linjc16/ctgov huggingface dataset:
Drug-Drug Interaction Study With PF-05089771

Study Overview
=================
Brief Summary
-----------------
This study will test the potential for PF-05089771 to interact with a cocktail of drugs

Official Title
-----------------
Evaluation Of The Effect Of PF-05089771 On The Metabolism Of Multiple Cytochrome P450 And OATP1B1 Transporter Substrates

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

Intervention / Treatment
-----------------
* Drug: Pravastatin, midazolam, losartan, omeprazole, caffeine and PF-05089771


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and/or female subjects between the ages of 18 and 55 years; Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs); Exclusion Criteria: Any condition possibly affecting drug absorption History of regular alcohol consumption Screening supine blood pressure >140 mm Hg (systolic) or >90 mm Hg (diastolic), Consumption of coffee, cola or other caffeine containing drinks

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active tratment<br>Pravastatin, midazolam, losartan, omeprazole, caffeine single dose alone or in combination with PF-05089771 | Drug: Pravastatin, midazolam, losartan, omeprazole, caffeine and PF-05089771<br>* PF-05089771 450mg single dose and titration from 150mg BID to 450mg BID Pravastatin 10mg dingle dose, Midazolam 7.5mg single dose, Losartan 25mg single dose, Caffeine 100mg single dose, Omeprazole 20mg single dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Observed Plasma Concentration (Cmax) |  | 24h | 
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) | 24h | 
| Minimum Observed Plasma Trough Concentration (Cmin) |  | 24h | 
| Time to Reach Maximum Observed Plasma Concentration (Tmax) |  | 24h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Lipid Parameters | Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations. | 14 days |
Efficacy of Nonsteroidal Anti-inflammatory Drugs in Treatment of Moderate and Severe Dry Eye Disease

Study Overview
=================
Brief Summary
-----------------
This clinical trial is to investigate whether nonsteroid anti-inflammatory drops have therapeutic effect on moderate to severe dry eye patients.And compare the efficacy of the two nonsteroid anti-inflammatory drops with topical corticosteroids.

Official Title
-----------------
Efficacy of Nonsteroidal Anti-inflammatory Drugs in Treatment of Moderate and Severe Dry Eye Disease

Conditions
-----------------
Moderate to Severe Dry Eye Syndrome

Intervention / Treatment
-----------------
* Drug: nonsteroid anti-inflammatory drops
* Drug: nonsteroid anti-inflammatory drops
* Drug: corticosteroids
* Drug: artificial tear substitute


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: moderate to severe dry eye syndrome tear film breakup time >0 second and ≤5 seconds,or schirmer test(no anaesthesia)≥2mm/5min and ≤5mm/5min corneal staining≥3 scores Exclusion Criteria: allergic to any composition of the drugs under experiment previous use of anti-inflammatory drugs or immunosuppressive agent viral,bacterial or fungal infection of the eye eyelid anomaly glaucoma or high IOP significant meibomian gland dysfunction

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group 1<br> | Drug: nonsteroid anti-inflammatory drops<br>* nonsteroid anti-inflammatory drops plus artificial tear substitute<br>* Other names: prunoprefen;|
| Experimental: group 2<br> | Drug: nonsteroid anti-inflammatory drops<br>* nonsteroid anti-inflammatory drops plus artificial tear substitute<br>* Other names: bronuck;|
| Experimental: group 3<br> | Drug: corticosteroids<br>* corticosteroids plus artificial tear substitute<br>* Other names: Fluorometholone;|
| Other: group 4<br> | Drug: artificial tear substitute<br>* artificial tear substitute alone<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tear osmolarity |  | Day 0, Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| corneal staining |  | 0 day,7th day and 14th day after treatment | 
| Schirmer test(without anaesthesia) |  | 0 day,7th day,14th day after treatment | 
| tear film breakup time(TBUT) |  | 0 day,7th day and 14th day after treatment | 
| meibomian gland function |  | 0 day,7th day and 14th day after treatment |
Influence of Losartan and Diphenhydramine on Emotional and Cognitive Functions in Healthy Human Subjects

Study Overview
=================
Brief Summary
-----------------
This project aims at identifying novel pharmacological targets for the treatment of memory disorders.

Detailed Description
-----------------
To investigate the effects of the histamine H1 receptor antagonist diphenhydramine and the angiotensin II receptor antagonist losartan on emotional and cognitive functions in healthy human subjects.

Official Title
-----------------
Influence of Losartan and Diphenhydramine on Emotional and Cognitive Functions in Healthy Human Subjects

Conditions
-----------------
Memory, Long-Term, Memory, Short-Term

Intervention / Treatment
-----------------
* Drug: Losartan, Diphenhydramine, Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy native or fluent German-speaking BMI between 19 and 27 kg/m2 able and willing to give written informed consent and comply with the requirements of the study protocol willing to donate saliva sample for DNA-analysis female: willing to perform a pregnancy test at the beginning of both test visits Exclusion Criteria: acute or chronic psychiatric or somatic disorder pathological ECG known hypersensitivity to the IMP under investigation (losartan, diphenhydramine) hypotension (RR < 110/70 mmHg) bradycardia (< 50 bpm) pregnancy, breast-feeding long-term medication within last 3 months (oral contraceptives are disregarded) smoking (> 3 cigarettes per day) concurrent participation in another study participation in one of our previous studies using the same memory tests inability to read and understand the participant's information

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Losartan, Diphenhydramine, Placebo<br>placebo controlled crossover study with two arms: Losartan, Diphenhydramine | Drug: Losartan, Diphenhydramine, Placebo<br>* placebo controlled crossover study with two arms: Losartan 40mg, Diphenhydramine 40mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Outcome Measures | Memory functions | during cognitive testing at study days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Outcome Measures | sleepiness, mood, anxiety, attention, fluid intelligence | during cognitive testing at study days |
Evaluating Contact Lens Optics

Study Overview
=================
Brief Summary
-----------------
This study will evaluate changes in refractive error and visual performance between a single vision soft contact lens and multifocal soft contact lens

Official Title
-----------------
Evaluating Contact Lens Optics

Conditions
-----------------
Myopia

Intervention / Treatment
-----------------
* Device: Single vision contact lens
* Device: Multifocal contact lens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to read and understand the informed consent document 18 to 39 years of age (inclusive) Best corrected visual acuity of 20/25 or better in the right eye Refractive error from -1.00D to -6.00D with astigmatism less than or equal to -1.00D in the right eye (corneal plane) Exclusion Criteria: Any ocular or systemic conditions affecting vision, refraction, or the ability to wear a soft contact lens History of ocular trauma or surgery causing abnormal or distorted vision Current Rigid Gas Permeable (RGP) contact lens wearers Unwilling to have contact lens fit photographed Pregnant and/or lactating females, by self-report

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 39 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single vision contact lens<br>Subjects will wear a single vision soft contact lens during the study visit | Device: Single vision contact lens<br>* Subjects will wear a single vision soft contact lens only during the study visit<br>* Other names: comfilcon A;|
| Other: Multifocal contact lens<br>Subjects will wear a multifocal soft contact lens during the study visit | Device: Multifocal contact lens<br>* Subjects will wear a multifocal soft contact lens only during the study visit<br>* Other names: comfilcon A;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual performance | Low contrast visual acuity will be measured for each subject while wearing each of the two lenses | Through completion of study visit, an average of 2.5 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Refractive error | Refractive error will be measured for each subject while wearing each of the two lenses | Through completion of study visit, an average of 2.5 hours |
ExBonAdAsia Study: A Study of Once Monthly Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis.

Study Overview
=================
Brief Summary
-----------------
This single arm study will continue drug safety surveillance, and assessment of adherence, in patients with postmenopausal osteoporosis who have received monthly oral Bonviva in ML19930, the BonAdAsia study. All patients completing 6 months in ML19930 will continue to receive Bonviva (150mg po, monthly) for an additional 6 months. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

Official Title
-----------------
An Open-label, Clinical Observation Extension Study to Assess Continuing Safety and Adherence in Patients With Postmenopausal Osteoporosis Receiving Monthly Oral Bonviva

Conditions
-----------------
Post Menopausal Osteoporosis

Intervention / Treatment
-----------------
* Drug: ibandronate [Bonviva/Boniva]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients responding to oral monthly Bonviva during the BonAdAsia study; willing to continue Bonviva treatment for a further 6 months. Exclusion Criteria: none specified.

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

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

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: 1<br> | Drug: ibandronate [Bonviva/Boniva]<br>* 150mg po monthly for 6 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SAEs, AEs including fractures, adherence to treatment, clinical improvement, osteoporosis symptoms |  | Throughout study |
Assessment of Impact Nutritional Program During Autologous Stem Cell Transplant

Study Overview
=================
Brief Summary
-----------------
Nestle Impact has shown efficacy in multiple surgical trials in relation to improving hospital length of stay and infection rate. 1 dose of Nestle Impact Advanced Recovery will be taken orally three times a day beginning on the morning following stem cell transplant and will continue until the day of hospital discharge.

Official Title
-----------------
Assessment of Impact Nutritional Program During Autologous Stem Cell Transplant

Conditions
-----------------
Hodgkin's Lymphoma, Multiple Myeloma, Non-Hodgkin's Lymphoma

Intervention / Treatment
-----------------
* Dietary Supplement: Nestle Impact Advanced Recovery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients receiving an autologous stem cell transplant using the preparative regimens of BEAM (Carmustine, Etoposide, Cytarabine, Melphalan), Melphalan 140mg/m2, or Melphalan 200mg/m2 Any prior diet or supplement will be allowed. Age >18 years. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: History of allergic reactions attributed to compounds of similar chemical or biologic composition to Nestle Impact including fish oil.

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nestle Impact Advanced Recovery<br>Nestle Impact Advanced Recovery 1 dose of Nestle Impact Advanced Recovery orally three times a day | Dietary Supplement: Nestle Impact Advanced Recovery<br>* dose of Nestle Impact Advanced Recovery orally three times a day beginning on the morning following stem cell transplant and continued until the day of hospital discharge.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital length of stay |  | Particpants will be followed for 14 days, the average length of time from stem cell infusion until dischcarge | 
| Days to engraftment |  | Particpants will be followed for 14 days, the average length of time from stem cell infusion until dischcarge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hodgkin's Lymphoma, Multiple Myeloma, Non-Hodgkin's Lymphoma
OCT Angiography in Vitreo and Chorioretinal Pathologies

Study Overview
=================
Brief Summary
-----------------
In many diseases of the vitreo and chorioretinal complex, perfusion changes have a diagnostic, prognostic or causative role. The visualisation of perfusion was limited to invasive techniques, which were only to depict vasculature in one plane. Optical coherence tomography is able to visualise and quantify eye perfusion layer-specific and non-invasive.

Official Title
-----------------
Optical Coherence Tomography Angiography in Vitreo and Chorioretinal Pathologies Under the Influence of Dark and Light Adaptation

Conditions
-----------------
Optical Coherence Tomography

Intervention / Treatment
-----------------
* Diagnostic Test: Optical coherence tomography angiography under dark and light adaptation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with vitreo and chorioretinal pathology, aged-adapted controls Exclusion Criteria: Minors, concomitant ocular pathologies, pregnancy, contra-indication for tropicamide

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br> | Diagnostic Test: Optical coherence tomography angiography under dark and light adaptation<br>* Optical coherence tomography angiography under dark and light adaptation with pupil dilatation<br>|
| Controls<br> | Diagnostic Test: Optical coherence tomography angiography under dark and light adaptation<br>* Optical coherence tomography angiography under dark and light adaptation with pupil dilatation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vessel density | Vessel density measurements of macula and optic nerve | 5 minutes after intervention ends |
Agaricus Blazei Murill (ABM) in Patients With Inflammatory Bowel Disease (IBD)

Study Overview
=================
Brief Summary
-----------------
Based on the anti-inflammatory and stabilising effect of the AbM, (Agaricus Blazei Murill) based mushroom extract AndoSanTM on cytokine release in blood in vivo and ex vivo in healthy volunteers after 12 days consumption, the aim in this study is to investigate whether same effect is valid in patients with IBD (inflammatory bowel disease). In addition, calprotectin an abundant cytosolic protein in neutrophils and a surrogate marker for degree of intestinal inflammation will be measured in blood and feces of these patients.

Official Title
-----------------
Potential Anti-inflammatory Effect of Mushroom Extract From Agaricus Blazei Murill (ABM) in Patients With Inflammatory Bowel Disease (IBD)

Conditions
-----------------
Inflammatory Bowel Disease

Intervention / Treatment
-----------------
* Dietary Supplement: AndoSan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Moderate disease activity Exclusion Criteria: No use of Imurel (Azathioprin) or anti-TNF treatment

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AndoSan, UC<br>AndoSan as a supplement to 10 UC patents | Dietary Supplement: AndoSan<br>* AndoSan, 20mlx3, 12 days<br>* Other names: Agaricus blazei Murill;|
| Experimental: AndoSan, CD<br>AndoSan as a supplement to 10 CD patients. | Dietary Supplement: AndoSan<br>* AndoSan, 20mlx3, 12 days<br>* Other names: Agaricus blazei Murill;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The ultimate goal is to see whether the ABM can be used as additional treatment of IBD. |  | 12 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Inflammatory, AbM, IBD
Finding Early Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
Research has shown that early aggressive use of medicines may stop rheumatoid arthritis (RA)or slow its damage. The key to this is to find people with early symptoms which could be RA and have them get a diagnosis, treatment and follow-up. This study will recruit persons who've gone to the internet looking for information about their symptoms. After answering a screening survey, the person with possible symptoms will be linked to the study website for a more detailed symptom questionnaire. After completing that questionnaire the person will receive information about the second part of the study which includes an examination with a rheumatologist (arthritis doctor)and laboratory tests. Based on the joint examination and laboratory tests, the rheumatologist will tell the person the likelihood of having RA, and make recommendations and if needed a referral for care and treatment. Treatment is not a part of this study. This study will also compare the information on the subject's questionnaires to the doctor's joint examination and the laboratory tests with the hope of developing a simple inexpensive case finding questionnaire.

Official Title
-----------------
Proof of Concept of an Internet-based Series Design Case-finding System for Very Early Rheumatoid Arthritis.

Conditions
-----------------
Joint Pain, Stiffness

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Joint pain or swelling for less than 3 months Be able to use the internet Exclusion Criteria: Non English speaking Diagnosis of rheumatoid arthritis

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
joint pain, stiffness