linjc16/ctgov huggingface dataset:
Comparative Clinical Evaluation of Daily Disposable Lenses in Symptomatic Daily Disposable Lens Wearers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the extent to which symptoms improve in symptomatic contact lens wearers when fit with one of two different daily disposable contact lenses.

Official Title
-----------------
Comparative Clinical Evaluation of Daily Disposable Lenses in Symptomatic Daily Disposable Lens Wearers

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

Intervention / Treatment
-----------------
* Device: Nelfilcon A contact lens
* Device: Narafilcon A contact lens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Currently wear daily disposable, spherical, soft lens wearers (except the two study products) for at least the past 6 months. Habitually wear lenses for at least 8 hours per day and 4 days per week. Report 2 or more qualifying symptoms with current contact lenses. Able to achieve visual acuity of at least 20/40 in each eye with habitual and with study lenses at dispense. Other protocol-defined inclusion/exclusion criteria may apply. Exclusion Criteria: Eye injury or surgery within twelve weeks immediately prior to enrollment. Currently enrolled in any clinical trial. Any use of ocular medications, exclusive of contact lens rewetting drops. History of corneal or refractive surgery. Cylinder correction greater than 1.00 D Current monovision contact lens wearers. Other protocol-defined inclusion/exclusion criteria may apply.
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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nelfilcon A<br>Nelfilcon A contact lens | Device: Nelfilcon A contact lens<br>* Daily disposable contact lens worn in a daily wear, daily disposable mode<br>|
| Active Comparator: Narafilcon A<br>Narafilcon A contact lens | Device: Narafilcon A contact lens<br>* Daily disposable contact lens worn in a daily wear, daily disposable mode<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lens Awareness | Lens awareness, as interpreted by the subject and reported by the subject in a questionnaire as a single, retrospective evaluation of 4-week's wear time. Frequency of lens awareness was measured on a 4-point scale, with 1 being never and 4 being always. Four-week ratings were compared to baseline ratings, and a negative difference (4 week minus baseline) represented an improvement. | 4 weeks of wear |
Breast Milk Content Expressed Manually Compared to Electric Pump

Study Overview
=================
Brief Summary
-----------------
Breast milk is a unique and unmatched nutritional and non-nutritive source of bioactive factors for the health and development of infants.Colostrum, which is produced in low quantities for the first 3 to 4 days after birth, is rich in immunologic components and developmental factors. Breastfeeding difficulties during the first days of life of an infant are common. Moreover, not all infants can be directly fed at the breast. Therefore, breast milk feeding at this early stage is initiated and promoted by the expression of breast milk either manually or by use of a pump. Whether the method of milk expression at this stage has a qualitative impact on colostrum is currently unknown. The purpose of this randomized controlled study is to compare the effect of manual expression with electric pump expression upon the macronutrient composition of breast milk.

Official Title
-----------------
Breast Milk Content Expressed Manually Compared to Electric Pump

Conditions
-----------------
Infant

Intervention / Treatment
-----------------
* Procedure: Pump


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy lactating mothers of term infants Exclusion Criteria: HIV infected mothers

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Manual expression followed by electric pump<br>Mothers will be assigned to first express breast milk manually followed by electric pump | Procedure: Pump<br>* Breast milk expression using manually or using an electric pump<br>|
| Experimental: Electric pump followed by manual expression<br>Mothers will be assigned to first express breast milk by electric pump followed by manual expression | Procedure: Pump<br>* Breast milk expression using manually or using an electric pump<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Macronutrient content of expressed breast milk | Mothers will express milk from the same breast indicated in the assigned arm. Macronutrient content will be analyzed using the Human Milk Analyzer | 3 to 5 min | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lactation, Breastmilk, Macronutrients
Barriers to Use of Remote Monitoring in Patients With Implantable Cardioverter Defibrillators

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether a teaching intervention can help increase the use of remote monitors in patients with implantable cardioverter defibrillators.

Official Title
-----------------
Barriers to Use of Remote Monitoring in Patients With Implantable Cardioverter Defibrillators

Conditions
-----------------
Cardiac Patients, Implantable Cardioverter Defibrillator

Intervention / Treatment
-----------------
* Behavioral: Teaching Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Received a Medtronic implantable cardioverter defibrillator (ICD) at Yale Electrophysiology, between January 2007 and June 2012 ICD is compatible with Carelink, Medtronic's remote monitoring system Exclusion Criteria: Less than 18 years of age From a vulnerable population Incompetent/suffers from dementia Non-English speaking

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Teaching Intervention<br>Patients will be taught how to install and use a remote monitor. | Behavioral: Teaching Intervention<br>* Patients will be taught how to install and use a remote monitor<br>|
| No Intervention: No Intervention<br>Patients will not be taught how to install and use a remote monitor | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of remote Transmissions of data using remote monitor made by patient |  | 6 months |
Long-term Outcomes of Superficial Esophageal Squamous Cell Carcinoma

Study Overview
=================
Brief Summary
-----------------
Tumor is the primary public health problem and the incidence of esophageal cancer showed the increasing trend in the past thirty years. According to the statistics in 2015, the new onset of esophageal cancer is about 477,900 yearly. The mainly pathologic type of esophageal cancer in China is esophageal squamous cell carcinomas, which accounts for more than 90% of patients in China. With the development of endoscopic technics, more and more patients choose to receive the endoscopic procedure rather than traditional surgery. However, the long-term efficacy and outcomes of patients with superficial esophageal squamous cell carcinoma received different interventions remained unclear. Thus, investigators aim to conduct a multi-center retrospective study to investigate the long term outcomes of superficial esophageal squamous cell carcinoma patients receiving endoscopic treatment and surgery.

Official Title
-----------------
Long-term Outcomes After Treatment for Superficial Esophageal Squamous Cell Carcinoma

Conditions
-----------------
Esophageal Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients received endoscopic treatment because of the superficial esophageal disease and had the pathologic diagnosis of squamous cell carcinoma. Exclusion Criteria: Combined with other severe disease With a history of esophageal surgery Combined with other malignant disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Endoscopic treatment<br>Patients underwent endoscopic treatment including Endoscopic Mucosal Resection (EMR), Endoscopic Submucosal Dissection (ESD), Multiband Mucosectomy (MBM), Endoscopic Mucosal Band Ligation(EMBL) and so on. | |
| Traditional surgery<br>Patients underwent traditional surgery | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 3 years after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence rate |  | 3 years after treatment | 
| Short-term complications incidence rate |  | 30 days after treatment | 
| Long-term complications incidence rate |  | 3 years after treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
superficial esophageal squamous cell carcinoma, efficacy, survival
The Use of Hospital and Emergency Department of Refugee Patients

Study Overview
=================
Brief Summary
-----------------
After Middle Eastern crisis, millions people were forced to migrate to European countries and especially neighboring countries. In Turkey, cities which are closed to east of border, face to cope more refugees' health care than those of other cities. The incidence of admission of hospital outpatient clinics and emergency department by refugee patients is not known clearly in our city, Nevsehir. In this study, we wanted to investigate use of health care among these patients in Nevsehir in Turkey.

Official Title
-----------------
The Use of Hospital Outpatient Clinics and Emergency Department by Refugee Patients in Turkey

Conditions
-----------------
Refugees, Health Care, Outpatients, Emergency Departments

Intervention / Treatment
-----------------
* Other: Refugee patients


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who visited an outpatient clinic and emergency department. Exclusion Criteria: Patients who have missing records.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Refugee patients|To investigate characteristics of outpatient visits of refugee patients|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of outpatient clinics and emergency department use by refugee patients | Hospital outpatient clinics and emergency department use by refugee patients in a secondary care hospital. | 2014-2017 |
Amyotrophic Lateral Sclerosis Registry Rhineland-Palatinate

Study Overview
=================
Brief Summary
-----------------
There is a lack of prospective and population-based epidemiological data on amyotrophic lateral sclerosis in Germany so far. The purpose of this registry is to investigate the incidence, course and phenotypic variety of ALS in Rhineland-Palatinate, a South-West German state of about 4 million inhabitants.

Official Title
-----------------
Amyotrophic Lateral Sclerosis Registry Rhineland-Palatinate

Conditions
-----------------
Amyotrophic Lateral Sclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of amyotrophic lateral sclerosis according to revised El Escorial criteria minimum of 18 years minimum of 6 months of residency in Rhinelnad-Palatinate Exclusion Criteria: patients below 18 years ALS patients outside Rhineland-Palatinate

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 |
| --- | --- |
| Amyotrophic lateral sclerosis patients<br>Patients were included into the registry if they had a new diagnosis of ALS, a minimum age of 18 years and lived in Rhineland-Palatinate for at least 6 months before date of diagnosis. Diagnosis was based upon the revised El Escorial criteria. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death | death of participating ALS patients independent of the cause of death | an average of 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tracheostomy | tracheostomy in ALS patients following respiratory failure | an average of 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
incidence, phenotype, mortality
Ultrasound Guidance Vs. Electrical Nerve Stimulation for Infraclavicular Brachial Plexus Block

Study Overview
=================
Brief Summary
-----------------
In an observer-blinded study ultrasound guidance and electrical nerve stimulation will be compared for lateral sagital infraclavicular blocks (LSIB). Block effectiveness, time consumption and patient acceptance will be registered in 80 patients. Ultrasound guidance may cause less discomfort and could be less time consuming than electrical nerve stimulation.

Conditions
-----------------
Hand Surgery, Brachial Plexus Block

Intervention / Treatment
-----------------
* Procedure: brachial plexus block
* Procedure: ultrasound guidance
* Procedure: electrical nerve stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infraclavicular brachial plexus block Hand surgery Exclusion Criteria: ASA > 2 Block assessment impossible Allergy to local anesthetic

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: brachial plexus block|nan|
|Procedure: ultrasound guidance|nan|
|Procedure: electrical nerve stimulation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Block effectiveness, time consumption; patient acceptance, discomfort |  |  |
Impact of CO2 on Cerebral Blood Flow in Infants Less Than 6 Months During General Anaesthesia

Study Overview
=================
Brief Summary
-----------------
The study aims at assessing cerebral blood flow variations following expired CO2 variations in anaesthetized infants less than 6 months, during a routine general anesthesia.

Detailed Description
-----------------
The study aims at assessing cerebral blood flow (measured with Near-Infrared Reflectance Spectroscopy - NIRS - and transcranial Doppler - DTC) variations following end-tidal expired CO2 variations in anaesthetized infants less than 6 months, during a routine general anesthesia performed according to standards of care.

Official Title
-----------------
Impact of CO2 on Cerebral Blood Flow in Infants Less Than 6 Months During General Anaesthesia

Conditions
-----------------
Anesthesia, General, Infant

Intervention / Treatment
-----------------
* Procedure: EtCO2 modification


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age < or = 6 months ASA class < or = 3 General anesthesia required for surgery Exclusion Criteria: No parental consent Emergency surgery Preexisting neurological condition Hemodynamic instability Preexisting hypoxemia and/or hypercapnia Laparoscopy or thoracoscopy, if expected EtCO2 level achieving would require unsafe ventilation parameters

Ages Eligible for Study
-----------------
Maximum Age: 6 Months

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

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

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

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: Cerebral blood flow is measured in each patient at 3 different, controlled levels of end-tidal CO2
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Main Arm<br>In each patient, under ongoing standard general anesthesia in a stable state, EtCO2 is manually modified to reach predefined values, and after waiting until cerebral blood flow has reached steady state, NIRS and DTC values are noted. | Procedure: EtCO2 modification<br>* Controlled modification of EtCO2 through modification of ventilation parameters under general anesthesia without spontaneous breathing<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NIRS variation | Near-Infrared Spectroscopy value variation after EtCO2 modification | 5 to 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DTC variation | Transcranial Doppler values variation after EtCO2 modification | 5 to 10 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pediatric Anesthesia, Near-Infrared Spectroscopy, End-Tidal CO2, Cerebral Blood Flow
Pelvic Fractures in the Elderly

Study Overview
=================
Brief Summary
-----------------
The aim of the project is to predict the patient under conservative therapy as a function of the patient Classification of Rommens and Hofmann and other potential prognostic factors. A corresponding prognostic score may be used in the future by patients and attending physicians support joint decision between surgical and conservative treatment.

Official Title
-----------------
PelvFx - Pelvic Fractures in the Elderly Patient Influence of Fracture Classification According to Rommens & Hofmann on Mobility, Operation and Independence

Conditions
-----------------
Pelvic Fracture

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pelvic fracture after low-energy trauma Treatment in the years 2006 to 2016 patients equal to or older than 60 years Exclusion Criteria: Pelvic fracture after a high-energy space Pathological fracture in the area of a tumor or a bony metastasis Existence of a documented refusal

Ages Eligible for Study
-----------------
Minimum Age: 60 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 |
| --- | --- | --- |
| mortality | number of patients who died within one year after pelvic fracture | from pelvic fracture until year 1 | 
| loss of independence | loss of independence defined as number of patients leaving their own home and starting to live in a retirement home or asylum within one year after pelvic fracture | from pelvic fracture until year 1 |
Study of ORL-1M (D-mannose) in Patients With CDG-Ib

Study Overview
=================
Brief Summary
-----------------
Study of ORL-1M in Patients With CDG-Ib

Official Title
-----------------
Study of ORL-1M (D-mannose) in Patients With CDG-Ib

Conditions
-----------------
CDG Ib

Intervention / Treatment
-----------------
* Drug: ORL-1M - D-mannose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of CGD-1b. Less than 18 years old. Exclusion Criteria: Diagnosis of any other disease that is not a manifestation of CGD-1b.

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- |
| Other: Treatment with ORL-1M - D-mannose<br> | Drug: ORL-1M - D-mannose<br>* Oral ORL-1M<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in hypoglycemia, diarrhea and vomiting. | Decreased frequency of hypoglycemic episode, diarrhea and vomiting frequency. | 6 months after treatment started | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved glycosylation pattern of serum transferrin. | Normalized isoelectric focusing pattern of serum transferrin. | 30 days after treatment started | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CDGIb MANNOSEPHOSPHATE ISOMERASE DEFICIENCY MPI DEFICIENCY PROTEIN-LOSING ENTEROPATHY-HEPATIC FIBROSIS SYNDROME SAGUENAY-LAC SAINT-JEAN SYNDROME SLSJ SYNDROME