linjc16/ctgov huggingface dataset:
CONDOR Impact of Dental Practice-Based Research Network

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to study the use of a Core Questionnaire that included several questions from each PBRN (DPBRN, PEARL, PRECEDENT - collectively know as CONDOR) that had been extracted from questionnaires previously administered as part of their initial research program activities. This protocol was the first administration of this core questionnaire with the purpose of assessing dental practice changes that may have occured since the earlier administration of the individual questions with the separate networks.It also collected baseline data for others.

Detailed Description
-----------------
The three dental PBRNs had a unique opportunity to measure the impact of research participation on potential changes in practice base of the research protocol. We were able to examine the effect of participation in research in general to the acceptance of research findings from other studies and the effect of association with but not participation in a research network.

Official Title
-----------------
CONDOR Impact of Dental Practice-Based Research Network (PIRG)

Conditions
-----------------
Behavior Changes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: DPBRN dentists and hygienists who had completed a DPBRN Enrollment questionnaire and for whom DPBRN had a current active address and who were currently licensed to practice reported on the Enrollment Questionnaire they were a general dentist, pediatric dentist, or dental hygienist, or reported doing at least some restorative dentistry procedures practiced in one of the five DPBRN regions (AL/MS, FL/GA, MN< PDA, or SK)

Ages Eligible for Study
-----------------
Minimum Age: 22 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 |
| --- | --- |
| Measure impact of research participation<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
-----------------
effect of participation, effect of association
Parathyroid Tissues Anatomic Localizations Are Displaced Downward in Parathyroid Hyperplasia Cases

Study Overview
=================
Brief Summary
-----------------
This study investigates if Parathyroid Tissues Anatomic Localizations Are Displaced Downward in Parathyroid Hyperplasia Cases or not.

Detailed Description
-----------------
Parathyroid tissues gets heavier when they become Hyperplasia. Because of this weight change, they change their normal anatomic positions. 125 patients who have been operated earlier will be included in the study.

Official Title
-----------------
Parathyroid Tissues Anatomic Localizations Are Displaced Downward in Parathyroid Hyperplasia Cases

Conditions
-----------------
Parathyroid Hyperplasia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have undergone an operation due to parathyroid hyperplasia Exclusion Criteria: -
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 |
| --- | --- |
| Upper 1/3 of thyroid tissue<br> | |
| Middle 1/3 of thyroid tissue<br> | |
| Lower 1/3 of thyroid tissue<br> | |
| Below thyroid tissue<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Size of the thyroid tissue | Longitudinal size (in mm) of each parathyroid tissue according to its anatomical location (upper, middle or lower 1/3 of the thyroid gland or below the thyroid) | one year |
Comparison of the Two and Six- Minute Walk Tests in Evaluating Oxygen Desaturation in Patients With Severe COPD

Study Overview
=================
Brief Summary
-----------------
All measurements are performed on two consecutive days at the beginning of a pulmonary rehabilitation program in a randomized cross-over study design. On the first day, each patient is randomly assigned to perform either the 2 minute walk test or the 6 Minute walk test. On the second day each patient performs the test that was not performed on the first day. All walk tests are performed by the same investigator on the same track and time of day, following the 2002 guidelines of the American Thoracic Society. Patients wear a mobile pulse oximeter that continuously records heart rate and oxygen saturation during testing. Baseline values of oxygen saturation, heart rate and ratings of perceived exertion on the modified Borg scale (0 to 10) for dyspnea and leg fatigue are recorded at rest after 10 minutes of sitting.

Official Title
-----------------
Comparison of the Two and Six- Minute Walk Tests in Evaluating Oxygen Desaturation in Patients With Severe COPD

Conditions
-----------------
Chronic Obstructive Lung Disease

Intervention / Treatment
-----------------
* Other: walk tests


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: confirmed diagnosis of chronic obstructive lung disease stage III or IV according to the Global Initiative for chronic Obstructive Lung Diseases definition ability to read and understand the German language and study procedures. written informed consent Exclusion Criteria: severe acute exacerbation of chronic obstructive lung disease severe respiratory failure (partial Oxygen pressure at rest lower than 55 millimeter mercury) non compliance to the study protocol.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 2 minute walk test<br> | Other: walk tests<br> <br> |
| Other: 6 minute walk test<br> | Other: walk tests<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oxygen desaturation |  | up to 6 minute walk test | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| heart rate |  | during 2 minute walk test and 6 minute walk test | 
| perceived exertion for dyspnea and leg fatigue | measured by a modified Borg scale from 0 to 10 | during 2 minute walk test and 6 minute walk test |
Home Non-invasive Ventilation for Chronic Obstructive Pulmonary Disease Patients

Study Overview
=================
Brief Summary
-----------------
Chronic Obstructive Pulmonary disease (COPD) patients with chronic hypercapnic respiratory failure are more likely to develop exacerbations. Non-invasive ventilation has been proposed to treat acute respiratory failure but little information is available about the benefits of home non-invasive ventilation in COPD patients with chronic hypercapnic respiratory failure surviving an acute hypercapnic respiratory failure. The purpose of this study is to determine whether home non-invasive ventilation can reduce recurrent acute hypercapnic respiratory failure in COPD patients who survived an episode of acute hypoxemic respiratory failure (AHRF) treated by Non-invasive ventilation (NIV).

Official Title
-----------------
Home Non-invasive Ventilation Versus Long-term Oxygen Therapy in COPD Survivors of Acute Hypercapnic Respiratory Failure. A Multicenter Randomized Controlled Trial

Conditions
-----------------
Chronic Obstructive Pulmonary Disease, Hypercapnic Respiratory Failure

Intervention / Treatment
-----------------
* Device: Non Invasive Ventilation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years old COPD patients who survived after an episode of acute hypercapnic respiratory failure Patients weaned from ventilation (non invasive ventilation or mechanical ventilation) for acute episode since at least seven days with stable arterial blood gas since at least two days: PaCO2 > 55 mmHg and pH > 7.35 Exclusion Criteria: Age > 85 years old Non- COPD causes of respiratory failure Obstructive sleep apnea excluded by polysomnography Adverse psychosocial status Serious co-morbidity

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Long Term Oxygen Therapy<br> | |
| Active Comparator: Non Invasive Ventilation<br> | Device: Non Invasive Ventilation<br>* NIV during night<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute hypercapnic respiratory failure episode |  | up to 102 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death |  | 1 month and every 6 months during 2 years |
Phase Out in Tinnitus Patients

Study Overview
=================
Brief Summary
-----------------
Phase shift treatment is a new tinnitus therapy that aims at sound cancelling via complete or partial residual inhibition. This technique is based on the theory by Choy advocating that the induction of a sound wave with a 180 degree phase shift compared to the sound experienced by the patient could result in sound cancelling, likely by negation of the cortical perception of tinnitus. The aim is to determine the efficacy of the Phase Out treatment in pure tone and narrow band noise tinnitus patients.

Official Title
-----------------
Phase Out Treatment for Tinnitus

Conditions
-----------------
Tinnitus

Intervention / Treatment
-----------------
* Device: Phase Out treatment in pure tone tinnitus patients


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: consult ENT department UZA with tinnitus pure tone tinnitus or narrow band noise tinnitus unilateral tinnitus, or bilateral tinnitus if both ears pure tone or both ears narrow band noise frequency tinnitus > 1kHz cochlear origin tinnitus tinnitus duration 3 months or longer age 18y or more patient being able to cooperate patiënt able to fill in VAS normal MRI pontine angle Exclusion Criteria: depression: BDI > 21 pulsatile tinnitus pregnancy epilepsy

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
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: narrow band noise<br>Phase out in narrow band noise tinnitus patients | Device: Phase Out treatment in pure tone tinnitus patients<br>* Phase Out treatment: 30 min 3x/w during 6 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale |  | 3x/week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score on Tinnitus Questionnaire |  | week 0, week 3, week 6 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tinnitus, Phase Out
Vascular Impact of Omega-3 in Metabolic Syndrome

Study Overview
=================
Brief Summary
-----------------
The overall aims of the present project are to investigate the impact of a nutritional approach based on omega-3 from vegetal origin on vascular function in hypertension associated with metabolic syndrome.

Official Title
-----------------
Cardiovascular Impact of Omega-3 Dietary Supplement From Vegetal Origin in Hypertension Associated With Metabolic Syndrome

Conditions
-----------------
Essential Hypertension, Metabolic Syndrome

Intervention / Treatment
-----------------
* Dietary Supplement: omega-3 from vegetal origin
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female and male patients with treated essential hypertension (blood pressure values<140/90 mmHg under antihypertensive treatment). Presence of at least two of the following criteria of the metabolic syndrome: abdominal girth >102 cm in men or >88 cm in women, HDL-C<0.4 g/L in men or <0.5 g/L in women, fasting triglyceride >1.5 g/L (or specific treatment for these lipid abnormalities), fasting glucose >1.10 g/L. Exclusion Criteria: Secondary hypertension, myocardial infarction, coronary artery disease, cerebrovascular disease, stroke or transient ischemia, cardiac failure, diabetes (or fasting glucose>1.26 g/L) or renal failure (MDRD < 50 ml/min) Severe hypercholesterolemia (total cholesterol > 2.5 g/l), alcohol or drug abuse, toxicomania, or clinically significant abnormalities in other current biological parameters.

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

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: omega-3 from vegetal origin<br> | Dietary Supplement: omega-3 from vegetal origin<br>* 6 months of supplementation with omega-3 from vegetal origin<br>* Other names: Cyclodextrin/Camelin oil;|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br>* 6 months of supplementation with placebo<br>* Other names: Cyclodextrin/Starch;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brachial artery flow-mediated dilatation |  | 6 months after omega-3 supplementation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aortic stiffness | carotid-to-femoral pulse wave velocity | 6 months after omega-3 supplementation |
Prospective Study of the Diagnostic and Therapeutic Management of Congenital Glaucoma in France

Study Overview
=================
Brief Summary
-----------------
Evidence of a relationship between age at discovery of congenital glaucoma and visual acuity at 4 years of age. The delay in diagnosis is a factor of poor visual acuity. Will justify the implementation of information programs with health and education professionals in order to improve the functional prognosis of patients with congenital glaucoma.

Detailed Description
-----------------
Prospective multicentre prospective cohort Enabling the identification and follow-up of an almost exhaustive population of incidents of congenital glaucoma in 23 ophthalmology centers in France Inclusion over 4 years Epidemiological data, all reports of consultation, medical and surgical procedures collected in an E-CRF. Database for gene research related to congenital glaucoma to provide screening, genetic counseling and personalized care

Official Title
-----------------
Prospective Study of the Diagnostic and Therapeutic Management of Congenital Glaucoma in France

Conditions
-----------------
Congenital Glaucoma

Intervention / Treatment
-----------------
* Procedure: TRABECULOTOMY


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Boys or girls under the age of 4, without antecedent, French or resident in France, Suspected Glaucoma Exclusion Criteria: Antecedent of surgery for glaucoma

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TRABECULOTOMY<br> | Procedure: TRABECULOTOMY<br>* Evaluation of the prognosis of different surgery in congenital glaucoma<br>* Other names: sclerectomy needling trabeculectomy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity by logarithmic scale of Sander-Zanlonghi | Evidence of a relationship between age at discovery of congenital glaucoma and visual acuity at 4 years of age | at 4 years of the child | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular pressure | measure intraocular pressure (Tonopen or Perkins initially, air tonometer or Goldman as soon as possible) for prognosis of congenital glaucoma | at 4 years of the child | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
visual acuity, prognosis epidemiology
High Dose BAYA1040_Nifedipine: a Long Term Combination Study

Study Overview
=================
Brief Summary
-----------------
This is a clinical study evaluating the safety and efficacy of long term administration of oral BAYA1040_Nifedipine 80 mg/day (40 mg twice daily) with other antihypertensives in patients with essential hypertension who are not at target blood pressure by the combination of BAYA1040_Nifedipine 40 mg once daily and other antihypertensives.

Official Title
-----------------
A Multicenter, Open Label, Long Term Study of Oral BAYA1040_CR 80 mg (40 mg Bid) in Combination With Other Antihypertensives for 52 Weeks in Patients With Essential Hypertension

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Nifedipine (Adalat, BAYA1040)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20 years or older Japanese male or female Outpatient with essential hypertension Patients who are treated with Adalat CR 40 mg od and at least one antihypertensive drug (other than Ca antagonists) for 4 weeks or more before entry in this study Exclusion Criteria: Patients whose sitting diastolic blood pressure (DBP) is 110 mm Hg or more Patients with secondary hypertension or hypertensive emergency

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Nifedipine (Adalat, BAYA1040)<br>* Nifedipine (Adalat, BAYA1040) 40mg twice a day (BID)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy changes measured by sitting diastolic blood pressure (DBP) |  | Up to 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy changes measured by sitting systolic blood pressure (SBP) |  | Up to 52 weeks | 
| Proportion of subjects achieving a target BP based on the Japanese Society of Hypertension (JSH) 2009 guidelines |  | Up to 52 weeks | 
| Proportion of subjects achieving a target DBP and SBP based on JSH 2009 guidelines or a >10 mmHg reduction of DBP |  | Up to 52 weeks | 
| Safety variables | Adverse events, vital signs, electrocardiography (ECG), and laboratory tests were evaluated. | Up to 30 days after the last dose of study drug | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
BAYA1040, Nifedipine, Essential hypertension, Japanese Patients, Phase III, combination study, 14024
Tenofovir, Emtricitabine and Efavirenz Late Switch to a Single Pill: Patients' Opinion Survey

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess adherence, tolerability and satisfaction of each eligible HIV subjects switching from a two- or three-pill tenofovir-emtricitabine-efavirenz (TDF-FTC-EFV) to a one-pill TDF-FTC-EFV treatment.

Detailed Description
-----------------
Each eligible patient will be screened from de SHCS database. Each refusal and drop-out will be documented. A pre-visit (V-1) will be scheduled for informed consent, V0 for inclusion (V-1 and V0 may occur on the same day), V1 one month post-inclusion and V2 4 to 7 months post-inclusion. V0, V1 and V2 will be planned during regular medical visits. Eligible patients either get their cART in their usual pharmacy according to standard of care, or take part in a routine adherence-enhancing program(adherence subgroup)run by the pharmacists of the outpatient medical clinic. In the adherence subgroup, adherence is assessed electronically by MEMS (Medication event monitoring system) monitors on a regular basis.

Official Title
-----------------
HIV-positive Patients Under Tenofovir, Emtricitabine and Efavirenz Therapy Switching From a Two-pill Regimen to a Single Pill Regimen: Patients'Opinion Survey

Conditions
-----------------
HIV Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients under TDF-FTC-EFV followed up at the Service of Infectious Disease of the University Hospital of Lausanne enrolled in the SHCS Exclusion Criteria: patients receiving TDF-FTC-EFV in combination with other ARTs patients under TDF-FTC-EFV for less than 3 months patients not fluent in French

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Patient adherence | by questionnaire in both subgroups and by MEMS data in the adherence subgroup | V0, V1, V2 | 
| Adverse events and symptoms | by questionnaires | V0, V1, V2 | 
| Treatment management | Treatment management according to meals, timing, disruptive daily schedule By questionnaire | V0, V1, V2 | 
| Patient satisfaction of the switch | By questionnaire | V1, V2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of switch on clinical outcomes | Clincal outcomes = viral load, CD4 count, resistance, EFV blood level. By medical file | V0, V1, V2 | 
| Patients' acceptance of switch |  | V-1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Medication Adherence, HIV Infection, efavirenz, emtricitabine, tenofovir disoproxil fumarate drug combination [Substance Name], efavirenz, emtricitabine, Patient Satisfaction, tenofovir disoproxil fumarate