linjc16/ctgov huggingface dataset:
Definition of ARDS in Qinghai Province: Verification of Berlin Definition Plateau Criteria

Study Overview
=================
Brief Summary
-----------------
The severity stratification criteria for acute respiratory distress syndrome (ARDS) in Xi'ning Qinghai province (mean altitude: 2200m) were clarified according to the oxygenation index (PaO2/FiO2).

Detailed Description
-----------------
This study is a single-center retrospective study. According to the Berlin diagnostic standard, ARDS patients admitted to the Department of severe Medicine, affiliated Hospital of Qinghai University from January 2018 to December 2018 were divided into three groups: mild (153mmHg < PaO2/ FiO2 ≥ 230 mmHg), moderate (76mmHg < PaO2/ FiO2 ≥ 153 mmHg) and severe (PaO2/ FiO2 ≥ 76 mmHg). The ICU mortality, 28-day mortality, non-ventilator time in ICU, ICU hospitalization time and non-I hospitalization were observed respectively. The difference of CU time and total hospitalization days.

Official Title
-----------------
Definition of Acute Respiratory Distress Syndrome in Plateau of Qinghai in China: Verification of Berlin Definition Plateau Criteria

Conditions
-----------------
ARDS, High Altitude

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age Meet the diagnostic criteria of ARDS Receive invasive mechanical ventilation Exclusion Criteria: Receive a large number of hormone shock therapy in a short period of time Death within a short period of time (< 24 h) after mechanical ventilation No chest imaging data Data missing

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Mild ARDS<br>153mmHg<PaO2/FiO2≤230mmHg | |
| Moderate ARDS<br>76mmHg<PaO2/FiO2≤153mmHg | |
| Severe ARDS<br>PaO2/FiO2≤76mmHg | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU mortality | Mortality during treatment in ICU | up to 24 weeks | 
| 28-days mortality rate | Mortality at 28 days of hospitalization | 28 days after discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventilator Free time | Ventilator time not used in ICU | up to 24 weeks | 
| Ventilator time | Ventilator time in ICU | up to 24 weeks | 
| Hospital length of stay | Total length of stay in hospital | up to 24 weeks |
Effect of a High-fat Meal on the Pharmacokinetics of SHR0302 and Mass Balance Study in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this open-label, randomized, two-period, two-treatment (single doses of 10 mg SHR0302 fasted or fed), crossover study was to evaluate the effect of a high-fat meal on the pharmacokinetics of SHR0302 and mass balance study in 14 healthy subjects.

Official Title
-----------------
An Open Label, Randomized, Two-period, Crossover Study to Assess the Effect of Food on SHR0302 and Mass Balance in Healthy Volunteers

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: SHR0302


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male BMI:19-24 kg/m2, weight > 50 kg. Age:18-45 Exclusion Criteria: History of clinically significant laboratory results or disease. History of alcohol or drug abuse.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SHR0302 fasted to fed<br>SHR0302 tablets (10 mg) administered on day 1 fasting, and day 7 with high fat, high calorie breakfast | Drug: SHR0302<br>* SHR0302 tablets (10 mg)<br>|
| Experimental: SHR0302 fed to fasted<br>SHR0302 tablets (10 mg) administered on day 1 with high fat, high calorie breakfast, and day 7 fasting | Drug: SHR0302<br>* SHR0302 tablets (10 mg)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The maximum plasma concentration (Cmax) of SHR0302 | up to 72 hrs postdose on day1 and day7 | up to 72 hrs postdose | 
| The area under the plasma concentration-time curve (AUC) of SHR0302 | up to 72 hrs postdose on day1 and day7 | up to 72 hrs postdose | 
| The accumulative excretion rate of SHR0302 and its metabolites in urine and feces | up to 96 hrs postdose on day1 and day7 | up to 96 hrs postdose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of volunteers with adverse events as a measure of safety | required last visit via telephone during D11 to D21 | up to Day 21 |
Effectiveness of Toric Intraocular Lenses for Treating Corneal Astigmatism in Patients With Cataract and Previous DALK

Study Overview
=================
Brief Summary
-----------------
the purpose of this study was to assess the efficacy of custom made toric intraocular lens implantation in patients with simultaneous post-DALK high corneal astigmatism and cataract.

Detailed Description
-----------------
Patients undergoing cataract surgery after DALK for keratoconus were enrolled. Total corneal astigmatism (TCA)was assessed by a rotating Scheimpflug camera combined with Placido disk corneal topography (Sirius; CSO, Firenze, Italy). A customized toric IOL (FIL 611 T, Soleko) was implanted in all eyes. One year postoperatively, refraction was measured, the IOL position was recorded, and vectorial and non-vectorial analysis were performed to evaluate the correction of astigmatism.

Official Title
-----------------
Customized Toric Intraocular Lens Implantation in Eyes With Cataract and Corneal Astigmatism After Deep Anterior Lamellar Keratoplasty (DALK): a Prospective Study

Conditions
-----------------
Corneal Astigmatism in Cataract Patients and Previous DALK

Intervention / Treatment
-----------------
* Device: Customized toric IOL for post-DALK atigmatism


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Corneal suture removal had been performed in all cases at least 1 year before cataract surgery. Corneal astigmatism was stable at least since 6 months before the cataract surgery Exclusion Criteria: other ocular pathologies as glaucoma, retinal disease.

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Customized toric IOL<br>Customized toric IOL for post-Dalk atigmatism in cataract patients | Device: Customized toric IOL for post-DALK atigmatism<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure postoperative refractive astigmatism | Postoperative refractive astigmatism expressed in diopters and measured with refraction examination | 6 months |
Osteoporosis in Children With ALL

Study Overview
=================
Brief Summary
-----------------
Hypothesis: Pediatric patients with acute lymphoblastic leukemia, treated with chronic glucocorticoids as a part of the leukemia treatment protocol, will have an increased incidence and severity of osteoporosis.

Detailed Description
-----------------
Osteoporosis is a disease characterized by low bone mass and microarchitectural deterioration of bone tissue. Osteoporosis is a devastating disorder with significant physical, psychosocial and financial consequences. Intensive chemotherapy and radiotherapy have led to significant improvements in long term, disease-free survival of children with malignancies. Unfortunately, there are many deleterious side effects associated with this therapy. Little is known about the longitudinal changes in bone mass accumulation and bone metabolism in these patients. The purpose of this study is to evaluate the timing and severity of changes in bone mineral metabolism for children treated for childhood leukemia. Data will be used to establish treatment protocols with the goal of preventing severe fractures and pain in the acute treatment stage and severe osteoporosis and related pathology in the chronic stage.

Official Title
-----------------
Incidence of Osteoporosis in Children With Acute Lymphoblastic Leukemia Undergoing Therapy

Conditions
-----------------
Leukemia, Lymphocytic, Acute, L1

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All pediatric patients with a new diagnosis of ALL between ages 4-18 Patients who are expected to receive glucocorticoids as part of the leukemia treatment protocol Bone density measurements must be performed at the diagnosis visit or maximally within 48 hours after the first dose of glucocorticoids Exclusion Criteria: Patients under 4 years of age are excluded due to lack of age appropriate standards for bone mineral density Glucocorticoid therapy of at least one month or longer within the six months prior to DX History of connective tissue or musculoskeletal disorders Biphosphonate therapy within the past 6 months Acute renal failure Serum creatinine equal to or higher than 4.5mg/dl Positive serum pregnancy test in adolescent females

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum 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
-----------------
Osteoporosis, Childhood acute lymphoblastic leukemia
Association Between VEGF-C and miRNA and Clinical Non-small Cell Lung Cancer and Esophagus Squamous Cell Carcinoma

Study Overview
=================
Brief Summary
-----------------
Lung cancer and esophageal cancer remain the leading causes of cancer death worldwide. The main problem is lack of effective tool in early detection that accounts for the poor outcome of cancer. Clinically, over 80% of patients with cancer were at late stage when they were diagnosed. Therefore, it is important for us to find the biomarker that serve as the early prediction of cancer. The investigators have published that VEGFC over-expressed in non-small cell lung cancer. VEGFC plays a critical role in regulating motility of tumor cells, promotes proliferation of lymphatic endothelial cells and enhances migration and invasion. Investigator found that VEGFC over-expressed in the serum of esophageal cancer patients. Therefore, it is worthwhile to investigate the correlation between VEGFC, clinical lung cancer and esophageal cancer. MicroRNAs (miRNAs) are conserved, endogenous, small, and noncoding RNA molecules of 21 23 nucleotides that function as post-transcriptional gene regulators. Recent studies indicated that certain microRNAs reduced in cancer patients. Therefore it is important to investigate whether specific microRNA changed in certain kinds of cancer patients.

Conditions
-----------------
VEGFC Protein in Serum, VEGFC Protein in Non Small Cell Lung Cancer, VEGFC Protein in ESCC, CTTN Protein in ESCC, miR326 in ESCC and Non Small Cell Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: tumor size > 0.5 cm3 Exclusion Criteria: tumor size < 0.5 cm3

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 80 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 |
| --- | --- |
| VEGF-C low<br> | |
| VEGF-C high<br> | |
| miR-326 low<br> | |
| miR-326 high<br> | |

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
-----------------
VEGFC, CTTN, miR326, ESCC, NSCLC
Comparison of Femoral Versus Jugular Routes for Temporary Hemodialysis in Seriously Ill Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether a jugular route leads to a lower rate of complications as compared with a femoral route for catheterization in patients admitted in several intensive care units in France who develop acute renal failure requiring hemodiafiltration or hemodialysis.

Official Title
-----------------
Complications of Jugular and Femoral Venous Catheterization in Critically Ill Patients Requiring Hemodialysis: A Randomized Controlled Trial

Conditions
-----------------
Kidney Failure, Acute, Critical Illness

Intervention / Treatment
-----------------
* Procedure: Femoral route for hemodialysis
* Procedure: Jugular route for hemodialysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Admitted in intensive care unit (ICU) Requiring hemodialysis Clinicians have the choice between jugular and femoral routes Exclusion Criteria: Chronic renal failure requiring long term dialysis

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Femoral route<br> | Procedure: Femoral route for hemodialysis<br> <br> |
| Experimental: Jugular route<br> | Procedure: Jugular route for hemodialysis<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of insertion without complication |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of mechanical complications |  |  | 
| Rates of infectious complications including cath-colonization |  |  | 
| Quality of hemodialysis by urea extraction ratio |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dialysis, Hemodialysis, Catheterization
Repeat Insult Patch Test for Daily Advance Cetaphil Moisturizing Lotion

Study Overview
=================
Brief Summary
-----------------
Human repeat insult patch test to assess the potential for Cetaphil Moisturizing Lotion Daily Advance to induce sensitization to the skin

Official Title
-----------------
Daily Advance Cetaphil Moisturizing Lotion: Human Repeat Insult Patch Test

Conditions
-----------------
Skin Irritation

Intervention / Treatment
-----------------
* Other: Cetaphil Moisturizing Lotion Daily Advance


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-65 years Good health willingness to cooperate and participate willingness to avoid topical products at test sites willingness to avoid direct sun exposure to test sites Exclusion Criteria: Individuals with active psoriasis or eczema individuals with sunburn, acne, abrasions, scar tissue, or tattoos on test sites, or disease of skin that might interfere individuals who have had a mastectomy with axillary nodes were removed individuals receiving anticancer, immunosuppressive treatments or medications, or radiation pregnant, nursing, or planned to become pregnant use of topical steroids or drugs at test sites active or untreated skin cancer active hepatitis current routine or frequent use of high doses of anti-inflammatory drugs individuals who have had les than two week rest period since completion of previous patch testing on upper back or upper arms individuals with uncontrolled metabolic diseases

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: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cetaphil Moisturizing Lotion Daily Advance<br>Each subject had Cetaphil Moisturizing Lotion Daily Advance applied | Other: Cetaphil Moisturizing Lotion Daily Advance<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Irritation responses | all patients will be assessed at 14 visits for redness (erythema), spreading, weeping, papules, vesicles, and bullae at application site | average of 5 weeks |
Efficacy and Safety of ReLEx Smile for Laser Correction of Myopia

Study Overview
=================
Brief Summary
-----------------
Evaluation of the safety and efficacy of the Carl Zeiss Meditec VisuMax femtosecond laser for lamellar resection (ReLEx smile) in the reduction of myopia.

Detailed Description
-----------------
Quality control study of patients treated with ReLEx smile for myopia at the Department of Ophthalmology, Aarhus University Hospital. The patients will be followed with standard clinical techniques (slit-lamp examination, refraction, topography) during their normal follow-up up to 12 months after treatment.

Official Title
-----------------
Use of the VisuMax Femtosecond Laser for the Correction of Myopia With Small Incision Lenticular Extraction

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Indication for keratorefractive correction of myopia Patient consent to undergo keratorefractive correction of myopia Exclusion Criteria: Pregnant or lactating women

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness | Achieved change in refraction (spherical equivalent, SE) in diopters will be compared with attempted change in refraction (SE) in diopters. Data will be reported as fraction of eyes within an error (achieved - attempted) of +/- 0.5 diopters (SE) and within an error of +/- 1 diopters (SE). | Refraction one year after surgery | 
| Safety | Data will be reported as: Percentage of eyes with best spectacle corrected visual acuity (BSCVA) worse than 20/40 for eyes with BSCVA of 20/20 or better before survey Percentage of eyes that lose 2 Snellen lines or more of BSCVA | One year after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Keratorefractive Surgical Procedures
Pharmacokinetic and Pharmacodynamic Properties of BIOD-105 and BIOD-107 Compared to Humalog® in Subjects With Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to assess the speed of absorption and onset of action of BIOD-105 and BIOD-107 and compare them to Humalog®.

Detailed Description
-----------------
The secondary objectives of this study are to assess other pharmacokinetic characteristics of BIOD-105 and BIOD-107 and compare those to Humalog®, to assess other pharmacodynamic characteristics of BIOD-105 and BIOD-107 and compare those to Humalog®, and to evaluate the safety and tolerability of BIOD-105 and BIOD-107 compared to Humalog®.

Official Title
-----------------
A Double-blind Study of the Pharmacokinetic and Pharmacodynamic Properties of BIOD-105 and BIOD-107 Compared to Humalog® in Subjects With Type 1 Diabetes Including Assessments of Safety and Injection Site Toleration

Conditions
-----------------
Diabetes Mellitus Type 1

Intervention / Treatment
-----------------
* Drug: Insulin LISPRO
* Drug: recombinant human insulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must present with the following: Body Mass Index: ≥ 18 - ≤ 28 kg/m2 Diagnosed with type 1 diabetes mellitus for at least 1 year Insulin antibody less than or equal to 10 μU/mL at screening Exclusion Criteria: Subjects presenting with any of the following will not be included in the study: Type 2 diabetes mellitus Serum C-peptide > 1.0 ng/mL HbA1c > 10.0% History of hypersensitivity to any of the components in the study medication Treatment with any other investigational drug in the last 30 days before screening visit Regular smoking as assessed clinically by the Investigator.

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Humalog®<br>Humalog®, administered subcutaneously on 1 occasion | Drug: Insulin LISPRO<br>* Single doses of: 0.15 U/kg<br>|
| Experimental: BIOD- 105<br>BIOD- 105 administered subcutaneously on 1 occasion | Drug: recombinant human insulin<br>* Single doses of: 0.15 U/kg<br>|
| Experimental: BIOD-107<br>BIOD-107 administered subcutaneously on 1 occasion | Drug: recombinant human insulin<br>* Single doses of: 0.15 U/kg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Speed of absorption | The speed of absorption will be assessed by the time to reach 50% of maximum insulin concentration (TINS-50%-early, time before CINS max) and the onset of action will be assessed by the time to reach 50% of the maximum glucose infusion rate (TGIR-50%- early). | 480 minutes |