linjc16/ctgov huggingface dataset:
Oxygen Insufflation To Reduce Postoperative Abscess In Laparoscopic Appendectomy

Study Overview
=================
Brief Summary
-----------------
Oxygen has inherent bactericidal properties. The investigators are testing to see if they can reduce the incidence of postoperative abscesses following laparoscopic appendectomy by insufflating with oxygen at the end of the case.

Detailed Description
-----------------
Intra-abdominal abscess a well-known complication of both open and laparoscopic appendectomy, especially in the setting of perforated and gangrenous appendicitis. The reviewed literature cites an incidence of about 10%. Besides peri-operative antibiotic administration there have been few developments to reduce this inherent risk. Oxygen rich environments are potently bactericidal, and thus it is our hypothesis that establishing an oxygen rich ambience within the abdomen at the conclusion of laparoscopy could curtail bacterial growth and subsequent abscess formation. In the experimental arm, at the conclusion of all surgical dissection and manipulation, the carbon dioxide insufflate will be exchanged with oxygen to generate a high intra-abdominal concentration. Oxygen will be infused for 15 seconds as CO2 is allowed to escape through the open trocars. In the control arm Co2 will be allowed to escape through the open trocar ports without any oxygen flush. Patients will receive a standardized operation as well as standard post-operative care and follow up.

Official Title
-----------------
Single-Blind, Randomized, Controlled Trial of Oxygen Insufflation to Reduce Incidence of Postoperative Abscess in Laparoscopic Appendectomy

Conditions
-----------------
Postoperative Abscess

Intervention / Treatment
-----------------
* Other: Oxygen Insufflation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Nonpregnant adults 18 or older Clinical or image proven appendicitis Undergoing Laparoscopic Appendectomy Exclusion Criteria: Any pregnant females Anyone under the age of 18

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
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxygen Insufflation<br>At the end of the laparoscopic appendectomy we will desufflate the abdomen of CO2 then reinsufflate with oxygen to washout the CO2 leaving an oxygen rich environment | Other: Oxygen Insufflation<br>* At the end of the case, abdomen will be desufflated with CO2 then insufflated with oxygen<br>* Other names: Oxygen;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Postoperative Abscess |  | 4 weeks |
The Effect of Nicardipine on Kidney Function During Orthognathic Surgery Under Hypotensive Anesthesia

Study Overview
=================
Brief Summary
-----------------
Since nicardipine is known to protect kidney function, nicardipine infusion will result in better renal parameters measured in this study.

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Drug: Nicardipine
* Drug: remifentanil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy adult patients undergoing hypotensive anesthesia Exclusion Criteria: patients with any co-morbidity

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nicardipine<br> | Drug: Nicardipine<br> <br> |
| Active Comparator: remifentanil<br> | Drug: remifentanil<br>* 0.1-0.5 ugkg/min during hypotensive anesthesia<br>* Other names: ultiva®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Creatinine Clearance | Hypotensive anesthesia means that we maintain the mean blood pressure between 55 & 65 mmHg during surgery to decrease the blood loss. The specific time point is exactly 2hr after we star to lower the blood pressure. | 2hr after the start of hypotensive anesthesia | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
healthy adult patients, ASA class I, hypotensive anesthesia
To Demonstrate the Relative Bioavailability of Atenolol Tablets

Study Overview
=================
Brief Summary
-----------------
To demonstrate the relative bioavailability of Atenolol tablets.

Official Title
-----------------
Bioavailability of Atenolol Tablets

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Atenolol Tablets 100 mg (Cord Laboratories)
* Drug: Atenolol Tablets 100 mg (Stuart Pharmaceutical)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: Positive test results for HIV or hepatitis B or C. Treatment for drug or alcohol dependence.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Atenolol Tablets 100 mg (Cord Laboratories) | Drug: Atenolol Tablets 100 mg (Cord Laboratories)<br> <br> |
| Active Comparator: 2<br>Atenolol Tablets 100 mg (Stuart Pharmaceutical) | Drug: Atenolol Tablets 100 mg (Stuart Pharmaceutical)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence based on AUC and Cmax |  | 11 days |
Phase II Randomized Study of the Effects of Growth Hormone on Children and Adolescents on Maintenance Dialysis

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Evaluate the separate and combined skeletal effects of recombinant human growth hormone (GH) and calcitriol in patients with adynamic renal osteodystrophy. II. Assess whether calcium-regulated changes in parathyroid hormone secretion predict changes in bone formation. III. Characterize the response to GH in cancellous bone and in growth plate cartilage in patients with secondary hyperparathyroidism during calcitriol therapy.

Detailed Description
-----------------
PROTOCOL OUTLINE: This is a randomized study. Patients are stratified by bone lesion turnover and secondary hyperparathyroidism. Patients in the first group are treated with recombinant human growth hormone subcutaneously every day for 8 months. Patients in the second group are treated with calcitriol for 8 months, administered as a daily oral dose or an intraperitoneal dose three times a week. Patients in the third group are treated with growth hormone and calcitriol (same dosages as above). A control group does not receive any hormonal therapy.

Conditions
-----------------
Renal Osteodystrophy, End Stage Renal Disease

Intervention / Treatment
-----------------
* Drug: calcitriol
* Drug: growth hormone


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- End-stage renal disease undergoing continuous cycling peritoneal dialysis at the University of California at Los Angeles --Prior/Concurrent Therapy-- No concurrent prednisone No concurrent cytotoxic agents At least 12 months since parathyroidectomy --Patient Characteristics-- Other: No documented history of poor compliance with medical treatment regimens

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
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
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: calcitriol|nan|
|Drug: growth hormone|nan|

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
-----------------
end stage renal disease, rare disease, renal and genitourinary disorders, renal osteodystrophy
T-DOC® 5 Fr Pediatric Clinical Investigation

Study Overview
=================
Brief Summary
-----------------
A Pivotal Study to Assess the Performance, Safety and Usability of a New 5 French Air-Charged Catheter for Performing Urodynamic Studies on Pediatric Subjects

Official Title
-----------------
A Pivotal Study to Assess the Performance, Safety and Usability of a New 5 French Air-Charged Catheter for Performing Urodynamic Studies on Pediatric Subjects

Conditions
-----------------
Incontinence, Urge

Intervention / Treatment
-----------------
* Device: TDOC 5Fr


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and Female (Children and infants, 12 years of age and younger) Subjects who are scheduled and normally indicated for urodynamics testing, for any medically necessary reason as per the physician. Exclusion Criteria: Subjects who suffer from bladder infections (not including subjects with asymptomatic bacteruria) Subjects with urethral strictures Subjects who require the use of a suprapubic catheter

Ages Eligible for Study
-----------------
Maximum Age: 12 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Urodynamics Arm<br> | Device: TDOC 5Fr<br>* A Pivotal Study to Assess the Performance, Safety and Usability of a New 5 French Air-Charged Catheter for Performing Urodynamic Studies on Pediatric Subjects<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Patients in Which the T-DOC® 5 Fr Catheters Are Safe in Measuring Urodynamic Pressures in Pediatric Subjects (12 Years of Age and Younger). | A binary clinician response after each UDS study is used to assess if it is clinically adequate (success) or inadequate (failure) in each patients questionnaire and presented to the clinician where safety (Yes the device is safe and No the device is not safe) will be reported. A minimum of 10 male and 10 female subjects, with an overall minimum of 28, and maximum of 33 subjects. | 2 months | 
| The Number of Patients in Which the T-DOC® 5 Fr Catheters Are Effective in Measuring Urodynamic Pressures in Pediatric Subjects (12 Years of Age and Younger). | A binary clinician response after each UDS study is used to assess if it is clinically adequate (success) or inadequate (failure) in each patients questionnaire and presented to the clinician where effectiveness (Yes the device is effective and No the device is not effective) will be reported. A minimum of 10 male and 10 female subjects, with an overall minimum of 28, and maximum of 33 subjects. | 2 months |
Survivorship and Outcomes of Robot Assisted Medial Partial Knee Replacement

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the survivorship rate of robotic assisted medial partial knee replacement at a two, five, and ten years.

Detailed Description
-----------------
The purpose of this study is to determine the survivorship rate of robotically guided MultiCompartmental Knee system (MCK) medial onlay Unicompartmental Knee Arthroplasty (UKA) implants at a two, five, and ten year follow up.

Official Title
-----------------
Survivorship and Outcomes of Robotically Assisted Medial UKA

Conditions
-----------------
Unicompartmental Knee Arthroplasty

Intervention / Treatment
-----------------
* Procedure: MAKOplasty® medial UKA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: over 21 years of age underwent primary robotically guided UKA and received a medial MCK onlay implant by the investigating surgeon at least 24 months post-operative Exclusion Criteria: Patients will be excluded from participation in the study if they are cognitively unable to answer study questions

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- |
| MAKOplasty® medial UKA<br>Patients knees that have received a MAKOplasty® robotically guided unicompartmental knee arthroplasty (UKA) and received a medial MCK onlay implant. | Procedure: MAKOplasty® medial UKA<br>* A robot guided medial Unicompartmental knee arthroplasty (UKA) is a procedure to replace only the medial tibiofemoral compartment of the knee.<br>* Other names: Robot Assisted Partial Knee Replacement;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 10 Year Survivorship of Components | Survivorship of components is defined as knee implant device(s) remaining in patient. | 10 years after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5 Year Survivorship of Components | Survivorship of components is defined as knee implant device(s) remaining in patient. | 5 years after surgery | 
| 2 Year Survivorship of Components | Survivorship of components is defined as knee implant device(s) remaining in patient. | 2 years after surgery |
Bradycardia Risk Stratification With Loop Recorder After Syncope

Study Overview
=================
Brief Summary
-----------------
Syncope is a common symptom that may be related to a conductive disorder. If no bradycardia is authenticated, it is often necessary to implant an implantable loop recorder. In somes cases, implantable loop recorder records cardiac conductive disorders. In this study, we want to try to identify a group of patients for whom we could immediately implant a pacemaker without prior implantation of an implantable loop recorder given the high probability of implantation of a pacemaker after interrogation of the implantable loop recorder. It would be interesting for the reduction of interventions for the patients and for the economic aspect of the healthcare system

Official Title
-----------------
Bradycardia High Risk Patient Identification After Syncope With Loop Recorder an Observational Study in Nancy University Hospital

Conditions
-----------------
Implantable Loop Recorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who have benefited from an Implantable Loop recorder in the Nancy's Teaching Hospital Exclusion Criteria: No Exclusion Criteria
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Syncope and Implantable loop recorder<br>Patients implanted with a subcutaneous Loop Recorder after syncope in Nancy University Hospital | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| significant bradycardia whitch result with an Indication of pacemaker implantation | 2° and 3° AV block, sinus node dysfunction with pause > 8 sec or > 3sec with concomitant symptoms, sick sinus syndrom | At the moment of enregistrement of a significative arrhythmia or at the end of the 3 years of follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient group without benefit of implantation of the Implantable Loop Recorder | non significant bradicardia or arythmias revealed by loop recorder during monitoring | At the end of the 3 years of follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Syncope, Arrhythmia
Percutaneous Excision Trial

Study Overview
=================
Brief Summary
-----------------
To confirm that a definitive diagnosis can be made from the tissue sample collected using the Intact BLES when defined radiology and pathology criteria are met.

Official Title
-----------------
Percutaneous Excision Trial (I-Pet): A Multi-Center Clinical Study Of The Intact Breast Lesion Excision System (Bles) To Demonstrate That A Definitive Diagnosis Can Be Made From The Tissue Sample Collected With The Intact Bles.

Conditions
-----------------
Imaged Breast Abnormalities

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient must be a female at least 18 years of age at the time of Intact BLES biopsy Patient must have had an imaged abnormality found via mammography or sonography that warrants a biopsy for further diagnosis Exclusion Criteria: Patients who have pre-pectoral breast implants Patients who have implantable devices such as pacemakers and defibrillators Patients who are pregnant or lactating Patients in whom the device is contraindicated Patients who are contraindicated for surgery due to factors such as anti-coagulant use which cannot be safely reversed or who exhibit fever or other clinical evidence of infection

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PSAP<br>This is the population of patients in whom surgical intervention could possibly be avoided. These patients will be those in whom all imaging evidence (mammographic or sonographic) was removed during the Intact BLES procedure, and in whom a definitive diagnosis of ADH could be made using the pathology assessment criteria outlined in the protocol. | |
| NPSAP<br>Patients with a pathology diagnosis of ADH in whom all imaging evidence (mammographic or sonographic) of the target lesion was NOT removed OR in whom a definitive diagnosis of ADH COULD NOT be made by implementing the pathology criteria for evaluation outlined in the protocol AND patients with a diagnosis of DCIS will undergo open surgical excision and will be analyzed separately from the PSAP group. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients in various populations who undergo an Intact procedure with an upgrade in the diagnosis after undergoing an open surgical excision. |  | Post Intact Excision |
The Effect of GIP(3-30)NH2

Study Overview
=================
Brief Summary
-----------------
Infusion of glucose-dependent insulintropic polypeptide (GIP) receptor antagonist and evaluation of effect of insulin secretion in healthy subjects.

Detailed Description
-----------------
Infusion of glucose-dependent insulintropic polypeptide (GIP) receptor antagonist and evaluation of effect of insulin secretion in healthy subjects. Six study hyperglycemic clamps (10 mmol/l) pr. participant.

Official Title
-----------------
The Effect of GIP(3-30)NH2

Conditions
-----------------
Endocrine - Other

Intervention / Treatment
-----------------
* Other: GIP receptor antagonist
* Other: GIP receptor agonist
* Other: Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy BMI 19-28 kg/m*m Stable body weight Exclusion Criteria: Diabetes Anemia First-degree relatives with diabetes

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo+placebo<br>Saline infusions | Other: Saline<br>* Placebo (vehicle for infusions)<br>|
| Active Comparator: GIP+placebo<br>GIP(1-42), receptor agonist | Other: GIP receptor agonist<br>* GIP(1-42)<br>Other: Saline<br>* Placebo (vehicle for infusions)<br>|
| Experimental: GIP+dose 1<br>GIP(1-42) and lowest dose of GIP(3-30)NH2 | Other: GIP receptor antagonist<br>* GIP receptor antagonist<br>Other: GIP receptor agonist<br>* GIP(1-42)<br>|
| Experimental: GIP+dose 2<br>GIP(1-42) and dose of GIP(3-30)NH2 | Other: GIP receptor antagonist<br>* GIP receptor antagonist<br>Other: GIP receptor agonist<br>* GIP(1-42)<br>|
| Experimental: GIP+dose 3<br>GIP(1-42) and dose of GIP(3-30)NH2 | Other: GIP receptor antagonist<br>* GIP receptor antagonist<br>Other: GIP receptor agonist<br>* GIP(1-42)<br>|
| Experimental: GIP+dose4<br>GIP(1-42) and highest dose of GIP(3-30)NH2 | Other: GIP receptor antagonist<br>* GIP receptor antagonist<br>Other: GIP receptor agonist<br>* GIP(1-42)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin secretion | Insulin secretion rates (ISR) calculated from serum levels of C-peptide | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GIP, Insulin secretin, Incretin hormone