linjc16/ctgov huggingface dataset:
A Phase III Trial Assessing the Pharmacodynamic Effect and the Tolerability of Grazax Treatment

Study Overview
=================
Brief Summary
-----------------
The study assess the pharmacodynamic effect and the tolerability of Grazax treatment initiated in the grass pollen season in subjects with seasonal grass pollen induced rhinoconjunctivitis

Official Title
-----------------
A Phase III Trial Assessing the Pharmacodynamic Effect and the Tolerability of Grazax Treatment Initiated in the Grass Pollen Season in Subjects With Seasonal Grass Pollen Induced Rhinoconjunctivitis

Conditions
-----------------
Grass Pollen Allergy

Intervention / Treatment
-----------------
* Drug: Grazax
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Positive skin prick test to Phleum pratense Positive IgE to Phleum pratense signed informed consent A clinical history of moderate to severe persistent rhinoconjunctivitis symptoms Exclusion Criteria: No uncontrolled asthma in the past 12 months No history of an IgE mediated systemic reaction due to food, insect venom, any kind of medication or induced by exercise, where there are symptoms both from the skin and the respiratory system with or without hypotension No history of an IgE mediated systemic reaction due to food, insect venom, any kind of medication or induced by exercise, where there are symptoms both from the skin and the respiratory system with or without hypotension

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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Grazax | Drug: Grazax<br>* 1 tablet, 75,000 SQ-T, daily during the trial period<br>|
| Placebo Comparator: 2<br> | Drug: placebo<br>* 1 placebo tablet, matching the active treatment, daily during the trial period<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacodynamics - Immunological assessments |  | Pre- and post treatment |
Evaluation of Safety and Efficacy of PDP-716

Study Overview
=================
Brief Summary
-----------------
The study will be conducted to evaluate the efficacy and safety of topical administration of PDP-716 compared with brimonidine tartrate ophthalmic solution.

Official Title
-----------------
A Randomized, Multi-Center, Investigator-Masked, Parallel Group, Equivalence Study of Once Daily Brimonidine Tartrate Ophthalmic Suspension Compared With Three Times Daily ALPHAGAN-P® in Subjects With Open Angle Glaucoma, or Ocular Hypertension

Conditions
-----------------
Open Angle Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: Brimonidine Tartrate Ophthalmic Suspension
* Drug: Brimonidine Tartrate Ophthalmic Solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be male or female, of 2 years of age or older Have open-angle glaucoma or ocular hypertension in both the eyes Be able and willing to follow study instructions and complete all required visits. Exclusion Criteria: Females who are pregnant/lactating. Have uncontrolled systemic disease which might interfere with the study Any known allergy or sensitivity to the study medications or their components Any other clinically relevant abnormality

Ages Eligible for Study
-----------------
Minimum Age: 2 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PDP-716<br> | Drug: Brimonidine Tartrate Ophthalmic Suspension<br>* PDP-716<br>|
| Active Comparator: Brimonidine Tartrate Ophthalmic Solution<br> | Drug: Brimonidine Tartrate Ophthalmic Solution<br>* Three Times Brimonidine Tartrate Ophthalmic Solution<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Mean Intraocular Pressure |  | Week 12 8 AM, 10 AM and 4 PM |
Air Pollution and Cardiovascular Disease

Study Overview
=================
Brief Summary
-----------------
To determine the effects of ambient airpollution exposures on cardiovascular responses among healthy adults without cardiovascular disease.

Official Title
-----------------
Air Pollution and Cardiovascular Disease

Conditions
-----------------
Metabolic Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: without CV disease or risk factors (e.g., hypertension, diabetes, or treated hyperlipidemia). Subjects are non-smokers in non-smoking household. Exclusion Criteria: Screening visit BP>140/90 mm Hg, fasting glucose >126 mg/dL, or positive urine pregnancy test (females). Subjects cannot be taking any medications or over-the-counter drugs that affect CV function.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dyslipidemia | Analyzed HDL by Beckman AU5800 | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| System oxidative stress | Analyzed oxidative stress biomarkers,such as MDA by HPLC | One year |
A Study of IRESSA in Relapsed and Refractory Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the disease control rate at trial closure and after the first stage of the study in patients with relapsed or refractory SCLC and measurable disease treated with gefitinib

Official Title
-----------------
Phase II Study of Iressa in Relapsed and Refractory Small Cell Lung Cancer

Conditions
-----------------
Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: Gefitinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of written informed consent Histologically confirmed, relapsed or refractory SCLCr Aged 18 or over and a life expectancy of more than 2 months Exclusion Criteria: Any evidence of clinically active interstitial lung disease Other co-existing malignancies or malignancies diagnosed within the last 5 years, with the exception of basal cell carcinoma or cervical cancer in situ.

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

| Intervention/Treatment |
| --- |
|Drug: Gefitinib|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the disease control rate in these patients |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the objective response rate at trail closure in these patients |  |  | 
| To determine the time to progression-or-death in these patients |  |  | 
| To determine overall survival in these patients |  |  |
Least Invasive Nonlinear Light Microscopy

Study Overview
=================
Brief Summary
-----------------
Evaluate the ability to image oral mucosa in healthy volunteer by nonlinear microscopy

Official Title
-----------------
Least Invasive Nonlinear Light Microscopy

Conditions
-----------------
Oral Leukoplakia, Oral Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Health volunteer Patient with suspected oral mucosa lesion Exclusion Criteria: Active infectious disease Inability to cooperate

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 |
| --- | --- |
| 1<br>Health volunteer | |
| 2<br>Patient with suspected oral mucosa lesion | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Long-Term Study of the Effects of Orally Administered SAR302503 in Patients With Myelofibrosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the long-term effects of orally administered SAR302503 (TG101348) in patients with myelofibrosis who have completed the MF-TG101348-001 study.

Detailed Description
-----------------
SAR302503 (TG101348) is a potent small molecule inhibitor of Janus kinase 2 (JAK2). This is an extension study for a first-in-man, dose escalation study (MF-TG101348-001). The safety, tolerability and clinical activity of SAR302503 (TG101348) in subjects with myelofibrosis will be evaluated.

Official Title
-----------------
An Open-Label Study to Evaluate the Long-Term Effects of Orally Administered SAR302503 in Patients With Primary or Secondary Myelofibrosis

Conditions
-----------------
Myelofibrosis

Intervention / Treatment
-----------------
* Drug: SAR302503 (TG101348)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Completion of MF-TG101348-001 study Diagnosis of myelofibrosis At least 18 years of age Exclusion Criteria: Any acute or chronic medical abnormality that may increase the risk associated with study participation

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: SAR302503 (TG101348)<br>* orally administered, once a day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (i.e. adverse events, effects on laboratory parameters, vital signs and ECGs) and tolerability |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical activity and pharmacodynamics |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
myelofibrosis
Sensitivity Evaluation of Serological Tests for Covid-19

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to test the diagnostic sensitivity of antibody tests for the diagnosis of SARS-CoV2 infection, available to clinical laboratories, within a national network of hospitals carrying out research activities. Test the diagnostic specificity of antibody tests for the diagnosis of SARS-CoV2 infection. Complete a systematic evaluation of the different approaches. Perform Health technology Assessment (HITA) of the methodologies under study, in order to verify their reliability to the immunoglobulin levels produced by each individual exposed patient.

Official Title
-----------------
Multicentric Sensitivity Assessment of Antibody Diagnostic Tests Developed for Diagnosis of SARS-CoV2 Infection

Conditions
-----------------
Covid19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients or individuals exposed to Sars-Cov2 Infection. Exclusion Criteria: There are no criteria for excluding patients or individuals, if not the refusal to participate to project
Sexes Eligible for Study
-----------------
All

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity | Sensitivity and Specificity Evaluation in Diagnostic Sierological tests | Up to 22 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specificity | Sensitivity and Specificity Evaluation in Diagnostic Sierological tests | Through study completion, an average of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
test sierologici
Reliability of Subjective Assessment of the Heart by Cardiac Point-of-Care Ultrasound

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate reliability of subjective qualitative assessment of the basic cardiac parameters by Point-pf-Care ultrasound.

Detailed Description
-----------------
Subjective qualitative assessment of ventricular function, diameter of the right ventricle and the size of inferior caval vein using cardiac Point-of-Care ultrasound is commonly performed by intensivists and emergency medicine physicians during the management of the patients with shock and/or acute respiratory failure. However, very little data is available to define the reliability of this qualitative examination. The presented study aims to assess this reliability. Physicians meeting inclusion and exclusion criteria will be sent by a questionnaire consisting of 19 ultrasound cases. Participants will be asked to perform qualitative evaluation of ultrasound findings of each case. Then, the results will be compared with quantitative measurements made by conventional transthoracic echocardiography and validity testing will be performed.

Official Title
-----------------
Reliability of Subjective Qualitative Assessment of the Heart by Cardiac Point-of-Care Ultrasound in Comparison With Conventional Transthoracic Echocardiography

Conditions
-----------------
Transthoracic Echocardiography

Intervention / Treatment
-----------------
* Other: Survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: physician with at least basic knowledge of cardiac Point-of-Care ultrasound who agrees to complete the questionnaire Exclusion Criteria: not meet the inclusion criteria

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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Survey|Each participant completes a questionnaire. In the questionnaire, he performs a subjective qualitative evaluation of Point-of-Care ultrasound records of the heart. Each participant will complete a questionnaire in which they perform a subjective qualitative evaluation of ultrasonographic recordings of the heart.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reliability of subjective qualitative assessment of the heart by Point-of-Care ultrasound in comparison with conventional transthoracic echocardiography | Subjective assessment of Point-of-Care ultrasound records of the heart will be performed by participants via completion of the questionnaire. Thereafter, results of the survey will be compared with the objective measurements taken by conventional transthoracic echocardiography from the same records than presented in the questionnaire. | four weeks |
Simple Continuous, Subcuticular and Interrupted Skin Suturing of Episiotomy and 2nd-degree Perineal Tears

Study Overview
=================
Brief Summary
-----------------
Millions of women worldwide undergo perineal suturing after childbirth and the type of repair may have an impact on pain and healing. The skin as a barrier between the internal structures and the external environment is exceptionally susceptible to injury, either through accidental injury or planned surgical incision. Today, as surgery increases in complexity, and the heightened public awareness of scar cosmesis and skin healing need to be optimized to ensure the overall success of the surgical procedure

Official Title
-----------------
Simple Continuous, Subcuticular and Interrupted Skin Suturing of Episiotomy and 2nd-degree Perineal Tears : A Comparative Study

Conditions
-----------------
Episiotomy Wound

Intervention / Treatment
-----------------
* Procedure: Episiotomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal vaginal delivery. At term (37 40 weeks ). Live baby. Vertex presentation Exclusion Criteria: Third and fourth degree perineal tear. Instrumental vaginal delivery. Previous perineal surgery. Anaemia with hemoglobin level < 9 g/dl. Diabetes mellitus. Coagulation abnormalities. Postpartum hemorrhage. Delivery conducted outside Woman HealthHospital. Breech delivery. Body mass index >35 kg/m2. Local infectious lesions. Anal fissures or hemorrhoid.
Sexes Eligible for Study
-----------------
Female

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: Simple continuous<br>the sutures will be taken continuously by simple method | Procedure: Episiotomy<br>* repair of perineal muscles and skin<br>|
| Active Comparator: subcuticular<br>the sutures will be taken subcuticular | Procedure: Episiotomy<br>* repair of perineal muscles and skin<br>|
| Active Comparator: interrupted<br>the sutures will be taken interrupted method | Procedure: Episiotomy<br>* repair of perineal muscles and skin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the mean score of Perineal pain during vaginal suturing | assessment through visual analog scale score from 0 - 10 at every step of repair | 10 minutes |
Investigation of TEST (Transcranial Electric Stimulation Therapy) for Chronic Pain

Study Overview
=================
Brief Summary
-----------------
The goal in this study is to investigate TEST (Transcranial Electric Stimulation Therapy) for chronic pain. It requires an inpatient stay on our research unit of about a month. The study is designed to address the cognitive and emotional aspects of chronic pain and other conditions that often accompany this disorder, such as major depression or drug use.

Detailed Description
-----------------
This project proposes to investigate the feasibility of TEST in subjects with chronic pain. This will be an open-label study where subjects (n=12) are administered 8-10 sessions of TEST over 4 weeks. Measurements of pain, mood, and memory will be obtained before and after the sessions. The hypothesis is that TEST will be feasible and tolerable in this population.

Official Title
-----------------
Investigation of TEST (Transcranial Electric Stimulation Therapy) for Chronic Pain

Conditions
-----------------
Chronic Pain

Intervention / Treatment
-----------------
* Device: Transcranial Electric Stimulation Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults (ages 22 to 60) who understand all procedures and have the ability to provide informed consent, with a score on the Mini-Mental Status Exam of at least 24; participants experiencing chronic pain, with ongoing pain symptoms, and score on the Brief Pain Inventory of > 5 on question #3 (which asks about maximal pain in the past 24 hours) or > 5 on question #5 (which asks about average pain in the past 24 hours); a diagnosis of chronic postoperative pain, low back pain, musculoskeletal pain, fibromyalgia, visceral pain or neuropathic pain, including complex regional pain syndrome or peripheral neuropathy; no significant changes in pain medications for at least one month prior to study entry.

Ages Eligible for Study
-----------------
Minimum Age: 22 Years
Maximum Age: 60 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Transcranial Electric Stimulation Therapy|TEST is a form of brain stimulation.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility will be assessed by the percent of participants who complete the study | Feasibility will be assessed by the percent of participants who complete the study | 4 weeks |
Clinical Guidelines for APL Treatment

Study Overview
=================
Brief Summary
-----------------
Therapeutic guidelines for treatment of patients with de novo APL to be used by every institution that wants to follow them. All patients who are reported may be retrospectively analyzed

Conditions
-----------------
APL

Intervention / Treatment
-----------------
* Drug: Atra
* Drug: Idarubicin
* Drug: methotrexate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Genetic diagnosis of acute promyelocytic leukemia Exclusion Criteria: No exclusion criteria
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: ATRA-Idarubicin<br> | Drug: Atra<br> <br> Drug: Idarubicin<br> <br> Drug: methotrexate<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence within 1 year of treatment | Induction therapy with simultaneous ATRA (45 mg/m2 day until CR) and idarubicin (12 mg/m2 day on days 2, 4, 6 and 8 or 12 mg/m2 day on days 2, 4 and 6 in patients older than or equal to 60 years). Three monthly consolidation courses with ATRA Maintenance therapy with ATRA (45 mg/m2/d, days 1-15 every 3 months), and low dose chemotherapy with methotrexate (15 mg/m2/d, weekly) and 6-mercaptopurine (50 mg/m2/d) for two years. | 3 years |