linjc16/ctgov huggingface dataset:
The Efficacy and Safety of Cordyceps Sinensis Mycelium Culture Extract(Paecilomyces Hepiali, CBG-CS-2) on Promotion of Immunity

Study Overview
=================
Brief Summary
-----------------
The investigators performed randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Cordyceps sinensis mycelium culture extract (Paecilomyces hepiali, CBG-CS-2) on promotion of immunity. The investigators measured promotion of immunity parameters , including Cytotoxicity, Cytokine (IL-1β, IL-2, IL-4, IL-10, IL-12, IFN-γ, TNF-α).

Conditions
-----------------
Immunity

Intervention / Treatment
-----------------
* Dietary Supplement: Cordyceps sinensis mycelium culture extract 1.68 g
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females 20-75 years old Able to give informed consent Exclusion Criteria: WBC concentration below 3000 ㎕, over 8000㎕ Subjects with BMI < 18.5 kg/m2 at screening visit Allergic or hypersensitive to any of the ingredients in the test products Diagnosed of gastrointestinal disease such as Immune-related diseases, severe hepatic, renal failure, and diabetes History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery History of alcohol or substance abuse Participation in any other clinical trials within past 2 months Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study Pregnant or lactating women etc.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 Years

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

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: Cordyceps sinensis mycelium culture extract<br>Cordyceps sinensis mycelium culture extract 1.68 g | Dietary Supplement: Cordyceps sinensis mycelium culture extract 1.68 g<br>* Cordyceps sinensis mycelium culture extract 1.68 g<br>|
| Placebo Comparator: Placebo<br>Placebo | Dietary Supplement: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in serum natural killer cell activity |  | Baseline, 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Cytokine(IL-1β, IL-2, IL-4, IL-10, IL-12, IFN-γ, TNF-α) |  | Baseline, 8 weeks |
Coadministration of Ezetimibe With Fenofibrate Versus Pravastatin Monotherapy for the Treatment of Hyperlipidaemia in HIV-infected Patients

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to compare the effects of coadministration of ezetimibe 10 mg/die + fenofibrate 200 mg/die versus pravastatin 40 mg/die monotherapy in HIV-infected patients treated with protease inhibitors. Single-centre, open, randomized, controlled, prospective pilot study. 60 patients will be enrolled in order to reach the target of 50 patients evaluable at the end of the study. The patients will be randomly assigned to a 6-month treatment with ezetimibe+fenofibrate or with pravastatin.The visit will be every month.

Official Title
-----------------
Coadministration of Ezetimibe With Fenofibrate Versus Pravastatin Monotherapy for the Treatment of Hyperlipidaemia in HIV-infected Patients Receiving Protease Inhibitors: a Randomized, Prospective, Controlled Pilot Study.

Conditions
-----------------
HIV, Hyperlipidemia, HIV Infections

Intervention / Treatment
-----------------
* Drug: ezetimibe
* Drug: fenofibrate
* Drug: pravastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients older than 18 years documented positive HIV antibodies test on stable therapy with PIs for at least 12 months LDL-cholesterol >130 mg/dl or triglycerides 200 - 500 mg/dl with non-HDL cholesterol >160 mg/dl unresponsive to dietary measures and regular physical exercise of at Exclusion Criteria: history of dyslipidemia before antiretroviral therapy cardiovascular and cerebrovascular diseases Cushing's syndrome concurrent therapy with lipid-lowering agents, oral anticoagulant, estrogens, thiazidic diuretics, beta-blockers hypothyroidism Type 1 diabetes mellitus renal failure

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 |
| --- | --- |
| Experimental: Ezetimibe and fenofibrate<br> | Drug: ezetimibe<br>* 10 mg ezetimibe/day<br>Drug: fenofibrate<br>* 200 mg fenofibrate/day<br>|
| Active Comparator: Pravastatin<br> | Drug: pravastatin<br>* 40 mg pravastatin/day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| per cent changes of LDL cholesterol, comparison between the 2 treatment regimens |  | After 6 month treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Treatment Experienced
Ventilation With Supraglottic Airway Devices

Study Overview
=================
Brief Summary
-----------------
Airo-Q Self Pressurized airway device with Blocker will be compared with Proseal LMA in anesthetized adult female patients undergoing elective surgeries to discuss the influence of different head and neck positions on the performance of both devices. Oropharyngeal leak pressure, peak inspiratory pressure, ventilation score and fiber-optic view will be assessed in neutral, flexion, extension and lateral positions in both groups.

Official Title
-----------------
Evaluation of Performance of Air-Q Self Pressurized Airway Device With Blocker and Proseal Laryngeal Mask Airway at Different Head and Neck Positions in Anesthetized Paralyzed Adult Female Patients Undergoing Elective Gynecological Operations

Conditions
-----------------
Laryngeal Masks Comparison

Intervention / Treatment
-----------------
* Device: Air-Q Self Pressurized Airway Device with Blocker
* Device: Proseal Laryngeal Mask Airway


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult female patients ASA I&II. age: 18-55 years old. BMI< 35. undergoing elective surgeries. Exclusion Criteria: Patients with history of upper respiratory tract infections and obstructive sleep apnea. Patients who are potentially full stomach such as trauma, pregnancy, history of gastric regurgitation &heart burn, those with esophageal reflux or hiatus hernia. Patients with coagulation disorders. Patients with El-Ganzouri airway score ≥ 5 will.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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 |
| --- | --- |
| Air-Q Self Pressurized Airway Device with Blocker<br> | Device: Air-Q Self Pressurized Airway Device with Blocker<br>* used in low risk adult females undergoing elective surgeries<br>|
| Proseal Laryngeal Mask Airway<br> | Device: Proseal Laryngeal Mask Airway<br>* used in low risk adult female patients undergoing elective surgeries<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oropharyngeal leak pressure | pressure at which air leak starts to occur | 1 year |
Clinical Study of the Solo+ Tympanostomy Tube Device

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the safety and performance of the Solo+ Tympanostomy Tube Device for the placement of tympanostomy tubes (grommets) in paediatric patients undergoing a tympanostomy procedure

Detailed Description
-----------------
The study will be a multi-site, prospective, treatment-only study of the Solo+ Tympanostomy Tube Device. Patients will already have a scheduled tympanostomy procedure.

Official Title
-----------------
Clinical Study of the Solo+ Tympanostomy Tube Device

Conditions
-----------------
Ear Infection, Otitis Media

Intervention / Treatment
-----------------
* Device: Solo+ Tympanostomy Tube Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Listed for bilateral tympanostomy tube insertion Exclusion Criteria: Anatomy that precludes sufficient visualisation of both the left and right eardrum Narrow ear canals Anatomy that precludes safe access to both the left and right eardrum Membrane >25% sclerosis Congenital or craniofacial abnormalities No available baseline audiometry and tympanometry

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 15 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: Solo+ Tympanostomy Tube Device<br>The Solo+ Tympanostomy Tube Device is a disposable surgical tool designed to deliver a tympanostomy tube (grommet) into the tympanic membrane of patients undergoing a tympanostomy tube placement procedure | Device: Solo+ Tympanostomy Tube Device<br>* The Solo+ Tympanostomy Tube Device is intended to deliver a tympanostomy tube through the tympanic membrane of a patient during a tympanostomy procedure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful delivery of the tympanostomy tube by the Solo+ Tympanostomy Tube Device | The number of ears in which the Solo Tympanostomy Tube Device tube is placed | Intra-operative | 
| Rate of Adverse Events | The number and type of Adverse Events | 24 months |
A Long-term Safety Study of Once-daily Travatan

Study Overview
=================
Brief Summary
-----------------
Long term safety study of TRAVATAN in patients with Open-angle glaucoma or ocular hypertension.

Official Title
-----------------
A Long-term Safety Study of Once-daily TRAVATAN

Conditions
-----------------
Glaucoma, Open-angle, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: Travatan


Participation Criteria
=================
Eligibility Criteria
-----------------
Adult patients of any race and either sex with chronic angle-closure glaucoma.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Travatan<br>Travoprost (0.004%) | Drug: Travatan<br>* Travoprost (0.004%) 1 drop each eye once daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Intraocular Pressure | Mean IOP for the patient's worse eye at baseline was used in the secondary endpoint analysis. 2 consecutive IOP measurements for each eye were taken. If the 2 measurements for the same eye differ by 4 mmHg or less, the average of the measurements would be considered as the mean IOP for that eye. If the 2 measurements for the same eye differ by more than 4 mmHg, then a third measurement was to be taken. All IOP measurements were performed with a Goldmann applanation tonometer. | At 5 years. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glaucoma, POAG, OAG, OHT
Valproate Sustained Release Minitablets (Orfiril(R) Long) Once Daily in the Evening

Study Overview
=================
Brief Summary
-----------------
Valproate is the first line therapy in primary generalized seizures. The applied drug contains sodium valproate in sustained release minitablets. As a multiple unit dosage form these can be easily swallowed and taken independent from meals. A simple dosage scheme like valproate sustained release minitablets once daily in the evening should improve the compliance and likely the seizure situation of the patients. The data of this non interventional trial were directly extracted from the physician's electronic patient database. The observational period was 7 weeks compared to a retrospective period 7 weeks before start of the study.

Official Title
-----------------
Non Interventional Trial of Valproate Sustained Release Minitablets Once Daily in the Evening

Conditions
-----------------
Epilepsy

Intervention / Treatment
-----------------
* Drug: sodium valproate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age of 12 years and above epilepsy patients indication to initiation / conversion to valproate sustained release minitablets once daily Exclusion Criteria: contraindication to valproate use no indication for conversion to valproate sustained release minitablets once daily

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 |
| --- | --- |
| 1<br>epilepsy patients | Drug: sodium valproate<br>* valproate sustained release minitablets, once daily.<br>* Other names: Orfiril (R) long;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Number of Seizures After Conversion To Valproate Retard Minitablets Once Daily |  | 7 weeks | 
| Number of Seizures Within 7 Weeks |  | 7 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Data About Efficacy, Safety and Compliance |  | 7 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
valproate, epilepsy, compliance, sustained released minitablet, Orfiril long
Lactobacillus Reuteri in Adult With Functional Chronic Constipation

Study Overview
=================
Brief Summary
-----------------
A double-blind, placebo Randomized Controlled Trial, To evaluate the effects of L. reuteri in adult patients with functional constipation.

Detailed Description
-----------------
Patients affected by functional constipation according to Rome III criteria. The increase of Bowel Movements/week frequency was the primary outcome, while the improvement of stool consistency was the secondary outcome.

Official Title
-----------------
The Effect of Lactobacillus Reuteri Supplementation to Adult With Functional Chronic Constipation: A Randomized, Double-Blind, Placebo-Controlled Trial

Conditions
-----------------
Functional Constipation

Intervention / Treatment
-----------------
* Drug: lactobacillus reuteri
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: functional constipation rome III Exclusion Criteria: hypothyroidism or other metabolic or renal abnormalities, or antibiotic's treatment, probiotic or prebiotic supplementation in the last month

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: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lactobacillus reuteri<br>Intervention: supplementation with the probiotic Lactobacillus reuteri (DSM 17938),Reuflor, was administered in the dose of 108 colony-forming units (CFU) in tablets of a commercially available preparation (Reuflor, Italchimici, Pomezia; BioGaia AB, Stockholm, Sweden), 30 minutes after feeding, twice per day for 4 weeks. | Drug: lactobacillus reuteri<br>* Lactobacillus reuteri (DSM 17938) was administered in the dose of 108 colony-forming units (CFU) in tablets of a commercially available preparation (Reuflor, Italchimici, Pomezia; BioGaia AB, Stockholm, Sweden), 30 minutes after feeding, twice per day for 4 weeks<br>* Other names: Reuflor;|
| Placebo Comparator: placebo<br>a supplementation with placebo was administered in tablets of a commercially available preparation 30 minutes after feeding, twice per day for 4 weeks | Drug: placebo<br>* a supplementation with placebo was administered in tablets of a commercially available preparation 30 minutes after feeding, twice per day for 4 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The increase of BMs/week frequency |  | January to June 2012 (up to 6 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the improvement of stool consistency |  | january to june 2012 (up to 6 months) |
The Analysis of Heart Rate Variability With 24hrs Holter ECG and Serum Cardiac Fibrosis Markers in Critical Illness Patients Who Are With Cardiogenic Shock, With ECMO or IABP Support, or With APACH II Score >25)

Study Overview
=================
Brief Summary
-----------------
The study is to show the prognostic factor of HRV parameter and cardiac fibrosis markers in critical illness patients

Detailed Description
-----------------
The analysis of Heart Rate Variability with 24hrs Holter ECG and serum cardiac fibrosis markers in critical illness patients who are with cardiogenic shock, with ECMO or IABP support, or with APACH II score >25)

Official Title
-----------------
The Analysis of Heart Rate Variability With 24hrs Holter ECG and Serum Cardiac Fibrosis Markers in Critical Illness Patients Who Are With Cardiogenic Shock, With ECMO or IABP Support, or With APACH II Score >25)

Conditions
-----------------
Cardiogenic Shock,, With ECMO or IABP Support,, With APACH II Score >25)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: critical illness patients who are with cardiogenic shock, with ECMO or IABP support, or with APACH II score >25) Exclusion Criteria: pacemaker rhythm, not sign the permit

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study group<br>ECMO Patients survived | |
| Control<br>ECMO Patient died | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Rate Variability and serum cardiac fibrosis markers in critical illness patients | Outcome measurement: The measure is a composite outcome measure consisting of multiple measures (results to be reported as a single value for each Arm/Group), no changes are required List the primary condition or disease being studied Shock needing ECMO support | 2-4weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ECMO, APACH II score
Predicting Outcome Following Standardized Exercise Therapy in Knee Osteoarthritis Patients

Study Overview
=================
Brief Summary
-----------------
Pain sensitization has been associated with pain severity in people with knee osteoarthritis (KOA) and a neuropathic pain component has been identified in up to 30% of KOA patients. Mechanistic pain profiling aims to identify the underlying mechanisms in the peripheral and central nervous systems, which are associated to the clinical pain. In addition, the mechanisms underlying the pain relieving effect of standardized exercise therapy are largely unknown, but it is hypothesized that they are linked to the patient's ability to activate the descending pain inhibitory pathways (conditioned pain modulation, CPM) in the central nervous system. Mechanistic pain profiling including CPM have been used prognostic to identify responders to treatment, but these measures as a prognostic tool for standardized exercise therapy has not been investigated. The primary aim of this study is to investigate if mechanistic pain profiling alone or in combination with clinical pain measures before standardized exercise therapy can predict the patients' pain reduction following the exercise therapy program

Official Title
-----------------
Smerteprofiler Som Redskab Til at prædiktere Effekten af 6-8 Ugers GLA:D®-forløb Hos Patienter Med Smertefuld Slidgigt i knæene

Conditions
-----------------
Knee Osteoarthritis

Intervention / Treatment
-----------------
* Behavioral: standardized exercise therapy for knee OA patients


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The American College of Rheumatology for clinical knee osteoarthritis (excluding radiological OA assessment) Exclusion Criteria: Known factors to influence pain and pain sensitization

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: standardized exercise therapy for knee OA patients|Standardized exercise therapy for 6-8 weeks (two times per week).|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain reduction | Pain measured on a numerical rating scale from 0 (no pain) to 10 (worst pain imaginable) | 1-2 weeks after last exercise session |