linjc16/ctgov huggingface dataset:
The Importance of Needle Gauge for Pain During Injection of Local Anaesthetic

Study Overview
=================
Brief Summary
-----------------
This study will investigate the influence of needle gauge on pain during injection of local anaesthetic. Healthy volunteers will be recruited, who will each receive three injections with either 21G, 23G or 27G subcutaneously on the abdomen. After each injection, the participants will be asked to evaluate the pain on a Visual analog scale (0-100 mm). It is anticipated that the pain will decrease with decreasing thickness of the needle. The aim of this study is to find a simple method for pain reduction that can be used in clinical practice.

Official Title
-----------------
The Importance of Needle Gauge for Pain During Injection of Local Anaesthetic

Conditions
-----------------
Needlestick Injuries

Intervention / Treatment
-----------------
* Procedure: Large needle gauge lidocaine injection
* Procedure: Normal needle gauge lidocaine injection
* Procedure: Small needle gauge lidocaine injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-65 years Exclusion Criteria: Kidney, heart or liver disease Eczema or psoriasis on injection site Neuropathy Regular use of painkillers Hypersensitivity of Lidocaine Pregnancy Diabetes

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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Needle gauge small<br>injection needle 23 G | Procedure: Large needle gauge lidocaine injection<br>* 21 G<br>Procedure: Normal needle gauge lidocaine injection<br>* 23 G<br>Procedure: Small needle gauge lidocaine injection<br>* 27 G<br>|
| Experimental: Needle gauge normal<br>injection needle 25 G | Procedure: Large needle gauge lidocaine injection<br>* 21 G<br>Procedure: Normal needle gauge lidocaine injection<br>* 23 G<br>Procedure: Small needle gauge lidocaine injection<br>* 27 G<br>|
| Experimental: Needle gauge large<br>injection needle 27 G | Procedure: Large needle gauge lidocaine injection<br>* 21 G<br>Procedure: Normal needle gauge lidocaine injection<br>* 23 G<br>Procedure: Small needle gauge lidocaine injection<br>* 27 G<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Visual analog scale Questionnaire | 60 seconds | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Injections, Pain, Healthy volunteers, Lidocaine
Compliance and Contamination in Soft Contact Lens Wearers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the lens and lens case microbial colonization associated with marketed care solutions used by experienced soft lens wearers.

Detailed Description
-----------------
The purpose of this study is to assess the lens and lens case microbial colonization associated marketed care solutions used by experienced soft lens wearers.

Official Title
-----------------
Compliance and Contamination in Soft Contact Lens Wearers

Conditions
-----------------
Contact Lens Wear

Intervention / Treatment
-----------------
* Device: OPTI-FREE RepleniSH
* Device: Clear Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Successful contact lens wear on a daily wear basis Normal Eyes Exclusion Criteria: Topical ocular medication use No active ocular issues

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 |
| --- | --- |
| OPTI-FREE Replenish<br>Multi-Purpose Solution for soft contact lenses | Device: OPTI-FREE RepleniSH<br>* Multi-Purpose Solution for soft contact lenses<br>|
| Clear Care<br>Lens Care Solution for contact lenses | Device: Clear Care<br>* Lens Care Solution for contact lenses<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbial colonization on soft contact lenses and lens cases associated with daily lens wear |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Regimen compliance |  | Baseline, 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
contact lens wear, multi-purpose solution, corneal staining
A Trial to Compare the Efficacy of Rotigotine Transdermal Patch to That of Ropinirole on Early Morning Motor Impairment and Sleep Disorders in Subjects With Early-Stage, Idiopathic Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
The objective of this trial is to compare the effect of rotigotine (SPM 962) and ropinirole on the control of early morning motor impairment and sleep disorders in subjects with early-stage PD. Subjects who meet eligibility criteria will be randomly assigned either to rotigotine transdermal patch or ropinirole tablets. Trial medication will be titrated for rotigotine and ropinirole until an individual optimal dose is achieved. Following a Titration period of up to 4 weeks in the rotigotine arm and 6 weeks in the ropinirole arm, subjects will be maintained on the optimal or maximal dose for 4 weeks. At the end of the Maintenance period, subjects will be given the opportunity to enter a 2-year rotigotine patch extension trial. The first subject was enrolled in December 2004. The last subject was enrolled in June 2005. Last subject out is expected for October 2005. The trial is still ongoing.

Official Title
-----------------
A Phase 3, Randomized, Open-Label, Two-Arm, Parallel-Group, Multicenter, Multinational Trial to Compare the Efficacy of Rotigotine Transdermal Patch to That of Ropinirole on Early Morning Motor Impairment and Sleep Disorders in Subjects With Early-Stage, Idiopathic Parkinson's Disease

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Drug: SPM 962


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Early-stage, idiopathic Parkinson's disease

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: SPM 962|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
-----------------
EARLY-STAGE, IDIOPATHIC PARKINSON'S DISEASE
Radical Gastrectomy Within Enhanced Recovery Programs(ERAS): a Prospective Randomized Controlled Trial

Study Overview
=================
Brief Summary
-----------------
This study is a prospective, single-center, randomized controlled trial. The study protocol was approved by the Ethics Committee at the First Hospital of Jilin University.ERAS is combined with the laprascopic gastrectomy to assess the efficacy and safety in patients with advanced gastric carcinoma.The hospitalized patients were randomly divided into ERAS group and conventional pathway group . Inter-group differences were evaluated for clinical recovery index, economic indicators, length of hospital stay, 3 years to 5 years long-term survival, etc.

Official Title
-----------------
Radical Gastrectomy Within Enhanced Recovery Programs: a Prospective Randomized Controlled Trial

Conditions
-----------------
Gastrostomy Complications

Intervention / Treatment
-----------------
* Procedure: ERAS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: (1) A preoperative cancer stage of T2, T3, T4, Any N, M0 without digestive obstruction confirmed by whole body CT scan, which could be treated with laparoscopic gastrectomy; (2) age 18-75 years; (3) pathologic confirmation of gastric adenocarcinoma by endoscopic biopsy; (4) normal hematological, renal, hepatic, and cardiac parameters, ASA score < III without severe systemic disease; and (5) no history of treatment with neoadjuvant chemotherapy and/or radiotherapy. Exclusion Criteria: patients requiring conversion to open gastrectomy; excessive bleeding (˃ 500 mL);and patients opting out of the study.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ERAS group<br>Patients were admitted 1-3 days prior to their respective dates of operation. A ERAS protocol was used in the ERAS group. | Procedure: ERAS<br>* optimized pain control, restricted I.V. fluids, early initiation of post-operative oral feeding and enforced mobilization<br>|
| No Intervention: conventional pathway group<br>The conventional pathway group received conventional care. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical parameters | length of post-operative stay | One week after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications | wound infection;post-opeartion bleeding;ileus;stenosis;leakage | 30 days after operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ERAS,gastric cancer
Assessment of the Outcome of Endodontic Treatment Using Cone Beam Computed Tomography.

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to assess the correlation between pre-obturation bacterial detection using fluorescence amplification and outcome of endodontic treatments. Thus, enabling a suitable detection threshold to predict the likelihood of treatment failure. This has the potential to be used a bench side tool in general dental practice to act as a surrogate endpoint for clinicians performing root canal treatment.

Detailed Description
-----------------
Pre-obturation root canal samples were taken using paper points from patients undergoing primary root treatments. The samples were analyzed using a fluorescent spectrometer and a molecular fluorescent vital dye (Calcein AM). Pre-operative and 1-year post-operative periapical radiographs and Cone Beam Computed Tomography (CBCT) scans were assessed by two calibrated expert examiners to evaluate the outcome of the root canal treatments. The use of a chairside bacterial stain can allow the clinician to predict the outcome of treatment with confidence. Sampling the root canal space with endodontic paper points followed by ex-situ fluorescent staining and analysis provides a patient-friendly, simple to use and rapid way of predicting root canal treatment outcome.

Official Title
-----------------
Assessment of the Outcome of Endodontic Treatment Using Cone Beam Computed Tomography-A Prospective Study

Conditions
-----------------
Periapical Periodontitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with at least one tooth diagnosed with the endodontic disease. teeth that were tender to percussion and palpation. teeth that had a sinus tract and/ swelling. Both primary treatment teeth and teeth which had already been root treated were considered. Exclusion Criteria: Patients were excluded if they were pregnant. Immunosuppressed patients. Non-restorable teeth. Teeth with a periodontal probing depth greater than 3mm. Teeth with apical radiolucencies with the longest dimension above 1.2cm.

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Periapical periodontium health | Assess the health of periapical periodontium of a tooth by examining the CBCT image | One year |
Paired Assessment of Two Electromyographic Neuromuscular Monitors: Stimpod NMX450X Versus Datex-Ohmeda E-NMT

Study Overview
=================
Brief Summary
-----------------
After anesthesia is induced, 2 EMG TOFF devices will be placed on the patients arms, one on the right arm, the other on the left. There will be a randomization per dominant hand and nondominant hand for the placing of the devices. The devices are the Stimpod NMX450X and the Datex-Ohmeda E-NMT.

Official Title
-----------------
Paired Assessment of Two Electromyographic Neuromuscular Monitors: Stimpod NMX450X Versus Datex-Ohmeda E-NMT

Conditions
-----------------
Neuromuscular Manifestations

Intervention / Treatment
-----------------
* Device: EMG TOF device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients (18 years old and above) undergoing General Anaesthesia for noncardiac surgery requiring the use of a neuromuscular blocking agent. Exclusion Criteria: Use of different types of neuromuscular blocking agents for the same patient within the same surgical procedure. Known Neuromuscular diseases/syndromes judged to condition accurate neuromuscular monitoring. Known acute or chronic hepatic disease.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomization per dominant and nondominant hand. So that there is an even share of number of patients with Stimpod NMX450X on dominant hand and Datex-Ohmeda E-NMT.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stimpod NMX450X<br> | Device: EMG TOF device<br>* Use of Stimpod NMX450X as an electromyographic neuromuscular monitor<br>|
| Active Comparator: Datex-Ohmeda E-NMT<br> | Device: EMG TOF device<br>* Use of Stimpod NMX450X as an electromyographic neuromuscular monitor<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TOF-ratio (percentage) | TOF = Train-of-four. TOF-ratio is the ratio of the fourth muscle response to the first one. This is used to assess neuromuscular transmission. TOF% indicates fade in non-depolarizing block. We are comparing the calculated TOF ratio of the stimpod NMX to the datex-ohmeda E-NMT | Up until 120 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TOF-count (absolute number) | TOF count is the actual number of detected muscle responses. The number that is used to calculate the percentage (TOF-ratio). When the TOF count drops below 4 responses, then the TOF% cannot be calculated. We are comparing the detected muscle responses of the stimpod NMX to the datex-ohmeda E-NMT | Up until 120 minutes. |
Coagulation and Fibrinolysis as Virulence Factors for Invasive Staphylococcus Aureus and Streptococcus Infections

Study Overview
=================
Brief Summary
-----------------
the aim of this study is to investigate the role of staphylokinase, streptokinase and MMP activation in invasive staphylococcal and streptococcal infections.

Official Title
-----------------
Coagulation and Fibrinolysis as Virulence Factors for Invasive Staphylococcus Aureus and Streptococcus Infections.

Conditions
-----------------
Infective Endocarditis, Necrotizing Fasciitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients that undergo surgical treatment for invasive streptococcal or staphylococcal infections, including acute infective endocarditis and necrotizing fasciitis, from the UZ Leuven University Hospital Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proteolytic activity |  | 1 day (on date of surgery (tissue sample)) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
virulence factors
Retrospective Evaluation of Commercial Spacers in Prostate Cancer Patients

Study Overview
=================
Brief Summary
-----------------
Assessment of efficacy and safety of implantable spacers when used to reduce the radiation dose delivered to the organs at risk in prostate cancer patients undergoing radiotherapy.

Detailed Description
-----------------
Multi-center, retrospective, observational study for assessment of rectal dose reduction following implantation of the BioProtect Balloon Implant System

Official Title
-----------------
Evaluation of Commercially Available Implantable Spacers, in Prostate Cancer Patients Undergoing Radiotherapy

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Other: Observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Males at least 18 years of age, who have undergone radiation therapy with implantable spacers Exclusion Criteria: Patients whose clinical and pathological data are not available. Patients have been histologically diagnosed with invasive adenocarcinoma that is extracapsular with posterior extension

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Observation|Assessment of rectal dosimetry change from pre-insertion to post-insertion in subjects with prostate cancer who have undergone radiotherapy with implantabale spacers.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Rectal radiation Dose | Dosimetry change to organs at risk in subjects with prostate cancer who have undergone radiotherapy with implantable spacers when compared to pre-implantation values. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prostate to rectum spacing | Measurement of prostate-rectum spacing | 1 month |
Compassionate Use of Omegaven

Study Overview
=================
Brief Summary
-----------------
This expanded access protocol is for infants or children with conditions preventing them from taking in enough nutrients from food and must receive nutrition intravenously. Standard intravenous nutrition contains fat emulsion made from soybean. If this fat emulsion is given over a long period of time, it can cause problems within the liver and if persistent and not addressed can even lead to severe and/or permanent injury to the liver. It is believed that a type of fish oil blend, called Omegaven®, may be used in place of the soybean fat blend. The Omegaven® fish oil blend may greatly reduce the risk of liver injury. Omegaven® is not approved by the Food and Drug Administration (FDA). It is only offered under an expanded access protocol as an alternative to the soybean fat blend.

Official Title
-----------------
Compassionate Use of an Intravenous Fat Emulsion Comprised of Fish Oil in The Treatment of Parenteral Nutrition Induced Liver Injury in Children

Conditions
-----------------
Cholestasis

Intervention / Treatment
-----------------
* Dietary Supplement: Omegaven


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female Older than 14 days and less than 5 years of age Direct bilirubin value is greater than 2 mg/dL Be expected to require intravenous nutrition for at least an additional 28 days Parent/legal guardian has agreed to provide consent/parental permission Exclusion Criteria: Patients who have a congenitally lethal condition (e.g. Trisomy 13). Patients who have clinically severe bleeding not able to be managed with routine measures. Patients who have evidence of a viral hepatitis or primary liver disease as the primary etiology of their cholestasis. Patients who have other health problems such that survival is extremely unlikely even if the infant's cholestasis improves. 5 The parent/legal guardian is unwilling to provide consent/parental permission.

Ages Eligible for Study
-----------------
Minimum Age: 15 Days
Maximum Age: 5 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: Omegaven|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |