linjc16/ctgov huggingface dataset:
AMIStem-H Radiographic Analysis

Study Overview
=================
Brief Summary
-----------------
Total hip replacement (THP) is widely used for hip osteoarthritis treatment. Surgeons are constantly looking to improve all aspects related to this procedure weather is improvement of implant design, instrumentation or surgical technique. Excellent clinical and radiological results were observed at medium and long term in the last years for AMIStem system. This observational study has the objective to survey hip prosthesis stability and function of the operated hip in patients who are not exposed to surgical risks. The principal investigator will contact all patients in order to perform the follow-up visit according to standard practice. Patients operated between January 2010 and December 2011 will be invited in the study during the clinical visit organised according to standard practice. Preoperative clinical and radiological data, intraoperative details and postoperative follow-up data at 1-year will be retrospectively collected. Five-year and ten-year data will be prospectively collected after inclusion in the study.

Official Title
-----------------
THP AMIStem-H: Open, Retrospective and Prospective, Monocentric, Non Randomised Observational Study

Conditions
-----------------
Hip, Arthroplasty, Replacement

Intervention / Treatment
-----------------
* Device: AMIStem-H


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient who has received a total hip arthroplasty between January 2010 and December 2011 Patient who has received an AMIStem H femoral component Patient who have signed the information letter in order to give agreement for the clinical data treatment Exclusion Criteria: Minor patient Pregnant or breast feeding woman Any patient who cannot or will not provide informed consent for participation in the study

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

| Intervention/Treatment |
| --- |
|Device: AMIStem-H|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiological analysis of radiolucency lines presence according to Gruen zone classification |  | 5 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| radiological assessment of femoral deformation |  | 5 year, 10 year | 
| radiological assessment of femoral stem subsidence |  | 5 year, 10 year | 
| radiological assessment of cortical bone density |  | 5 year, 10 year | 
| radiological assessment of calcar resorption |  | 5 year, 10 year | 
| Radiological analysis of radiolucency lines presence according to Gruen zone classification |  | 10 year |
SENSIMED Triggerfish Discomfort During IOP Monitoring

Study Overview
=================
Brief Summary
-----------------
Evaluation of the wearing discomfort (safety and tolerability) involved during IOP monitoring with the SENISMED Triggerfish, a sensor embedded in a telemetric contact lens

Official Title
-----------------
Evaluation of SENSIMED Triggerfish for 24 Hour IOP Monitoring in Healthy Subjects and Glaucoma Patients

Conditions
-----------------
Safety and Tolerability of SENSIMED Triggerfish in Glaucoma Patients

Intervention / Treatment
-----------------
* Device: SENSIMED Triggerfish


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is able to comply with the study procedure Patient is 18-80 years old Healthy subject or glaucoma patient Patient has consented to be in the trial and signed informed consent is available before any study related procedures are carried out Cylinder refraction of no more than +/- 2 diopters in the study eye Visual acuity of 20/80 or better in the study eye Ability of subject to understand the character and individual consequences of the study For women with childbearing potential, adequate contraception Exclusion Criteria: Subjects wearing contact lenses within the last two years Subjects with contraindications for wearing contact lenses History of refractive surgery History of intraocular surgery in the last three months Severe dry eye syndrome Keratoconus or other corneal abnormalities Conjunctival or intraocular inflammation Pregnancy and lactation Simultaneous participation in other clinical trials

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy subjects<br> | Device: SENSIMED Triggerfish<br>* Ocular Telemetry Sensor for IOP monitoring<br>|
| Glaucoma patients<br> | Device: SENSIMED Triggerfish<br>* Ocular Telemetry Sensor for IOP monitoring<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ocular discomfort on a visual analogue scale |  | 24 hours |
The Influence of Infant Feeding Type on Preterm Infant's Intestinal Microbiome

Study Overview
=================
Brief Summary
-----------------
This study aims to examine the factors associated with preterm infant's intestinal microbiota depending on feeding type (breast milk or preterm formula)

Detailed Description
-----------------
The gut microbiome has been increasingly found to affect human health. Feeding plays an important role in determining the composition and diversity of the neonatal gut microbiome. Preterm infants are at a high risk of gut microbiota disruption and dysbiosis because of physiological immaturity and environmental factors. In preterm infants, breast milk has been associated with improved growth and cognitive development and a reduced risk of necrotizing enterocolitis and late onset sepsis. The objective of study is to determine the impact of feeding type on gut microbiome of very preterm infants admitted in a neonatal intensive care unit (NICU). Meconium and the additional 2 fecal samples will be collected from preterm infants. Fecal samples will be collected every 14 days, during 28 days, from diapers into sterile tubes. DNA will be extracted from fecal samples and different bacterial genus and species will be analyzed. The type of infant feeding (breast milk or preterm formula) is recorded daily to classify the type of infant feeding received during the 14 days prior to each fecal sample collection.

Official Title
-----------------
The Influence of Infant Feeding Type on Preterm Infant's Intestinal Microbiome

Conditions
-----------------
Microbial Colonization

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Very preterm infants (< 32 weeks gestational age) admitted in the NICU of CHA Bundang Medical Center within the first 24 hours after birth Exclusion Criteria: Parents refuse to participate/sign informed consent Major congenital anomalies
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Very Preterm Infants<br>preterm infants were born at gestational age of less than 32 weeks | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intestinal microbiome composition according to the type of feeding | comparison of intestinal microbiome with 16s RNA gene specific sequencing in stool | within 24 hours after birth | 
| intestinal microbiome composition according to the type of feeding | comparison of intestinal microbiome with 16s RNA gene specific sequencing | 2 weeks after birth | 
| intestinal microbiome composition according to the type of feeding | comparison of intestinal microbiome with 16s RNA gene specific sequencing | 4 weeks after birth | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intestinal microbiota, very preterm infant, breast milk, preterm formula
Clinical Application of BioCleanse Meniscus

Study Overview
=================
Brief Summary
-----------------
This study will follow patients after routine surgery of a meniscal allograft transplant.

Detailed Description
-----------------
The BioCleanse meniscus is available to to all orthopedic surgeons for transplantation. The purpose of this registry is to allow close monitoring of a subgroup of patients receiving the BioCleanse Meniscus. All patients who have selected a BioCleanse Meniscus for their Meniscal Allograft transplant will be asked to join the registry. Outcomes will be measured by subjective subject questionnaires as well as X-rays and MRI.

Official Title
-----------------
Clinical Application of BioCleanse Meniscus Registry

Conditions
-----------------
Tear of Meniscus of Knee

Intervention / Treatment
-----------------
* Other: BioCleanse Meniscus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients, up to 10 who have selected a BioCleanse Meniscus transplant Exclusion Criteria: Anyone not eligible for a meniscal transplant

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: BioCleanse Meniscus|Subjects will undergo routine meniscal allograft transplant surgery.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | The score is an index score from 0 to 100, with 0 representing extreme problems and 100 representing no problems. | 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI Assessments | MRI images were assessed for integration of the meniscal allograft transplant for integration of the anterior horn, body and posterior horn. Images were also assessed for oedema in each of these 3 regions of the meniscus. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Meniscus transplant, Meniscal allograft, MAT, Knee
Epidemiology of Helicobacter Pylori Infection Among Shanghai Children

Study Overview
=================
Brief Summary
-----------------
Epidemiology of Helicobacter Pylori Infection Among Shanghai Children.

Detailed Description
-----------------
To get an understanding of the Hp infection general situation and provide evidence for Hp control, we are planning to run a free physical examination and lab test for a group of children. We are going to proceed with Hp-IgG test, 13C urea breath test and salivary Hp urea antigen test together to screening and diagnosing it.

Official Title
-----------------
Epidemiology of Helicobacter Pylori Infection Among Shanghai Children

Conditions
-----------------
Bacterial Infection Due to Helicobacter Pylori (H. Pylori)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 3 18 Not been Clinical diagnosis of Exclusion Criteria: Had antibiotics in the past week Had Bismuth or PPI

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 18 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 |
| --- | --- |
| Children<br>Children | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HP Infection Rate Estimation for Shanghai Children | Get the population of infection with HP and calculate the infection rate for the sampling group, to estimate the infection rate for whole population of Shanghai children | Sampling complete before June 30, 2014. Lab test finish within 10 weeks. Report release within 3 weeks after all test finished. |
The Prospective Segeberg Registry for Rotational Atherectomy in Coronary Lesion/s

Study Overview
=================
Brief Summary
-----------------
A Prospective Follow-up Assessment in Bad Segeberg with Patients undergoing a Rotational Atherectomy in Coronary Lesion/s

Detailed Description
-----------------
A prospective single center registry including all patients treated with Rotational Atherectomy in Coronary Lesion/s at the Heart Center, Bad Segeberg, Germany. Patients undergo a routine clinical follow-up schedule, including a long-term follow-up.

Official Title
-----------------
A Prospective Follow-up Assessment in Bad Segeberg With Patients Undergoing a Rotational Atherectomy in Coronary Lesion/s

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Procedure: Rotational Atherectomy in Coronary Lesion/s


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients undergoing a rotational atherectomy of coronary lesion/s Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| Patients with Coronary Artery Disease<br>Patients with Coronary Artery Disease undergoing a Rotational Atherectomy in Coronary Lesion/s | Procedure: Rotational Atherectomy in Coronary Lesion/s<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of in-hospital and long-term cardiovascular adverse events in percent | Peri-procedural events and in-hospital cardiovascular events and long-term cardiovascular events (bleeding, peripheral and coronary vascular complication, stroke, myocardial infarction, stent thrombosis, revascularization, death) | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Calcified coronary artery lesions
Conscious Sedation Efficacy of the MKO Melt (Midazolam, Ketamine, Ondansetron)

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesized that the combination of Valium, Tramadol and Zofran is superior to the substantially more expensive MKO melt in patient satisfaction after cataract surgery.

Detailed Description
-----------------
The MKO melt is being marketed as an anesthetic medication for cataract surgery that has the advantage that it eliminates the need for an IV in 85% of patients although that number was established anecdotally. This alternative, however, is very cost limiting.The investigators wanted to see if the current regimen (valium only) or a combination similar to the MKO melt (valium + tramadol + zofran) are as good if not better than the MKO melt for anesthesia and how many patients could have indeed gone with an intravenous line (didn't need any extra medications).

Official Title
-----------------
Conscious Sedation Efficacy of the Novel Medication, MKO Melt (Midazolam, Ketamine, Ondansetron), During Cataract Surgery

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Drug: Diazepam
* Drug: Tramadol
* Drug: Ondansetron
* Drug: MKO melt


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients scheduled to undergo cataract surgery with Drs. Mayo and Wade at Kirby Glen Surgery Center Exclusion Criteria: Age <18 years Patient is not suitable for the medications for reasons such as unsteady gait, cane, wheelchair, severe dementia (unable to consent), terminal illness Allergy to a medication in protocol

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: diazepam only (group 1)<br>Patients are given 5 or 10mg of diazepam for sedation before surgery for sedation | Drug: Diazepam<br>* 5 or 10mg<br>|
| Active Comparator: diazepam/tramadol/ondansetron (group 2)<br>Patients are given 5 or 10mg of diazepam, 50 or 100mg of tramadol and 4 or 8mg of ondansetron orally before surgery for sedation | Drug: Diazepam<br>* 5 or 10mg<br>Drug: Tramadol<br>* 50mg or 100mg<br>Drug: Ondansetron<br>* 1 or two tabs<br>|
| Experimental: MKO only (group 3)<br>Patients are given 1 or 2 MKO melts (each contain 3mg midazolam, 25mg ketamine, 2mg ondansetron) sublingually before surgery for sedation | Drug: MKO melt<br>* 1 or 2 MKO melts<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patient who needed additional IV medication for cataract surgery | Patients who require IV medications for self-reported pain or anxiety during surgery. | 1 day |
The Impact of Remimazolam for Postoperative Sedation on the Left Ventricular Systolic Performance in Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
This study analyzes the impact of intraoperative Remimazolam infusion for postoperative sedation on the left ventricular global longitude strain (LV-GLS) patients undergoing cardiac surgery

Official Title
-----------------
The Impact of Remimazolam on the Left Ventricular Systolic Performance for Cardiac Surgery: a Speckle Tracking Analysis of the Left Ventricular Strain Using Transthoracic Echocardiography

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Drug: Remimazolam Injection [Byfavo]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elective off-pump coronary artery bypass surgery Exclusion Criteria: arrhythmia LV ejection fraction < 50 % preoperative inotropic support

Ages Eligible for Study
-----------------
Minimum Age: 20 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: remimazolam infusion<br>Intraoperative remimazolam infusion for postoperative sedation | Drug: Remimazolam Injection [Byfavo]<br>* Remimazolam injection and continuous infusion for postoperative sedation, 0.2 mg/kg for 1 min and continuous infusion of 1-2 mg/kg/hour<br>* Other names: Remimazolam infusion;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of the left ventricular global longitudinal strain | mean values of the left ventricular global longitudinal strain after 3 minutes, 5 minutes and 10 minutes after the Remimazolam administration | 1 minutes |
A Single-Center Evaluation of the Pattern of Allergic Signs and Symptoms During 4 Weeks in Ragweed Season

Study Overview
=================
Brief Summary
-----------------
The study was designed to evaluate the pattern of seasonal allergic signs and symptoms consistent with ongoing ocular allergic inflammation during ragweed season. It was hypothesized that a pattern of ongoing ocular allergic inflammation existed in certain subjects.

Detailed Description
-----------------
Subjects who had a positive skin test to ragweed within 24 months of Visit 1 were instructed to complete a diary, which assessed their allergic signs and symptoms 3 times a day for 4 weeks. During the in-office visits, subjects were asked to completed a quality of life questionnaire, as well as a retrospective and/or prospective eye allergy questionnaire.

Conditions
-----------------
Allergic Conjunctivitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must: be willing and able to read, sign, and date the informed consent and HIPAA documents prior to initiation of Visit 1 procedures or exams; be at least 18 years of age; be willing to avoid disallowed medication, such as anti-allergy therapies have a positive history of ocular allergies and a positive skin test reaction to ragweed within the past 24 months; have a calculated logMAR visual acuity score using the ETDRS Chart of 0.60 or better in each eye at Visit 1; Exclusion Criteria: Subjects may not: have preauricular lymphadenopathy or any ocular condition that could affect study parameters (particularly, clinically significant blepharitis, follicular conjunctivitis and iritis); have had any ocular infection within the last 30 days; have a positive diagnosis of moderate to severe dry eye syndrome (i.e., requiring daily use of artificial tears); wear contact lenses to each office visit; Note: Subjects will be allowed to use cold compresses.

Ages Eligible for Study
-----------------
Minimum 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 |
| --- | --- | --- |
| Diary Data |  | 4 weeks |