linjc16/ctgov huggingface dataset:
CP-690,550 Pharmacokinetics In Healthy Chinese Subjects

Study Overview
=================
Brief Summary
-----------------
This study is designed to evaluate the levels of CP-690,550 in the blood of healthy Chinese subjects following both single doses and multiple doses of drug.

Official Title
-----------------
An Open Label, Single And Multiple Dose Study To Investigate The Pharmacokinetics, Safety And Tolerability Of CP-690,550 In Healthy Chinese Subjects

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

Intervention / Treatment
-----------------
* Drug: CP-690,550


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Chinese Volunteers No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB) Exclusion Criteria: Clinically significant infections within the past 3 months Positive screening test for hepatitis B surface antigen, anti-hepatitis C antibody, or human immunodeficiency virus Pregnant or nursing women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CP-690,550 Dose Group<br> | Drug: CP-690,550<br>* Days 1 and 6 dose of 10 mg once daily Days 2-5 doses of 10 mg twice daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Single-dose: Cmax, Tmax, t½, AUCinf and AUClast |  | 1 day | 
| Multiple-dose: Cmin, Cmax, Ctrough, Tmax, t½, AUCtau, and Rac |  | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events and number of participants with adverse events |  | 6 days | 
| Changes in complete blood count and serum chemistry profile |  | 6 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rheumatoid Arthritis
The Prevalence of Bone Degenerative Diseases in Beijing - a Cross-sectional Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this observational study is to investigate the prevalence and risk factors of bone degenerative diseases

Official Title
-----------------
The Prevalence of Bone Degenerative Diseases in Beijing - a Cross-sectional Study

Conditions
-----------------
Cross-sectional Study, Degenerative Disease Joint, Degenerative Disc Disease

Intervention / Treatment
-----------------
* Other: Risk factors


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18-65 years， residents of Beijing city Must demonstrate willingness to participate in the study by signing the written informed consent Exclusion Criteria: Subjects who had surgery on disc or knee Pregnent women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Risk factors|Risk factors associated bone degenerative diseases|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of bone degenerative diseases | Degree of disc and knee degeneration based on imaging examination (etc. CT OR MRI) | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prevalence, Bone Degenerative Disease
Study to Evaluate the Effect of Bimosiamose on Ozone Induced Sputum Neutrophilia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety, tolerability and efficacy of repeated inhalative doses of Bimosiamose on ozone induced sputum neutrophilia in healthy subjects.

Official Title
-----------------
A Double-blind, Placebo Controlled, Randomized, Cross-over, Phase IIa Study to Evaluate the Effect of Bimosiamose on Ozone Induced Sputum Neutrophilia in Healthy Subjects

Conditions
-----------------
Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
-----------------
* Drug: Bimosiamose
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to produce sputum with normal sputum neutrophil levels at screening (< 65% of non-epithelial cells). Ozone responsive, defined as ≥ 20% relative increase in sputum neutrophils cell count after 3 h ozone challenge. At screening FEV1 at least 80% of predicted. Exclusion Criteria: Smokers (use of tobacco products in the previous 3 months). Urine cotinine levels will be measured during screening for all subjects. Smokers will be defined as any subject who reports of a recent tobacco use and/or who has a urine cotinine ≥ 500 ng/mL. Significant illness within two weeks prior to dosing (e.g., infection). Recent (within the last three years) and/or recurrent history of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bimosiamose<br> | Drug: Bimosiamose<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Analysis of TU-LESS by 3D Laparoscopy in the Treatment of Infertility

Study Overview
=================
Brief Summary
-----------------
This study intends to carry out a prospective, randomized controlled trial to compare the trans-umbilical laparoendoscopic single-site surgery by 3D laparoscopy with normal laparoendoscopic surgery in the treatment of infertility patient, so as to further clarify the safety and curative effect of TU-LESS by 3D laparoscopy and provide evidence-based basis for its application in infertility population.

Official Title
-----------------
Analysis of Trans-umbilical Laparoendoscopic Single-site Surgery by 3D Laparoscopy in the Treatment of Infertility

Conditions
-----------------
Infertility, Female

Intervention / Treatment
-----------------
* Procedure: 3D group
* Procedure: normal group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients are younger than 36 and older than 24. Clearly diagnosed with female Infertility. Infertility within 1 to 10 years. informed consent form signed Exclusion Criteria: Over the age of 35. Indefinite diagnosis. With severe medical problems (severe liver disease, kidney disease, respiratory diseases, heart disease or uncontrolled diabetes, epilepsy, etc., dysfunction of important organs). abdominal surgery history Unwilling to comply with the research plan.

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 35 Years

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: 3D group<br>infertility patient get TU-LESS by 3D Laparoscopy | Procedure: 3D group<br>* infertility patient get TU-LESS by 3D Laparoscopy<br>|
| Other: normal group<br>infertility patient get normal laparoscopic surgery | Procedure: normal group<br>* infertility patient get normal laparoscopic surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain score | Visual Analogue Score for the pain feeling of the patient | in 24 hours after surgery | 
| pregnancy rate |  | 6 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operation time |  | intraoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Infertility, TU-LESS, 3D laparoscopy
Conséquences of the COVID-19 Lockdown Measures on the CHRU Nancy Pediatric Emergency Services

Study Overview
=================
Brief Summary
-----------------
The first period of COVID 19 Lockdown Measures (From 18 March to 11 may 2020) change the French people way of life and their medicine knowledges. A study which evaluates the Nancy's Pediatric emergencies population utilization during this time could detect pathological changes. The medical impact of Home Confinement will show an increase (trauma, maltreatment) or decrease (virus disease) of several pathology. The study aims to help clinicians to the children care if another time of Home Confinement happened. The main objective is to evaluate the behavioural changes and the reason consultation in Nancy's Pediatric Emergencies from 18 March to 30 June 2020 comparate to the same time in 2019. We will continue the search after the end of Home Confinement until 30 June 2020 to evaluate what happened just after.

Official Title
-----------------
Conséquences of the COVID-19 Lockdown Measures on the CHRU Nancy

Conditions
-----------------
Number of Patients During the Studying Period, Reason for Consultation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children who are cared during the study period to the Nancy's pediatric emergencies Exclusion Criteria: be more than 18 years old Not being seen by a doctor

Ages Eligible for Study
-----------------
Maximum Age: 17 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children who came to the Nancy's Pediatric emergencies during the study period in 2019<br> | |
| Children who came to the Nancy's Pediatric emergencies during the study period in 2020<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patient who came to Nancy's pediatric emergencies during the study period |  | from 18 March to 30 June 2019 and 2020 | 
| Reason of consultation during the study period |  | from 18 March to 30 June 2019 and 2020 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of children who was send by a General practician |  | from 18 March to 30 June 2019 and 2020 | 
| Medical reason to be sending by a General practician |  | from 18 March to 30 June 2019 and 2020 |
Study of Gefitinib Compared With Pemetrexed/Cisplatin in Advanced Non-Small Cell Lung Cancer Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the efficacy and safety of gefitinib combinated with Pemetrexed/Cisplatin in advanced non-small cell lung cancer (NSCLC).

Official Title
-----------------
Phase 2 Study of Gefitinib Compared With Pemetrexed/Cisplatin in Advanced Non-Small

Conditions
-----------------
Toxicity, Non-small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: Gefitinib
* Drug: Pemetrexed
* Drug: Cisplatin or carboplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who were diagnosed by the histologic, cytologic diagnosis of IV non-small cell lung cancer Age from 18 to 70 years old At least one target lesion diameter spiral CT ≥ 1 cm, or the common CT ≥ 2 cm, and can be measured by imaging tools ECOG 0-1 Expected life time longer than 12 weeks Normal laboratory values: leucocyte≥ 4×109/L neutrophil≥ 1.5×109/L platelet≥100×109/L Hemoglobin≥ 10g/L ALT and AST ≤2.5×ULN (≤5×ULN if liver metastasis) Exclusion Criteria: Patients have not used drugs according to protocol Patients were allergic to pemetrexed or cisplatin Patients received radiotherapy or other biological treatment 4 weeks before the trial Uncontrolled hydrothorax or hydropericardium neuropathy toxicity ≥ CTC 3 Severe symptomatic heart disease Active upper gastrointestinal ulcer or digestive disfunction Severe infection or metabolic disfunction Patients with other malignant tumor Uncontrolled brain metastases Patients have accepted other clinical trials Female patients during their pregnant and lactation period, or patients without contraception

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

| Intervention/Treatment |
| --- |
|Drug: Gefitinib|250mg qd po d3-16|
|Drug: Pemetrexed|500mg/m2 venous infusion,D1,q3w|
|Drug: Cisplatin or carboplatin|Cisplatin:75mg/m2, venous infusion,D1,q3w or Carboplatin: AUC 5, venous infusion, D1,q3w|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response rate |  | six weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events | according to NCI CTC V3.0 | six weeks | 
| Progression free survival |  | six weeks | 
| quality of life | according to FACT-LCS scores | six weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Objective response rate, Time to Progression, Quality of Live
A Phase I, Bioequivalence Study to Evaluate Two Formulations of Bendamustine (BDM) Hydrochloride (HCl) Administered to Cancer Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate that a new formulation of an Bendamustine (BDM) Hydrochloride (HCl) is bioequivalent (BE) (similar) to the commercially available product in patients with cancer.

Detailed Description
-----------------
This is an open-label, randomized, crossover, Phase I study intended to demonstrate the BE, and safety and tolerability profile of 2 formulations of BDM HCl administered to cancer patients: Eagle-BDM and Teva-BDM Histologically confirmed diagnosis of any malignant disease (solid tumors and hematologic malignancies are eligible) for which no curative or standard therapy is appropriate. At the end of the study, patients may be enrolled into an open-label extension (OLE) study (Study EGL-BDM-C-1301-OLE), at the discretion of the investigator.

Conditions
-----------------
Cancer Which Has Either Progressed or Relapsed After Standard Therapy, or for Which no Curative or Standard Therapy is Appropriate

Intervention / Treatment
-----------------
* Drug: Test Product (Bendamustine)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed diagnosis of any malignant disease for which no curative or standard therapy is appropriate. Bone Marrow Function and Blood Chemistry results within protocol limits Exclusion Criteria: CLL HIV Presence of brain metastases

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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Eagle-BDM; Teva-BDM; Teva-BDM<br>Eagle-BDM: IV Teva-BDM: IV | Drug: Test Product (Bendamustine)<br> <br> |
| Other: Teva-BDM; Eagle-BDM;Teva-BDM<br>Eagle-BDM: IV Teva-BDM: IV | Drug: Test Product (Bendamustine)<br> <br> |
| Other: Teva-BDM, Teva-BDM, Eagle-BDM<br>Eagle-BDM: IV Teva-BDM: IV | Drug: Test Product (Bendamustine)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate bioequivalent area under the time concentration curve (AUC) for both drug products | Each patient will receive 3, single doses of study medication in a 56 day treatment period (2 cycles of 28 days each). Medication will be administered on Cycle 1, Day 1; Cycle 1, Day 2; and Cycle 2, Day 1. Each patient will receive 1 dose of Eagle-BDM and 2 doses of Teva-BDM in 3 randomly assigned, varying treatment sequences(Eagle-BDM, Teva-BDM, Teva-BDM; Teva-BDM, Eagle-BDM, Teva-BDM; or Teva-BDM, Teva-BDM, Eagle-BDM). Pharmacokinetic assessments will be performed. | Participants will be in the study for up to 65 days |
Study for Evaluating the Real Use of Inhaled Aztreonam Lysine in Patients With Cystic Fibrosis

Study Overview
=================
Brief Summary
-----------------
The aim of this observational trial is to evaluate the pulmonary function in cystic fibrosis patients that have been treated with inhaled aztreonam lysine comparing the previous 12 months before the treatment and the forward 12 months after initiating the treatment.

Official Title
-----------------
Study for Evaluating the Real Use of Inhaled Aztreonam Lysine in Patients With Cystic Fibrosis

Conditions
-----------------
Cystic Fibrosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients above 6 years old that have been treated with Aztreonam Lysine (AZLI) at any time within 12 months before starting the treatment Diagnosis of Cystic Fibrosis confirmed Chronic infection by Pseudomonas aeruginosa Patients can be treated with any inhaled antibiotic before or after AZLI treatment Patients have to have the following FEV1 measures: 12 months before starting AZLI; at AZLI initiation; 12 months after starting AZLI For lung transplant patiens, only data before the transplant will be collected. Exclusion Criteria: Non applicable

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 65 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 |
| --- | --- | --- |
| FEV1 | Forced expiratory volume in one second (FEV1) measured during pulmonary function test. | 12 months |
Prevalence of Different Etiologies of Ocular Dryness in Patients Previously Diagnosed With Dry Eye Disease in A Sample of Egyptian Patients

Study Overview
=================
Brief Summary
-----------------
Proposed Study Title: Prevalence of Different Etiologies of Ocular Dryness in Patients Previously Diagnosed with Dry Eye

Detailed Description
-----------------
Dry eye disease (DED) is a common chronic multifactorial condition of the ocular surface characterized by failure to produce high quality or sufficient amounts of tears to moisturize the eyes (1) DED can be categorized as dry eye with reduced tear production (aqueous deficient) and dry eye with increased evaporation of the tear film known as the hyperevaporative type… Although 10% of individuals have aqueous deficient DED, more than 80% have either the hyperevaporative type related to meibomian gland dysfunction (MGD), or a combination of

Official Title
-----------------
Search Protocol 1. Study a-Proposed Study Title: Prevalence of Different Etiologies of Ocular Dryness in Patients Previously Diagnosed With Dry Eye Disease in A Sample of Egyptian Patients

Conditions
-----------------
Dryness, Dry Eye Syndromes, Meibomian Gland Dysfunction

Intervention / Treatment
-----------------
* Device: Dry eye device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Egyptian people between 20 and 70 years old coming to outpatient clinic BUT< 10 seconds.. No previous surgery. No previous trauma. Not using eye drops in the last 3 months. Exclusion Criteria: Diabetic patients. Patients with rheumatological diseases that may affect ocular surface as RA.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 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 |
| --- | --- |
| A<br>Left eye | Device: Dry eye device<br>* Dry eye analysis<br>|
| B<br>Right eye | Device: Dry eye device<br>* Dry eye analysis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Meibomian gland dysfunction | Meibomian gland dysfunction | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dry eye disease