carriage at end of treatment |  | one year |
Oral Health and Severe COPD

Study Overview
=================
Brief Summary
-----------------
This case-control study aims to investigate the association of severe COPD with oral health.

Official Title
-----------------
Oral Health in Patients With Severe Chronic Obstructive Pulmonary Disease (COPD)

Conditions
-----------------
COPD, Periodontitis, Caries, Quality of Life, Tooth Loss

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged ≥ 40 years and ≤ 85 years; Test group: patients with COPD GOLD 3 and 4 with available pulmonary function test values (FEV1, FVC) within the last two weeks; Control group: patients without diagnosed or self-suspected pulmonary disease matched for age, sex, smoking and number of systemic diseases to the test group; Understanding of measures performed in the study; Written informed consent. Exclusion Criteria: - Pregnancy.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 85 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 |
| --- | --- |
| Test Group<br>Severe COPD (GOLD 3 and 4). | |
| Control Group<br>Matched to Test Group regarding age, sex, smoking history and number of systemic diseases. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tooth loss | Is the number of teeth different in patients with severe COPD compared to patients without COPD? | one year |
New Tumor Models in Three Dimensions and in a Human Skin Environment for Personalized Melanoma Therapy

Study Overview
=================
Brief Summary
-----------------
The choice of treatment of patients with metastatic melanoma depends on the status of B-RAF of the tumor: in the absence of mutation, treatment with immunotherapy (currently anti-PD1) is proposed in the first line; When B-RAF is mutated, treatment with targeted therapies is retained: B-RAF and MEK inhibitors are prescribed in combination (vemurafenib + cobimetinib or dabrafenib + trametinib). Patient response rates for targeted therapies range from 50 to 60%, and the occurrence of sometimes severe side effects is not predictable. There are currently no predictive biomarkers of patients' response to targeted therapy molecules. The in vitro evaluation of the intrinsic sensitivity of the cells of patients to different combinations of targeted therapy molecules would make it possible to propose the best therapeutic combinations. The cutaneous metastases are chosen in the model because of easy access to collect tumor tissue. The most relevant in vitro models for mimicking cutaneous melanoma metastases are explant cultures and human skin equivalents.

Official Title
-----------------
New Tumor Models in Three Dimensions and in a Human Skin Environment for Personalized Melanoma Therapy

Conditions
-----------------
Melanoma (Skin)

Intervention / Treatment
-----------------
* Other: Development of the most specific physiologically relevant experimental patient models


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Major Patients, patients with melanoma (stage IV) with cutaneous metastases, seronegative HIV, HBV, HCV, HTLV1. Exclusion Criteria: Absence of cutaneous metastasis or in transit HIV or HBV or HCV or HTLV1 seropositivity Patient minor, patient under guardianship or curatorship

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patient with stage IV melanoma<br> | Other: Development of the most specific physiologically relevant experimental patient models<br>* Development of the most specific physiologically relevant experimental patient models: organotypic culture of biopsies, reconstituted skin (equivalents of dermis with melanoma, dermis equivalents and epidermis with melanoma), and in vitro evaluation The response of tumor cells to different combinations of targeted therapy molecules<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluating in vitro the response of tumor cells to different combinations of targeted therapy molecules |  | 30 months |
Diabetes Mellitus Care Decision Making Model Through Data Mining

Study Overview
=================
Brief Summary
-----------------
We tried to use data mining method to find out the new model of factors that affects the progression of diabetes mellitus.

Detailed Description
-----------------
The advanced development of medical technology had led to the accumulation of a large amount of medical data. Unfortunately, these useful and meaningful clinical data were not properly managed or analyzed. Therefore, data mining technology has become an essential instrument for hospital management and medical research. Possible meaningful information can be obtained from the database through data mining. About 2,000 diabetic patients had been enrolled in Diabetes Care Program since Oct 2002 in our hospital. We intend to look for the determining factors that affect the prognosis of diabetes mellitus in our patients group.

Official Title
-----------------
Diabetes Mellitus Care Decision Making Model Through Data Mining

Conditions
-----------------
Diabetes Mellitus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diabetes mellitus who had been enrolled into the Diabetes Care Program from year 2002 until 2007. Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetes mellitus, care decision, data mining
Long-term Study in Patients Under Anti-retroviral Combination Therapy Switching to Viramune®

Study Overview
=================
Brief Summary
-----------------
Collecting data on maintaining anti-retroviral activity (quantitative HIV RNA determination) and immunological activity (CD4 cells) after switching from protease inhibitor or NNRTI to Nevirapine (Viramune®) and collecting of routinely observed laboratory data on lipids, and liver enzymes.

Official Title
-----------------
Long-term Observational Study in Patients Under Anti-retroviral Combination Therapy Who Were Switched From Protease Inhibitors or Other NNRTI to Viramune® Plus Two Nucleoside Reverse Transcriptase Inhibitors (NRTI) for Reasons of Therapy. (Long-Term Switch)

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Viramune® tablets


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult male and female out-patients with HIV type 1 infection who have achieved a viral load below detection limit (50 copies/ml) for more than 6 months under a previous combination therapy with protease-inhibitors (PI) or non-nucleoside reverse transcriptase inhibitors (NNRTI) Women can only be included, if a test has excluded pregnancy Only women can be included, who use a reliable means of contraception during the observational study Exclusion Criteria: Known sensitivity to Viramune or one of its excipients Clinically relevant changes in lab findings (e.g. increase in aspartate aminotransferase (AST) or alanine aminotransferase (ALT) by more than five-fold of upper limit normal) Patient is not able to abstain from treatment with ketoconazole, oral contraceptives, and other medication CYP3A metabolism For females: Pregnancy Breast-feeding Insufficient or unreliable contraception

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 |
| --- | --- |
| Viramune®<br> | Drug: Viramune® tablets<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in viral load (HIV-RNA) |  | Baseline, up to 36 months | 
| Changes in CD4 cell count |  | Baseline, up to 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in body weight |  | Baseline, up to 36 months | 
| Changes in general well-being assessed on a 4-point scale |  | Baseline, up to 36 months | 
| Changes in lipid parameters | mg/dl | Baseline, up to 36 months | 
| Changes in glucose | mg/dl | Baseline, up to 36 months | 
| Changes in liver enzymes | U/l | Baseline, up to 36 months | 
| Number of patients with adverse events |  | up to 36 months |
Evaluation of Safety and Efficacy of Once Monthly Ranibizumab Injections in Chinese Patients With Wet Age Related Macular Degeneration (AMD) Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to provide efficacy and safety data for monthly ranibizumab 0.5 mg intravitreal injections in Chinese patients with subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD). The study results will support the regulatory submission in China to make ranibizumab available for clinical use.

Official Title
-----------------
An Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Ranibizumab (0.5 mg) in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-related Macular Degeneration Over 12 Months

Conditions
-----------------
Age Related Macular Degeneration

Intervention / Treatment
-----------------
* Drug: ranibizumab 0.5 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female Chinese patients 50 years of age or greater. Patients with primary or recurrent subfoveal CNV secondary to AMD. Patients who have a BCVA score from 73 to 24 characters in the study eye. Exclusion Criteria: Active, or history of, ocular inflammation or infection in the study eye within the last 30 days. Uncontrolled glaucoma in the study eye. Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

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

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> | Drug: ranibizumab 0.5 mg<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate efficacy of ranibizumab 0.5 mg by mean change in best-corrected visual acuity (BCVA) from Baseline to Month 4 as assessed with early treatment of diabetic retinopathy study (ETDRS) like charts at a distance of 4 meters. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the effects of ranibizumab 0.5 mg on the change in BCVA from Baseline to Month 12. |  | 12 Months | 
| To evaluate effects of ranibizumab 0.5 mg on retinal structure at Month 4 and Month 12 as assessed by fundus photography, fluorescein angiography, and optical coherence tomography. |  | 12 Months | 
| To evaluate safety of ranibizumab 0.5 mg by rates of adverse events/SAEs, ophthalmic exams, tonometry, and changes in laboratory values/vital signs at Months 4 and 12. |  | 12 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AMD, Ranibizumab