linjc16/ctgov huggingface dataset:
Total Shoulder Replacement Outcomes With Autologous Bone Graft as Fixator for Glenoid Anchor Peg.

Study Overview
=================
Brief Summary
-----------------
We hypothesize that there will be a low incidence of glenoid loosening with a total shoulder arthroplasty using an anchor peg glenoid and autologous bone grafting. In addition, we suggest that the absence of radiolucent lines will correlate with excellent shoulder function.

Detailed Description
-----------------
This will be five year follow-up of glenoid anchor peg component fixation utilizing autologous bone graft in total shoulder arthroplasty. The purpose of this study is to investigate if the use of autologous bone graft around the anchor peg glenoid prosthesis correlates with better shoulder function. Subjects having had this surgery who are five years or more out from surgery will have computed tomography and three plain radiographs to monitor for bony apposition, radiolucent lines and component loosening. These testings are not a study intervention and are for monitoring purposes.

Official Title
-----------------
Five Year Outcome Follow-up of Glenoid Anchor Peg Component Fixation Utilizing Autologous Bone Graft in Total Shoulder Arthroplasty.

Conditions
-----------------
Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Have had a total shoulder replacement with an anchor peg glenoid and autologous bone grafting at the Department of Orthopaedic Surgery at University of Nebraska and The Nebraska Medical Center five years or longer ago. Exclusion Criteria: unable to comprehend the consent form information pregnant women
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| shoulder replacement<br>Subjects who had shoulder replacement surgery at The University of Nebraska and The Nebraska Medical Center at least 5 or more years ago and autologous bone graft around the anchor-peg glenoid prosthesis was used. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of lower incidence of glenoid loosening and absence of radiolucent lines confirmed by CT and radiographs. | To investigate if the use of autologous bone graft around the anchor-peg glenoid prosthesis correlates with (1.) bony apposition on computed tomography scans, (2.) decreased radiolucent lines, (3.) a decrease in component loosening, and (4.) better functional outcomes. | 5 years after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Total Shoulder Arthroplasty, Glenoid anchor peg component fixation, Autologous bone grafting
Are we Loading Our Patients With Sodium During Hemodialysis Treatments?

Study Overview
=================
Brief Summary
-----------------
The objectives of the data search is to find out if there is correlation between pre, post serum sodium concentration, dialysate sodium concentration, interdialytic weight gain and associated changes in pre and post systolic and diastolic blood pressure, mean arterial pressure, number of blood pressure medications and adherence to 3 times per week dialysis, mortality.

Conditions
-----------------
Renal Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hemodialysis patient

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 88 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 |
| --- | --- | --- |
Long-term Prognosis in Stroke Patients

Study Overview
=================
Brief Summary
-----------------
A single-center cohort of patients with acute ischemic stroke and transient ischemic attack who admitted to the Severance hospital of Yonsei university and their long-term outcomes.

Detailed Description
-----------------
This is a single-center cohort of consecutive patients with acute ischemic stroke and transient ischemic attack who admitted to the Severance hospital of Yonsei university in Republic of Korea. Stroke recurrence, Cardiovascular event, all cause mortality and cardiovascular mortality were collected through long-term follow up.

Official Title
-----------------
Long-term Prognosis in Stroke Patients

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with acute ischemic stroke or transient ischemic attack Exclusion Criteria: A patient who did not agree with enrollment of this study
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Long-term follow up, observational<br>This cohort does not involve interventions, just follow up of prognosis of ischemic stroke/transient ischemic attack patients. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event of Stroke or transient ischemic attack | The time of a stroke or transient ischemic attack occurs (through study completion) | through study completion, up to 10 years | 
| Event of cardiovascular disease (include stroke/transient ischemic attack) | The time of a cardiovascular disease (stroke/transient ischemic attack) occurs (through study completion) | through study completion, up to 10 years | 
| All cause mortality | The time of death from any cause (through study completion) | through study completion, up to 10 years | 
| Cardiovascular cause mortality (include stroke/transient ischemic attack mortality) | The time of death from cardiovascular cause (through study completion) | through study completion, up to 10 years | 
| The modified Rankin Scale (mRS) | Measure functional outcome as the form of mRS at 3 months | 3 months |
Aprepitant for Postoperative Nausea and Vomiting in Laparoscopic Hysterectomy

Study Overview
=================
Brief Summary
-----------------
Gynecological surgery is associated with a high incidence of postoperative nausea and vomiting. NK1 receptor antagonists such as aprepitant appear to be highly effective for treating acute and delayed emesis, and yet understanding of the efficacy of different doses of aprepitant is limited. We performed a prospective, randomized, double-blinded placebo-controlled study of 123 female adults scheduled for laparoscopic hysterectomy who received 80 mg aprepitant, 125 mg aprepitant, or a placebo.

Detailed Description
-----------------
123 female patients (ages 21-60) undergoing laparoscopic hysterectomy 80mg aprepitant 125mg aprepitant placebo Incidences of nausea, vomiting/retching, and use of rescue antiemetics were recorded at 0, 1, 2, 24, and 48 h after surgery.

Conditions
-----------------
Postoperative Nausea and Vomiting

Intervention / Treatment
-----------------
* Drug: Aprepitant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female laparoscopic hysterectomy isoflurane anesthesia postoperative opioid use Exclusion Criteria: liver disease neurologic disease active pulmonary disease cardiac arrhythmia allergies to any perioperative medications

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: aprepitant 125mg<br>NK1 receptor antagonist | Drug: Aprepitant<br>* Aprepitant 80 mg, Aprepitant 125 mg<br>|
| Active Comparator: Aprepitant 80 mg<br> | Drug: Aprepitant<br>* Aprepitant 80 mg, Aprepitant 125 mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The numbers (and percentages) of patients who experienced complete response | The numbers (and percentages) of patients who experienced complete response, i.e. no nausea, retching, vomiting, or need for rescue treatment required rescue therapy and peak nausea scores Adverse effects in the three treatment groups | 48 hours postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postoperative Nausea and Vomiting
Clinical Effects of a Nucleotides-Supplemented Infant Formula

Study Overview
=================
Brief Summary
-----------------
The study hypothesis is that different concentrations of nucleotides' supplementation of an infant formula might affect differently growth and/or other clinical parameters in neonates.

Detailed Description
-----------------
Three groups of 50 newborn infants each, will be fed for 30 days an infant formula supplemented with either 4.9 mg/100 kcal or 10.6 mg/100 kcal of nucleotides or with no supplementation. Newborns will be monitored prospectively for the following outcome parameters: Growth percentiles. Behaviour and infantile colic. Bowel habits. Side effects.

Official Title
-----------------
The Clinical Effects of an Infant Formula Supplemented With Various Concentrations of Nucleotides

Conditions
-----------------
Nutritional Requirements

Intervention / Treatment
-----------------
* Drug: Nutritional supplementation (nucleotides)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy newborns aged 0-30 days. Exclusion Criteria: Prematurity Chronic illness Failure to thrive Milk allergy

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 30 Days

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Nutritional supplementation (nucleotides)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth percentiles, Behaviour and infantile colic, Bowel habits. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Infant nutrition, Nucleotides, Infant formula
A Long-Term Study of MP-214 in Patients With Receiving Multiple Drugs Schizophrenia

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the long-term safety, tolerability, and efficacy of MP-214 in patients with receiving multiple drugs schizophrenia.

Official Title
-----------------
A Long-Term Study of MP-214 in Patients With Receiving Multiple Drugs Schizophrenia

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: MP-214


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent obtained from the patient before the initiation of any study-specific procedures Patients diagnosed with schizophrenia according to the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia Patients who receive 1 or more antipsychotic drugs Patients with normal physical examination, laboratory, vital signs, and/or electrocardiogram (ECG) Exclusion Criteria: Patients with a DSM-IV-TR diagnosis of schizoaffective disorder, schizophreniform disorder, other psychotic disorders other than schizophrenia, or bipolar I or II disorder The information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 64 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: MP-214 1.5-9 mg<br> | Drug: MP-214<br>* Patients who meet eligibility criteria will be administered a once daily oral fixed dose (3mg) of MP-214 for four weeks, then flexible dose (1.5-9 mg) of MP-214<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability |  | Up to 60 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schizophrenia, Antipsychotic Agents, Mental Disorder, Psychotropic Drugs, Dopamine Agents, Central Nervous System Agents
Effect of F2695 on Brain Activity Measured by Functional Magnetic Resonance Imaging

Study Overview
=================
Brief Summary
-----------------
The aim of this functional Magnetic Resonance Imaging (MRI) study is to assess the effect of single dose of F2695 at 75mg on modulation of the cerebral motor network.

Conditions
-----------------
Subject

Intervention / Treatment
-----------------
* Drug: F2695
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male right-handed*, healthy volunteers 18 to 40 years of age. Having signed and dated an informed consent form Exclusion Criteria: Any significant disease or history of any clinically important drug allergy. Acute disease state within 7 days. History of drug abuse within 1 year. History or current excessive use of alcohol and / or positive alcohol screen. History of narrow angle glaucoma, seizures or epilepsy or brain injury. History of Gluten sensitivity, Gluten intolerance (celiac disease), Wheat allergy or Wheat intolerance. History of obstructive voiding symptoms, including urinary retention.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: F2695<br>Single dose - 2 capsules / Day on Day 1 and Day 8 | Drug: F2695<br> <br> |
| Placebo Comparator: placebo<br>Single dose - 2 capsules / Day on Day 1 and Day 8 | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motor system cortical areas activation magnitude during a paced motor task. | Location coordinates (x,y,z), Voxel cluster size expressed in terms number of voxels, Intensity as measured with a Z-score | 1 day (Period 1/Day +1, Period 2/Day +8) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events (AEs) as a measure of safety and tolerability |  | up to 2 weeks |
Lateral Versus Anterior Spanning External Fixator for Tibial Plateau Fractures

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate patients with tibial plateau fractures.

Detailed Description
-----------------
The purpose of this study is to evaluate patients with tibial plateau fractures. The goal is to compare the differences between anteriorly placed (front of leg) femoral external fixator pins and laterally placed (side of leg) femoral external fixator pins. Specifically, we are evaluating how this placement affects the quadriceps muscle and knee function. The parameters that will be assessed are knee function, pain, and range of motion.

Official Title
-----------------
Lateral Versus Anterior Spanning External Fixator for Tibial Plateau Fractures

Conditions
-----------------
Fractures, Closed

Intervention / Treatment
-----------------
* Device: Anterior pin placement
* Device: Lateral pin placement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age and above (adult population) All open and closed tibial plateau fractures Exclusion Criteria: 17 years of age and less (pediatric population) Quadriplegic patients Vascular Injury to Extremity Ipsilateral femur fractures Ipsilateral Hip fractures

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anterior pin placement<br>Anterior pin placement | Device: Anterior pin placement<br>* Anteriorly-placed (front of the leg) femoral external fixator pins<br>|
| Experimental: Lateral pin placement<br>Lateral pin placement | Device: Lateral pin placement<br>* Laterally-placed (side of the leg) femoral external fixator pind<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quadriceps Strength | measurement of quadriceps muscle strength at final followup = 1 year data at interim time points recorded, but only final reported for this purpose | (admission, 6 weeks, 3 months, 6 months) 1 year |
Evaluation of UroShield Device Impact Upon Side Effects and Complications of Urinary Catheter Usage

Study Overview
=================
Brief Summary
-----------------
Evaluation of UroShield device impact upon side effects and complications of urinary catheter usage. The use of urinary catheters is a common medical practice in the perioperative setting. As such, it exposes the patient to certain comorbidities, including urinary tract infections. The infectious process is known to begin with a development of a biofilm on the catheter's surface. This fact makes it an attractive target for UTI prevention technology. Ultrasound waves were shown to reduce biofilm buildup in-vitro. We plan to determine the efficacy of this method in vivo.

Official Title
-----------------
Evaluation of UroShield Device Impact Upon Side Effects and Complications of Urinary Catheter Usage

Conditions
-----------------
Infectious

Intervention / Treatment
-----------------
* Device: UroShield device
* Device: Sham UroShield device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who need to insert a catheter urine as part of their treatment and rehabilitation at the orthopedic ward. Exclusion Criteria: Patients undergoing an invasive procedure in the past month some urinary tract, or the existence of a well-known structural pathology. patients with a urinary tract infection in the past year. Patients with a urinary tract infection when inserting a catheter. pregnant women. Patients under the age of 18. without judgment.

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Patients receive active UroShield device<br>Patients receive active UroShield device | Device: UroShield device<br>* The UroShield device is Consists of two units:Actuator and Driver.<br>|
| Sham Comparator: Patients receive inactive UroShield device<br>Patients receive inactive UroShield device | Device: Sham UroShield device<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| side effects and complications of urinary catheter usage | the measure is a composite of :complaints related to the uro-genital system, the results of blood and urine tests, monitoring fever, blood pressure and pulse | One Year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
introduction of urinary catheter
Anatomical and Perioperative Predisposing Factor for Limb Occlusion of Incraft Infrarenal Endograft (LIMIT Study)

Study Overview
=================
Brief Summary
-----------------
The aim was to determine, within the patient enrolled in three controlled prospective studies, INNOVATION, INSPIRATION and INSIGHT (Sponsor: Cordis, A Cardinal Health Company) studies which are preoperative and postoperative anatomical risk factors associated to limb occlusion. In the three studies the total number of enrolled patients was 400, of whom 134 enrolled in the US

Official Title
-----------------
Anatomical and Perioperative Predisposing Factor for Limb Occlusion of Incraft Infrarenal Endograft (LIMIT Study)

Conditions
-----------------
Aneurysm Abdominal

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with abdominal aortic aneurysm, who have been treated with the INCRAFT® Grafting System (AAA Stent-Graft System). All cases treated with Incraft who were enrolled in three controlled prospective studies, INNOVATION, INSPIRATION and INSIGHT (Sponsor: Cordis, A Cardinal Health Company) Exclusion Criteria: no exclusion criteria

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 |
| --- | --- | --- |
| limb occlusion | freedom from limb occlusion | 30 days | 
| freedom from death | survival | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
abdominal aortic aneurysm