linjc16/ctgov huggingface dataset:
Safety and Performance Study of the CyPass System Applier Model 241

Study Overview
=================
Brief Summary
-----------------
This is a retrospective chart review of cases in which the CyPass Micro-Stent was implanted using the Model 241 Applier. The objective of this study is to characterize and evaluate the safety of the Model 241 Applier when used for CyPass Micro-Stent implantation.

Official Title
-----------------
A Study Assessing the Safety and Performance of the Transcend CyPass System Applier Model 241 for Implantation of the CyPass Micro-Stent in Subjects With Open Angle Glaucoma Who Underwent Cataract Surgery

Conditions
-----------------
Open Angle Glaucoma (OAG)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of OAG CyPass Micro-Stent implantation (using the CyPass system 241) following uncomplicated phacoemulsification cataract removal and intraocular lens implantation Exclusion Criteria: Diagnosis of acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma Prior incisional glaucoma surgery

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- | --- |
| Ocular adverse events in the study eye |  | Intraoperatively though the first 3 postoperative months |
Systemic Steroids Plus Antibiotics in Sleep Apnea Syndrome in Children

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the effect of treatment with a steroid and antibiotic on the size of the tonsils and symptoms of children with OSAS.

Detailed Description
-----------------
We will enroll children between 18 months and 12 years of age with mild sleep apnea and treat them with 5 days of prednisolone and 10 days of amoxicillin/clavulanate. We will obtain a questionnaire pre and post treatment and ask the parents to tell us if they think the child has improved enough after treatment to forego surgery. If not, they will undergo an adenotonsillectomy to relieve their sleep apnea and if yes, we will repeat the sleep study to make sure that the apnea has resolved.

Official Title
-----------------
The Effect of a Combination of Systemic Steroids and Antibiotics on Obstructive Sleep Apnea Syndrome in Children

Conditions
-----------------
Obstructive Sleep Apnea Syndrome

Intervention / Treatment
-----------------
* Drug: Prednisolone and amoxicillin/clavulanate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Polysomnogram results showing mild obstructive sleep apnea. Exclusion Criteria: Significant medical problems Chronic medication intake (except bronchodilators and inhaled steroids) Allergy to penicillin or its derivatives.

Ages Eligible for Study
-----------------
Minimum Age: 18 Months
Maximum Age: 12 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Prednisolone and amoxicillin/clavulanate|Prednisolone 1mg/kg QD for 5 days Amoxicillin/clavulanate 45mg/Kg/d divided BID for 10 days|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep apnea questionnaire |  | 1-2 weeks post treatment | 
| Size of tonsils |  | before and after treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obstructive sleep apnea syndrome (OSAS) in children
Impact of Surgical Technique on Post-operative Complications in Urgency Ostomy Confection

Study Overview
=================
Brief Summary
-----------------
This is a single-center retrospective cohort study on cancer patients who underwent emergency ostomy. Our objective was to compare the incidence of surgical complications as well as the length of hospital stay among three different techniques for ostomy confection (laparotomy, the conventional local approach, described as trephination, and laparoscopy).

Official Title
-----------------
Impact of Surgical Technique (Laparoscopic, Open or Trephine) on Post-operative Complications in Urgency Ostomy Confection - a Single Center Retrospective Cohort

Conditions
-----------------
Colostomy Stoma, Colostomy Complication, Obstruction Bowel, Surgical Complication, Surgical Procedure, Unspecified

Intervention / Treatment
-----------------
* Procedure: Intestinal ostomy confection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who underwent emergency colostomy or ileostomy Exclusion Criteria: Patients who underwent other major procedures at the time of the surgery, such as enterectomy, colectomy, or tumor or other organ resection
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Open Surgery<br> | Procedure: Intestinal ostomy confection<br>* Surgical procedure for fecal diverting<br>|
| Laparoscopic Surgery<br> | Procedure: Intestinal ostomy confection<br>* Surgical procedure for fecal diverting<br>|
| Trephine Surgery<br> | Procedure: Intestinal ostomy confection<br>* Surgical procedure for fecal diverting<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical complications | Early and late surgical complications related to the stoma and severe complications | Between cohort enter (2008-2019) and study finish (2021) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative length of hospital stay | Length of hospital stay after surgery | Between cohort enter (2008-2019) and study finish (2021) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
colostomy, laparoscopy, ostomy
Drug-Drug Interaction Study of Mitiglinide and Gemfibrozil

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to determine the extent of effect of gemfibrozil on the pharmacokinetics and pharmacodynamics of mitiglinide.

Official Title
-----------------
A Double-Blind, Placebo-Controlled Study to Assess the Effect of Gemfibrozil Co-Administration on the Pharmacokinetics and Pharmacodynamics of Mitiglinide in Healthy Volunteers

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: placebo for gemfibrozil
* Drug: gemfibrozil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: non-smoker Body mass index (BMI) of 19-28 kg/m2 no relevant food allergies Exclusion Criteria: any subject for whom gemfibrozil is contraindicated any subject with a history of hypoglycemia or who tend to get easily hypoglycemic clinically significant history of or current abnormality or disease of any organ system

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2<br>mitiglinide + gemfibrozil | Drug: gemfibrozil<br>* Mitiglinide + 600 mg gemfibrozil bid<br>|
| Placebo Comparator: 1<br>mitiglinide + placebo for gemfibrozil | Drug: placebo for gemfibrozil<br>* mitiglinide + placebo for gemfibrozil 600 mg bid<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pharmacokinetics of mitiglinide |  | 3 days of treatment with gemfibrozil | 
| pharmacodynamics of mitiglinide |  | 3 days of treatment with gemfibrozil | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety and tolerance of mitiglinide when co-administered with 600 mg gemfibrozil |  | 3 days of treatment with gemfibrozil |
Outpatient Treatment of Low-risk Pulmonary Embolism

Study Overview
=================
Brief Summary
-----------------
This study is looking at the safety and effectiveness of treating Patients diagnosed with a low-risk Pulmonary Embolism (PE) in an outpatient setting instead of the standard, in-patient hospitalization. Patients have several medical tests done during their Emergency Department visit. Based on those tests, those who are determined to have a low-risk PE are eligible to participate in the study. Those choosing to participate are discharged after 12 hours of medical observation. Patients who choose to participate are followed up by telephone approximately 90 days later.

Official Title
-----------------
Rapid Risk Stratification for Outpatient Treatment of Low-risk Pulmonary Embolism

Conditions
-----------------
Pulmonary Embolism

Intervention / Treatment
-----------------
* Other: Outpatient Treatment of Pulmonary Embolism


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pulmonary Embolism, diagnosed by CTA or high probability VQ Scan Total Pulmonary Embolism Severity Index (PESI) score <86 Exclusion Criteria: Massive Pulmonary Embolism: Hypotension with signs of right heart strain on CTA or Echocardiogram Sustained Systolic Blood Pressure (SBP) <95 mmHg during Emergency Department or observation stay. Age <18 Pregnant Renal insufficiency (Creatinine Clearance <30) Hepatic Dysfunction (AST/ALT/ALP > 3 times upper limit of normal) Unreliable social situation or inability to follow up Contraindication to enoxaparin, warfarin and rivaroxaban Atrial or ventricular dysrhythmia(s)

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 |
| --- | --- |
| Outpatient Treatment<br>All patients eligible for the study will have their PE treated in the outpatient setting. | Other: Outpatient Treatment of Pulmonary Embolism<br>* Patients who participate in the study will be treated for their pulmonary embolism in an outpatient setting instead of being hospitalized.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 90-day all-cause mortality, recurrent VTE, and Major Bleeding during outpatient treatment of Low-risk PE | This is a composite outcome of the above. | 90 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of medical costs due to outpatient treatment. |  | 90 Days | 
| Level of patient satisfaction as measured by survey. |  | 90 Days Post study enrollment |
Bone Mineral Density in Adults With Hyperphenylalaninemia

Study Overview
=================
Brief Summary
-----------------
Hyperphenylalaninemia (HPA) is a rare metabolic disorder caused by a deficiency of the enzyme phenylalanine hydroxylase (PAH). Elevated plasma levels of phenylalanine (phe) cause mental retardation, microcephaly, delayed speech, seizures, eczema, and behavior problems. Adequate control of the plasma levels of phe by a phe-restricted diet can prevent the developmental and behavioral problems. The foundation of this diet is a phe-free medical product/formula made from free amino acids. Based on longitudinal studies, it has been reported that the most benefit is attained by individuals who maintain a phe-restricted diet throughout life. Despite the obvious benefits of the diet, it has been suggested that the dietary restrictions may be associated with poor bone health in these patients. However, data supporting this has been reported in studies with small sample sizes and/or inadequate sample populations that include children. There is a paucity of data on bone health in adults with HPA. The investigators propose an observational study to describe the bone health status among adults with a diagnosis of HPA and to compare them to established normative age and gender-specific values among healthy individuals. The investigators hypothesize that adults with HPA will have lower bone density as measured by a dual x-ray absorptiometry (DXA) scan compared to the established normative values.

Official Title
-----------------
Bone Mineral Density in Adults With Hyperphenylalaninemia

Conditions
-----------------
Phenylketonurias

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of HPA at birth Aged 18 or older Exclusion Criteria: Peri-menopausal women Menopausal women Patients taking bisphosphonates Pregnant women Women who have been pregnant within one year of study enrollment Women who have breastfed within one year of study enrollment

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bone Mineral Density, Adults
The Role of Peptide YY (PYY)in Inhibiting Food Intake.

Study Overview
=================
Brief Summary
-----------------
12 obese subjects will receive peripheral administration of placebo and 4 escalating doses of PYY1-36 and another 12 obese subjects will receive peripheral administration of placebo and 4 escalating doses PYY3-36 on 5 different test days within one week. The patients will be tested in a single blinded dose escalating protocol. Measurements of appetite, ad libitum energy intake, blood pressure and blood sampling will be performed during the test day.

Official Title
-----------------
The Effects of Peripheral Administration of Saline, PYY1-36 and PYY3-36 on ad Libitum Energy Intake and Appetite.

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Drug: peripheral Peptide YY administration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal weight (BMI: 18-23 kg/m2) or 12 overweight/obese (BMI: 27-40 kg/m2) Body weight fluctuations < 5 kg over the past 2 months. Blood pressure normal to mildly hypertensive(<159/99 mm Hg) Non-elite athletes and not planning to change physical activity during the study. Exclusion Criteria: Any physiological or psychological illnesses that could influence the study results. Regular use of medicine. Smoking defined as <1 cigarette per day. Substance abuse or dependence. Blood donation within the past 3 months before entering the study. Drinking >21 alcoholic units/week. Food allergies. Special diets (e.g. vegetarian) or dislikes to any of the foods served during the study.

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: peripheral Peptide YY administration|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| appetite |  |  | 
| energy intake |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma PYY profile |  |  | 
| Blood pressure |  |  |
ICP Waveform Analysis in Stroke Patients

Study Overview
=================
Brief Summary
-----------------
This is a study on how acute clinical state and final clinical outcome in patients with stroke (exclusive subarachnoid hemorrhage) relate to ICP/ABP-derived pressure waveform parameters recorded during intensive care management.

Detailed Description
-----------------
Aim of study: Prospectively collect clinical and radiological data as well as management data. Perform retrospective analysis of ICP/ABP recordings (mean ICP, mean ICP wave amplitude, mean ABP, mean ABP wave amplitude, CPP) Relate the prospectively collected data with results of retrospective pressure analysis.

Official Title
-----------------
Retrospective ICP Waveform Analysis in Stroke Patients Followed Prospectively

Conditions
-----------------
Stroke

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute apoplexy Exclusion Criteria: Subarachnoidal bleeding

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 |
| --- | --- | --- |
| Clinical outcome |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
apoplexia, Intracranial and intraarterial pressure curves in acute apoplectic patients
Safety and Efficacy of IDEC-152 in the Treatment of Chronic Lymphocytic Leukemia (CLL)

Study Overview
=================
Brief Summary
-----------------
To determine what side effects and what clinical effects if any the administration of this investigational product, IDEC-152 (an antibody against CD23 which is an important protein on leukemia cells and certain cells in the body's immune system), has on the CLL patient population.

Official Title
-----------------
A Phase I Multicenter, Dose-Escalation Study of IDEC-152 (Anti-CD23 Monoclonal Antibody) in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

Conditions
-----------------
Chronic Lymphocytic Leukemia

Intervention / Treatment
-----------------
* Drug: IDEC-152


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed IRB-approved informed consent. Greater than 18 years of age Proof of CD23+ CLL or small lymphocytic lymphoma (SLL) Progressive disease after at least 1 course of chemotherapy Acceptable hematologic status, liver function, renal function, and pulmonary function Patients of reproductive potential must agree to follow accepted birth control methods during treatment and for 3 months after completion of treatment Exclusion Criteria: Previous exposure to IDEC-152 or other anti-CD23 antibodies Presence of HIV infection or AIDS Serious nonmalignant disease Active uncontrolled bacterial, viral or fungal infections. Clinically active autoimmune disease Pregnant or currently breast feeding

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

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: IDEC-152|6 Dosing groups: 125mg/m2 weekly x 4, 250mg/m2 weekly x 4, 375mg/m2 weekly x 4, 500mg/m2 weekly x 4, 500mg/m2 3 times first week then weekly x 3, 500mg/m2 3 times per week x 4|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine a recommended Phase II dose for the treatment of patients with relapsed or refractory CLL |  | 48 months | 
| Characterize the safety profile of IDEC-152 |  | 48 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the pharmacokinetics and pharmacodynamics of IDEC-152 in patients with relapsed or refractory CLL |  | 48 months | 
| Evaluate the efficacy of IDEC-152 in patients with relapsed or refractory CLL |  | 48 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Lymphoblastic Leukemia, Leukemia, Lymphoblastic, Chronic, Chronic Lymphocytic Leukemia, CLL
Comparison of NICOM and Innocor for Non-Invasive Determination of Cardiac Output

Study Overview
=================
Brief Summary
-----------------
Cardiac output (CO) is an important parameter in the diagnosis and therapy of cardiac diseases. The aim of the study at hand was to evaluate NICOM (bioreactance) as a new method for determinion of CO and to compare it to Innocor (inert gas rebreathing), which previously showed promising results.

Conditions
-----------------
Cardiac Disease

Intervention / Treatment
-----------------
* Device: NICOM cardiac output measurement
* Device: Innocor cardiac output measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hemodynamic stability respiratory stability Exclusion Criteria: patient unwilling to participate

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: NICOM cardiac output measurement|nan|
|Device: Innocor cardiac output measurement|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of NICOM and Innocor |  | at time of inclusion | 
| Precision of NICOM and Innocor |  | at time of inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Agreement of NICOM and Innocor