linjc16/ctgov huggingface dataset:
Sedation by Dexmedetomidine and Propofol

Study Overview
=================
Brief Summary
-----------------
Under the hypothesis that dexmedetomidine sedation would result in less upper airway obstruction, we evaluated the occurrence of upper airway collapse or the requirement of airway intervention in patients with obstructive sleep apnea during dexmedetomidine or propofol sedation.

Official Title
-----------------
Comparison of the Upper Airway Patency by Dexmedetomidine and Propofol Used for Sedation

Conditions
-----------------
Anesthesia, Spinal

Intervention / Treatment
-----------------
* Drug: Dexmedetomidine
* Drug: Propofol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Surgery under spinal anesthesia Intraoperative sedation American Society of Anesthesiology physical status 1 or 2 Apnea/hypopnea index 5-14/h in Watch-PAT 200 analysis Exclusion Criteria: Anatomical defects on upper respiratory tract Psychotic disorder Drug addition Alcohol addition body mass index ≥ 35 kg/m2

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexmedetomidine<br>Intraoperative sedation is performed by using dexmedetomidine. | Drug: Dexmedetomidine<br>* As a loading dose, 0.5 μg/kg dexmedetomidine was administered over 10 min, which was then administered continuously at a dose of 0.2-0.8 μg/kg/h. Sedation was maintained at modified observer's assessment of alertness/sedation scale 3<br>|
| Experimental: Propofol<br>Intraoperative sedation is performed by using propofol | Drug: Propofol<br>* Propofol was infused continuously via a target-controlled infusion device, and the effect-site concentration was maintained with a range of 0.5-2.0 μg/ml. Sedation was maintained at modified observer's assessment of alertness/sedation scale 3<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The occurrence of upper airway obstruction | When end-tidal carbon dioxide was not detected in spite of the respiratory effort during the sedation period, the case will be regarded as the occurrence of upper airway obstruction. | During the sedation period, an average of 3 hours. |
Usefulness of Myocardial Deformation Imaging for Trastuzumab-induced Cardiotoxicity

Study Overview
=================
Brief Summary
-----------------
Trastuzumab prolongs survival in patients with human epidermal growth factor receptor type 2-positive breast cancer. Sequential left ventricular (LV) ejection fraction (EF) assessment has been mandated to detect myocardial dysfunction because of the risk of heart failure with this treatment. Myocardial deformation imaging is a sensitive means of detecting LV dysfunction, but this technique has not been evaluated in patients treated with trastuzumab. The aim of this study was to investigate whether changes in tissue deformation, assessed by myocardial strain and strain rate (SR), are able to identify LV dysfunction earlier than conventional echocardiographic measures in patients treated with trastuzumab.

Detailed Description
-----------------
The investigators will prospectively evaluate whether changes in tissue deformation, assessed by myocardial strain and strain rate (SR) and identify possibility of early detection of LV dysfunction in patients treated with trastuzumab.

Official Title
-----------------
Usefulness of Myocardial Deformation Imaging in Breast Cancer Patients Treated With Trastuzumab for Early Detection of Myocardial Dysfunction

Conditions
-----------------
Left Ventricular Function Systolic Dysfunction, Cardiotoxicity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HER2(+) breast cancer, anticipating Trastuzumab therapy Exclusion Criteria: Refusal to informed consent Congenital heart disease Significant arrhythmia in EKG Regional wall motion abnormality (+) in echocardiography Poor sonic window

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

Sexes Eligible for Study
-----------------
Female

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 |
| --- | --- | --- |
| LV systolic dysfunction | LV systolic dysfunction was defined as following; An EF unit drop of ≥10% from the baseline available echocardiogram or Change in strain or strain rate : drop(decrement) corresponding to ≥1 SD of the relevant parameter assessed at the baseline available echocardiogram | 3-month F/U | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LV systolic dysfunction | LV systolic dysfunction was defined as following; An EF unit drop of ≥10% from the baseline available echocardiogram or Change in strain or strain rate : drop(decrement) corresponding to ≥1 SD of the relevant parameter assessed at the baseline available echocardiogram | 6,9, and 12-month F/U | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
myocardial deformation imaging, Trastuzumab
Efficacy and Safety of Lumiracoxib 400 mg in Arthroscopic Knee Surgery

Study Overview
=================
Brief Summary
-----------------
This study is designed to investigate the efficacy and safety of a single daily dose of 400 mg lumiracoxib given pre-emptively versus post-operatively in terms of efficacy in reducing pain associated with ambulatory arthroscopic knee surgery

Official Title
-----------------
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Compare Efficacy of a Single Dose of Lumiracoxib 400 mg Given Pre-Emptively Versus Post-Operatively, in Reducing Pain Associated With Ambulatory Arthroscopic Knee Surgery

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: Lumiracoxib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who need scheduled minor ambulatory arthroscopic knee surgery. Exclusion Criteria: Patients with any surgical or medical conditions which could place the patient at higher risk from his/her participation in the study, or are likely to prevent the patient from complying with the requirements of the study or completing the trial period. Other protocol-defined inclusion/exclusion criteria may apply.

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Lumiracoxib|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Intensity (PI) in the target knee after movement at the 2 h time-point |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PI at 1, 2, 3, 4 and 24 h time-points while at rest |  |  | 
| PI at 1, 3, 4 and 24 h time-points after movement |  |  | 
| Time to first rescue medication intake |  |  | 
| Patient's global evaluation of response to study medication |  |  | 
| Safety and tolerability profile |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
arthroscopic knee surgery, cyclooxygenase-2 inhibitors, lumiracoxib, COX189, Ambulatory arthroscopic knee surgery
Estradiol and Testosterone Levels in Seminal Plasma of Men With Non-obstructive Azoospermia

Study Overview
=================
Brief Summary
-----------------
Estradiol and Testosterone are two important hormones for the regulation of an effective spermatogenesis in human testis. The evaluation of levels of estradiol and testosterone in seminal plasma of men with non-obstructive azoospermia may be a predictive test before surgical testicular biopsy to determine the chance of a positive sperm extraction to use for ICSI.

Detailed Description
-----------------
The aim of this study is to compare the levels of esttradiol and testosterone in seminal plasma of men with non-obstructive azoospermia. Indeed, for these patients, none biological test allows to predict a positive sperm extraction before the surgical testis biopsy is performed. Since the involvement of estradiol and testosterone in the regulation of spermatogenesis, the measurement of these hormones in seminal plasma may be a predictive tool for these men before testis biopsy.

Official Title
-----------------
Are Estradiol and Testosterone Levels in Seminal Plasma Predictive for Efficient Spermatogenesis in Men With Non- Obstructive Azoospermia

Conditions
-----------------
Non-obstructive Azoospermia With Testicular Biopsy for Spermatozoa Extraction

Intervention / Treatment
-----------------
* Other: ESTRADIOL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Azoospermia confirmed by two semen analysis (at minimum 74 days between the both analysis) Volume of seminal plasma >0.6ml Testicular biopsy one month after the last semen analysis Informed consent signed by the patient Exclusion Criteria: obstructive azoospermia cryptozoospermia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: ESTRADIOL|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of estradiol and testosterone in seminal plasma of men with non-obstuctive azoospermia |  | at 1 month | 
| Issue of testicular biopsy (sperm extraction positive or negative) |  | at day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degrees of alteration of testis histology |  | at day 1 | 
| Serum levels of estradiol and testosterone |  | at day 1 |
D-serine Adjuvant Treatment for Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
The proposed experiment will evaluate the effects of the NMDA receptor full agonist D-serine ( 2g/day) on persistent symptoms of Parkinson's Disease and on antiparkinsonian drugs-induced dyskinesias. D-serine will be used as add-on therapy to on-going medications received by Parkinson's Disease patients. The rational for this study stems from observations made in pervious clinical trials with schizophrenia patients, in which it was demonstrated that D-serine adjuvant treatment resulted in:1)improvement of parkinsonian side effects induced by antipsychotic drugs and 2) improvement of depression and negative (i.e apathy, blunted effects, anhedonia) symptoms which are similar to symptoms encountered in Parkinson's Disease. The study will have a crossover design in accordance to which each patient will receive, in random order D-serine and placebo for a 6 weeks period each. Thus, any participant will have the opportunity to receive the experimental treatment.

Official Title
-----------------
D-serine Adjuvant Treatment for Parkinson's Disease

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

Intervention / Treatment
-----------------
* Drug: D-serine ( 2g/day)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PD diagnosis ≥2 on UPDRS items 32,33 receive treatment with L-dopa alone or in combination with other antiparkinsonian medications. Exclusion Criteria: current or previous history of other neurological disorders unstable medical conditions renal pathology pregnant female patients excluded

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 75 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br> | Drug: D-serine ( 2g/day)<br>* Two 6 weeks treatment arms. One arm: adjuvant treatment with D-serine ( 2g/day). Second arm : adjuvant treatment with placebo ( 2g/day).<br>|
| Experimental: 2<br> | Drug: D-serine ( 2g/day)<br>* Two 6 weeks treatment arms. One arm: adjuvant treatment with D-serine ( 2g/day). Second arm : adjuvant treatment with placebo ( 2g/day).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| UPDRS scores |  | 6 weeks | 
| PANSS scores |  | 6 weeks |
Bacterial Ano-rectitis Sexually Transmitted in a Specialized Consultation Center

Study Overview
=================
Brief Summary
-----------------
Infectious ano-rectitis is poorly described. Their epidemiology is poorly known, as are their clinical, diagnostic (diagnoses are regularly corrected in gastroenterology and new diagnostic tools are now available) and therapeutic aspects. Analysis of data from this large population of patients referred to the proctology center for suspicion of Neisseria gonorrhoeae and / or Chlamydia trachomatis ano-rectitis will help identify risk factors and target prevention strategies and optimized therapeutic management.

Official Title
-----------------
Epidemiological, Clinical, Microbiological and Therapeutic Aspects of Sexually Transmitted Bacterial Ano-rectitis in a Specialized Consultation Center

Conditions
-----------------
Ano-Rectal Infection Bacterial Nos

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient over the age of 18 Patient consulting or hospitalized in the proctology center Patient for whom an anorectal sampling will be performed for suspicion of sexually transmitted infectious ano-rectitis Exclusion Criteria: Patient's opposition to participate Patient deprived of liberty Patient under guardianship

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 |
| --- | --- | --- |
| Evaluate the clinical presentation | Prevalence of clinical signs : fever (yes/no), ulcerations (yes/no), purulent proctisis (yes/no), erythematosus proctisis (yes/no), condyloma (yes/no) | Day 1 |
Rib Microtia and the Erector Spinae Plane (ESP) Block

Study Overview
=================
Brief Summary
-----------------
The erector spinae plane block is a novel regional anesthetic technique that allows for analgesia of the thorax and abdomen with a peripheral nerve block. This study is being performed to assess the effectiveness of this technique in reducing post-operative pain scores and opiate requirements in pediatric and adult patients undergoing rib cartilage grafting surgeries.

Official Title
-----------------
Erector Spinae Plane Block for Rib Cartilage Graft Reconstruction Surgery

Conditions
-----------------
Microtia, Congenital, Microtia, Anesthesia, Local, Anesthesia

Intervention / Treatment
-----------------
* Procedure: Erector Spinae Plane Block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages 2-17 Able to consent (if greater than 7 years) and have parental consent Pediatric patients undergoing rib cartilage resection surgeries Exclusion Criteria: Participants who do not consent or have parental consent Patients who are clinically unstable or requires urgent/emergent intervention

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 17 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: Treatment Arm<br>ESP Block | Procedure: Erector Spinae Plane Block<br>* Erector Spinae Plane block for patents undergoing rib cartilage grafting surgeries<br>|
| No Intervention: Control Arm<br>Standard of Care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opiate Intake in Morphine Equivalents in Both Control and Treatment Group |  | Duration of procedure and postoperative recovery (throughout study completion, typically 4-5 days) | 
| Evaluating Pain Scores Using 0-10 Numeric Pain Scale (0=No Pain, 10=Worst Pain) | Scale will be used to asses pain initially prior to the procedure and postoperatively approximately every 6 hours. | Duration of Study (Typically 4-5 days) | 
| Evaluating Pain Scores Using Wong-Baker FACES Pain Rating Scale | Scale will be used to asses pain initially prior to the procedure and postoperatively approximately every 6 hours. | Duration of Study (Typically 4-5 days) | 
| Evaluating Pain Scores Using Faces, Legs, Activity, Cry, and Consolability (FLACC) Scale | Scale will be used to asses pain initially prior to the procedure and postoperatively approximately every 6 hours. | Duration of Study (Typically 4-5 days) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Erector Spinae Plane, Erector Spiane Plane Block, Rib Cartilage
Outcomes of Intrathecal Analgesia in Colorectal Surgery

Study Overview
=================
Brief Summary
-----------------
Multimodal analgesia, sometimes including intrathecal analgesia (IA), is essential in any enhanced recovery pathway (ERP). This study aimed to evaluate the safety, feasibility, and optimal IA regimen in colorectal surgical patients.

Official Title
-----------------
Efficacy and Outcomes of Intrathecal Analgesia As Part of an Enhanced Recovery Pathway in Colon and Rectal Surgical Patients

Conditions
-----------------
Surgery

Intervention / Treatment
-----------------
* Drug: Hydromorphone Hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All adult colorectal patients from October 2012 through December 2013 in which patients received single-injection IA as part of a multimodal analgesic strategy for ERP. Undergoing an elective colorectal operation (minimally invasive or open) Exclusion Criteria: Patients aged < 18 years American Society of Anesthesiologists (ASA) 5 and 6 classification pregnancy failure to provide research authorization. emergent operations

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 |
| --- | --- |
| Opioid Only Intrathecal<br> | Drug: Hydromorphone Hydrochloride<br>* All intrathecal injections were performed preoperatively using a 22g or 25 g Whitacre or 24g Sprotte spinal needle. The IA regimen, medication(s) and dose(s), was at the discretion of the attending anesthesiologist, and consisted of one of the following regimens: (1) hydromorphone + local anesthetic (IA-L), or (2) hydromorphone only (IA-O). In patients receiving IA, no other interventional locoregional analgesic techniques (such as rectus sheath blocks or transversus abdominis plane blocks) were utilized.<br>|
| Opioid + Local Anesthetic Intrathecal<br> | Drug: Hydromorphone Hydrochloride<br>* All intrathecal injections were performed preoperatively using a 22g or 25 g Whitacre or 24g Sprotte spinal needle. The IA regimen, medication(s) and dose(s), was at the discretion of the attending anesthesiologist, and consisted of one of the following regimens: (1) hydromorphone + local anesthetic (IA-L), or (2) hydromorphone only (IA-O). In patients receiving IA, no other interventional locoregional analgesic techniques (such as rectus sheath blocks or transversus abdominis plane blocks) were utilized.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to return of bowel function | Time to return of bowel function is defined by the presence of flatus and a bowel movement | post resection, approximately up to 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intrathecal analgesia, colorectal, enhanced recovery