linjc16/ctgov huggingface dataset:
Sino-nasal Inhalation of Colistin in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Colonization

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the nasal inhalation of Colistin is effective to decrease the Pseudomonas aeruginosa bacterial count in the nasal lavage fluid.

Official Title
-----------------
Sino-nasal Inhalation of Colistin Via the Pari Sinus Nebulizer in Patients With Cystic Fibrosis and Colonization of the Upper Airways With Pseudomonas Aeruginosa

Conditions
-----------------
Cystic Fibrosis, Pseudomonas Aeruginosa

Intervention / Treatment
-----------------
* Drug: Colistin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: subject has a confirmed diagnosis of cystic fibrosis detection of P. aeruginosa in nasal lavage (culture) with chronic P.a. colonization of the lung (from day -28) informed consent of the patients or parents subject >= 6 years subject is able to comply with the inhalation procedures and nasal lavage procedures scheduled in the protocol women of childbearing potential are only included into the study, if they are using an effective method of birth control during the protocol Exclusion Criteria: subject has a critical condition defined as: forced expiratory volume at one second < 30% and / or arterial oxygen saturation < 93% without O2-substitution; need of O2-substitution subject had an ear, nose, and throat surgery within 3 months prior to study subject shows signs of nasal bleeding subject has an ear drum perforation subject had an acute rhinosinusitis or a pulmonary exacerbation at study entry with need of additional systemic antibiotic therapy against pseudomonas aeruginosa subject is unlikely to comply with the procedures scheduled in the protocol subject has a known allergic reaction to the medication subject is pregnant or breastfeeding subject participates in another clinical trial within 30 days prior to study entry or 30 days after end of the study. systemic (oral or intravenous) antibiotic treatment against P.a. 14 days prior to the inclusion and during the study

Ages Eligible for Study
-----------------
Minimum Age: 6 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

| Intervention/Treatment |
| --- |
|Drug: Colistin|Sino-Nasal inhalation, approximately 1 ml / day in each nostril|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease of Pseudomonas aeruginosa in Nasal lavage fluid |  | 60 days |
Pycnogenol for the Treatment of Lymphedema

Study Overview
=================
Brief Summary
-----------------
The objectives of this study are to evaluate the effectiveness of Pycnogenol (French maritime pine bark extract) for arm lymphedema in women following treatment for breast cancer, to evaluate the accuracy and sensitivity of bioelectric impedence as a measurement of lymphedema of the arm, and to validate the proposed arm lymphedema quality-of-life questionnaire.

Official Title
-----------------
Treatment of Arm Lymphedema in Breast Cancer Survivors: A Double-Blind, Randomized Study of Pycnogenol vs. Placebo

Conditions
-----------------
Lymphedema

Intervention / Treatment
-----------------
* Drug: Pycnogenol
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 6 months from last surgical and/or radiation treatment to the affected axilla Unilateral lymphedema of the upper extremity Exclusion Criteria: May not be receiving or be scheduled to receive cytotoxic or radiation chemotherapy treatment while on this study

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: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>pycnogenol daily | Drug: Pycnogenol<br>* pycnogenol 300 mg daily<br>|
| Placebo Comparator: 2<br>placebo daily | Drug: Placebo<br>* placebo 3 capsules daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction of arm lymphedema |  | monthly | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparison/validation of bioelectric impedance to measure lymphedema changes, validation of lymphedema questionnaire |  | monthly | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lymphedema of the arm in breast cancer survivors
Remote Monitoring of Uroflowmetry

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to assess the possibility of using remote monitoring of urination.

Official Title
-----------------
Study of Remote Monitoring of Urination Dynamics

Conditions
-----------------
Lower Urinary Tract Symptoms

Intervention / Treatment
-----------------
* Procedure: Uroflowmetry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men over 18 years old. The patient has performed uroflowmetry according to indications in the hospital no later than 7 days before the planned inclusion in the trial. Qmax = or <15 ml / sec. The patient has a smartphone (with Android 4.0 and higher, iOS 10.0 and higher) with Internet access Exclusion Criteria: A patient with emergency conditions requiring surgical treatment Intellectual and cognitive abilities of the patient that do not allow him to follow the doctor's instructions and make it difficult to use the smartphone.

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

Sexes Eligible for Study
-----------------
Male

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: Patients with LUTS<br>Patients who are indicated for uroflowmetry | Procedure: Uroflowmetry<br>* The patient is given a portable uroflowmeter for performing uroflowmetry at home, and the NetHealth app is installed on his smartphone. The patient registers his account in the app. A personal uroflowmeter is paired with the patient's smartphone using the installed app via a Bluetooth connection. The investigator trains the patient how to use the app and how to conduct uroflowmetry at home. The patient within 1 day (24 hours) at home performs uroflowmetry during all urination, including night urination.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uroflowmetry during 24 hours | Registration of remote uroflowmetry using portable uroflowmeter during 24 hours | 1 day |
A Study Of The Safety and Efficacy Of Viagra In Men With Erectile Dysfunction Who Do Not Self Identify.

Study Overview
=================
Brief Summary
-----------------
To compare the efficacy and safety of Viagra (sildenafil citrate) vs. placebo for the treatment of men with ED and at least 1 prespecified risk factor who do not self identify as having ED.

Official Title
-----------------
A Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Flexible-Dose Study To Assess The Efficacy And Safety Of Viagra (Sildenafil Citrate) In Men With Erectile Dysfunction (ED) Who Do Not Self Identify.

Conditions
-----------------
Impotence

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: Viagra (sildenafil citrate)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men who do not identify as having ED with documented ED Men 30 years of age and older At least one prespecified risk factor for ED Exclusion Criteria: Subjects currently prescribed, taking and/or likely to be treated with nitrates or nitric oxide donors in any form on either a regular or intermittent basis Subjects with a known history of retinitis pigmentosa.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo tablet orally approximately 1 hour before sexual activity, with no more than 1 dose in a 24-hour period, for a total of 8 weeks (DB phase). In 4-week OL phase, subjects received sildenafil 50 mg or 100mg orally approximately 1 hour before sexual activity, with no more than 1 dose in a 24-hour period.<br>|
| Experimental: Sildenafil<br> | Drug: Viagra (sildenafil citrate)<br>* Sildenafil 50 mg or 100mg orally approximately 1 hour before sexual activity, with no more than 1 dose in a 24-hour period, for a total of 12 weeks (8-week DB phase and 4-week OL phase).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the change from baseline in Erectile Function (EF) domain of International Index of Erectile Function (IIEF). |  | Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other questionnaires and variables such as IIEF, SEAR, GEAQ, SEX-Q, QEQ, EDITS, SEP, Event Log, Erection Hardness Grading Score, and Morisky Compliance. |  | Weeks 8 and 12 | 
| Safety and Tolerability |  | up to 12 Weeks |
Impact of Brief Motivational Interviewing on Periodontal Clinical Outcomes: a 3-year Post-trial Follow-up

Study Overview
=================
Brief Summary
-----------------
The objective is a 3-year follow-up clinical trial to evaluate longitudinal indicators of periodontal disease (plaque score, bleeding on probing (BOP), and gingival index (GI)) in 58 participants who completed NCT03571958. These participants were randomized to a brief motivational (BMI) test group or a traditional oral hygiene instruction (OHI) group for a 1-year clinical trial from 2018-2020. In addition, analysis of retrospective data to determine health topics that emerge from the behavior change strategy of BMI compared to traditional OHI by transcription of audio recordings from 2018-2020.

Official Title
-----------------
Impact of Brief Motivational Interviewing on Periodontal Clinical Outcomes: a 3-year Post-trial Follow-up

Conditions
-----------------
Periodontal Diseases, Plaque Score, Bleeding on Probing, Gingival Index

Intervention / Treatment
-----------------
* Other: BMI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ° Completed all study visits of STUDY00003697 (NCT03571958) Exclusion Criteria: Current smoker or quit smoking within the last year Pregnant, planning to become pregnant, or unsure of pregnancy status (self-reported) Uncontrolled diabetes (HbA1C > 7) Medical conditions that may influence the outcome of the study (neurologic or psychiatric disorders, systemic infections, cancer, and/or HIV/AIDS) Current use of oral bisphosphonates History of IV bisphosphonates Require pre-medication or on long-term antibiotics Current orthodontic treatment or planning to begin orthodontic treatment during the study Unable to comply with the study protocol

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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMI<br> | Other: BMI<br>* Longitudinal data will be collected to determine the effectiveness of BMI compared to traditional OHI to maintain and improve periodontal health.<br>|
| No Intervention: Traditional Oral Hygiene Instruction<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plaque score | Excellent hygiene: 0-20%, Good hygiene: 21-40%, Fair hygiene: 41-60%, Poor hygiene: 61-100% | Recorded one time 2 years +/- 8 months | 
| Bleeding on probing | Presence of bleeding (yes) or absent of bleeding (no) | Recorded one time 2 years +/- 8 months | 
| Gingival index | 0= normal gingiva, 1=mild inflammation (no BOP), 2=moderate inflammation (BOP), 3=severe inflammation (spontaneous bleeding) | Recorded one time 2 years +/- 8 months |
Phase I Study of Alferon N Injection in Persons With Asymptomatic Human Immunodeficiency Virus (HIV) Infection

Study Overview
=================
Brief Summary
-----------------
To determine the safety and tolerance of subcutaneous injections of natural interferon alpha (IFN) in asymptomatic HIV-positive persons and record its effects on the HIV virus in these individuals.

Official Title
-----------------
Phase I Study of Alferon N Injection in Persons With Asymptomatic Human Immunodeficiency Virus (HIV) Infection

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

Intervention / Treatment
-----------------
* Drug: Interferon alfa-n3


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have: HIV-1 seropositivity. CD4 count > 400/mm3. Eligibility for care in the military medical system. Prior Medication: Allowed: Acyclovir. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: AIDS- or ARC-defining condition (unexplained weight loss, fever, diarrhea, night sweats). Evidence of AIDS dementia. Chronic hepatitis with severe liver dysfunction. Active gastrointestinal, renal, respiratory, endocrine, hematologic, cardiovascular, or psychiatric disorder that would limit ability to complete the study. Hemophilia. Co-existent disease likely to result in death within the next 2 years. Known hypersensitivity to human interferon alpha. Known anaphylactic hypersensitivity to mouse immunoglobulin (IgG), egg protein, or neomycin. Concurrent Medication: Excluded: Any other concurrent experimental medications. Patients with the following prior conditions are excluded: History of AIDS- or ARC-defining condition (unexplained weight loss, fever, diarrhea, night sweats). Evidence of chronic hepatitis with severe liver dysfunction. Prior Medication: Excluded within 5 days prior to study entry: Immunosuppressive agents. Chemotherapy. Steroids. Excluded within 45 days prior to study entry: BCG vaccine. Isoprinosine. Other immune modulators. Excluded within 3 months prior to study entry: Any form of interferon. Antiviral therapy. Immunoregulatory therapy (other than acyclovir). 1. Active drug abuse (narcotic or alcohol abuse documented within the past 6 months). Unlikely or unable to comply with the requirements of the protocol.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Interferon alfa-n3|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
-----------------
Drug Evaluation, Interferon-alpha
Pulmonary Nodule Localization Prospective Validation

Study Overview
=================
Brief Summary
-----------------
Localization is the key for successful excision of small target nodules under thoracoscopy, but the procedure also brings risks to patients. However, the criteria is still unclear. The investigators will validate the prediction model produced by institutional retrospective analysis in the prospective cohort.

Detailed Description
-----------------
Excision of targeted lung nodules during thoracoscopy sometimes needs placing a mark before surgery. The procedure of mark placement (localization) could probably cause damages to the patients. However, the criteria for patient selection is still not clear. Through respective analysis, the investigators have set up a prediction model and wish to validate this model prospectively.

Official Title
-----------------
Pulmonary Nodule Localization Under Thoracoscopic Surgery- a Machine Learning Based Retrospective Analysis and Prospective Validation

Conditions
-----------------
Video-assisted Thoracic Surgery, Pulmonary Nodules

Intervention / Treatment
-----------------
* Procedure: Thoracoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≧ 20 years Lung nodule size ≦2cm on the pre-operative computed tomography (CT) Nodulectomy is performed under thoracoscopy Exclusion Criteria: Age < 20 years Lung nodule size > 2cm on CT or in the final pathology report Open surgery for nodulectomy

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Thoracoscopy|Patients who are indicated for thoracoscopic nodulectomy.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nodule detection | Whether the nodule could be detected by conventional visualization or palpation | During surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Video-assisted thoracic surgery, Thoracoscopy, Localization, Pulmonary nodules
Registry for End Stage Renal Failure

Study Overview
=================
Brief Summary
-----------------
The rein registry collects case record data from patients with end stage renal disease followed in French Guiana. This allows to generate incidence and rates for terminal renal disease, mortality rates for each territory. The regional data are pooled in order to get national statistics for end stage renal disease and transplantation activity in order to adapt prevention to the main causes of renal failure and treatment and care infrastructure.

Official Title
-----------------
Réseau, Epidémiologie, Information, Néphrologie (Network Epidemiology Information Nephrology)

Conditions
-----------------
End Stage Renal Failure

Intervention / Treatment
-----------------
* Other: Registry (No intervention)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: End Stage Renal Failure Exclusion Criteria: Refusal to participate
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Registry (No intervention)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death |  | 10 years | 
| Transplant |  | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Renal Transplant
To Demonstrate the Relative Bioavailability of Cetirizine Hydrochloride/Pseudoephedrine Hydrochloride 5 mg/120 mg Extended Release (ER) Tablets Under Fasting Conditions

Study Overview
=================
Brief Summary
-----------------
To demonstrate the relative bioavailability of Cetirizine Hydrochloride/Pseudoephedrine Hydrochloride 5 mg/120 mg ER tablets under fasting conditions.

Official Title
-----------------
A Single-Dose Comparative Bioavailability Study of Two Formulations of Cetirizine Hydrochloride/Pseudoephedrine Hydrochloride 5 mg/120 mg Extended Release Tablets Under Fasting Conditions

Conditions
-----------------
Allergies

Intervention / Treatment
-----------------
* Drug: Cetirizine HCl/Pseudoephedrine HCl 5 mg/120 mg (Sandoz, USA)
* Drug: Zyrtec-D 12 Hour 5 mg/120 mg Extended Release Tablets (Pfizer, USA)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: Positive test results for HIV or hepatitis B or C. Treatment for drug or alcohol dependence.

Ages Eligible for Study
-----------------
Minimum Age: 24 Years
Maximum Age: 54 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Cetirizine HCl/Pseudoephedrine HCl 5 mg/120 mg (Sandoz, USA) | Drug: Cetirizine HCl/Pseudoephedrine HCl 5 mg/120 mg (Sandoz, USA)<br> <br> |
| Active Comparator: 2<br>Zyrtec-D 12 Hour 5 mg/120 mg Extended Release Tablets (Pfizer, USA) | Drug: Zyrtec-D 12 Hour 5 mg/120 mg Extended Release Tablets (Pfizer, USA)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence based on AUC and Cmax |  | 10 days |