linjc16/ctgov huggingface dataset:
VEGA System® Study in the Total Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
This post-market clinical follow-up study intends to investigate long-term functionality of the VEGA System®. The design of the VEGA System® is meant to provide the patient with more knee mobility compared to their pre-operative state.The endpoint is the revision of at least one of the prosthesis components

Official Title
-----------------
Prospective Non-interventional, Prospective Multicenter Study of VEGA System® Prosthesis in the Total Knee Arthroplasty

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

Intervention / Treatment
-----------------
* Device: total knee prothesis VEGA System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patient from 18 to 75 years old Patient is able to comply with follow-up requirements including postoperative self-evaluations. Patient requires a primary knee replacement. Patient has a diagnosis of osteoarthritis Patient has intact collateral ligaments. Exclusion Criteria Vulnerable patient under legal protection Patients with inflammatory arthritis. Patients that have had a high tibial osteotomy or femoral osteotomy. Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: total knee prothesis VEGA System|total knee replacement|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rate of the prosthesis at 5 years | If a patient withdraws from the study for any reason, counts as the end date for the survival of the implant of the last day on which the implants were well known even in place | needs of revision of at least one of the prosthesis component evaluated 5 years after the knee arthroplasty |
Intranasal Civamide for Episodic Cluster Headache

Study Overview
=================
Brief Summary
-----------------
This is a 49-day study to evaluate the effectiveness of Intranasal Civamide (Zucapsaicin) in the treatment of an episodic cluster headache period compared to placebo (medically inactive substance which does not contain any active ingredients).

Official Title
-----------------
A Phase III, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Evaluation of Civamide (Zucapsaicin) Nasal Solution in the Treatment of Episodic Cluster Headache

Conditions
-----------------
Episodic Cluster Headache

Intervention / Treatment
-----------------
* Drug: Civamide (Zucapsaicin)
* Drug: Sodium Chloride


Participation Criteria
=================
Eligibility Criteria
-----------------
At least 2 year history of episodic cluster headache (meeting IHS criteria) At least 2 previous episodes Expected duration of cluster period is at least 6 weeks but not longer than 24 weeks At least 1 but not more than 8 headaches on each of the 3 days immediately prior to treatment

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Civamide<br>Nasal Solution 0.01% | Drug: Civamide (Zucapsaicin)<br>* Nasal Solution 0.01%<br>|
| Placebo Comparator: Placebo<br>Placebo nasal solution with sodium chloride 10% | Drug: Sodium Chloride<br>* Nasal Solution 10%<br>|

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
-----------------
Headache, Cluster, EC, Episodic Cluster
N-Acetylcysteine in Severe Acute Alcoholic Hepatitis

Study Overview
=================
Brief Summary
-----------------
Acute alcoholic hepatitis (AAH) is the most severe form of alcoholic liver disease (ALD) and is associated with a high risk of dying in the short term. Corticosteroids are generally recommended in patients with severe AAH, but its use is still controverted and contraindicated in case of active infection or gastrointestinal bleeding. Therefore, alternative therapeutic options are needed.Ethanol consumption results in the depletion of endogenous antioxidant capabilities and patients with ALD have evidence of antioxidant deficiencies.Due to its effects on glutathion stores restoration and as such the limitation of the oxidative stress and its good tolerance and safety profile, N-acetylcysteine (NAC) is an attractive agent for the treatment of AAH.In this context, we hypothesized that NAC might be beneficial in severe AAH.

Official Title
-----------------
N-Acetylcysteine for the Treatment of Alcoholic Hepatitis: a Belgian Multicenter Randomised Trial

Conditions
-----------------
Alcoholic Hepatitis

Intervention / Treatment
-----------------
* Drug: N-Acetylcysteine
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Biopsy proven alcoholic hepatitis Severe disease defined by a Maddrey score superior to 32 Exclusion Criteria: Neoplastic disease compromising 6 months survival HIV patients Hepatorenal syndrome

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 |
| --- | --- |
| Active Comparator: nutritional support + N-Acétylcysteine<br>N-Acétylcysteine 300 mg/kg intravenously for 14 days Beside usual meals, patients must receive at least 27 kcal/kg/day enteral nutrition for 14 days | Drug: N-Acetylcysteine<br>* 300 mg/kg for 14 days, intravenously<br>|
| Placebo Comparator: nutritional support + placebo<br>placebo perfusion for 14 days Beside usual meals patients must receive at least 27 kcal/kg/day enteral nutrition for 14 days | Drug: placebo<br>* Glucosé 5% perfusion for 14 days, intravenously<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six months survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of infections, clinical and biological parameters |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
alcoholic hepatitis, N-Acetylcysteine, enteral nutrition, oxidative stress, severe acute alcoholic hepatitis
Pharmacokinetics and Pharmacodynamics and Selected Antibiotics During Pregnancy

Study Overview
=================
Brief Summary
-----------------
This protocol is a prospective, open-label, multicenter, population pharmacokinetic and pharmacodynamic study of selected anti-infective agents in pregnant women being treated for suspected or documented infections.

Official Title
-----------------
Pharmacokinetics and Pharmacodynamics and Selected Antibiotics During Pregnancy

Conditions
-----------------
Pregnancy

Intervention / Treatment
-----------------
* Drug: ciprofloxacin
* Drug: azithromycin
* Drug: gentamicin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women in their second or third trimester of pregnancy Women currently receiving treatment or whose physician has made the decision to start treatment with ciprofloxacin, azithromycin or gentamicin for a suspected or documented infection Of childbearing potential and who either have never been pregnant or whose most recent pregnancy ended 3 months previously (control group) Women greater than 3 months postpartum and currently breast-feeding (substudy) Exclusion Criteria: Women with significant gastrointestinal disease which may be expected to interfere with the absorption of the orally administered anti-infective agents

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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 |
| --- | --- |
| 1<br>ciprofloxacin | Drug: ciprofloxacin<br>* ciprofloxacin 500 mg twice a day for five doses.<br>|
| 2<br>azithromycin | Drug: azithromycin<br>* azithromycin 500 mg on day 1 followed by 250 mg on days 2-5<br>|
| 3<br>gentamicin | Drug: gentamicin<br>* a single intravenous dose of gentamicin 1.5mg/kg infused over 60 minutes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Safety and Efficacy Study of OmniWave Endovascular System to Treat Deep Vein Thrombosis

Study Overview
=================
Brief Summary
-----------------
This is a prospective, multi-center single arm registry to assess the use of the OmniWave Endovascular System in subjects presenting with either lower or upper extremity acute (symptoms have been present for greater than or equal to 14 days) DVT.

Official Title
-----------------
Study of the OmniWave Endovascular System in Subjects With Lower and Upper Extremity Deep Vein Thrombosis - SONIC I Study

Conditions
-----------------
Deep Vein Thrombosis

Intervention / Treatment
-----------------
* Device: OmniWave Endovascular System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: DVT confirmed by venographic and ultrasound imaging, which has been symptomatic for a maximum of 14 days, or diagnosed within past 14 days defined as either first episode (no prior history in affected segment), or recurrent episode. Written informed consent Agreement to comply with follow up requirements Exclusion Criteria: Known R-L shunt, pulmonary A-V malformation Excessive tortuosity and/or sharp angulation in target treatment zone Isolated calf vein thrombosis Isolated DVT in veins peripheral to axillary vein Thrombus in peripheral vessel smaller than 5 mm Target treatment zone cannot be adequately accessed within the 100 cm working length of device
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 |
| --- |
|Device: OmniWave Endovascular System|Treatment with mechanical thrombolysis/thrombectomy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural success rate defined as at least 50% reduction in thrombus burden in each target treatment zone following use of the OmniWave Endovascular System |  | Post-Index procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death, clinically detectable PE, significant vessel damage in target treatment area |  | through 6 months post-index procedure | 
| Restoration and maintenance of antegrade in-line flow in target treatment area |  | through 6 months post-index procedure | 
| QOL SF-36 |  | through 6 months post-index procedure | 
| Incidence of clinically significant hemolysis |  | Prior to discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DVT, Peripheral Vascular Disease, Venous Thrombosis, Deep Vein Thrombosis
Anticipatory & Preventive Team Care (APTCare): At Risk Patients of Family Health Networks

Study Overview
=================
Brief Summary
-----------------
The University of Ottawa and Élisabeth Bruyère Research Institute are conducting a study of preventive care for frail patients at risk of functional decline. At risk patients are assigned by chance to continue receiving their standard care from their family physician or receive additional care from a nurse practitioners and a pharmacist. In collaboration with the family physician, they develop an individualized care plan, a treatment and management road plan, for each patient, which they implement over the study period of one approximately year. The objective of the study is to compare the effectiveness of the model of care that includes the nurse practitioners and pharmacist against standard care in preventing functional decline, to determine the acceptability of this model of care to patients, their caregivers and the medical team, and to evaluate the cost implication of the program.

Conditions
-----------------
Diabetes, Chronic Obstructive Pulmonary Disease, Congestive Heart Failure, Hypertension

Intervention / Treatment
-----------------
* Behavioral: Self-management of chronic illness


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 50 years and over 'At Risk' by having one or more of the following: a. Visits to emergency dept within the past 6 months; b. Admission to hospital for a medical problem in past 6 months; c. High service use profiles; d. Polypharmacy; e. Other high risk factors Capable of giving informed consent Able to use the Care Companion technology Exclusion Criteria: Cognitive impairment such that they cannot give informed consent Unable or unwilling to use the telehomecare equipment Unlikely to tolerate the intensive intervention Language or cultural barriers Being acutely ill or having an unstable condition on entry to the study

Ages Eligible for Study
-----------------
Minimum Age: 50 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Self-management of chronic illness|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Retrospective Data Analysis on the Application of Swan-Ganz Catheter in Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
The investigators aimed to investigate postoperative complications associated with Swan-Ganz Catheter based on the clinical data of Wuhan Union Hospital and Wuhan Asian heart hospital for 10 years, including major cardiovascular, respiratory adverse events, ICU time, mechanical ventilation time, length of hospital stay, in-hospital mortality, and 30-day postoperative mortality events.

Official Title
-----------------
Retrospective Data Analysis on the Application of Swan-Ganz Catheter in Cardiac Surgery

Conditions
-----------------
Postoperative Complications

Intervention / Treatment
-----------------
* Procedure: Swan-Ganz Catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 18 years old; Patients undergoing major cardiac surgery under general anesthesia; Patients with complete sex, age, use of floating catheter and prognosis data Exclusion Criteria: ASA grade V and above; End stage renal disease requiring (or undergoing) renal replacement therapy; Pregnant or lactating women

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Swan-Ganz Catheter|Swan-Ganz Catheter|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with cardiovascular events | 1) Cardiac death; 2) Non fatal myocardial infarction; 3) Intra aortic balloon counterpulsation (IABP); 4) Thoracotomy exploration; 5) Heart failure. | one week after operation | 
| Number of participants respiratory adverse events | 1) Acute lung injury: Diagnosis according to Berlin diagnostic standard; 2) Atelectasis: X-ray confirmed with body temperature >37.5c or abnormal pulmonary manifestations; 3) Pneumothorax: chest X-ray diagnosis; 4) Pneumonia: confirmed by radiology or bacteriology | one week after operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Swan-Ganz Catheter, Cardiac Surgery, Postoperative complications
Sperm DNA Damage to Intracytoplasmic Sperm Injection Outcome

Study Overview
=================
Brief Summary
-----------------
In the current era of assisted reproductive techniques where technology can help overcome defects in sperm function, the value of semen analysis has become even more inaccurate. Initial reports of intracytoplasmic sperm injection revealed its ability to bypass the natural selection process and enable men with severely impaired semen parameters to achieve both clinical pregnancy and live birth

Official Title
-----------------
Relation of Sperm DNA Damage to Intracytoplasmic Sperm Injection Outcome in Couples With Male Infertility

Conditions
-----------------
Infertility, Male

Intervention / Treatment
-----------------
* Diagnostic Test: Sperm DNA integrity by flow cytometry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infertile male patients with abnormal semen parameters. Normal female partner aged <38 years. Exclusion Criteria: Female patients with obvious infertility factor. Male patients with azoospermia. Male patients with systemic diseases. Male patients receiving cytotoxic therapy. Male patients with genital pathology as cryptorchidism.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Sperm DNA integrity by flow cytometry|flowcytometric test where sperm DNA breaks are evaluated indirectly through the DNA denaturability. The assay measures the susceptibility of sperm DNA to acid-induced DNA denaturation in situ, followed by staining with the fluorescence dye acridine orange. By using a flow cytometer 5.000-10.000 sperm can be analyzed within few seconds and thus provide a less subjective result compared to the World health organization analysis where only 1-300 cells are analyzed.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical pregnancy rate |  | 4 weeks |
Mannitol Versus Supportive Care in Ciguatera Fish Poisoning

Study Overview
=================
Brief Summary
-----------------
Ciguatera poisoning, caused by the ingestion of ciguatoxin-containing fish, is a global public health concern. In the US, the vast majority of ciguatera poisonings occur in Florida, followed by Hawaii and California. Equipoise exists in the medical literature regarding the effectiveness of mannitol therapy in treatment of ciguatera poisoning. While there are many case reports attesting to its utility, the only randomized control trial (RCT) comparing mannitol therapy with supportive care failed to show any significant benefit from mannitol treatment for a variety of clinical outcomes. Investigators therefore propose a second, larger RCT to test this question.

Official Title
-----------------
Mannitol Versus Supportive Care in Ciguatera Fish Poisoning: A Randomized Control Trial

Conditions
-----------------
Ciguatoxin

Intervention / Treatment
-----------------
* Drug: Mannitol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History consistent with ciguatera poisoning Exclusion Criteria: Minors pregnant patients those unable to give consent severe congestive heart failure or renal failure

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Patients will receive supportive care measures. | |
| Experimental: Investigational<br>Patients will receive 500mL of 20% mannitol | Drug: Mannitol<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom score | Covers a variety of neurological and gastrointestinal symptoms on a 0-4 score | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mannitol, treatment