linjc16/ctgov huggingface dataset:
The Relation Between Serum Level of Amioterminal Propeptide of Type I Procollagen and Diastolic Dysfunction in Hypertensive Patients Without Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
In the present study, we assessed the relation between diastolic dysfunction and myocardial fibrosis in hypertensive patients without diabetes mellitus. A total of 20 medically treated ambulatory non-diabetic hypertensive patients with normal left ventricular (LV) systolic function were enrolled into this study. Myocardial fibrosis was evaluated by serum concentrations of amino-terminal propeptides of type I and III procollagen (PINP and PIIINP). All patients underwent examinations of diastolic function by echocardiography and technetium-99m (99mTc) radionuclide ventriculography. There were 8 patients with PINP ≦53 μg/l (group 1) and 12 patients with PINP >53 μg/l (group 2). Patients in group 2 had significantly lower LV peak filling rate (PFR; 3.2 ± 0.3 vs. 2.5 ± 0.2 end-diastolic volume/s) and shorter time to PFR ( 257 ± 41 vs. 174 ± 22 ms). Besides, the group 2 patients also had lower right ventricle PFR (1.9 ± 0.2 vs. 1.5 ± 0.1 end-diastolic volume/s) and shorter time to PFR ( 221 ± 29 vs. 154 ± 29 ms). Echocardiographic parameters for LV diastolic dysfunction (E/A ratio of mitral flow, deceleration time of E flow, velocities of pulmonary venous flow [retrograde A wave, systolic /diastolic velocity ratio], isovolumetric relaxation time, Tei index) were all comparable between two groups. In multiple regression analysis, LV time to peak filling rate was the only parameter that independently predicted serum PINP level (p<0.05). In conclusion, elevated serum PINP level reflected LV diastolic dysfunction in hypertensive patients without diabetes.

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: We enrolled 20 medically treated ambulatory, non-diabetic, hypertensive patients in this study. Exclusion Criteria: Patients with abnormal liver functions, leukocytosis, elevated serum levels of C-reactive protein, systolic dysfunction (LV ejection fraction <50%) and LV hypertrophy due to etiologies other than hypertension were excluded from this study.

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Standard Length Catheters vs Long Catheters in Peripheral Vein Cannulation.

Study Overview
=================
Brief Summary
-----------------
The Long and Short is a prospective, randomized, controlled, open label trial to test the complications of different device for peripheral vein cannulation, standard length (about 5 cm in length) and long catheter (about 12 cm in length), inserted with Seldinger technique.

Detailed Description
-----------------
The trial will compare the main complications: infiltration rate, phlebitis rate, occlusion and/or dislocation rate, thrombosis rate, number of percutaneous sticks, successful cannulation. Will be made for a cost analysis.

Official Title
-----------------
Standard Length Catheters vs Long Catheters in Peripheral Vein Cannulation. A Randomized Controlled Clinical Trial to Test the Complications.

Conditions
-----------------
Complications

Intervention / Treatment
-----------------
* Device: Standard Device for peripheral vein cannulation
* Device: Long Catheters for peripheral vein cannulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients infusional therapy more than 72 hours Exclusion Criteria: need for central venous catheter

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: standard length catheter<br>Standard Device for peripheral vein cannulation | Device: Standard Device for peripheral vein cannulation<br> <br> |
| Experimental: Long catheter<br>Standard Device for peripheral vein cannulation | Device: Long Catheters for peripheral vein cannulation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complications rate |  | 3 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
infiltration, phlebitis, occlusion, thrombosis
Lymphoma in the Orbit

Study Overview
=================
Brief Summary
-----------------
Imaging techniques have considerably improved over the last decades and ocular adnexal lymphomas (OALs) nowadays can be detected. As major advances in immunophenotyping and molecular diagnostics in histology have been achieved offering an accurate diagnosis, the investigators would like to introduce that surgical biopsy of an orbital lymphoma becomes crucial for the possibility of a correct diagnosis and proper treatment. As radiotherapy accomplished great preciseness as well and OALs respond excellently to radiation, this therapy should be the treatment of choice in local defined lymphomas instead of blind treatment with steroids. Radiation results in great local control rates of 85% to 100% Trial with surgical intervention

Conditions
-----------------
Ocular Adnexal Mucosa-Associated Lymphoid Tissue Lymphoma

Intervention / Treatment
-----------------
* Procedure: Lymphoma-Biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: - both genders >17 years of age underwent biopsy of an ocular adnexal lymphoma between 01/2006 and 12/2010 at the University Hospital Zurich, Division of Ophthalmology diagnosis histologically proven Exclusion criteria: less than 18 years of age patient underwent no MRI before surgery (biopsy)

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

| Intervention/Treatment |
| --- |
|Procedure: Lymphoma-Biopsy|Patients after biopsy of orbital lymphoma|

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
-----------------
ocular adnexal lymphomas
Efficacy and Safety Study of ME-609 and Acyclovir for Treatment of Herpes Simplex Labialis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether ME-609 is more efficient than acyclovir and placebo for the treatment of recurrent herpes labialis.

Detailed Description
-----------------
This was a randomized, double-blind, active- and vehicle-controlled study comparing the effects of ME-609, acyclovir in ME-609 vehicle, and vehicle alone. Treatment was subject-initiated within 1 hour of experiencing the first signs or symptoms of a herpes recurrence. The subject visited a study clinic as soon as possible after treatment initiation, but no later than midnight of the following day, for evaluation.

Official Title
-----------------
A Randomized, Double-Blind, Active Controlled, Vehicle-Controlled, Subject Initiated Study Comparing Efficacy and Safety of ME-609 Versus Acyclovir Cream for Treatment of Recurrent Herpes Simplex Labialis

Conditions
-----------------
Herpes Labialis

Intervention / Treatment
-----------------
* Drug: ME-609
* Drug: acyclovir in ME-609 vehicle
* Drug: Vehicle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Generally good health History of recurrent herpes labialis with at last three episodes during the prior 12 months Exclusion Criteria: Treatment with antivirals or immunosuppressive agents within 2 weeks prior to randomization Pregnant and/or nursing women Continuous daily treatment with pain medication Significant skin condition that occur in the area of herpes recurrences

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>ME-609 | Drug: ME-609<br>* Cream, dose 5 times daily during 5 days.<br>|
| Active Comparator: 2<br>Acyclovir in ME-609 vehicle | Drug: acyclovir in ME-609 vehicle<br>* Dose 5 times daily for 5 days<br>|
| Placebo Comparator: 3<br>Vehicle | Drug: Vehicle<br>* Dose 5 times daily for 5 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with non-ulcerative recurrences measured as the proportion of subjects in whom the study recurrence did not progress beyond the papule stage. |  | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Episode duration |  | until healing |
Viaskin® Peanut (DBV712) Expanded Access Protocol

Study Overview
=================
Brief Summary
-----------------
This is an open label expanded access program for male and female patients ≥ 4 years old.

Detailed Description
-----------------
This study is an open-label Intermediate-size EAP designed to provide treatment access for eligible Peanut-Allergic Children. This EAP entails visits every three months to assess patient status, safety, and to provide drug supply. Viaskin® Peanut treatment will continue until, in the clinical judgment of the Investigator, the patient is no longer benefiting from continuation of the treatment, the drug becomes approved and available by prescription, or the study is terminated.

Official Title
-----------------
Viaskin® Peanut (DBV712) Expanded Access Protocol in Peanut-Allergic Children

Conditions
-----------------
Peanut Allergy

Intervention / Treatment
-----------------
* Drug: Viaskin Peanut


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female ≥ 4 years of age Prior participation in a Viaskin® Peanut REALISE or PEOPLE clinical study for peanut-allergic patients Exclusion Criteria: Pregnancy or lactation or planning a pregnancy. Generalized dermatologic disease (for example, active atopic dermatitis, uncontrolled generalized active eczema, ichthyosis vulgaris) extending widely on the skin and especially on the back with no intact zones to apply the Viaskin® patches. Patients who developed hypersensitivity to excipients of the Viaskin® patches. Received or planning to receive anti-tumor necrosis factor drugs or anti-IgE drugs (such as omalizumab) or any biologic immunomodulatory therapy. Receiving or planning to receive any other type of immunotherapy to any food (for example, EPIT, OIT, or SLIT or specific oral tolerance induction) or any aeroallergen or venom immunotherapy during their participation in the study. Use of cyclosporine or other immunosuppressive agents within 3 months before entering the study. Topical calcineurin inhibitors are permitted. A history of important non-compliance during the REALISE or PEOPLE studies. Important non-compliance includes patients not applying the patches for 60 or more days in total and/or for 30 or more consecutive days during the REALISE or PEOPLE studies.

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 12 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Viaskin Peanut|Daily epicutaneous delivery|

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
-----------------
Peanut allergy, EPIT, Epicutaneous, Immunotherapy, Viaskin®
Intermittent Preventive Treatment in Infant in Mali

Study Overview
=================
Brief Summary
-----------------
Studies have shown that Intermittent preventive treatment in infants (IPTi) with Sulfadoxine-pyrimethamine (SP)reduced the incidence of clinical malaria and anemia without modifying infants' serological response to EPI vaccines. Thus IPTi was seen as a potential public health tool of great benefit to the children of Africa and a logical addition to the Immunization Plus package. The objectives of this operational researcher were to develop an implementation model for IPTi in the health care system in Mali to assess its impact on the EPI vaccines and other health interventions coverage and on molecular makers of resistance to SP

Detailed Description
-----------------
The study was implemented in districts of the region of Koulikoro; the district of Koulikoro and the district of Kolokani. The whole district of Koulikoro was covered by the intervention while in Kolokani, the 22 health areas (sub districts) were randomized in 1:1 ratio with the intervention in 11 health areas and the other 11 serving as control for the assessment of the impact of IPTi implementation on EPI vaccines and other health interventions coverage as well as its impact on the resistance to SP. The implementation consisted of administration of ½ tablet of Sulfadoxine -Pyrimethamine with EPI vaccines (DTP2, DTP3 and Measles vaccine) from December 2006 to December 2007.

Conditions
-----------------
Malaria

Intervention / Treatment
-----------------
* Drug: Sulfadoxine pyrimethamine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Resident of Kolokani, Mali Age less than 24 months Exclusion Criteria: Not Resident of Kolokani Age of 24 months or above

Ages Eligible for Study
-----------------
Maximum Age: 23 Months

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Sulfadoxine pyrimethamine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EPI vaccines and other health interventions coverage |  | 1 year | 
| Molecular makers of resistance of P. falciparum to Sulfaxodine- pyrimethamine |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Malaria, Intermittent Preventive Treatment, EPI vaccine coverage, Resistance of P. falciparum to Sulfadoxine- Pyrimethamine
Pulmonary Embolism: Mechanism and Therapeutic Innovation

Study Overview
=================
Brief Summary
-----------------
To explore the pathogenesis, therapy and outcome of pulmonary embolism (PE) and chronic thromboembolic pulmonary hypertension (CTEPH).

Detailed Description
-----------------
The study recruited consecutive outpatients or hospitalized patients diagnosed with pulmonary embolism (PE cohort) and chronic thromboembolic pulmonary hypertension (CTEPH cohort). The follow-up of all patients was performed annually by phone or outpatient visit. The main outcomes were bleeding, recurrent events, and survival. The objective of the study was to explore the pathogenesis, therapy and outcome of PE and CTEPH.

Official Title
-----------------
Pulmonary Embolism: Mechanism and Therapeutic Innovation

Conditions
-----------------
Pulmonary Embolism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All hospitalized patients or outpatients diagnosed with PE or CTEPH; Age ≥18. Exclusion Criteria: Refused informed consents.

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 |
| --- | --- | --- |
| Recurrent Incidence of Patients | Recurrent PE was measured by computed tomography pulmonary angiography (CTPA) or ventilation/perfusion (V/Q) lung scans. Recurrent deep venous thrombosis was measured by lower extremity Doppler ultrasound. | through study completion, an average of 1 year. | 
| Bleeding Rate of Patients | Events were recored by follow-up. | through study completion, an average of 1 year. | 
| Survival Rate of Patients | Events were recored by follow-up. | through study completion, an average of 1 year. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pulmonary embolism, chronic thromboembolic pulmonary hypertension, mechanism, therapy, outcome
Effect of Chronic Supplementation of L-arginine in the Muscular Performance

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to evaluate the effect of oral administration of L-arginine in the muscular fatigue of the quadriceps, expressed in terms of the Fatigue Resistance Factor (FRF). The secondary purpose of this study is to evaluate the effect of oral administration of L-arginine in the muscular force the quadriceps.

Official Title
-----------------
Randomized, Double Blind, Placebo Controlled Study of Parallel Groups to Evaluate the Effect of Chronic Supplementation of L-arginine in the Muscular Performance.

Conditions
-----------------
Muscular Fatigue

Intervention / Treatment
-----------------
* Drug: L-arginine aspartate (Targifor)
* Drug: Placebo L-arginine aspartate (Targifor)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Healthy young adults for both sex; Age between 20 and 55 years; Slight or moderate physical activity, 30 minutes per day, at least 3 times a week; Exclusion criteria: Cardiac or pulmonary disease; Previous history of knee surgery or skeletal muscular dysfunctions in hip, knee or ankle joints; Athletic person (intensive anaerobic activity); None practiced of physical activity regularly; Medications usage The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>L-arginine aspartate (Targifor) | Drug: L-arginine aspartate (Targifor)<br>* 3g of L-arginine taken orally in a single daily dose for 8 weeks<br>|
| Placebo Comparator: 2<br>Placebo | Drug: Placebo L-arginine aspartate (Targifor)<br>* Placebo of L-arginine taken orally in a single daily dose for 8 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue Resistance Factor (FRF) |  | Throughout the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum force in Newton (N) and fast or explosive force |  | at time 30% of the maximum isometric force | 
| Maximum force in Newton (N) and fast or explosive force |  | at time 50% of the maximum isometric force | 
| Maximum force in Newton (N) and fast or explosive force |  | at time 90% of the maximum isometric force |
Validation of Sexual Function Scale in Female Cancer

Study Overview
=================
Brief Summary
-----------------
To validate the FSFI(Female Sexual Function Index)-K, FSFI - 6 item and Quality of Sexual Function(QSF) version in Korean language of the cancer patients.

Detailed Description
-----------------
Due to the observational nature of the study which aims to evaluate the internal consistency and validity of the Korean version of Questionnaire, formal sample size and power calculations were not performed. When the number of observations (items) per subject ranges from 4 to 6, roughly 152-199 patients are required to show 10% increase in intraclass correlation from baseline ICC of 30% with 85% power and 5% type I error rate. The sample size was determined based on this calculation and practical considerations. The pilot study will be performed based on 30 people (include reference), and the main study will include 1100 people (considering 10% drop-out from 200 people in each group) cancer type (ovary, cervix, endometrium, and breast) and healthy female. Total 1130 patients.

Conditions
-----------------
Sexuality, Cancer, Healthy Women

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy women Female without history of cancer Cancer free as of the most recent linkage At least 18 years of age Able to speak and read Korean Sexual activity within 3months. Female cancer patient History of gynecological or breast cancer At least 18 years of age Able to speak and read Korean Sexual activity within 3months. Exclusion Criteria: Women who are unable to complete the questionnaires. Refuse to participate in the survey.

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

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

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 |
| --- | --- | --- |
| sexuality |  | 2-4 weeks |