linjc16/ctgov huggingface dataset:
PulmonarOM (Bacterial Lysates) in Respiratory Tract Infections

Study Overview
=================
Brief Summary
-----------------
Primary - To evaluate the efficacy of Pulmonaron in the decrease of interleukin-4/interferon gamma after second period of treatment Secondary To evaluate the efficacy of Pulmonarom in the prevention of upper respiratory tract infections symptoms through patient evaluation of fever or respiratory presence after second period of treatment To evaluate loss of working or study days after second period of treatment To evaluate the safety and tolerability of Pulmonarom in the population under study

Official Title
-----------------
Prospective, Pivotal Unicentre, Randomized Double-bind, Placebo-controlled Study, to Evaluate Efficacy and Safety of Bacterial Lysates (Pulmonarom) in the Prevention of Respiratory Tract Infections

Conditions
-----------------
Respiratory Tract Infections

Intervention / Treatment
-----------------
* Drug: Bacterial Lysates
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with history of relapse or recurrence of respiratory infections or disease Patients with chronic respiratory disease as asthma, bronchitis or sinusitis Exclusion Criteria: Patients unlikely to comply with the protocol, for example, uncooperativeness or impossibility to return for follow-up visits Patients who are participating or who have participated in another clinical trial during the previous 3 months Patients who have received immunology response stimulants during the previous 30 days Hypersensitivity 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: 6 Months
Maximum Age: 6 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: 1<br> | Drug: Bacterial Lysates<br>* Bacterial Lysates ampoules 3 mL, oral route, daily for 10 days, followed by 30 days free of medication and then 10 days of administration of the drug<br>|
| Placebo Comparator: 2<br> | Drug: placebo<br>* placebo controlled<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease of interleukin-4/interferon gamma index at baseline values |  | 60 days, 120 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events and laboratory evaluation |  | 120 days |
Osteoprotegerin Before and After Periodontal Surgery

Study Overview
=================
Brief Summary
-----------------
The study hypothesis: Is Osteoprotegerin a diagnostic and/or prognostic marker of periodontal disease?

Detailed Description
-----------------
assessment of osteoprotegerin in patients with chronic periodontitis before and after periodontal surgery in gingival crevicular fluid, saliva and gingival tissues.

Official Title
-----------------
Effect of Periodontal Surgery on Osteoprotegerin Levels in Gingival Crevicular Fluid, Saliva and Gingival Tissues.

Conditions
-----------------
Chronic Periodontitis

Intervention / Treatment
-----------------
* Procedure: Open flap debridement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: severe chronic periodontitis, having pocket depth of ≥ 5 mm and clinical attachment level ≥ 5 mm Exclusion Criteria: pregnant women subjects had <22 permanent teeth having any given systemic disease taking any type of medication and/or antibiotic therapy during the 3 months before the study received periodontal treatment within the past 12 months current or former smokers.

Ages Eligible for Study
-----------------
Minimum Age: 32 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: Diagnostic
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Open flap for periodontitis patients<br>Open flap debridement | Procedure: Open flap debridement<br>* an access flap<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Osteoprotegerin levels at 3 and 6 months |  | Baseline, 3 months and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes from baseline in Clinical attachment level at 3 and 6 months. |  | Baseline, 3 months and 6 months | 
| Changes from baseline in probing pocket depth at 3 and 6 months |  | baseline, 3 months and 6 months | 
| Changes from baseline in plaque index at 3 and 6 months |  | baseline, 3 months and 6 months | 
| Changes from baseline in gingival index at 3 and 6 months |  | baseline, 3 months and 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoprotegerin, Biomarker, Chronic periodontitis, Open flap debridement
Costs of the Patient's Stay Under ExtraCorporeal Membrane Oxygenation From the Hospital Point of View: a Pilot Study at the Rennes University Hospital Center

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to determine the average cost of stay of a patient supported by ExtraCorporeal Membrane Oxygenation from the point of view of the hospital facility, during the hospitalization in which the ECMO was implanted.

Official Title
-----------------
Costs of the Patient's Stay Under ExtraCorporeal Membrane Oxygenation From the Hospital Point of View: a Pilot Study at the Rennes University Hospital Center

Conditions
-----------------
ExtraCorporeal Membrane Oxygenation

Intervention / Treatment
-----------------
* Procedure: ExtraCorporeal Membrane Oxygenation (ECMO)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients ≥18 years old who have benefited from an ECMO (no type, no indication) between 2004 and 2016 at the Rennes University Hospital, identified in the database of the Rennes University Hospital Center will be included in this study. Exclusion Criteria: Neither

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 |
| --- |
|Procedure: ExtraCorporeal Membrane Oxygenation (ECMO)|The objective of this study is to determine the average cost of stay of a patient supported by ExtraCorporeal Membrane Oxygenation from the point of view of the hospital facility, during the hospitalization in which the ECMO was implanted.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average net costs | Average net costs (total and by expense) for the hospital facility (Rennes University Hospital) of the initial hospitalization. The average net cost for the institution is defined as the average difference between the production costs for the hospital and the incomes donated to the institution by the Health Insurance. | 1 day of inclusion |
Reliability of [18F]-FTC-146 Brain Uptake in Healthy Controls

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to understand the reliability of [18F]-FTC-146 brain uptake in healthy controls.

Detailed Description
-----------------
The purpose of this study is to understand the reliability of [18F]-FTC-146 brain uptake in healthy controls under test and retest conditions.

Official Title
-----------------
Reliability of [18F]-FTC-146 Brain Uptake in Healthy Controls

Conditions
-----------------
Healthy Controls

Intervention / Treatment
-----------------
* Drug: [18F]-FTC-146


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ages 18-65 either gender and all ethno-racial categories capacity to provide informed consent Female participants are expected to use an effective method of birth control throughout the study Exclusion Criteria: Any current or lifetime psychiatric diagnosis Current or past use of psychotropic medication Pregnant or nursing females Major medical or neurological problem Presence of metal in the body that is contraindicated for MRI scans

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: [18F]-FTC-146<br>[18F]-FTC-146 | Drug: [18F]-FTC-146<br>* Two 5 mCi [18F]-FTC-146 doses will be administered intravenously on two separate scan days at least one week apart (total per study = 10 mCi) Participants who complete both test days will receive 10 mCi total dose; however, if a participant is unable to return for a second test day due to unforeseen circumstances, they will receive 5 mCi total dose.<br>* Other names: Sigma-1 receptor radioligand;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reliability under test retest conditions | Regional brain uptake of [18F]FTC-146 will be analyzed by kinetic modeling with metabolite-corrected arterial input functions to establish stability and reproducibility of [18F] FTC-146 VT in humans (n=6) under test and retest conditions. | 1 week |
Patient Activation in Dialysis

Study Overview
=================
Brief Summary
-----------------
Patient activation refers to patients' willingness and ability to make independent actions to manage their health and care and requires knowledge, skill and confidence. This study aims to explore activation levels of incident dialysis patients at start of dialysis and after 3 months of dialysis.

Detailed Description
-----------------
Patient activation refers to patients' willingness and ability to make independent actions to manage their health and care and requires knowledge, skill and confidence. This study aims to explore activation levels, using the 13 item PAM-13 survey, of incident dialysis patients at start of dialysis and after 3 months of dialysis.

Official Title
-----------------
Patient Activation in Incident Dialysis

Conditions
-----------------
Renal Dialysis, Kidney Failure, Chronic

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Incident dialysis patients commencing at Satellite Healthcare during study recruitment dates Exclusion Criteria: Age < 18 years Started dialysis more than 3 weeks prior to identification Transitioning to dialysis at a participating center from a non-participating center, when that patient has been on dialysis for more than 3 weeks at any center. Transitioning to dialysis after kidney transplant failure Inability to participate because of cognitive impairment or active psychological condition

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: No intervention|No Intervention. Observational Study.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Activation | Patient Activation as measured by PAM-13 instrument | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
patient activation, self management
Study of Histological Findings of the Internal Inguinal Ring in Patients With Indirect Inguinal Hernia

Study Overview
=================
Brief Summary
-----------------
The histology of the internal inguinal ring in patients with indirect hernia submitted to elective surgery was studied. In contrast with recently published studies, the investigators believe that histological findings of the internal inguinal ring would reflect those associated and expected with normal aging.

Official Title
-----------------
Histological Findings of the Internal Inguinal Ring in Patients With Indirect Inguinal Hernia

Conditions
-----------------
Indirect Inguinal Hernia

Intervention / Treatment
-----------------
* Procedure: Lichtenstein hernioplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male gender Older than 15 years-of-age Unilateral indirect inguinal hernia Non-smokers Non-diabetics Non-connective tissue conditions Primary inguinal hernia Exclusion Criteria: Female gender Younger than 15 years-of-age Bilateral inguinal hernia Direct or combined direct-indirect inguinal hernia Femoral hernia Smokers Diabetics Other connective tissue diseases Recurrent inguinal hernia

Ages Eligible for Study
-----------------
Minimum Age: 15 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients age: 15 - 40 years-old<br>Patients within the 15 to 40 years-old age-group | Procedure: Lichtenstein hernioplasty<br>* Mesh hernioplasty Ultrapro mesh (Ethicon, Johnson & Johnson)<br>|
| Patients age: 41 to 60 years-old<br>Patients within the group-age from 41 to 60 years-old | Procedure: Lichtenstein hernioplasty<br>* Mesh hernioplasty Ultrapro mesh (Ethicon, Johnson & Johnson)<br>|
| Patients age: older than 61 years-old<br>Patients within the group-age from 61 years-old and older | Procedure: Lichtenstein hernioplasty<br>* Mesh hernioplasty Ultrapro mesh (Ethicon, Johnson & Johnson)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histology of the internal inguinal ring | Histology and histological findings of the internal inguinal ring in patients submitted to elective surgical reparation of an indirect inguinal hernia | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Inguinal hernia, Inguinal ring, Histology, Hernioplasty, Lichtenstein
Intraoperative Aromatherapy Versus Placebo for Port-a-Cath Placement Under Monitored Anesthesia Care. A Randomized Controlled Trial

Study Overview
=================
Brief Summary
-----------------
This is a prospective, controlled, randomized trial. Primary objective is to compare the time to readiness for discharge (minutes) from Post-Anesthesia Care Unit (PACU) after Port-a-Cath placement surgery between patients who are randomized to receive intraoperative aromatherapy versus placebo. 70 Eligible subjects will be identified from within the patient population of the study site. There will be no advertisements for study subjects.

Detailed Description
-----------------
Primary Objective: To compare the time to readiness for discharge (minutes) from Post-Anesthesia Care Unit (PACU) after Port-a-Cath placement surgery between patients who are randomized to receive intraoperative aromatherapy versus placebo. Secondary Objective: To evaluate the following secondary outcomes: Anxiety score (HADS) in preoperative holding area Midazolam use intraoperatively (mg) Itraoperative opioid use (morphine equivalents) Intraoperative anti-emetic use Time to first occurrence of postoperative nausea or vomiting (PONV) in PACU Rate and intensity of PONV in PACU Antiemetic use in PACU Opioid use in PACU (morphine equivalents) Pain intensity in PACU (0-10 numerical rating scale) Patient satisfaction in PACU

Official Title
-----------------
Intraoperative Aromatherapy Versus Placebo for Port-a-Cath Placement Under Monitored Anesthesia Care. A Randomized Controlled Trial

Conditions
-----------------
Cancer Pain

Intervention / Treatment
-----------------
* Other: ELEQUIL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients (≥ 18 years old) Port-a-Cath placement under Monitored Anesthesia Care Signed informed consent Exclusion Criteria: Patients undergoing other surgical procedures during Port-a-Cath placement (including explantation of a Port-a-Cath or other previous vascular access device) Patients requiring general anesthesia or those not eligible for MAC

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ELEQUIL<br>Aromatherapy will be provided using a lavender-peppermint patch called an Aromatab. | Other: ELEQUIL<br>* patch placed on skin<br>* Other names: Aromatabs;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the time to readiness for discharge from PACU (minutes) after Port-a-Cath placement surgery between patients who are randomized to receive intraoperative aromatherapy versus placebo |  | through study completion, an average of 1 year |
To Demonstrate the Relative Bioavailability of Metformin HCL 500 mg Extended Release (XR) Tablets Under Fasting Conditions

Study Overview
=================
Brief Summary
-----------------
To demonstrate the relative bioavailability of Metformin HCl 500 mg XR tablets under fasting conditions.

Official Title
-----------------
A Relative Bioavailability Study of Metformin HCL 500 mg XR Tablets Under Fasting Conditions

Conditions
-----------------
Type II Diabetes

Intervention / Treatment
-----------------
* Drug: Metformin HCL 500 mg Extended-Release Tablets, Geneva PTC
* Drug: Metformin HCL 500 mg Extended-Release Tablets, Geneva PTC
* Drug: GLUCOPHAGE XR 500 mg ER Tablets Bristol-Myers Squibb
* Drug: GLUCOPHAGE XR 500 mg ER Tablets Bristol-Myers Squibb


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

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 49 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Metformin HCL 500 mg Extended-Release Tablets, Geneva PTC | Drug: Metformin HCL 500 mg Extended-Release Tablets, Geneva PTC<br> <br> |
| Experimental: 2<br>Metformin HCL 500 mg Extended-Release Tablets, Geneva PTC | Drug: Metformin HCL 500 mg Extended-Release Tablets, Geneva PTC<br> <br> |
| Active Comparator: 3<br>GLUCOPHAGE XR 500 mg Extended-Release Tablets Bristol-Myers Squibb | Drug: GLUCOPHAGE XR 500 mg ER Tablets Bristol-Myers Squibb<br> <br> |
| Active Comparator: 4<br>GLUCOPHAGE XR 500 mg Extended-Release Tablets Bristol-Myers Squibb | Drug: GLUCOPHAGE XR 500 mg ER Tablets Bristol-Myers Squibb<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence based on AUC and Cmax |  | 23 days |
Fall Risk Assessment in People With Diabetic Neuropathy

Study Overview
=================
Brief Summary
-----------------
Fall risk is increased in people with diabetic peripheral neuropathy (DPN) and yet, minimal research has been conducted to identify appropriate fall risk assessment tools and improve our understanding of falls in these individuals. Purpose: The primary purpose of this study is to establish a foundation of knowledge needed to address falls in people with DPN. This will be accomplished through 1) comparing the validity of 4 fall risk assessment tools, 2) identifying risk factors for falls and 3) determining how quality of life is influenced by factors related to falls in people with DPN.

Detailed Description
-----------------
All subjects participate in testing that involves questionnaires, cognitive testing, fall risk assessment, and other testing related to physical parameters including body mass index, glycosylated hemoglobin, lower extremity nerve conduction study, and ankle range of motion, proprioception and strength. After testing, subjects are interviewed to determine fall status (faller or non-faller). A faller is defined as someone that has fallen at least 2 times in the past year. Data Analysis: The validity of the fall risk assessment tools will be compared using sensitivity and specificity analyses. Variables related to ankle function, neuropathy, glycemic control and general activity will be analyzed for association with recent fall history through multivariable logistic regression. Variables related to falls, neuropathy and activity level will be analyzed for association with health-related quality of life through multivariable linear regression.

Official Title
-----------------
Fall Risk Assessment in People With Diabetic Neuropathy

Conditions
-----------------
Diabetic Peripheral Neuropathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosed with diabetic peripheral neuropathy Exclusion Criteria: major medical depression non-diabetes related musculoskeletal problems that limit ambulation open wounds on the weight bearing surfaces of the feet requires another person's assistance to walk uncorrected visual deficits that influence gait and/or balance history of stroke or other CNS pathology that impairs gait and/or balance diagnosed untreated vestibular disorder that results in gait and/or balance disturbances

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Falls Risk Assessment, Diabetic Peripheral Neuropathy Patients<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
-----------------
neuropathy, diabetes