linjc16/ctgov huggingface dataset:
Study to Assess Exactech's Guided Personalized Surgery eGPS® in Total Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
Study to collect outcomes data for patients who are undergoing an Exactech Optetrak® primary total knee replacement using the Exactech Guided Personalized Surgery (eGPS®) manufactured or distributed by (Exactech, Gainesville, Florida, USA).

Detailed Description
-----------------
The purpose of this study is to collect patient outcomes data for patients who are undergoing an Exactech Optetrak® primary total knee replacement using the Exactech Guided Personalized Surgery (eGPS®) manufactured or distributed by (Exactech, Gainesville, Florida, USA). Patient outcomes data are important for assessing the post-market safety and effectiveness of orthopedic medical devices.

Official Title
-----------------
A Prospective Multi-center Data Collection to Assess the Exactech Guided Personalized Surgery eGPS® in Total Knee Arthroplasty

Conditions
-----------------
Osteoarthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient requires a primary Optetrak Logic Total Knee Arthroplasty Patient is skeletally mature with no obvious mechanical defect Patient is mentally capable of completing follow-up visits Patient is 18 years of age or greater at time of surgery Patient will be available for follow-up out to 2 years Patient has consented to participate in the clinical study Exclusion Criteria: Patient has a mental or physical condition that may invalidate evaluation of the data Patient is a prisoner Surgery is contraindicated according to the applicable product package insert Patient has a local or systemic infection Patient has a known sensitivity to one or more of the materials in the knee replacement system to be used Patient is pregnant

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 |
| --- | --- | --- |
| Hospital for Special Surgery knee score (HSS) | total score, pain, function | 24 Months | 
| Oxford Knee Score (OKS) | function, pain | 24 Months | 
| Knee Society Score (KSS) | total score, pain, function | 24 Months | 
| Knee injury and Osteoarthritis Outcome Score (KOOS) | total score and subscales | 24 Months |
Efficacy and Safety of Activated Recombinant Human Factor VII in Severely Injured Trauma Patients

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Africa, Asia, Europe, Oceania and North America. The aim of this trial is to evaluate the efficacy of activated recombinant human factor VII given in conjunction with standard therapy in the treatment of massive bleeding in subjects with severe blunt and/or penetrating trauma injury.

Official Title
-----------------
A Multi-centre, Randomised, Double-blind, Parallel Group, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Activated Recombinant Factor VII (rFVIIa/NovoSeven®/ Niastase®) in the Treatment of Bleeding in Severely Injured Trauma Subjects

Conditions
-----------------
Acquired Bleeding Disorder, Trauma

Intervention / Treatment
-----------------
* Drug: activated recombinant human factor VII
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent obtained from the subject and/or his/her legally authorised representative (LAR) before any trial-related activities Injury(ies) due to a blunt and or penetrating trauma Receipt of 6 units of PRBC within a 4 hour period following admittance to the trauma centre Receipt of 8 units of PRBC upon administration of trial drug Exclusion Criteria: Prehospital cardiac arrest Cardiac arrest in the ER or OR Gunshot wound to the head Glasgow Coma Scale below 8 Base deficit of above 15 mEq/l or severe acidosis Transfusion of 8 units or more of PRBC prior to arrival in trauma centre

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 65 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Activated recombinant human factor VII<br> | Drug: activated recombinant human factor VII<br>* Standard therapy in conjunction with three single doses of rFVIIa administered over a 3 hour period. Administered once the subject has received 8 units of PRBC<br>|
| Placebo Comparator: Placebo<br> | Drug: placebo<br>* Standard therapy in conjunction with three single doses of placebo administered over a 3 hour period. Administered once the subject has received 8 units of PRBC<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of PRBC (packed red blood cells) units (allogeneic/autologous) transfused |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events |  |  | 
| Changes in coagulation related parameters: APTT (activated partial thromboplastin time), fibrinogen, D-dimers, anti thrombin-III, F1+2 (prothrombin fragment 1+2) and TAT (thrombin anti thrombin complex) |  |  |
Fat Globules in Breast Milk

Study Overview
=================
Brief Summary
-----------------
The aims of this study is: To investigate the diet influence on size and composition of fat globules in breast milk under controlled diet. To study the changes in globules distribution along one session of lactation and during the day. Study design: Subjects: This will be a open label study. Each subject will serve as his own control. Study population will include 45 volunteer mothers, that will divide to 3 groups: 15 vegetarians, 15 western diet and 15 Bedouins. Each participant will be nursing a 2-5 months baby. Each participant will sign an informed consent. Each participant will be ask to collect 2 milk samples twice a day i.e.- once on the first nursing in the morning (in the beginning and at the end of the nursing session), and once in the evening on last nursing again, (in the beginning and at the end). Each sample will contain 5 ml of milk. Participants will be asked to repeat the procedure one month later.

Conditions
-----------------
Fat Globules in Breast Milk

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Volunteers nursing only babies aged 2-5 months. Age: 20-45 years old. Written informed consent. Exclusion Criteria: Nursing babies more than 5 months or less than 2 months. Infants who consume breast milk replacement formulas on top of breast milk.

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Western Diet<br>Volunteer mothers with western diet. | |
| Vegetarians<br>volunteer mothers with vegetarians diet | |
| Bedouins<br>Volunteer mothers who are Bedouins | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the diet influence on size and composition of fat globules in breast milk under controlled diet. |  |  | 
| To study the changes in globules distribution along one session of lactation and during the day. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast Milk, Fat Globules
LANTUSTITR: Insulin Glargine in Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
The rationale of the study is to determine: the first dose and the titration of basal insulin the exact daily time administration of basal insulin in poorly controlled type II diabetic patients.

Official Title
-----------------
The Determination of the First Dose and the Optimal Time of Administration of Insulin Glargine Combined With Oral Antidiabetic Drug in Poorly Controlled Type II Diabetic Patients

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

Intervention / Treatment
-----------------
* Drug: Insuline glargine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 Diabetes Mellitus Insufficient combined oral antidiabetic treatment (biguanide + sulfonylurea) BMI >25 kg/m2 , <30 kg/m2 HbA1c value >7.0%, <9.0% within one month Exclusion Criteria: Type 1 Diabetes Mellitus Known malignancy Drug or alcohol abuse Severe liver disease Renal failure (se Creatinine > 150 micro mol/l) The above 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: 40 Years
Maximum Age: 65 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

| Intervention/Treatment |
| --- |
|Drug: Insuline glargine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HgbA1c measurement |  |  |
The Influence of Exercise and Hydration to the Pharmacological Response to Inhaled Terbutalin and Salbutamol in Men

Study Overview
=================
Brief Summary
-----------------
To investigate the effects of dehydration and exercise for the urine secretion of beta2-agonists.

Detailed Description
-----------------
No studies have examined the influence of factors such as exercise and dehydration on the pharmacokinetic profile of asthmatic drugs (beta2-agonists). Exercise may modify the metabolism and excretion of drugs, and sweat loss during exercise can result in dehydration, both affecting the urine concentration of the drug.

Official Title
-----------------
The Influence of Exercise and Hydration to the Pharmacological Response to Inhaled Terbutalin and Salbutamol in Men

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Behavioral: Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: men aerobic capacity more than 50ml / min / kg more than 5h training pr week Exclusion Criteria: smokers allergy for the medicine chronic diseases

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: Other
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Exercise<br>Exercise vs. non-exercise | Behavioral: Exercise<br>* Exercise vs non-exercise<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urine concentration of salbutamol and terbutalin | Urine concentration of salbutamol and terbutalin | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
exercise, dehydration, Salbutamol, Terbutalin
Sensitivity/Specificity Study of Non-invasive Imaging for Melanoma Diagnosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to show how well a new device, confocal microscope, works to detect malignant melanoma, a type of skin cancer.

Official Title
-----------------
Sensitivity/Specificity Study of Non-invasive Imaging for Melanoma Diagnosis

Conditions
-----------------
Melanoma

Intervention / Treatment
-----------------
* Device: VivaScope System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 12 or older Patient who has already been selected by their dermatologist for biopsy of a suspicious pigmented lesion and who consents to participate in the study Signed informed consent Exclusion Criteria: Age < 12 years

Ages Eligible for Study
-----------------
Minimum Age: 12 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 |
| --- | --- |
| Pigmented Lesion<br>Patients identified as having a concerning pigmented lesion and the physician believes it is appropriate to biopsy to rule out melanoma. | Device: VivaScope System<br>* VivaScope System, Model#s 1500 and 2500<br>* Other names: Confocal Microscope;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of confocal microscope to improve melanoma detection | Determine the sensitivity of confocal microscopy in the diagnosis of melanoma by comparison to the gold standard histopathologic diagnosis. | Up to 1 year | 
| Specificity of the confocal microscope to improve melanoma detection | Determine the specificity of confocal microscopy in the diagnosis of melanoma by comparison to the gold standard histopathologic diagnosis | Up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patterns seen on the confocal image | Evaluate and confirm patterns seen on the confocal image, which are characteristic of melanoma and atypical nevi: A) Pagetoid melanoma cells: melanocytes in suprabasal areas of the epidermis B) Irregular dermal-epidermal junction | Up to 1 year |
Palliation of Dyspnea With Mouth Piece Ventilation in AECOPD

Study Overview
=================
Brief Summary
-----------------
An uncontrolled feasibility study on using mouth piece ventilation in palliation of dyspnea in subjects with acute exacerbation of COPD without acute hypercapnic respiratory failure. Subjects are recruited from the local respiratory ward. The main outcomes are the compliance of the subjects with the treatment and alleviation of dyspnea during the treatment period.

Official Title
-----------------
Palliation of Dyspnea With Mouth Piece Ventilation in Acute Exacerbation of COPD Without Respiratory Insufficiency

Conditions
-----------------
COPD Exacerbation, Dyspnea

Intervention / Treatment
-----------------
* Device: Trilogy 100 ® (Philips Respironics)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: a previous diagnosis of COPD hospitalized due to acute exacerbation of COPD at least moderate dyspnea (NRS = Numeric Rating Scale ≥ 4) no acute hypoventilation (pH ≥ 7.35 and PCO2 ≤ 6.0 kPa) able to understand the study and to give informed consent Exclusion Criteria: unable to participate and use MPV due to e.g. delirium or lack of co-operation acute hypoventilation (pH < 7.35 or PCO2 > 6.0 kPa) acute need for ventilatory support the cause of the dyspnea can be successfully treated unable to give informed consent a previous chronic hypoxemic or hypercapnic respiratory insufficiency that has been treated on a long-term basis also at home

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MPV-arm<br>Subjects use mouth piece ventilation (MPV) according to their will for 24 hours to alleviate dyspnea. | Device: Trilogy 100 ® (Philips Respironics)<br>* Mouth piece Ventilation (MPV) using Trilogy 100 ® (Philips Respironics).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in dyspnea after initial period of using MPV | Change in dyspnea after initial period of using MPV | 5-60 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in dyspnea after 24 hours of using MPV | Change in dyspnea after 24 hours of using MPV | 24 hours | 
| Proportion of subjects having side-effects or not being compliant with MPV | Proportion of subjects having side-effects or not being compliant with MPV | 24 hours | 
| Proportion of subjects gaining from MPV | Proportion of subjects gaining from MPV | 24 hours | 
| Proportion of subjects willing to continue on MPV after the intervention | Proportion of subjects willing to continue on MPV after the intervention | 24 hours |
Aloe Vera on Irradiated Breast Tissue

Study Overview
=================
Brief Summary
-----------------
The investigators are testing two over the counter aloe veras on irradiated breast tissue.

Official Title
-----------------
A Phase III Double Blind Study on the Efficacy of Topical Aloe Vera Gel on Irradiated Breast Tissue

Conditions
-----------------
Irradiated Breast Tissue

Intervention / Treatment
-----------------
* Other: Klean & Klear The Dandy Day Corp
* Other: The Skin Gel Herbal Answers, Inc


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women over 18 years of age who had undergone lumpectomy or partial mastectomy for breast cancer, and who then received postoperative radiation therapy using tangential fields, with or without a boost to the tumor bed. Chemotherapy as part of the treatment regimen was acceptable. No major medical or psychiatric illness that might interfere with patient's completion of study requirements Signed study-specific informed consent form prior to study entry Exclusion Criteria: Those requiring nodal radiation therapy were excluded. Subjects who have a breast infection at the commencement of radiation treatment Before randomization, subjects who have agreed to participate are asked if they are allergic to any topical preparation. Those allergic to aloe vera were ineligible.

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

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Klean & Klear<br>aloe vera gel | Other: Klean & Klear The Dandy Day Corp<br> <br> |
| Active Comparator: The Skin Gel<br>aloe vera gel | Other: The Skin Gel Herbal Answers, Inc<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| erythema | since we are testing two over the counter products we wanted to wee if one tested better than the other | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| itching | is there a difference in itching | one year |
Study of Shunt Flow Sensor Accuracy in Extra-ventricular Drains.

Study Overview
=================
Brief Summary
-----------------
The study hypothesis is that an ultrasonic flow sensor can accurately measure flow in hydrocephalic shunts. The ultrasonic sensor will measure cerebrospinal fluid drainage in hydrocephalus patients with external ventriculostomies and extra-ventricular drainage systems. The sensor measurements will be compared with the volume of fluid collected by the drainage bag. After a 24-hour measurement period, the doctor will change the drainage bag position to simulate the patient sitting up and leaning back, to see if this temporarily stops flow through the drainage line. This data will show whether the sensor accurately measures typical drainage flows seen in hydrocephalus patients. This research will help develop an implantable flow monitor for pediatric hydrocephalus patients.

Official Title
-----------------
A Flow Monitor for Pediatric Hydrocephalic Shunts

Conditions
-----------------
Hydrocephalus, Nervous System Diseases, Infant, Newborn Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with hydrocephalus Instrumented with an Extraventricular drainage system Exclusion Criteria: Not diagnosed with hydrocephalus Not instrumented with an extraventricular drainage system
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Extraventricular Drainage<br>Includes hydrocephalus patients that are in recovery from shunt explanation. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volumetric flow of patient cerebrospinal fluid through an Extra-Ventricular Drainage system. |  | 24 hour-period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recording of the pressure waveform related to the volumetric flow of patient cerebrospinal fluid through an Extra-Ventricular Drainage system. |  | 24 hour period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hydrocephalus, Shunt Dysfunction, Shunt Flow