linjc16/ctgov huggingface dataset:
Testosterone MD-Lotion Residual Washing Study

Study Overview
=================
Brief Summary
-----------------
The study will evaluate the amount of Testosteron MD-Lotion 2% remaining on the axilla after a single dose application in healthy males who undergo a post dose washing procedure.

Official Title
-----------------
A Healthy Volunteer, Single Dose Phase I Trial to Determine the Amount of Testerone MD-Lotion 2% Remaining on the Axilla After Washing.

Conditions
-----------------
Hypergonadism

Intervention / Treatment
-----------------
* Drug: Testosterone MD-Lotion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male subjects ≥18 and ≤ 70 years Exclusion Criteria: Disqualifying concurrent condition or allergy/sensitivity to Testosterone MD-Lotion

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Testosterone MD-Lotion|Single dose Testosterone MD-Lotion 2%|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The amount of Testerone MD-Lotion 2% remaining on the axilla after a single dose application in healthy males who undergo a post dose washing procedure. |  | March 2010 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The safety and tolerability of Testosterone MD-Lotion 2% following a single dose application. This will be performed by review of adverse events, EKG and assessment of laboratory parameters (haematology, biochemistry, urinalysis and hormone levels). |  | March 2010 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypergonadism, Testosterone Transfer
Lollipop on Gastric Volume

Study Overview
=================
Brief Summary
-----------------
To observe the effect of chewing lollipop on residual gastric volume in healthy volunteers with fasting.

Official Title
-----------------
Effect of Chewing Lollipop on Gastric Residual Volume

Conditions
-----------------
Gastric Volume

Intervention / Treatment
-----------------
* Other: lollipop


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: volunteer aged 18 years-45 years old volunteer with a body mass index between 18 and 28 kg/m2 Exclusion Criteria: those with history of diabetes mellitus those with gastric diseases those with history of gastro-intestinal surgery those with history of smoking those with use of gastric mobility medicines those with pregnancy or breeding

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lollipop<br> | Other: lollipop<br>* chewing lollipop for 20min<br>|
| No Intervention: control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| residual gastric volume at 30 minutes after chewing lollipop |  | from starting chewing lollipop to 30 minutes after chewing, on an average of 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| residual gastric volume at 2 hours after chewing lollipop |  | from starting chewing lollipop to 2 hours after chewing, on an average of 2 hours | 
| residual gastric volume at 1 hour after chewing lollipop |  | residual gastric volume at 1 hour after chewing lollipop | 
| time to peak gastric volume |  | from starting chewing lollipop to gastric volume reaching peak , on an average of 1 hour |
National Project to Implement Mesenchymal Stem Cell for the Treatment of Perianal Crohn's Fistula (the PRIME Study)

Study Overview
=================
Brief Summary
-----------------
Darvadstrocel is an expanded allogeneic adipose-derived mesenchymal stem cell therapy for the treatment of complex perianal fistulas in patients with Crohn's disease. Safety and efficacy of the procedure has been sufficiently demonstrated and the Spanish Agency of Medication approved its application a few months ago. Being aware about the difficulties to a proper application and management of the stem cells the Spanish Stem Cell therapy group devised, in a joint activity with the Spanish Group GERM (Grupo Español de Rehabilitacion Multimodal) dedicated to expand the best surgical clinical practices, a national project for the application of the therapy. The objective is to get a homogeneous implementation in all hospitals in Spain that have being baked to use this biological therapy.

Official Title
-----------------
National Project to Implement Mesenchymal Stem Cell for the Treatment of Perianal Crohn's Fistula (the PRIME Study)

Conditions
-----------------
Safety, Efficacy, Self

Intervention / Treatment
-----------------
* Procedure: Stem Cell Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults aged 18 years or older who have complex perianal Crohn ﬁstula non-active or mildly active luminal Crohn's disease for at least 6 months. The ﬁstula had to have been draining for at least 6 weeks before inclusion. Exclusion Criteria: • Patient with recto-vaginal ﬁstula; rectal or anal stenosis; or active severe proctitis.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Stem Cell Therapy|Application of Darvadstrocel locally, after fistula tract curettage and internal opening closure.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Therapeutic Efficacy of Darvadstrocel-Clinical | Clinical closure of the Fistula | 6 moths | 
| Therapeutic Efficacy of Darvadstrocel-MRI | MRI imaging closure of the Fistula | 6 moths | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life (QoL) | QoL according to dedicated questionnaire (EuroQoL 5D-3L) | 6 moths | 
| PATIENT REPORTED OUTCOMES (PROs) | A Dedicated self complementary questionnaire (PROMs) | 6 moths | 
| Efficiency | Cost-Effectiveness of the procedure | 6 moths |
Ofloxacin Concentration-toxicity Relationship in the Elderly

Study Overview
=================
Brief Summary
-----------------
Ofloxacin is a gold standard antibiotic for the treatment of bone and joint infections due to sensible staphylococcus strains. However, in the elderly, inter-individual variability of the pharmacokinetics may reduce the efficacy or increase toxicity. The occurrence of ofloxacin side effects is likely to be increased in case of higher exposition. However, the serum concentration-toxicity relationship has not yet been determined. The purpose of this project is to assess the association between the residual serum concentration of ofloxacin at day 3 and the occurrence of at least one adverse effect attributable to ofloxacin, and determine a threshold toxicity concentration if this association exists.

Official Title
-----------------
Determination of a Trough Serum Concentration of Ofloxacin Associated to Increase in Side Effects Frequency in Elderly Treated for Bone and Joint Infection

Conditions
-----------------
Ofloxacin, Bone and Joint Infection, Therapeutic Drug Monitoring, Adverse Drug Reactions

Intervention / Treatment
-----------------
* Drug: ofloxacin
* Other: questionnaire
* Biological: Ofloxacin Serum concentration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged over 65 years hospitalized at the University Hospital of Amiens for an uncomplicated bone and joint infections Indication for oral switch to ofloxacin Exclusion Criteria: Patient refusing to participate in the study Patient under guardianship or curators or deprived of public rights Any liver or biliary injury Any contraindications to ofloxacin

Ages Eligible for Study
-----------------
Minimum Age: 65 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

| Intervention/Treatment |
| --- |
|Drug: ofloxacin|ofloxacin treatment in patients with bone and joint infections|
|Other: questionnaire|questionnaire of ofloxacine side effects will be completed by the clinician at Day 3, Day 21 and Day 42|
|Biological: Ofloxacin Serum concentration|Serum concentration of ofloxacin will be measured at Day 3 (Cmin and Cmax), Day 21 and Day 42 (Cmin).|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of one adverse reaction attributable to ofloxacin in patients with bone and joint infections | Frequency of at least one adverse reaction attributable to ofloxacin in patients with bone and joint infections | day 3 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ofloxacin, Bone and Joint Infection, therapeutic drug monitoring, Adverse Drug Reactions
Intraoperative Hemodynamics in CABG

Study Overview
=================
Brief Summary
-----------------
The study is to determine the effects of the intraoperative hemodynamics in patients undergoing coronary artery bypass graft on the short-term and long-term outcomes.

Official Title
-----------------
Intraoperative Hemodynamics in Patients Undergoing Coronary Artery Bypass Graft for Long-term Outcom

Conditions
-----------------
Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age18-80 for CABG surgery only Exclusion Criteria: Emergency surgery atrial fibrillation using ECMO/VAD

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| low-hemosynamics<br> | |
| high-hemodynamics<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| long-time motality after CABG | To determine the motality in patients undergoing CABG after 1 year | 1 year |
Optimal Dose of Propofol for Induction of Deep Sedation for Brain MRI Scanning in Children With Cerebral Palsy

Study Overview
=================
Brief Summary
-----------------
The children with CP has been shown different drug responses from the normal population of children and it may related with a various oral medications such as baclofen, tizanidine, diazepam, dantrolene, or anticonvulsant drugs. The aim of this study is to establish the optimal induction dose of propofol for deep sedation to start MRI for < 30 min in children with CP.

Official Title
-----------------
Optimal Dose of Propofol for Induction of Deep Sedation for Brain MRI Scanning in Children With Cerebral Palsy

Conditions
-----------------
Cerebral Palsy

Intervention / Treatment
-----------------
* Drug: propofol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children with cerebral palsy with patient agreement Exclusion Criteria: sleep apnea, difficult airway, cardiorespiratory disease, allergic history to propofol

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 5 Years

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

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

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

Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: propofol|optimization of propofol dose from 1.5 mg/kg to 2.5 mg/kg using Dixon's up and down method during MRI scanning|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Short Term Outcomes From Minimally Invasive Surgery for the Treatment of Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the efficacy of minimally invasive surgery for atrial fibrillation.

Detailed Description
-----------------
Patients who are undergoing or who have undergone minimally invasive surgery for atrial fibrillation will be followed prospectively. At 6 to 9 months, 1 and two years post surgery follow-up subjects will receive a trans-telephonic monitor to wear for approximately 1 month, and will submit transmissions on a daily basis. Episodes of atrial fibrillation will be documented during this time. The overall efficacy of the procedure will be assessed based on the freedom from atrial fibrillation at the time of transtelephonic monitoring.

Official Title
-----------------
Prospective Analysis of the Wolf Minimaze Procedure for Treatment of Atrial Fibrillation

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 or older paroxysmal, persistent, or permanent atrial fibrillation Exclusion Criteria: concomitant heart surgery requiring open thoracotomy

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transtelephonic monitoring for the identification of post surgical Atrial Fibrillation |  | six months and 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
surgery, ablation, radiofrequency, minimaze, transtelephonic monitoring
High Volume Specialty Knee Replacement Surgeons Achieve Better Clinical and Quality-of-Life Scores

Study Overview
=================
Brief Summary
-----------------
To determine whether specialty training or high volume of operative experience is associated with better clinical outcome and quality-of-life scores.

Detailed Description
-----------------
Primary total knee replacements are becoming a commonly performed procedure. Many general orthopaedists can perform large numbers of such surgeries. Thus, we aim to find out if there is value of having surgeons with AR fellowship training to perform primary total knee arthroplasty. This has an implication in the direction of the training of future AR surgeons and in the distribution of operative cases.

Official Title
-----------------
High Volume Specialty Knee Replacement Surgeons Achieve Better Clinical and Quality-of-Life Scores

Conditions
-----------------
Total Knee Arthroplasty

Intervention / Treatment
-----------------
* Other: Specialty training for knee surgeons


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who require total knee arthroplasty seen during the specified period Exclusion Criteria: revision total knee arthroplasty unicompartmental or bicompartmental knee arthroplasty

Ages Eligible for Study
-----------------
Minimum Age: 37 Years
Maximum Age: 90 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 operated by AR trained surgeons<br>patients who had their total knee replacements performed by surgeons who have completed a fellowship training in adult reconstruction surgery | Other: Specialty training for knee surgeons<br> <br> |
| Patients operated by non-AR surgeons<br>patients who had their total knee replacements performed by orthopaedic surgeons who did not complete an adult reconstruction fellowship training | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine whether specialty training or high volume of operative experience is associated with better clinical outcome and quality-of-life scores. |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine which other factors are predictors of better outcome score and quality-of-life scores. |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
outcome, quality of life, total knee arthroplasty, clinical outcome scores post total knee arthroplasty, quality of life scores post total knee arthroplasty
Cricopharyngeal Dysfunction in Adults

Study Overview
=================
Brief Summary
-----------------
The objective of the study, after reviewing the recent literature, is to corroborate the thesis of the authors considering the injection of botulinum toxin as a gesture that is both diagnostic and therapeutic in the disorders of the Upper Esophageal Sphincter and reinforce the results already published with a larger series of patients.

Official Title
-----------------
Cricopharyngeal Dysfunction in Adults: Diagnostic and Therapeutic Effects of Cricopharyngeal Botulinum Toxin (Botox) Injection

Conditions
-----------------
Upper Esophageal Sphincter

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Man or woman whose age older than 18 years Dysphagia with solids and / or liquids Dysfunction of primary or secondary Upper Esophageal Sphincter with indirect video-fibroscopy and / or video-fluoroscopy and / or high resolution pharyngo-oesophageal manometry Subject having at least one injection of botulinum toxin A in the crico-pharyngeal muscle for Upper Esophageal Sphincter dysfunction in the ENT department and cervico-facial surgery of Hautepierre. Subject who has consented to the use of his data from his medical file for the purpose of this research Exclusion Criteria: Myotomy in the first place Refusal of the subject to participate in the study Subject under the protection of justice Subject under guardianship or curatorship

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Deglutition Handicap Index |  | The period from January 1st, 2017 to December 31st, 2017 will be examined | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Upper Esophageal Sphincter, botulinum toxin, Cricopharyngeal dysfunction, Cricopharyngeal botulinum toxin injection
MEDTRONIC ADAPTA, VERSA AND SENSIA nEw3 POST APPROVAL STUDY

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to assess the long term reliability of the Medtronic Adapta®/Sensia™/Versa™ platform of devices. This study is required by FDA as a condition of approval of nEw3 devices. Patients will be followed for 5 years after implant. This study utilizes data collected from the System Longevity Study (SLS).

Detailed Description
-----------------
The rate of device malfunctions will be determined and a comparison to historical controls will be done.

Official Title
-----------------
Medtronic Adapta/Versa/Sensia Long Term Reliability Study

Conditions
-----------------
Arrhythmia, Bradycardia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects or appropriate legal guardians provide written informed consent and/or authorization for access to and use of health information, as required by an institution's IRB/MEC/REB. AND one of the following must also apply: Subjects indicated for implant or within six months post-implant of a Medtronic market-released lead connected to a Medtronic Adapta®, Sensia™, or Versa™ IPG. The Medtronic lead must be used for pacing, sensing or defibrillation application. Subjects who participated in a qualifying study (IDE) of a Medtronic cardiac therapy product and: 1) have a Medtronic Adapta®, Sensia™, or Versa™ IPG 2)product is market-released 3) complete implant and follow-up data, including product-related adverse events are available and 4) subject of appropriate legal guardian authorizes release of subject study data to SLS Subjects implanted with a Medtronic Adapta®, Sensia™, or Versa™ IPG and Medtronic CapSure Epi Leads (model 4965 and 4968) at a minimum of three pre-selected sites to retrospectively collect data for post approval requirements. Exclusion Criteria: Subjects who are, or will be inaccessible for follow-up at a SLS center Subjects with exclusion criteria required by local law (EMEA only) Subjects receiving an implant of a Medtronic device at a non-participating center and the implant data and current status cannot be confirmed within 30 days after implant Subjects implanted with a Medtronic device whose predetermined enrollment limit for that specific product has been exceeded
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 |
| --- | --- | --- |
| Rate of device malfunctions |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pacemaker