linjc16/ctgov huggingface dataset:
Study of the Effect of a Fermented Dairy Product on Gastrointestinal Well Being in Adult Women

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of a commercially available fermented dairy product containing probiotics (4 weeks, twice a day) on the improvement of gastrointestinal well being and digestive symptoms in adult women reporting minor digestive troubles among the general population.

Official Title
-----------------
Effect of the Consumption of a Fermented Dairy Product on Gastrointestinal Well-being in a Healthy Population of Women With Minor Digestive Symptoms

Conditions
-----------------
Healthy Adult Women

Intervention / Treatment
-----------------
* Other: 1-Fermented Probiotic Dairy Product (test)
* Other: 2-Milk-based non-fermented dairy product(control)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female free-living subject aged from 18 to 60 years. Subject with a body mass index between 18 and 30. Subject with minor digestive symptoms as defined by screening questionnaire of frequency of digestive symptoms. Subject with normal stool frequency Exclusion Criteria: Subject with a diagnosis of Irritable Bowel Syndrome (IBS) or other functional bowel disease (constipation, diarrhoea…) Subject with known organic disease, including an inflammatory bowel disease, a benign or malign tumour of intestine or colon and significant systemic disease Subject under prescription for medication for digestive symptoms such as anti-spasmodic, laxatives and anti-diarrheic drugs Subject having taken antibiotics in the last 4 weeks Pregnant subject or subject planning to become pregnant during the study; breast-feeding subject. Subject with known lactose intolerance or immunodeficiency Subject with known allergy to product component (milk protein for example)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 = Test product<br>Arm 1 - Intervention 1 (probiotics) | Other: 1-Fermented Probiotic Dairy Product (test)<br> <br> |
| Other: 2 = Control product<br>Arm 2 - Intervention 2 (control) | Other: 2-Milk-based non-fermented dairy product(control)<br> <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
-----------------
probiotics, gastrointestinal well being, digestive symptoms, healthy population
Envision® Surface Evaluation

Study Overview
=================
Brief Summary
-----------------
This observational study will acquire initial clinical practice utilization and product safety data for the Envision® surface.

Detailed Description
-----------------
This is a single site, open label, observational study to acquire initial clinical practice utilization information, product safety, and wound healing data, as defined by changes in wound volume and/or surface area, for patients with pressure ulcers placed on this surface.

Official Title
-----------------
Envision® Surface Evaluation for Patients With Stage II, Stage III, or Stage IV Pressure Ulcers

Conditions
-----------------
Pressure Ulcer

Intervention / Treatment
-----------------
* Device: Envision® Patient Support System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject Weight < 400 lbs. Subject has Stage II, III, or IV pressure ulcer on weight bearing aspect of the body Subject estimated length of stay at least 7 days Subject Ability to provide informed consent Exclusion Criteria: Inability to provide informed consent
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Envision® Patient Support System|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
-----------------
Pressure Ulcer
Comparison of Thoracic Epidural Analgesia and Intercostal Blockade in Patients Undergoing Thoracotomy

Study Overview
=================
Brief Summary
-----------------
Postoperative pain is an important issue after thoracotomy operations. Thoracic epidural analgesia is most popular analgesic method, but sometimes it is not sufficient for pain. This study is designed to compare intercostal block with thoracic epidural analgesia in patients undergoing thoracotomy

Official Title
-----------------
Comparison of Thoracic Epidural Analgesia and Intercostal Blockade in Patients Undergoing Thoracotomy

Conditions
-----------------
Analgesia, Postoperative

Intervention / Treatment
-----------------
* Other: epidural


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: lung cancer Exclusion Criteria: patient refusal bleeding diathesisi emergency cases -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| thoracic epidural<br>patients receiving thoracic epidural | Other: epidural<br>* thoracic epidural analgesia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| verbal analog score |  | postoperative 24 hour |
Effectiveness of an Educational Program in the Prevention of Osteoporosis and Fractures

Study Overview
=================
Brief Summary
-----------------
The study will elucidate the effectiveness of an educational program in the prevention of osteoporosis and fractures. A random sample of the female population in Southern Finland (Uusimaa region) within the age group of 60-70 years was drawn from the population registry. From 1996 through 2000, 2181 women from the population register were recruited and randomly assigned to the intervention and to the control group. The subjects in the intervention group have been on a multidisciplinary program and the subjects in the control group received osteoporosis prevention information through the media and health care system. An end point is any fracture during the ten-year follow-up.

Official Title
-----------------
Effectiveness of an Educational Program in the Prevention of Osteoporosis and Fractures

Conditions
-----------------
Fractures, Osteoporosis

Intervention / Treatment
-----------------
* Behavioral: multidisciplinary osteoporosis prevention educational program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 60-70 years and living in southern Finland (Uusimaa region)

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 70 Years

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

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>The multidisciplinary osteoporosis prevention study started with a five-day program at a rehabilitation centre and will be followed by one-day group appointments twice. | Behavioral: multidisciplinary osteoporosis prevention educational program<br>* The program includes individualized counseling aimed at improving diet, muscle strength, balance, and informing individuals about home hazards and the use of medicine.<br>|
| No Intervention: 2<br>The control group will get information about osteoporosis through media and health care system. | |

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
-----------------
vitamin D, bone density
Pitch and Loudness Perception by Cochlear Implant Listeners: Psychophysics and Objective Measures

Study Overview
=================
Brief Summary
-----------------
Cochlear implants (CIs) have restored some sense of hearing to more than 120 000 people worldwide. While most patients show good scores of speech recognition in quiet, a large majority of them also struggle in more challenging listening situations, such as speech in noise or music. This project aims to understand the basic mechanisms of electrical stimulation of the auditory nerve, in order to identify the important cues that the electrical signal should convey and to possible improve sound perception by CI users.

Detailed Description
-----------------
This study will take place in the ENT department of La Timone hospital in Marseille, where more than 120 adults have been implanted. Our study will comprise several phases, including (1) temporal coding of pitch, (2) spatial coding of pitch, and (3) loudness perception. Eight adult implant users will be recruited for each of these phases.

Official Title
-----------------
Pitch and Loudness Perception by Cochlear Implant Listeners: Psychophysics and Objective Measures

Conditions
-----------------
Cochlear Implant Listeners

Intervention / Treatment
-----------------
* Device: Cochlear implants


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The adults of more than 18 years old at the beginning of the study without notion of minimal or maximal duration of setting-up(presence). The adults WITH cochlear implant listeners . Exclusion Criteria: Presence of intrusive disorders of the personality or mental deficiency. Presence of associated driving disorders. Pregnant or breast-feeding woman.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cochlear implants<br> | Device: Cochlear implants<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify waveforms aimed to improve sound perception by CI recipients |  | 2 YEARS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To correlate the results of our measures psychophysiques with recordings électrophysiologiques of the neuronal activity of the hearing nerve. |  | 2 YEARS |
Post-Operative Sub-Tenon Kenalog in Glaucoma Filtering Surgery

Study Overview
=================
Brief Summary
-----------------
Determine efficacy of sub tenon kenalog injections for post-operative management of trabeculectomy procedures.

Detailed Description
-----------------
Postoperative sub-Tenon Triamcinolone Acetonide in glaucoma filtering surgery Objectives: Trabeculectomy is a surgical procedure designed to reduce internal eye pressure by draining fluid from within the eye to the sub-conjunctival (superficial eye lining) space. Scar formation from conjunctival and Tenon's capsule fibroblast proliferation represents the most common cause of failure of trabeculectomies. A number of drugs have been use to prevent failure of trabeculectomies from the scarring process including intraoperative mitomycin C (MMC) and preoperative Triamcinalone Acetonide (TA). Over the past several years, intraoperative MMC has become a preferred method of preventing scar formation. This study looks to determine in a prospective, double-blind, randomized method the long-term efficacy and safety of MMC with postoperative TA compared to the standard practice of intraoperative MMC with postoperative prednisolone acetate drops in preventing scar related failures of trabeculectomies.

Official Title
-----------------
Post-Operative Sub-Tenon Kenalog in Glaucoma Filtering Surgery

Conditions
-----------------
Glaucoma

Intervention / Treatment
-----------------
* Drug: Triamcinolone injection, sub-tenon


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:Trabeculectomy surgery patient, age 18 or older - Exclusion Criteria:Pregnant, nursing, age less than 18, known allergy to medication being studied

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: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Triamcinolone injection, sub-tenon|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular pressure |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual field progression, need for further surgery or medications |  |  |
Reliability of the Preoperative Work-up in Patients Submitted to Surgery for Cystic Neoplasms of the Pancreas

Study Overview
=================
Brief Summary
-----------------
Prospective, observational, cohort study to evaluate the reliability of preoperative work-up of patients submitted to surgery for pancreatic cystic neoplasms, in a tertiary referral center. A comparison between the preoperative diagnostic suspicion and the final pathologic report will be done.

Official Title
-----------------
Reliability of the Preoperative Work-up in a Prospective Series of Patients Submitted to Surgery for Cystic Neoplasms of the Pancreas

Conditions
-----------------
Pancreatic Cystic Neoplasms

Intervention / Treatment
-----------------
* Other: good clinical practice


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of pancreatic cystic neoplasms indication to surgery Exclusion Criteria: pregnancy, breastfeeding

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

| Intervention/Treatment |
| --- |
|Other: good clinical practice|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of cases with confirmed preoperative diagnosis |  | Through study completion, on average 18 months |
Influence of Age on Trauma Femoral Fractures

Study Overview
=================
Brief Summary
-----------------
This study aimed to determine the influence of ageing on the incidence and site of femoral fractures in trauma patients, by taking the sex, body weight, and trauma mechanisms into account.

Detailed Description
-----------------
This retrospective study reviewed data from adult trauma patients aged ≥ 20 years who were admitted into a Level I trauma center, between January 1, 2009 and December 31, 2016. According to the femoral fracture locations, 3859 adult patients with 4011 fracture sites were grouped into five subgroups: proximal type A (n = 1,359), proximal type B (n= 1,487), proximal type C (n = 59), femoral shaft (n = 640), and distal femur (n = 466) groups. A multivariate logistic regression analysis was applied to identify independent effects of the univariate predictive variables on the occurrence of fracture at a specific site. The propensity score accounts for the risk of a fracture at a specific femoral site was calculated and presented visually with age in a two-dimensional plot.

Official Title
-----------------
The Influence of Ageing on the Incidence and Site of Trauma Femoral Fractures: a Cross-sectional Analysis

Conditions
-----------------
FEMORAL FRACTURES

Intervention / Treatment
-----------------
* Other: Proximal type A
* Other: Proximal type B
* Other: Proximal type C
* Other: femoral shaft
* Other: distal femur


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients to be aged ≥20 years and hospitalized for the treatment of femoral fracture following injury Exclusion Criteria: Patients with incomplete data were excluded

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 100 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 |
| --- | --- |
| Trauma femoral fracture<br>Patients to be aged ≥20 years and hospitalized for the treatment of femoral fracture following injury. Patients were grouping into five subgroups as patients with fracture of proximal type A, proximal type B, proximal type C, femoral shaft, and distal femur. | Other: Proximal type A<br>* Patients with fracture of proximal type A<br>Other: Proximal type B<br>* Patients with fracture of proximal type B<br>Other: Proximal type C<br>* Patients with fracture of proximal type C<br>Other: femoral shaft<br>* Patients with fracture of femoral shaft<br>Other: distal femur<br>* Patients with fracture of distal femur<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Locations of femoral fracture | To provide a summary of covariate information regarding the occurrence of femur Fractures at a specific site. | up tp 2 months |
Use of Ultrasound in Lower Extremity Blocks.

Study Overview
=================
Brief Summary
-----------------
Nerve freezing injections of the leg are very useful in providing anesthesia and pain relief for knee and ankle surgery. However, current nerve freezing techniques are blind. As a result, they are not always successful and may cause complications, albeit infrequent. The objective of the current study is to determine any advantage in performing these freezing injections under direct ultrasound guidance, to visualize the nerves. We feel that by developing this technique, it will allow us to perform these procedures with greater success and fewer complications.

Detailed Description
-----------------
This study is a randomised controlled trial. Its objective is to compare results and complications between two techniques of nerve localisation for nerve blocks of the lower limb. We have developed a real-time, image guided approach to nerve blocks of the lower extremities in three locations: the femoral nerve in the groin and the sciatic nerve in the buttock and/or popliteal fossa. We have used ultrasound imaging to locate and asess the nerves of the lower extremities and to use it as a real-time guidance for performance of lower extremity blocks in patients undergoing orthopaedic procedures. The results of our previous study will be presented as a case series reporting anatomical appearance of the nerves studied, time for block performance and success rates. In this study we aim to compare these parambeters between standard and ultrasound techniques of lower extremity block, to show any advantage.

Official Title
-----------------
Does Ultrasound Guidance Improve the Success of Sciatic Nerve Block at the Popliteal Fossa? A Prospective, Randomized, Controlled Trial.

Conditions
-----------------
Regional Anesthesia

Intervention / Treatment
-----------------
* Procedure: Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: English-speaking ASA physical status I-III 18-85 years of age, inclusive 50-110 kg, inclusive 150 cm of height or grater Scheduled for elective foot or ankle surgery Exclusion Criteria: Contraindications to sciatic nerve block (e.g., allergy to local anesthetics, coagulopathy, malignancy or infection in the popliteal area) Significant peripheral neuropathy or neurologic disorder affecting the lower extremity Pregnancy Contraindications to, allergies to, and/or past adverse reactions to local anesthetics History of alcohol or drug dependency/abuse

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Ultrasound|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Safety and Effectiveness of Left Atrial Appendage Occlusion

Study Overview
=================
Brief Summary
-----------------
This study is to evaluate acute and long-term safety and effectiveness of Left atrial appendage occlusion (LAA)with the AtriCure LAA Occlusion System. This device will be applied in patients with atrial fibrillation (AF), paroxysmal, persistent and permanent, undergoing cardiac surgery with a concomitant Maze/Ablation procedure.

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Device: AtriCure LAA Exclusion System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented history (paroxysmal, persistent or permanent) of AF [one episode within the last 12 months of enrollment] Elective Maze procedure Suitable anatomy Able and willing to sign informed consent Age over 18 years Exclusion Criteria: Patient from Intensive Care Unit with either: intra-venous catecholamines ventilator cardiac index <1.8 l/min. Reoperative Cardiac Surgery Systemic or Inflammatory disease Dialysis Recent myocardial infarction (< 21 days) History of pericarditis Patient taking part in any other device or drug study Patient with known sensitivity or allergy to any of the device components Pregnancy

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: LAA Clip<br>AtriCure LAA Exclusion System | Device: AtriCure LAA Exclusion System<br>* Placement of clip of LAA.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety - Device related complications |  | 30 days | 
| Efficacy - Occlusion of the LAA |  | 6 months |