linjc16/ctgov huggingface dataset:
The Purpose of This Study is to Determine Whether Topical Application of PEP005 is Safe for the Treatment of Common Wart(s)

Study Overview
=================
Brief Summary
-----------------
Verruca vulgaris, otherwise known as the common wart, is caused by the human papillomavirus (HPV). Common warts are generally located on the hands and feet, but can also occur elsewhere (e.g., any areas of frequent contact). Common warts have a characteristic cauliflower-like surface, are typically slightly raised above the surrounding skin and are generally diagnosed by visual inspection.The treatment of warts poses a therapeutic challenge for physicians. No single therapy has been proven effective at achieving complete remission in every patient.This study will aim to evaluate an up-to a three-day course of therapy with 0.05% PEP005 Topical Gel.

Official Title
-----------------
A Phase I, Single-Centre, Open-Label, Fixed-Dose Study of the Safety and Efficacy of up- to Three-Days Application of 0.05% PEP005 Topical Gel in the Treatment of Patients With Common Wart(s) (Verruca[e] Vulgaris) on the Dorsal Hand

Conditions
-----------------
Warts

Intervention / Treatment
-----------------
* Drug: PEP005


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients at least 18 years of age. A clinically diagnosed, single common cutaneous viral wart (verruca vulgaris) on the dorsal hand. Written informed consent has been obtained. Agreement from the patient to allow photographs of the common wart(s) treatment area to be taken and used as part of the study package.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Three day application of 0.05% PEP005 Topical Gel to one or two common warts located on the hand. | Drug: PEP005<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of Common Wart(s) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PEP005, Common Wart(s), Common warts (verruca[e] vulgaris)
mNGS Versus Blood Culture in FN

Study Overview
=================
Brief Summary
-----------------
Blood stream infection (BSI) during febrile neutropenia (FN) is a lethal complication, while confirmed diagnosis via blood culture is usually with low sensitivity and time delay. The new technique of metagenome next generation sequencing (mNGS) has the potential of early and more accurate detection of pathogens. However, this technique has not been well validated for BSI diagnosis in patients with hematological disease. Therefore, we designed a prospective multicenter study to compare the diagnosis performance in BSI.

Official Title
-----------------
The Comparison of mNGS Versus Blood Culture for Early Diagnosis of Blood Stream Infection During the Febrile Neutropenia in Patients With Hematological Disease

Conditions
-----------------
Infections, Hematologic Diseases, Febrile Neutropenia

Intervention / Treatment
-----------------
* Diagnostic Test: blood culture versus mNGS detection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hematologic disease febrile neutropenia Exclusion Criteria: refuse to consent age<=14 not caused by infection

Ages Eligible for Study
-----------------
Minimum Age: 15 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: blood culture versus mNGS detection|peripheral 4ml for mNGS detection|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diagnosis performance | the sensitivity and specificity of mNGS | 14 days after sapmpling |
Results of a Program of Newborn Hearing Screening (NHS) in Cuiaba-Brazil

Study Overview
=================
Brief Summary
-----------------
The study aims to demonstrate the indices of quality of a Newborn Hearing Screening (NHS).

Detailed Description
-----------------
The data refer to infants underwent newborn hearing screening by evoked otoacoustic emissions by transient stimulation, using the analyzer EOA Biologic. Examinations archived in the computer's service were analyzed for the amount of infants who passed or failed the screening, as well as the correlations with the same age and gender.

Official Title
-----------------
Results of a Program of Newborn Hearing Screening in Cuiaba-Brazil

Conditions
-----------------
Showing the Results of a Program of NHS in Cuiaba_ Brazil

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: middle ear conditions integrates Exclusion Criteria: middle ear conditions inadequate

Ages Eligible for Study
-----------------
Minimum Age: 2 Days
Maximum Age: 3 Months

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hearing, newborn, screening
Acute Ischemic Stroke Registry for Endovascular Treatment

Study Overview
=================
Brief Summary
-----------------
The Acute Ischemic Stroke Registry for Endovascular Treatment (AIS-EVT) is an academic, prospective, multicenter, observational registry study. Consecutive stroke patients treated with endovascular treatment will be enrolled in stroke centers. Baseline information and clinical follow-up information at 90 days of stroke onset are collected. Data collected include demographics, comorbidities, pathogenesis, blood pressures, stroke severity on admission, time intervals, reperfusion condition, and functional outcome, et al.

Official Title
-----------------
Acute Ischemic Stroke Registry for Endovascular Treatment in China

Conditions
-----------------
Acute Ischemic Stroke

Intervention / Treatment
-----------------
* Procedure: Endovascular Treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of acute ischemic stroke; Imaging confirmed intracranial large vessel occlusion: intracranial internal carotid artery (ICA), middle cerebral artery (MCA M1/M2), anterior cerebral artery (ACA A1/A2), basilar artery (BA), vertebral artery (VA V4), and posterior cerebral artery (PCA P1); Initiation of any type of endovascular treatment, including intra-arterial thrombolysis, mechanical thrombectomy, aspiration, angioplasty, and stenting; Verbal and written informed consent was provided at the time of admission by patients or their legal authorized representatives. Exclusion Criteria: No evidence of large vessel occlusion on digital subtraction angiography.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Endovascular Treatment|Re-open the occluded cerebral artery using endovascular treatment|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The modified Rankin Scale score at 90 days | The range of the modified Rankin Scale is from 0 to 6. A higher score indicates a worse outcome. 0-No symptoms; 1-No significant disability; 2-Slight disability; 3-Moderate disability; 4-Moderately severe disability; 5-Severe disability; 6-Dead. | 90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute ischemic stroke, Endovascular treatment, Outcome, Registry
A Study to Assess the Effect of CellCept (Mycophenolate Mofetil) and Reduced Corticosteroids in Controlling Symptoms of Myasthenia Gravis

Study Overview
=================
Brief Summary
-----------------
The efficacy and safety of CellCept (1g po, bid for 36 weeks) will be assessed in patients with myasthenia gravis receiving prednisone, or other corticosteroids. During the study, patients will undergo gradual corticosteroid dose reduction, if they respond to treatment. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Official Title
-----------------
A Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter, 36-Week Trial to Assess the Efficacy and Safety of Adjunct Mycophenolate Mofetil (MMF) to Maintain or Improve Symptom Control With Reduced Corticosteroid in Subjects With Myasthenia Gravis

Conditions
-----------------
Myasthenia Gravis, Generalized

Intervention / Treatment
-----------------
* Drug: mycophenolate mofetil (CellCept)
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients 18 to 80 years of age; diagnosis of myasthenia gravis; history of myasthenia weakness involving more than ocular (ie eye) or peri-ocular muscle; duration of myasthenia gravis symptoms (including ocular symptoms) <=10 years; prednisone dose >=20 mg/day (or equivalent alternate-day dose) for >=4 weeks. Exclusion Criteria: female patients who are pregnant, breastfeeding, or lactating; regularly scheduled plasma exchange (PE) or intravenous immunoglobulin (IVIG) treatment, or PE or IVIG treatment within 2 weeks prior to randomization; any prior clinically significant use of CellCept or other immunosuppressive therapy (except corticosteroids), or within 8 weeks prior to randomization.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: mycophenolate mofetil (CellCept)<br>* 1g bid for 36 weeks<br>|
| Placebo Comparator: 2<br> | Drug: placebo<br>* po bid for 36 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects reaching responder status |  | Week 36 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to start of response |  | Event driven | 
| Mean and median prednisone dose and cholinesterase inhibitor dose |  | Week 36 | 
| Adverse events, lab parameters, vital signs |  | Throughout study |
The Prediction Model of Hypoxemia for Safe Bronchoscopy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to develop the hypoxemia prediction model during fiberoptic bronchoscopy under MAC(monitored anesthesia care) anesthesia.

Detailed Description
-----------------
Currently, diverse sedatives and analgesic methods are used during fiberoptic bronchoscopy for reducing patients' discomfort and facilities of procedures as British Thoracic Society recommendation. MAC anesthesia, one of the widely used sedative method during bronchoscopy, have many advantages, occurrence of respiratory depression, hypoxemia are not uncommon during the procedures. The investigators try to find out risk factors and develop the prediction model for hypoxemia during bronchoscopy under MAC anesthesia.

Official Title
-----------------
The Prediction Model of Hypoxemia for Safe Bronchoscopy Under MAC Anesthesia

Conditions
-----------------
Hypoxemia, Obstructive Sleep Apnea

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age> 15 yrs patients who are planned to get fiberoptic bronchoscopy under MAC anesthesia in Seoul National University Bundang Hospital Exclusion Criteria: Patients who will get Endobronchial ultrasound guided transbronchial needle aspiration patients whose baseline oxygen saturation is below 90% Intubated patients Patients do not agree with the study enrollment

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- | --- |
| Lowest oxygen saturation during bronchoscopy, development of hypoxemia(SpO2<90%) during bronchoscopy |  | during the fiberoptic bronchoscopy, estimated procedure time is about 15min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for oxygen flow increment |  | during the fiberoptic bronchoscopy, estimated procedure time is about 15min | 
| the proportion of subjects who is require of mandible lift |  | during the fiberoptic bronchoscopy, estimated procedure time is about 15min | 
| time delay for procedure due to hypoxemia |  | during the fiberoptic bronchoscopy, estimated procedure time is about 15min | 
| the proportion of subjects with snoring | snoring | during the fiberoptic bronchoscopy, estimated procedure time is about 15min | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypoxemia, Model, Bronchoscopes, Monitored anesthesia care
Extravascular Lung Water Index in Severe Sepsis

Study Overview
=================
Brief Summary
-----------------
To investigate whether extravascular lung water index (EVLI) is an independent predictor for multiorgan dysfunction syndrome (MODS) in patients with severe sepsis and to determine if increased EVLI may serve as an predictor for MODS and mortality in those patients.

Conditions
-----------------
Severe Sepsis

Intervention / Treatment
-----------------
* Procedure: EVLI was determinated by PiCCO plus system.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All enrolled patients were recruited consecutively on the day of MICU admission and within 24 hours of the diagnosis of severe sepsis. Exclusion Criteria: Pregnancy, Age less than 18 years old, and Uncontrolled malignancy.

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

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: With and without MODS developement<br>EVLI was determinated by PiCCO plus system. | Procedure: EVLI was determinated by PiCCO plus system.<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Developement of MODS (multiorgan dysfunction syndrome) and mortality |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
severe sepsis, intensive care units
Clinical Feasibility of Birth- Track II System

Study Overview
=================
Brief Summary
-----------------
The Study purpose is to monitor the cervix dilation, head descent, FHR and to follow contraction in a women in active labor.

Official Title
-----------------
Clinical Feasibility of Birth- Track II System

Conditions
-----------------
Obstetrics, Labor

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Laboring women referred to the Maternity Center in active labor (3cm dilatation and contractions). Gestational age 37-42 weeks. (GA) Single fetus Subjects who understood, agreed and signed the informed consent form Exclusion Criteria: Women with abnormal placentation (placenta previa) Abnormal fetal presentation (breech presentation) Maternal History of HIV and/or blood transmitted hepatitis and/or active genital Herpes. Need for immediate delivery (cord prolapsed or suspected placental abruption)

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 50 Years

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
women in active labor
Colonoscope Passive Bending Function

Study Overview
=================
Brief Summary
-----------------
A prototype colonoscope with an extra passively bending distal section has been developed by Olympus Japan (ref. publications). The present study (2006-2007) is testing refinements of this function.

Detailed Description
-----------------
Results from the first prototype evaluation has been published.Modifications are presently evaluated.

Official Title
-----------------
Evaluation of a Novel Colonoscope Designed for Easier Passage Through Flexures: A Randomised Study

Conditions
-----------------
Adenoma, Colitis, Carcinoma, Functional Colonic Disease

Intervention / Treatment
-----------------
* Device: Passive bending function
* Device: No passive bending function


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients referred for routine outpatients colonoscopy Exclusion Criteria: Pregnant women Age below 18 years

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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prototype colonoscope<br>Colonoscopy using prototype colonoscope with passive bending function | Device: Passive bending function<br>* Colonoscope with a passive bending function<br>* Other names: passive bending colonoscope;|
| Placebo Comparator: Standard colonoscope<br>Colonoscopy using standard colonoscope with no passive bending function | Device: No passive bending function<br>* Examination using standard colonoscope without passive bending function<br>* Other names: standard colonoscope;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Assessment of Pain Experienced During Colonoscopy | The proportion of patients reporting no pain when examined with prototype or standard colonoscope, respectively. Pain experienced was assessed by the patient in a questionnaire to be filled in at home on the day after the examination and mailed in a pre-paid envelope to a national quality register (Gastronet). | Pain experienced during colonoscopy |
Genetics of Periodontal Diseases in European Caucasians

Study Overview
=================
Brief Summary
-----------------
(A retrospective case control study to validate the association between Interleukin-1 gene variations and adult chronic periodontal disease in European Caucasians)

Conditions
-----------------
Periodontitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ethnicity: Dutch or German Caucasian Exclusion Criteria: None (however, diabetics were excluded during original patient recruitment at several clinical sites).

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Periodontitis<br> | |
| Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Genetic Polymorphisms Associated With Vertebral Osteochondrosis

Study Overview
=================
Brief Summary
-----------------
The present study is proposed for the identification of phenotype, biochemical and genetic markers in adult symptomatic spinal osteochondrosis to promote the early diagnosis of this pathological condition and to establish possible therapeutic targets that favor a conservative approach aimed at treating patients.

Detailed Description
-----------------
The primary outcome is to determine the association between specific phenotypic characteristics of osteochondrosis, in particular linked to osteo-cartilaginous degeneration, with the identified vitamin D receptor genotypes. The secondary outcomes are to evaluate the circulating levels of the osteo-cartilage degradation markers, of the vitamin D and to evaluate the association of the osteochondrosis phenotype with variants in genes involved in inflammatory processes.

Official Title
-----------------
Evaluation of Polymorphisms in the Vitamin D Receptor and Involved in Inflammation Associated With Vertebral Osteochondrosis

Conditions
-----------------
Spinal Osteochondrosis

Intervention / Treatment
-----------------
* Genetic: presence of genetic variants


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria males and females 18≤age ≤ 65 years old patients with adult spinal osteochondrosis Exclusion criteria age < 18 or > 65 years old chronic major diseases such as diabetes, autoimmune diseases, cardiovascular diseases, malignancies

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: presence of genetic variants|identification of the presence of genetic variants|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| association of spinal osteochondrosis with specific VDR genotypes | Determine the association between specific phenotypic characteristics of osteochondrosis identified by means of MRI, in particular the presence of wavy/Irregular, notched endplates or Shmorl's nodes with FokI, BsmI, ApaI, TaqI VDR genotypes, assessed by means of TaqMan SNP Genotyping Assays | 1st year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| association of spinal osteochondrosis with specific biochemical markers | Determine the association between specific phenotypic characteristics of osteochondrosis identified by means of MRI, in particular the presence of wavy/Irregular, notched endplates or Shmorl's nodes with the circulating levels of the osteo-cartilage degradation markers CTx-I, CTx-II and of the vitamin D. | 2nd year |