linjc16/ctgov huggingface dataset:
Spacer Comparison In Adult Asthmatics

Study Overview
=================
Brief Summary
-----------------
Spacers are used by people with respiratory diseases who have problems using MDIs (metered dose inhalers). This study used fluticasone propionate/salmeterol to look at the pharmacokinetic profiles produced by different spacers in their washed and un-washed states.

Detailed Description
-----------------
A randomised, open label, five-way crossover study to assess the systemic exposure of fluticasone propionate and salmeterol from SERETIDE™/ADVAIR™ 250 HFA MDI without spacer and with AeroChamber-Max spacer and VOLUMATIC™ both in their washed and unwashed states in adult subjects with mild or intermittent asthma.

Official Title
-----------------
A Randomised, Open Label, Five-way Crossover Study to Assess the Systemic Exposure of Fluticasone Propionate and Salmeterol From SERETIDE/ADVAIR 250HFA MDI Alone and With AeroChamber-Max Spacer and VOLUMATIC Both in Their Washed and Unwashed States in Adult Subjects With Mild or Intermittent Asthma

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: fluticasone propionate/salmeterol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Non-smoking with a BMI of 19 - 30 Diagnosed with mild or intermittent asthma and taking medication for it. Exclusion criteria: Taking oral corticosteroids or inhaled fluticasone propionate Have certain medical conditions or are not otherwise healthy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: fluticasone propionate/salmeterol|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The pharmacokinetic profile of fluticasone propionate (in particular the area under the curve to time t and the maximum concentration) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The pharmacokinetic profile of salmeterol and the time to maximum concentration of fluticasone propionate |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
asthma, spacer
Arginase Inhibition and Microvascular Endothelial Function in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The present project is designed to test the hypothesis that arginase contributes to microvascular endothelial dysfunction in patients with type 2 diabetes and microvascular complications.

Detailed Description
-----------------
Background The development of microvascular complications in diabetes is a complex process, in which endothelial dysfunction is of importance. Emerging evidence suggests that arginase is a key mediator of endothelial dysfunction in type 2 diabetes mellitus (T2DM) by reciprocally regulating nitric oxide bioavailability. The aim of this study was to test the hypothesis that arginase activity is increased and that arginase contributes to microvascular endothelial function in patients with T2DM and microvascular dysfunction. Method Microvascular endothelium-dependent and -independent vasodilatation are investigated in patients with T2DM (n =12) and healthy age-matched control subjects (n =12) with laser-Doppler flowmetry during iontophoretic application of acetylcholine and sodium nitroprusside, respectively, before and after intra-arterial administration of the arginase inhibitor N-hydroxy-nor-L-arginine (0.1 mg/min) for 120 min.

Official Title
-----------------
Effect of Arginase Inhibition on Microvascular Endothelial Function in Patients With Type 2 Diabetes and Microvascular Dysfunction.

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Other: N-hydroxy-nor-L-arginine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of type 2 diabetes mellitus and microvascular dysfunction defined as microalbuminuria > 3.0 mg/mmol or presence of retinopathy. Exclusion Criteria: Myocardial infarction or unstable angina within the last three months, Changed dose of any vasodilator drug during the preceding six weeks, Ongoing treatment with warfarin Concomitant disease that may have interfered with the possibility for the patients to comply with or complete the study protocol

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arginase inhibition<br>N-hydroxyl-nor-L-arginine, i.a. 0.1 mg/min for 120 min | Other: N-hydroxy-nor-L-arginine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cutaneous microvascular endothelial function | Laser Doppler flow rate | 2 hours |
Measurement of the Cervix During Pregnancy According to Age of Conization

Study Overview
=================
Brief Summary
-----------------
Treatment of precancerous lesions of the cervix by conization has been shown to increase the risk of premature delivery and premature rupture of the membranes. It has now been clearly established that the cervix is a growing organ during adolescence and early adulthood, It has been hypothetized that cervical conization during the growth phase reduced its growth potential, and induced shorter cervix during the upcoming pregnancy. No studies have been conducted investigating the age at which conization no longer had an impact on cervical size during pregnancy. This will help to identify the age at conisation below which patients will be identified as being at risk event, and thus offer increased monitoring and possibly prophylactic management by programmed strapping. We propose to measure the length of the cervix of pregnant patients who have benefited from conization, which is currently recommended by the Collège National des Gynécologues Obstetriciens Français .In addition, the investigators will use a control group consisting of non-con conical, parity-matched pregnant patients in whom a cervical measurement will also be performed.

Official Title
-----------------
Measurement of the Cervix During Pregnancy According to Age of Conization

Conditions
-----------------
Cervix; Pregnancy

Intervention / Treatment
-----------------
* Other: Previous conization
* Other: no previous conization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient referred since January 2008 with pregnancy between 2008 and 2017 Pregnancy after conisation Cervix size between 21 and 24 SA before any obstetric event Control group: parity matching, asymptomatic patients Exclusion Criteria: Threat of late miscarriage, Premature rupture of membranes before cervical echography, Other pregnancies after study of 1st pregnancy after conisation, No measurement of the conization specimen, Lost to follow-up, Age <18 Twin Pregnancies Patient under guardianship

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| a group of women who have been conized<br>Previous conization | Other: Previous conization<br>* a group of women who have been conized,<br>|
| control group with asymptomatic patients<br>on routine second trim no previous conization | Other: no previous conization<br>* group with asymptomatic patients on routine second trimester echography<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The main objective is to study the correlation between the size of the cervix and the age at conization. age at conization | Cervix length Measured during the second semester echography | 1 day |
A Phase 2 Study of Immunogenicity, Safety and Tolerability of CSL412 in Elderly Participants

Study Overview
=================
Brief Summary
-----------------
Current influenza vaccines have a reduced efficacy in the elderly. This study will investigate the immunogenicity, safety and tolerability of an adjuvanted influenza vaccine in elderly participants.

Official Title
-----------------
A Phase II, Double-Blind, Randomised, Controlled, Multi-Centre Study to Evaluate the Immunogenicity, Safety and Tolerability of Three Formulations of CSL412 in Adults (≥ 18 to ≤ 45 Years) and Older Adults (≥ 60 Years)

Conditions
-----------------
Influenza

Intervention / Treatment
-----------------
* Biological: CSL412
* Biological: Inactivated trivalent influenza vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged ≥ 18 to ≤ 45 OR ≥ 60 Ability to provide pre-vaccination venous blood sample Exclusion Criteria: History of clinically significant medical conditions Immunomodulative therapy Acute infection

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

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Inactivated trivalent influenza vaccine | Biological: Inactivated trivalent influenza vaccine<br> <br> |
| Experimental: 2<br>CSL412 formulation | Biological: CSL412<br> <br> |
| Experimental: 3<br>CSL412 formulation | Biological: CSL412<br> <br> |
| Experimental: 4<br>CSL412 formulation | Biological: CSL412<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| seroprotection rate, HI titre & seroconversion/ significant increase |  |  | 
| grade 3 or higher, vaccine associated fever or vaccine associated site ulceration, abscess or necrosis |  |  |
The Effect of Thyroid Antibodies on Female Reproductive Function and Pregnancy Outcomes

Study Overview
=================
Brief Summary
-----------------
Some women at reproductive age have positive antithyroid antibodies (ATAs). Thyroid peroxidase antibody (TPOAb) and thyroglobulin antibody (TgAb) are the most common ATAs. This study aimed to evaluate the impact of ATAs on maturation of women reproductive system and pregnancy outcomes.

Official Title
-----------------
The Effect of Thyroid Antibodies on Female Reproductive Function and Pregnancy Outcomes

Conditions
-----------------
Thyroiditis, Autoimmune

Intervention / Treatment
-----------------
* Drug: LT4


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age during 18-45y; Women tested for TPOAb and/or TgAb, TSH, free T3, free T4, total T3 and total T4 during the 1st trimester of pregnancy Exclusion Criteria: Multiple pregnancies; Age < 18 y or > 40 y; L-T4 or PTU intervention before pregnancy; Other autoimmune diseases.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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 |
| --- | --- |
| ATA-positive<br> | Drug: LT4<br>* LT4 is used to improve the thyroid function of pregnant women.<br>|
| ATA-negative<br> | Drug: LT4<br>* LT4 is used to improve the thyroid function of pregnant women.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rate of pregnancy complications in women with or without thyroid antibodies |  | 1 year |
Cell Therapy for Motor Neuron Disease/Amyotrophic Lateral Sclerosis

Study Overview
=================
Brief Summary
-----------------
The effect of autologous bone marrow mononuclear cells on Motor Neuron Disease/Amyotrophic Lateral Sclerosis patients.

Official Title
-----------------
The Effect of Autologous Bone Marrow Mononuclear Cell Transplantation on Motor Neuron Disease/Amyotrophic Lateral Sclerosis

Conditions
-----------------
Amyotrophic Lateral Sclerosis

Intervention / Treatment
-----------------
* Biological: Stem Cell


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with the diagnosis of definite Motor Neuron Disease/amyotrophic lateral sclerosis. Age 18-80 years Exclusion Criteria: HIV/HBV/HCV Malignancies Bleeding tendencies Pneumonia Renal failure Severe liver dysfunction Severe anemia [hb < 8] Any bone marrow disorder Space occupying lesion in brain Pregnancy and lactation Other acute medical conditions/infections such as respiratory infection and pyrexia left ventricular ejection fraction < 25% Patient on artificial ventilatory support

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stem Cell<br>bone marrow mononuclear cell transplantation | Biological: Stem Cell<br>* intrathecal autologous bone marrow mononuclear cell transplantation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amyotrophic Lateral Sclerosis Functional rating scale-revised |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stem cells, Motor Neuron Disease, Amyotrophic Lateral Sclerosis, Autologous Mononuclear Cell therapy
Antifungal Potential of Moringa Olifera Against Otomycosis

Study Overview
=================
Brief Summary
-----------------
patients with Otomycosis were recognized by an ENT specialist. 20 patients were distributed randomly into two groups. The first group will be treated with Nystatin ear drops twice daily. The second group will be treated with Moringa ear drops. patients will be examined endoscopically by the ENT specialist. patient's swabs will be isolated and analyzed by ELISA.

Detailed Description
-----------------
Inclusion criteria: (1) Otomycosis . Exclusion criteria: tympanic membrane perforation; concurrent immune suppression, and concurrent bacterial infection.

Official Title
-----------------
Antifungal Potential of Moringa Olifera-loaded Nanoparticles Against Otomycosis; Preparation, Characterization, and Clinical Evaluation

Conditions
-----------------
Otomycosis

Intervention / Treatment
-----------------
* Drug: Moringa oleifera leaf 10mg/100ml
* Drug: Ear Drop


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Otomycosis ear inflammation Exclusion Criteria: tympanic membrane perforation concurrent immune suppression, concurrent bacterial infection.

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Parallel Assignment
Interventional Model Description: moringa extract ear drops
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Placebo group<br>Nystatin ear drops formulations prepared as intervention except for the addition of Moringa prepared using biodegradable polymers in aseptic condition and tested for sensitivity | Drug: Ear Drop<br>* plain ear drop formulation without moringa<br>|
| Experimental: Moringa group<br>Moringa ear drops prepared using biodegradable polymers in aseptic condition and tested for sensitivity | Drug: Moringa oleifera leaf 10mg/100ml<br>* ear drops<br>* Other names: ear drops;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants recovered with clear endoscopic examination | Number of participants recovered with clear endoscopic examination | one week | 
| Identification of different microorganisms infected ear | Patients swabs (microorganisms concentration) | up to 1 month |
A Radiolabeled Mass Balance Study of [14C]-Ertugliflozin (PF04971729, MK-8835) In Healthy Male Participants (MK-8835-038)

Study Overview
=================
Brief Summary
-----------------
This is single dose study of radiolabeled [14C]-ertugliflozin (PF04971729, MK-8835) in healthy male volunteers to study the absorption, distribution, metabolism and elimination of ertugliflozin.

Official Title
-----------------
An Open Label, Single-Period, Phase 1 Study To Evaluate The Pharmacokinetics, Excretion Balance And Metabolism Of [14C]-PF04971729 In Healthy Adult Male Subjects

Conditions
-----------------
Type 2 Diabetes Mellitus (T2DM)

Intervention / Treatment
-----------------
* Drug: Ertugliflozin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male participants with Body Mass Index of 17.5 to 30.5 kg/m2 and a total body weight >50 kg (110 lbs) Exclusion Criteria: Female participants. Participants enrolled in a previous radionucleotide study or who have received radiotherapy or exposed to significant radiation within 12 months prior to screening

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: [14C]Ertugliflozin<br>Single dose - oral dosing suspension | Drug: Ertugliflozin<br>* Ertugliflozin 25 mg will be administered as a single oral suspension containing approximately 100 uCi of [14C]ertugliflozin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Percent of Dose Recovered in Urine and Feces Following a Single Oral Dose of [^14C]Ertugliflozin (100 µCi). |  | Up to 7 Days | 
| Area under the plasma concentration-time curve (AUC) from time 0 to time of the last quantifiable concentration (AUClast) for ertugliflozin |  | Up to 7 Days | 
| AUC from Hour 0 to infinity (AUCinf) for ertugliflozin |  | Up to 7 Days | 
| Maximum plasma concentration (Cmax) of ertugliflozin |  | Up to 7 Days | 
| Time taken to reach the maximum observed plasma concentration (Tmax) of ertugliflozin |  | Up to 7 Days | 
| Ertugliflozin half life (t1/2) |  | Up to 7 Days | 
| Amount of Ertugliflozin and metabolites in plasma, urine, and feces |  | Up to 7 Days | 
| Number of Participants Experiencing an Adverse Event (AE) |  | Up to 7 Days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Absorption, Distribution, Metabolism, and Excretion, Mass Balance, Metabolic Profile, Radiolabel Study
Study of GW685698X In Patients With Seasonal Allergic Rhinitis

Study Overview
=================
Brief Summary
-----------------
This study was designed to compare the efficacy and safety of an investigational nasal spray compared with placebo nasal spray and commonly used drug in the treatment of seasonal allergic rhinitis. Allergic rhinitis is an inflammatory disorder of the upper airway that occurs following allergen exposure. The focus of this study, seasonal allergic rhinitis (SAR), is one type of allergic rhinitis that is triggered by the pollen from trees, grasses, and weeds. Typical symptoms are sneezing, nasal congestion and pruritus, rhinorrhea, and pruritic, watery, red eyes.

Official Title
-----------------
Clinical Evaluation of GW685698 for Seasonal Allergic Rhinitis -A Placebo-controlled Study to Determine the Non-inferiority of GW685698 Over Fluticasone Propionate Using a Double-blind Manner-

Conditions
-----------------
Rhinitis, Allergic, Seasonal

Intervention / Treatment
-----------------
* Drug: GW685698X Aqueous Nasal Spray


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Informed consent Outpatient Diagnosis of seasonal allergic rhinitis with symptoms Able to comply with study procedures Exclusion Criteria: Significant concomitant medical condition Use of corticosteroids/allergy medications Laboratory abnormality Positive pregnancy test Allergy to any component of investigational product

Ages Eligible for Study
-----------------
Minimum Age: 16 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: GW685698X Aqueous Nasal Spray|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline over the entire treatment period in three total nasal symptom scores. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline over the entire treatment period in four total nasal symptom scores. |  |  | 
| Mean change from baseline over the entire treatment period in individual total nasal symptom scores. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GW685698X, allergic rhinitis, Seasonal Allergic Rhinitis