linjc16/ctgov huggingface dataset:
Comparing Intravenous and Oral Paracetamol for Cholecystectomy

Study Overview
=================
Brief Summary
-----------------
To determine the amount of paracetamol in the blood when given in either intravenous or oral forms prior to cholecystectomy. The clinical effectiveness of each form will also be evaluated with pain scores and the use of other pain relief drugs.

Official Title
-----------------
Comparative Pharmacokinetics of Intravenous and Oral Paracetamol in the Peri-Operative Period of Laparoscopic Cholecystectomy

Conditions
-----------------
Laparoscopic Cholecystectomy

Intervention / Treatment
-----------------
* Drug: Paracetamol (acetaminophen)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females aged 18-75 Scheduled to have elective laparoscopic cholecystectomy under general anaesthesia Exclusion Criteria: Inadequate English comprehension (difficult to obtain informed consent and cooperation), and when interpreters are not available. History of allergy or sensitivity to paracetamol Administration of oral paracetamol within previous 8 hours American Society of Anesthesiologists (ASA) grade IV or V, indicating serious cardio-respiratory co-morbidity Not suitable for protocol anaesthetic technique (eg: history of nausea and vomiting with morphine)

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Paracetamol (acetaminophen)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early pharmacokinetics (0-240 minutes) of a single dose of 1g paracetamol in IV and oral formulations |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in analgesia achieved (15-120 minutes post-operative) with IV and oral paracetamol. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
paracetamol, acetaminophen, pharmacokinetic, intravenous, oral, analgesia, pain, opioid
Predictive Value of Heart Rate Variability on Outcome in Patients Admitted to the Intensive Care Department

Study Overview
=================
Brief Summary
-----------------
This study is designed to evaluate the predictive value of heart rate variability on medial outcome in patients admitted to the intensive care department

Official Title
-----------------
Predictive Value of Heart Rate Variability on Outcome in Patients Admitted to the Intensive Care Department

Conditions
-----------------
Critical Illness

Intervention / Treatment
-----------------
* Other: non interventional study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults admitted to ICU Exclusion Criteria: rhythm other then sinus presence of cardiac pacemaker

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients admitted to the intensive care department<br> | Other: non interventional study<br>* non interventional study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU stay |  | 6 months | 
| Hospital stay |  | 6 months |
ProSat - Effect of Probiotics on Satiety

Study Overview
=================
Brief Summary
-----------------
The aim of the ProSat study is to examine the effects of a probiotic capsule containing one of two doses (low and high dose) of Lb. Casei on subjective appetite sensation, ad libitum energy intake, and appetite hormone response in a single meal test and to determine whether the acute effects persist after daily supplementation of the probiotic capsule.

Official Title
-----------------
Probiotics and Satiety - Acute Effects and Persistence of Acute Effects

Conditions
-----------------
Obesity, Appetite Regulation

Intervention / Treatment
-----------------
* Dietary Supplement: probiotic
* Dietary Supplement: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy men and women Normal to slight overweight (BMI: 22-28 kg/m2) 20-45 years of age Exclusion Criteria: Smoking Daily medicine use (oral contraceptives excluded) Use of pre- and probiotic supplements and foods Blood donation 3 months prior to the study Hb<8mmol/l Chronic illnesses such as hyperlipidemia, diabetes inflammatory diseases Pregnancy or breastfeeding Elite athletes (>10 hours hard exercise/week) Vegetarians

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>High dose Lb. casei | Dietary Supplement: probiotic<br>* One capsule per meal test (high dose or low dose)<br>|
| Active Comparator: 2<br>Low dose Lb. Casei | Dietary Supplement: probiotic<br>* One capsule per meal test (high dose or low dose)<br>|
| Placebo Comparator: 3<br> | Dietary Supplement: placebo<br>* 1 capsuel every morning<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose; Insulin; GLP-1; CCK; PYY; grehlin; PP; amylin; LPS; TNF-alfa; hsCRP; fibrinogen |  | 2013 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective appetite measurements; Spontaneous food intake |  | 2012 |
Effectiveness of Sitagliptin in Glycemic Control in Real World

Study Overview
=================
Brief Summary
-----------------
This study will evaluate whether the addition of sitagliptin treatment provides additional decrease in HbA1C levels and increase in goal attainment in patients with inadequate glycemic control on their current oral anti-glycemic therapy in real world practice.

Detailed Description
-----------------
To explore the change of glycemic control (HbA1c or FPG) before and after 24 weeks of Sitagliptin treatment in Type 2 Diabetic patients who have started Sitagliptin as add on therapy during the index period and received Sitagliptin continuously* for at least 24 weeks.

Official Title
-----------------
A Retrospective, Observational Study to Assess the Effectiveness of Glycemic Control of Diabetes in Real World After Sitagliptin Usage

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All subjects diagnosed of type 2 diabetes (ICD-9 code= 250.0; 250.1; 250.2; 250.3; 250.4; 250.5; 250.6) and have been followed up regularly in the study center who have started to receive Sitagliptin as an add-on treatment to their prior regimen during the index period Subjects must be on a stable dose of all antidiabetic regimens, with stable dose defined as at least 3 months with no therapy/dose change prior to adding sitagliptin Subjects in whose medical records a minimum core data set can be found. Outpatient Exclusion Criteria: Subjects with type 1 DM Subjects have been treated with insulin regularly Subject with DM which results from other general diseases, e.g. surgery, pharmaceutical products, malnutrition, infections and other conditions Subjects who participated in a clinical trial or other clinical study during the index period

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Type 2 Diabetes Mellitus, No treatment<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
-----------------
retrospective,sitagliptin, glycemia control,real world
Assessment of Cellular and Tissue Characteristics in Lipoaspirates Stirred by VorFat

Study Overview
=================
Brief Summary
-----------------
Single-center, prospective, open-label study. The study aims to assess the structure and viability of fat collected during the LipoLife liposuction procedure

Official Title
-----------------
Assessment of Cellular and Tissue Characteristics in Lipoaspirates Harvested With the LipoLife System and Stirred by VorFat

Conditions
-----------------
Laser Assisted Liposuction

Intervention / Treatment
-----------------
* Device: LipoLife system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects scheduled to undergo abdominal w/wo flanks laser-assisted liposuction surgery and are willing to donate the harvested adipose tissue for the study assessment. Between 18 and 70 years of age. Estimated fat harvesting of at least 300 milliliters. Provided written Informed Consent. Exclusion Criteria: Pregnant or intending to become pregnant during the course of study. Current smoker. Presence of known malignancy. Active infection in the treatment area. History of autoimmune disorder (e.g., Systemic Lupus Erythematosus [SLE]). History of connective, metabolic, or atrophic skin disease. History of keloid scarring. Chronic use (>7 consecutive days) of anticoagulants (such as aspirin) or NSAIDs within 15 days before enrollment. Subjects with immune system diseases. Any other reason that in the opinion of the investigator, prevents the subject from participating in the study or compromises the subject safety.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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: Laser-assisted liposuction<br>Laser-Assisted Liposuction with the LipoLife system. | Device: LipoLife system<br>* Abdominal Laser-Assisted Liposuction<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average adipose cell cluster size | Assessment of adipose cell cluster size by microscope | 6 months |
Targeting Microbiota in Female Overactive Bladder Syndrome

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to compare the urinary viral microbiome and bacterial microbiome between overactive bladder syndrome (OAB) patients and healthy controls in order to determine a possible alteration in the urinary microbiome which may predispose women for OAB, and also in order to determine a possible influence of the urinary viral microbiome on the urinary bacterial microbiome which may predispose the individual to OAB. Furthermore, we aim to compare the urinary bacterial microbiome to the vaginal, rectal, urethral and salivary bacterial microbiome within the same individual and between the two groups in order to determine a possible route of colonization of the urinary bladder.

Official Title
-----------------
Targeting Microbiota in Female Overactive Bladder Syndrome

Conditions
-----------------
Microbiota, Urinary Bladder, Overactive

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria (case group): symptoms of overactive bladder (urgency with or without urinary leakage, usually with frequency and nocturia) Exclusion Criteria (case group): Pregnant or lactating females Neurological conditions (such as MS, Parkinson, spinal cord injury, stroke..) Pelvic Organ Prolapse (stage ≥ 3) Lower Urinary Tract surgery within past 6 months Known history of interstitial cystitis or pain associated with OAB Recurrent urinary tract infections > 3/year Acute urinary tract infection Urinary retention (with or without required self- catheterization) Stress urinary incontinence or mixed urinary incontinence Bladder cancer Renal insufficiency Urinary tract stones Inclusion Criteria (control group): without symptoms of overactive bladder or any other form of lower urinary tract symptoms Age-matched to case group (+/- 5 years) BMI-matched to case group (18,5- 24,9 kg/m2 normal weight; 25- 29,9 kg/m2 overweight; 30- 34,9 kg/m2 obesity grade I) Exclusion criteria (control group): As case group plus any form of lower urinary tract symptoms including OAB

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| overactive bladder syndrome<br>female patients with overactive bladder syndrome | |
| controls<br>women without overactive bladder syndrome | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| urinary bacterial and viral microbiome |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bacterial and viral microbiome of vagina, urethra, feces and oral cavity |  | 1 day |
Efficacy Study of Nebulized TD-4208 for Chronic Obstructive Pulmonary Disease (COPD)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to measure the effectiveness and safety of TD 4208, an investigational drug being developed to treat people with moderate to very severe COPD, compared to placebo, a treatment without activity.

Official Title
-----------------
A Phase 3, 12-week, Randomized, Double-blind Placebo-controlled Parallel Group Study of Nebulized TD-4208 in Subjects With Chronic Obstructive Pulmonary Disease

Conditions
-----------------
Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
-----------------
* Drug: TD-4208
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is a male or female subject 40 years of age or older Exclusion Criteria: Females who are pregnant, lactating, breast-feeding or planning to become pregnant during the study

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TD-4208-1<br>88 mcg | Drug: TD-4208<br> <br> * Other names: revefenacin;|
| Active Comparator: TD-4208-2<br>175 mcg | Drug: TD-4208<br> <br> * Other names: revefenacin;|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Trough FEV1 on Day 85 |  | Day 85 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Summary of Trough FEV1 Overall Treatment Effect From Day 15 to Day 85 |  | Days 15 to 85 | 
| Summary of Change From Baseline to Peak FEV1 After First Dose |  | 0-2 hours after First Dose Day 1 | 
| Summary of Rescue Medication Use: Puffs Per Day |  | 1-3 Months | 
| Percentage of Albuterol Rescue-free 24-hour Periods |  | 1-3 Months | 
| St. George's Respiratory Questionnaire (SGRQ) Proportion of Responders on Day 85 | A Responder is defined as someone who experienced a decrease in SGRQ score of 4 or more units | Baseline to Day 85 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Obstructive Pulmonary Disease, COPD
Supplemental Anterior Lumbar Interbody Fusion (ALIF) in Spinal Deformity

Study Overview
=================
Brief Summary
-----------------
Within the last decade there has been an increase in the number of surgical procedures for deformities of the spine. This is caused by the increase in the elderly population, improved surgical techniques and an increased number of patients who have undergone previous surgical treatment for degenerative conditions of the spine. Surgical treatment of spinal deformities bears a revision rate between 15 and 30% depending on definition, and one of the primary reasons for revision surgery is implant loosening in the lumbosacral region. The hypothesis of the study is that a procedure resulting in anterior fusion of the lumbar spine in addition to the usual posterior instrumentation can reduce the revision rate with 50%.

Official Title
-----------------
Supplemental Anterior Lumbar Interbody Fusion in Posterior Instrumented Fusion in Surgical Treatment of Spinal Deformities. A Randomized Study

Conditions
-----------------
Spinal Deformity

Intervention / Treatment
-----------------
* Device: Tantalum cage from Zimmer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or more of age planned posterior instrumented fusion from thoracic spine to sacrum and/or ilium Exclusion Criteria: malignancy infection

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Anterior lumbar interbody fusion<br>Anterior lumbar interbody fusion using a tantalum cage. Cage will be inserted through a left sided retroperitoneal approach. | Device: Tantalum cage from Zimmer<br>* A tantalum cage will be inserted through a left sided retroperitoneal approach<br>* Other names: Tantalum;|
| Active Comparator: Posterior instrumentation alone<br>Posterior pedicle screw instrumentation | Device: Tantalum cage from Zimmer<br>* A tantalum cage will be inserted through a left sided retroperitoneal approach<br>* Other names: Tantalum;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Revision | Surgical revision rate because of implant failure or pseudarthrosis within 12 months after primary procedure | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
spine, deformity, instrumentation, ALIF
A Safety and Immunology Study of a DNA Trivalent Influenza Vaccine

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate how well the vaccine is tolerated at sites where administrations are given and any effects it may have on subjects' wellbeing. The study will also test the ability of vaccine to cause particular immune responses in the body.

Detailed Description
-----------------
Influenza is a contagious disease of the upper airways and the lungs. It rapidly spreads around the world in seasonal epidemics, killing hundreds of thousands of people and having high economic consequences due to healthcare costs and lost productivity. Each year governments recommend groups who are at risk of influenza or its complications to receive influenza vaccination. Current vaccine supply is not sufficient to meet the demand if this recommendation were to be taken up by all. This study is part of the clinical development of a particle mediated epidermal delivery (PMED) trivalent DNA vaccine for the prevention of influenza.This study will investigate the safety and tolerability of this vaccine as well as assess the humoral and cellular immunogenicity of the vaccine in healthy subjects.

Official Title
-----------------
A Phase I Study to Assess Safety, Tolerability and Immunogenicity of a Trivalent Influenza Vaccine Administered by Particle Mediated Epidermal Delivery (PMED) to Healthy Subjects

Conditions
-----------------
Influenza

Intervention / Treatment
-----------------
* Biological: Trivalent DNA Vaccine (PIA0601) with or without DEI-LT (pPJV2012)


Participation Criteria
=================
Eligibility Criteria
-----------------
Ages Eligible for Study: 18 Years - 50 Years Genders Eligible for Study: Both Accepts Healthy Volunteers Criteria Inclusion Criteria: Healthy adult volunteers (women must be of non child-bearing potential) Provided written informed consent Exclusion Criteria: No significant concomitant illness No allergy to gold No immunosuppression due to disease or treatment No previous flu vaccination in 2005 or 2006

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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

| Intervention/Treatment |
| --- |
|Biological: Trivalent DNA Vaccine (PIA0601) with or without DEI-LT (pPJV2012)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety, tolerability and local reactogenicity - AEs and laboratory parameters |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity of the vaccine |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PowderMed, DNA vaccine, influenza