linjc16/ctgov huggingface dataset:
A Genetic Substudy Associated With the Avastin (Bevacizumab) Study MO19390 in Patients With Advanced or Recurrent Non-Squamous Cell Lung Cancer.

Study Overview
=================
Brief Summary
-----------------
This single arm genetic substudy of MO19390 will test the hypothesis that there is a positive relationship between mRNA BRCAI levels and the response to different chemotherapy combinations plus Avastin. A subset of patients participating in MO19390, and receiving Avastin 15mg/kg iv on day 1 and subsequently once every 3 weeks, will undergo BRCAI mRNA expression determination. Depending on the BRCAI mRNA level (low, medium or high) they will receive a different chemotherapy regimen in combination with Avastin: a)gemcitabine/cisplatin, b)vinorelbine + cisplatin/docetaxel + cisplatin or c)vinorelbine or docetaxel. Avastin treatment will continue after completion of chemotherapy cycles until disease progression, and the target sample size is 100-500 individuals.

Official Title
-----------------
Local Substudy Associated to the International Study MO19390 to Determine the BRCA1 Gene mRNA Expression as a Predictive Marker of Response to Chemotherapy

Conditions
-----------------
Non-Squamous Non-Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: Standard chemotherapy
* Drug: bevacizumab [Avastin]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: participating in, and meeting all inclusion/exclusion criteria of, MO19390. Exclusion Criteria: not meeting the inclusion/exclusion criteria of MO19390.

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Standard chemotherapy<br>* As prescribed--chemotherapy may be a)gemcitabine/cisplatin, b)vinorelbine + cisplatin/docetaxel + cisplatin or c)vinorelbine or docetaxel.<br>Drug: bevacizumab [Avastin]<br>* 15mg/kg iv or 7.5mg/kg on day 1, and subsequently once every 3 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  | Event driven | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival; response rates |  | Event driven | 
| Adverse events |  | Throughout study |
Bromfenac 0.09% vs Ketorolac 0.4% for Cyclosporine Induction Phase

Study Overview
=================
Brief Summary
-----------------
To compare bromfenac 0.09% and ketorolac 0.4% when used concomitantly with cyclosporine ophthalmic emulsion 0.05% in improving patient comfort during the induction phase of treatment for chronic dry eye disease

Official Title
-----------------
Bromfenac 0.09% vs. Ketorolac 0.4% During the Induction Phase of Treatment With Topical Cyclosporine for Chronic Dry Eye Patients

Conditions
-----------------
Dry Eye Disease, Ocular Comfort

Intervention / Treatment
-----------------
* Drug: bromfenac
* Drug: ketorolac


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be in general good health Diagnosis of moderate to severe dry eye syndrome Exclusion Criteria: Patients who are unlikely to respond to cyclosporine ophthalmic emulsion therapy Patients who are pregnant or nursing females Unwilling to discontinue use of contact lenses during the run-in and duration of the study Presence or history of any systemic or ocular disorder or condition that could possibly interfere with the interpretation of the study results in the study eye Previous treatment failure on CSA 0.05% (Restasis) Known hypersensitivity to any component of the study or procedural medications Participation in any other clinical trial within 30 days prior to screening Known contraindication to any study medication or any of their components. Should not be taking any oral anti-histamines, beta blockers or diuretics.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Active treatment arm bromfenac 0.09% BID for 6 weeks | Drug: bromfenac<br>* 0.09%, BID, 6 weeks<br>|
| Active Comparator: 2<br>ketorolac 0.4% BID for 6 weeks | Drug: ketorolac<br>* 0.4%, BID, 6 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular comfort |  | six weeks |
IMFINZI Specific-Clinical Experience Investigation in Patients With NSCLC After Definitive Chemoradiation Therapy

Study Overview
=================
Brief Summary
-----------------
To investigate the impact of presence/absence or grade of radiation pneumonitis before starting IMFINZI, on the onset of interstitial lung disease (including radiation pneumonitis) after starting IMFINZI, in the real world in patients with locally advanced unresectable non-small cell lung cancer who are treated with the product as maintenance therapy after definitive chemoradiation therapy.

Official Title
-----------------
IMFINZI® Injection 120 mg, 500 mg Specific-Clinical Experience Investigation in Patients With Locally Advanced Unresectable Non-small Cell Lung Cancer Who Are Treated With Maintenance Therapy After Definitive Chemoradiation Therapy.

Conditions
-----------------
Carcinoma, Non-Small-Cell Lung

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Patients with locally advanced unresectable non-small cell lung cancer who are treated with IMFINZI for the first time as maintenance therapy after definitive chemoradiation therapy Exclusion Criteria: -No past history of hypersensitivity to the components of IMFINZI
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 |
| --- | --- | --- |
| Incidence of Interstitial lung disease (including radiation pneumonitis) by post-chemoradiation therapy radiation pneumonitis (yes/no) and by severity (CTCAE grade) |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lung Diseases, Interstitial, Radiation Pneumonitis
Impact Of Timing Of Drainage Of Massive Ascites On Operative And Post-Operative Course In Living-Donor Liver Transplant Recipients. A Prospective Randomized Controlled Trial.

Study Overview
=================
Brief Summary
-----------------
Massive ascites is usually controlled over several weeks pre-operatively in liver transplant recipients with the risk of encephalopathy and peritonitis. We hypothesized that intra-operative drainage of ascites will be safe and avoids the inherent risks of pre-operative drainage.

Official Title
-----------------
Impact Of Timing Of Drainage Of Massive Ascites On Operative And Post-Operative Course In Living-Donor Liver Transplant Recipients. A Prospective Randomized Controlled Trial.

Conditions
-----------------
Massive Ascites

Intervention / Treatment
-----------------
* Procedure: ultrasound guided ascitic fluid drainage
* Procedure: operative drainage of ascites through small skin incision after induction of anesthesia
* Device: ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: liver transplant candidates with tense acsites Exclusion Criteria: severe coagulpathy (INR more than 2 or platlet count less than 50) MELD more than 20

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Preop-drainage<br>ascites drained over the pre-operative week through multiple ultrasound guided paracentesis | Procedure: ultrasound guided ascitic fluid drainage<br> <br> Device: ultrasound<br> <br> |
| Active Comparator: Op-drainage<br>ascetic fluid drained through an abdominal incision after anesthesia | Procedure: operative drainage of ascites through small skin incision after induction of anesthesia<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| graft survival |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient survival |  | one year |
A577-nm Pro -Yellow Laser In Treatment of Striae Rubra

Study Overview
=================
Brief Summary
-----------------
Stretch marks or striae are common skin condition occurring in both genders, but they are more prevalent among women. These are linear dermal scars that are accompanied by epidermal atrophy. They usually occur frequently in numerous physiological and pathological conditions, such as adolescent growth, pregnancy, obesity, Cushing disease, Marfan syndrome, and long-term systemic or topical steroid use. Decreased expression of collagen and fibronectin genes has also been associated with striae. The pro-yellow laser systems can be used in a wide range of indications such as facial erythema, facial telangiectasia, port wine stain nevus, rosacea, poikilo derma civatte, and Becker's nevus Some of these indications are clinical lesions in the vascular pattern; some are related to the factors that trigger vascularity, such as vascular endothelial growth factor (VEGF) in etiopathogenesis

Official Title
-----------------
A577-nm Pro -Yellow Laser In Treatment of Striae Rubra

Conditions
-----------------
Striae Rubra

Intervention / Treatment
-----------------
* Device: Pro-Yellow laser 577


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: .Patients diagnosed with striae rubera. .Age groups: at any age. .Sex : ( females). Co-operative patient Exclusion Criteria: Pregnancy . Patient using drugs exacerbating stria as topical or systemic steroid, and patients using other forms of treatment for stria as topical tretinoin, emollients, glycolic acid peel and laser, because that might affect the result of our study. Stria Alba. Skin infection (viral, bacterial or parasitic). Immunosuppressed patients or with history of malignancy or radiation therapy and chronic debilitating diseases and Cushing syndrome. Hypersensitivity to light and intak of photosensitizing drugs.
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Pro-Yellow laser 577|4 session for cases with digtal photo before and after sessions|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dermoscopic change of width of striae rubrae | dermoscopic photo for width of striae | 1 year |
Local Tolerability and Safety of Povidone K25 Eye Drops (Artificial Tears Containing Povidone) Versus Placebo in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
Instillation of artificial tears is standard treatment in dry eye syndrome and in patients experiencing dry eye symptoms when wearing contact lenses. Povidone K25 eye drops (povidone) is an isotonic solution containing povidone to simulate normal tears viscosity. Safety and local tolerability of Povidone K25 is evaluated in healthy volunteers in comparison to placebo eye drops.

Official Title
-----------------
Local Tolerability and Safety of Povidone K25 (Artificial Tears Containing Povidone) vs. Placebo in Healthy Volunteers

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

Intervention / Treatment
-----------------
* Drug: Povidone K25 eye drops (povidone)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects Older than 18 years Ocular discomfort less than 20 mm on 100 mm visual analogue scale (VAS) prior to treatment Exclusion Criteria: Known hypersensitivity to any of the constituents of the medications Known allergic disposition (e.g. hay fever) Wearing of contact lenses Any kind of current eye disease (e.g. dry eye) Additional exclusion criteria are defined in the protocol

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

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Povidone K25 eye drops (povidone)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ocular discomfort by using a visual analogue scale (VAS) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| slit lamp assessment (conjunctival edema, palpebral hyperemia, lid edema) |  |  | 
| adverse events |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Artificial eye drops, tolerability, healthy volunteers, povidone, healthy subjects
GDF 15 in Sickle Cell Disease and Hereditary Spherocytosis

Study Overview
=================
Brief Summary
-----------------
Patients with thalassemia intermedia, congenital dyserythropoietic anemia type I , and sideroblastic anemia were found to express very high levels of serum GDF15, and this contributed to the inappropriate suppression of hepcidin with subsequent secondary iron overload.The aim of our present study is to asses the levels of GDF15 and hepcidin in patients with Sickle cell disease and hereditary spherocytosis

Detailed Description
-----------------
The identification of the ferroportin/hepcidin axis has allowed the effect of erythroid activity on iron balance to be studied and has created the basis for better defining the erythroid regulators. In iron-loading anemias, ineffective erythropoiesis suppresses hepcidin production, which result in dysregulating iron homeostasis. Miller and co-workers showed that release of cytokines like growth differentiation factor 15 (GDF15) during the process of ineffective erythropoiesis inhibits hepcidin production, thus defining a molecular link between ineffective erythropoiesis, suppression of hepcidin production and parenchymal iron loading.

Official Title
-----------------
The Impact of Growth Differentiating Factor (GDF) 15 in Sickle Cell Disease and Hereditary Spherocytosis

Conditions
-----------------
Patients With Thalassemia Intermedia,, Congenital Dyserythropoietic Anemia Type I

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: non Exclusion Criteria: non

Ages Eligible for Study
-----------------
Minimum Age: 5 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sickle cell disease<br> | |
| hereditary spherocytosis.<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GDF 15 |  | year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hepcidine |  | year |
Portable Monitoring Device for the Diagnosis of Sleep Apnea in Obese Patients

Study Overview
=================
Brief Summary
-----------------
Introduction The portable monitoring system (PMS) recording of cardiopulmonary parameters (level III of ASDA) has been validated in subjects with high probability of Obstructive Sleep Apnea (OSA) without comorbidities. However, there is not any study evaluating this system when OSA is associated with morbid obesity, so the validation of PMS will be very useful in order to properly work-up this highly risk population. Objective: To evaluate the accuracy of level III type of PMS - Stardust™ (STD), on patients with level II and III of obesity and high clinical suspicion of OSA. Methods:Participants with BMI > 35 kg/m2 and with suspicion of OSA will consecutively be selected from an Outpatients Sleep Clinic of UNIFESP. They will be randomized for the following order of recordings: 1) STD at home for 1 night 2) STD in the sleep lab simultaneous to PSG. AHI will be taken for subsequent analysis:a) AHI PSG b) AHI STD -lab and c) AHI STD- home.

Official Title
-----------------
Validation of a Portable Monitoring System for the Diagnosis of Obstructive Sleep Apnea Syndrome in Patients With Level II and III Obesity

Conditions
-----------------
Obstructive Sleep Apnea Syndrome, Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI > 35 Complaints of snoring, sleep apnea, daytime sleepiness Exclusion Criteria: use of home oxygen other sleep diseases inability to perform PSG

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Obese patients<br>BMI > 35 | |

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
-----------------
obesity, sleep apnea, portable monitoring
NMDA Enhancer for the Treatment of Mild Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
NMDA neurotransmission plays an important role in learning and memory. NMDA receptors (NMDAR) were found to decrease in the frontal lobe and hippocampus of Alzheimer's disease (AD). This study is a randomized, double-blind, placebo controlled drug trial for testing the efficacy of NMDAR-enhancer. All subjects will be allocated randomly to 4 groups: (1) DAOI-A group; (2) DAOI-B group; (3) DAOI-C group; (4) placebo group. The study period is 24 weeks. The investigators hypothesize that DAOI may yield better efficacy than placebo for cognitive function in patients with AD.

Official Title
-----------------
NMDA Enhancer for the Treatment of Mild Alzheimer's Disease

Conditions
-----------------
Alzheimer Disease

Intervention / Treatment
-----------------
* Drug: DAOI-A group
* Drug: DAOI-B group
* Drug: DAOI-C group
* Drug: Placebo oral capsule


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of Alzheimer's disease MMSE between 10-26 CDR 1 Exclusion Criteria: Hachinski Ischemic Score > 4 Substance abuse/dependence Parkinson disease, epilepsy, dementia with psychotic features Major depressive disorder Major physical illnesses Severe visual or hearing impairment

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 100 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DAOI-A group<br> | Drug: DAOI-A group<br>* DAOI with A dose<br>|
| Experimental: DAOI-B group<br> | Drug: DAOI-B group<br>* DAOI with B dose<br>|
| Experimental: DAOI-C group<br> | Drug: DAOI-C group<br>* DAOI with C dose<br>|
| Placebo Comparator: Placebo group<br> | Drug: Placebo oral capsule<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the Alzheimer's disease assessment scale - cognitive subscale at week 8, 16 and 24 | Cognitive assessment | week 0, 8, 16, 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Clinician's Interview-Based Impression of Change plus Caregiver Input at week 8, 16 and 24 | Global assessment | week 8, 16, 24 | 
| Change from baseline in speed of processing (Category Fluency) at week 24 | Cognitive assessment | week 0, 24 | 
| Change from baseline in working memory (Wechsler Memory Scale, Spatial Span) at week 24 | Cognitive assessment | week 0, 24 | 
| Change from baseline in verbal learning and memory tests (Wechsler Memory Scale, Word Listing) at week 24 | Cognitive assessment | week 0, 24 |