linjc16/ctgov huggingface dataset:
The Safety of Tenofovir Disoproxil Fumarate Taken With Other Anti-HIV Drugs to Treat HIV-Infected Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety of tenofovir disoproxil fumarate (tenofovir DF) in combination with other anti-HIV drugs in patients who have participated in other tenofovir DF studies (GS-98-902 or GS-99-907), are able to tolerate the drug at different doses, and may benefit from having tenofovir DF treatment.

Detailed Description
-----------------
Patients take tenofovir DF in combination with other antiretrovirals.

Official Title
-----------------
A Phase 3, Open-Label, Multicenter Study of the Safety of Tenofovir Disoproxil Fumarate Administered in Combination With Other Antiretroviral Agents for the Treatment of HIV-1 Infected Patients

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

Intervention / Treatment
-----------------
* Drug: Tenofovir disoproxil fumarate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients may be eligible for this study if they: Have completed another study on tenofovir DF without toxicity. Are willing to use intrauterine or effective barrier methods of birth control, both men and women, during the study and for 30 days following tenofovir DF treatment. Exclusion Criteria Patients will not be eligible for this study if they: Are taking drugs that may damage the kidney (nephrotoxic) including aminoglycoside antibiotics, amphotericin B, cidofovir, cisplatin, foscarnet, IV pentamidine, vancomycin, and oral or IV ganciclovir. Are taking agents that affect kidney function, such as probenecid. Are receiving systemic chemotherapy. Are taking systemic corticosteroids. Are taking experimental drugs except those that are approved by Gilead. Are currently participating in the GS-99-908 or GS-00-912 (expanded access) studies. Are pregnant or breast-feeding.

Ages Eligible for Study
-----------------
Minimum Age: 0 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tenofovir disoproxil fumarate|nan|

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
-----------------
HIV-1, Drug Therapy, Combination, Reverse Transcriptase Inhibitors, Anti-HIV Agents, 9-(2-phosphonylmethoxypropyl)adenine
Nurse Smoking Cessation of Patients With Chronic Obstructive Pulmonary Disease (COPD) With Nicotine Replacement Therapy (NRT) and Behavioral Support

Study Overview
=================
Brief Summary
-----------------
This is a smoking cessation study with COPD patients where the researchers wanted to evaluate if nicotine sublingual tablets or placebo combined with low or high individual support could increase ½ and 1 year quit rates.

Detailed Description
-----------------
Placebo, controlled, randomized, double-blind trial with 400-1000 smoking COPD patients with FEV-1 < 90 % predicted normal with the use of nicotine sublingual nicotine tablets or placebo for 12 weeks combined with individual clinic visits with low or high intensity conducted by trained nurses in several centres in pulmonary clinics in Denmark. Outcome was smoking cessation and smoking reduction after ½ and 1 year as self declared smoking status confirmed by carbon monoxide in expired air< 10 ppm. Secondary outcomes were change in body-weight, quality of life (SF-36 and SGRQ), symptoms, lung function, adverse events.

Official Title
-----------------
Smoking Cessation of Patients With COPD: A Multi-Center, Randomized, Placebo Controlled Nurse Conducted Smoking Cessation Trial

Conditions
-----------------
Smoking, COPD

Intervention / Treatment
-----------------
* Drug: nicotine sublingual tablets
* Behavioral: low and high behavior support


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COPD patients (FEV1/FVC<70% and FEV1<90 % predicted) Smoking 1 cigarette daily or more Willing to follow the protocol Exclusion Criteria: Used NRT or bupropion the last week Not able or willing to adhere to the protocol Estimated survival < 1 year

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: nicotine sublingual tablets|nan|
|Behavioral: low and high behavior support|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| smoking cessation after 6 and 12 months |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| smoking reduction after 12 months |  |  | 
| change in quality of life (St. George Respiratory Questionnaire) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
smoking cessation, nicotine sublingual tablets, behaviour support, smoking reduction, quality of life, COPD, weight
Trichomonas Vaginalis Repeat Infections Among HIV Negative Women

Study Overview
=================
Brief Summary
-----------------
The overall goal of this project is to determine the influence of patient treatment and host factors on repeat Trichomonas vaginalis (TV) infections among HIV-negative women

Detailed Description
-----------------
This study is a phase III randomized clinical trial. HIV-negative women who test positive for TV at their routine gynecological exam at participating clinics will be referred to the nurse/study coordinator to screen for eligibility, provide a description of the study, and obtain written, informed consent (N=700). Subjects will undergo an audio computer assisted self- interview (ACASI), and will self-collect vaginal swabs for Trichomonas testing by InPouch and Nucleic Acid Amplification Test (NAAT), Gram stain testing, and a future microbiome specimen. They will be randomized into one of two arms; metronidazole (MTZ) 2 g single dose (CDC recommended treatment regimen) or MTZ 500 mg twice daily x 7-day dose (CDC alternative treatment regimen). All enrolled women will be scheduled for a follow-up visit at four weeks post treatment completion (window 3-13 weeks).

Official Title
-----------------
Trichomonas Vaginalis Repeat Infections Among HIV Negative Women

Conditions
-----------------
Vaginitis Trichomonal or Due to Trichomonas

Intervention / Treatment
-----------------
* Drug: MTZ 500 mg twice daily x 7 days
* Drug: MTZ 2 g


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female English speaking >= 18 years old Exclusion Criteria: HIV-infected unable to provide informed consent pregnant breast feeding treated by their provider for Bacterial vaginosis (BV) at visit

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MTZ 2 g<br>Single dose MTZ | Drug: MTZ 2 g<br>* MTZ 2 g<br>* Other names: Single dose MTZ;|
| Experimental: MTZ 500 mg twice daily x 7 days<br>Multi dose MTZ | Drug: MTZ 500 mg twice daily x 7 days<br>* MTZ 500 mg twice daily x 7 days<br>* Other names: Multi-dose MTZ;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects That Were Trichomonas Vaginalis (TV) Positive After Treatment With Metronidazole (MTZ) | Presence of TV is assessed by nucleic acid amplification test (NAAT) of vaginal swab collected 4 weeks post treatment completion. | 4 weeks post treatment completion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Trichomonas vaginalis, metronidazole
Aripiprazole and Lexapro Drug Interaction Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical research study is to learn whether aripiprazole has effect on the steady-state pharmacokinetics of escitalopram in healthy subjects. The safety and tolerability of aripiprazole and escitalopram co-administration will also be studied.

Official Title
-----------------
Effects on Aripiprazole on the Steady-State Pharmacokinetics of Escitalopram in Healthy Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Escitalopram on days -7 to day 14; Aripiprazole dosed starting Day 1 to day 14: 3 days at 10 mg, 4 days at 15 mg and 7 days at 20 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and female subjects, ages 18 to 45. (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the study in such a manner that the risk of pregnancy in minimized. Body Mass Index (BMI) of 18 to 33 kg/m2 inclusive. Exclusion Criteria: Subjects with a decrease in SBP of >=20 mm Hg and increase in HR of >=20 bpm after 2 minutes standing vs. 2 minutes supine at screening or with frank orthostatic hypotension at screening. Supine BP of 90/50 mm Hg or lower at screening.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br> | Drug: Escitalopram on days -7 to day 14; Aripiprazole dosed starting Day 1 to day 14: 3 days at 10 mg, 4 days at 15 mg and 7 days at 20 mg<br>* Tablets, Oral, Escitalopram: 10 mg; Aripiprazole: 10, 15, 20 mg, once daily, 14 days.<br>* Other names: Abilify;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multiple dose PK parameters for Lexapro when administered alone and coadministered with aripiprazole will be derived. Cmin for aripiprazole,dehydro-aripiprazole will be measured |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety will be based on review of AEs, VS, ECGs, physical exam, clinical labs |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy Subjects
Research of the Application of Triple Antibiotic Paste in Primary Teeth With Pericpical Periodontitis

Study Overview
=================
Brief Summary
-----------------
The triple antibiotic paste is widely used in young permanent teeth and permanent teeth root canal therapy with excellent antiantimicrobial effect.We hypothesize that its application in the treatment of periapical periodontitis of deciduous teeth is superior to other drugs currently in use as creosote.

Detailed Description
-----------------
We design to collect a group of patients presenting primary teeth with periapical periodontitis in certain criterion. We will divide the patients into two groups randomly.One group will get treated with triple antibiotic paste while the other with creosote.We want to evaluate the short-term and long-term effects of the two groups to get a conclusion of the clinical value of triple antibiotic paste.

Official Title
-----------------
Randomized Controlled Research of the Application of Triple Antibiotic Paste in Primary Teeth With

Conditions
-----------------
Periapical Diseases

Intervention / Treatment
-----------------
* Drug: Metronidazole-Ciprofloxacin gatifloxacin-Clindamycin paste
* Drug: creosote


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical diagnosis of periapical periodontitis must be primary teeth must be 3 8 years old the permanent tooth germ is complete and didnot be involved Exclusion Criteria: blood disease residual root that is advised to extract serious periodontitis allergy to the triple antibiotic paste

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 8 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: creosote<br>Creosote ，once，three weeks Triple Antibiotic Paste ，none | Drug: creosote<br>* Pulp removal,Root canal irrigation and disinfection<br>* Other names: oily liquid obtained by distillation of wood tar;|
| Experimental: Triple Antibiotic Paste<br>Triple Antibiotic Paste,once,three weeks creosote,none | Drug: Metronidazole-Ciprofloxacin gatifloxacin-Clindamycin paste<br>* Pulp removal,Root canal irrigation and disinfection,<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of lesion healing confirmed by cone beam computed tomography and X-rays |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
periapical periodontitis,primary teeth
Evaluating the Effect of Mucinex® 1200 mg on Mucociliary and Cough Clearance From the Human Lung

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to test the ability of Mucinex, an oral, over-the-counter, FDA approved expectorant) to stimulate the clearance of inhaled particles from the subject's lungs (called mucociliary clearance). The study will also monitor the metabolism of the drug by the subject's body.

Official Title
-----------------
An Open-Label, 2-way Crossover Placebo-Controlled , Radio-Labeled Tracer Study Evaluating the Effect of MUCINEX® 1200 mg on Mucociliary and Cough Clearance From The Human Lung In Healthy, Non-Smoking Adults

Conditions
-----------------
Mucociliary Clearance

Intervention / Treatment
-----------------
* Drug: Mucinex 1200mg
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Non smoker BMI 19-29 Normal lung function Exclusion Criteria: Pregnant Smokers Any illness

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mucinex 1200mg<br>Pill | Drug: Mucinex 1200mg<br>* Compared to Placebo<br>|
| Placebo Comparator: Placebo<br>Pill | Drug: Placebo<br>* Compare to active Mucinex<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between drug and placebo in the percentage of particles cleared from the lung. |  | Measurements at 60, 90 and 180 min | 
| Difference between drug and placebo as an estimate of small airway clearance. |  | Measurements at 60, 90 and 180 min | 
| Difference between drug and placebo between study days. |  | Measurements at 60, 90 and 180 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood will be drawn to determination of guaifenesin in the serum. |  | at baseline and every 30 min x8 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
healthy nonsmokers
MitraClip® After Surgical Mitral Valve Repair

Study Overview
=================
Brief Summary
-----------------
Percutaneous edge-to-edge repair of the mitral valve has been shown to be a safe and effective alternative treatment option for selected patients at high risk for cardiac surgery. Patients with recurrent mitral regurgitation after surgical mitral valve repair (sMVR) are per se at increased risk for another cardiac surgery. The purpose of this multicenter retrospective analysis of patients treated with a MitraClip® after sMVR, is to evaluate the effectiveness and durability of this minimally invasive treatment option in this subset of patients.

Detailed Description
-----------------
In this multicenter retrospective analysis of MitraClip® cases after MVR the effectiveness and durability of this minimally invasive treatment option in this subset of patients will be evaluated.

Official Title
-----------------
MitraClip® for the Treatment of Recurrent Severe Mitral Regurgitation After Surgical Mitral Valve Repair

Conditions
-----------------
Mitral Regurgitation

Intervention / Treatment
-----------------
* Device: Percutaneous edge-to-edge repair of the mitral valve


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with recurrent mitral regurgitation treated with a MitraClip®. Exclusion Criteria: Patient with endocarditis, Patients with torn mitral valve ring.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Percutaneous edge-to-edge repair of the mitral valve|MitraClip in patients with recurrent MI after surgical mitral valve repair.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  | 1 year | 
| MR (mitral regurgitation) grade after clip treatment | Scale 0-4 | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MR (mitral regurgitation) grade at latest follow up | Scale 0-4 | 1 year | 
| NYHA status at latest follow up |  | 1 year | 
| Distance in 6 minute walk test at latest follow up |  | 1 year | 
| LVEF (left ventricular ejection fraction) at latest follow up |  | 1 year | 
| LVEDV (left ventricular enddiastolic volume) at latest follow up |  | 1 year | 
| LVEDD (lef ventricular enddiastolic diameter) at latest follow up |  | 1 year | 
| Mean mitral valve gradient |  | 1 year | 
| Procedural complications |  | index procedure | 
| Death, recurrent mitral regurgitation grade > 2, repeat intervention/operation of mitral valve | combined endpoint defined as freedom from each Event (death, MR grade >2 or reintervention/Operation) | 1 year | 
| Clip success based on type of sMVR | success defined as reduction of 1 MR grade (scale 0-4) | index procedure |
First Trimester Screening for Trisomy 21, 18, 13 and 22q11.2 Deletion Syndrome

Study Overview
=================
Brief Summary
-----------------
Combined first-trimester screening represents the gold standard of risk assessment for the presence of trisomy 21, 18, and 13. The concept is based on the age risk, the measurement of fetal nuchal translucency (NT), and the determination of serum markers free beta-hCG and PAPP-A in maternal blood. In recent years it has been shown that the risk assessment can be improved by combining in-depth ultrasound and cell-free DNA analysis from maternal blood. In their latest study, the investigators were able to detect all fetuses with trisomy 21, 18, and 13 through this procedure. No normal fetus displayed an increased risk. In contrast, the detection rate in classic, combined first-trimester screening is about 95% and the false-positive rate is 3-5%. In this study the investigator examine the test quality - especially the false positives - of cell-free DNA analysis on trisomy 21, 18 and 13 as well as on the microdeletion 22q in 1000 pregnancies.

Official Title
-----------------
First Trimester Screening for Trisomy 21, 18, 13 and 22q11.2 Deletion Syndrome - ReFaPo02

Conditions
-----------------
Pregnancy

Intervention / Treatment
-----------------
* Diagnostic Test: cfDNA screening


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Maternal age of 18 years and more Crown rump length 45 - 84mm Referral for first trimester risk assessment Singleton pregnancy Written consent Exclusion Criteria: No consent Known parental microdeletion 22q11.2 Crown rump length <45mm or >84mm Multiple pregnancies including vanishing twins

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| cfDNA screening<br>Pregnant women who are referred for FTS or for further follow-up examinations in case of a suspected anomaly or increased nuchal translucency at 11-13 weeks' gestation can be recruited for this study. | Diagnostic Test: cfDNA screening<br>* cfDNA screening test for aneuploidy risk assessment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Screen positive rate | Screen-positive rate will be calculated by proportion of high risk results compared to all cfDNA tests performed | 15 month | 
| Screen false-positive rate | False-positive rate will be calculated by proportion of high risk results compared to all cfDNA tests performed in pregnancies with a normal offspring | 15 month | 
| Uninformative test rate in cfDNA screening for 22q11.2 deletion | Rate of uninformative tests will be defined by proportion of cfDNA screening for 22q11.2 deletion without results compared to all cfDNA tests performed | 15 month |