linjc16/ctgov huggingface dataset:
Dose Titration of Propofol for Tracheal Intubation in Children With Sevoflurane Inhalation Induction

Study Overview
=================
Brief Summary
-----------------
Dose titration of propofol for tracheal intubation in children with sevoflurane inhalation induction.

Official Title
-----------------
Dose Titration of Propofol for Tracheal Intubation in Children With Sevoflurane Inhalation Induction

Conditions
-----------------
Pediatric Urinary Disorders

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric patients scheduled for elective day case surgery were enrolled. Exclusion Criteria: History of obstructive sleep apnea Evidence of cardiorespiratory disease Those who were obese or allergic to any of the anesthetic agents in this study Those with an anticipated difficult airway, full stomach History of malignant hyperthermia or other myopathy were excluded.

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: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: propofol<br> | Drug: propofol<br>* intravenous propofol with sevoflurane inhalation induction<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of intubation conditions | Assessment of intubation conditions (vocal cord, intubation condition, cough, movement) , peri-induction HR and BP change, post-operative agitation socre at recovery room. ED50 and ED 95 of each group by uring Dixon's up and down methods. peri -induction period -comparison of above factors among each groups (GroupA: ETSevo 3vol%, Group B: ETSevo 3.5vol%, Group: ET Sevo 4vol%) | 30 minutes after the surgery |
Recto-Anal-Repair in the Treatment of Advanced Haemorrhoidal Disease

Study Overview
=================
Brief Summary
-----------------
Prospective observational study to evaluate the impact of Recto-Anal-Repair (a technique of ultrasound guided haemorrhoidal ligation) in the treatment of stage III/IV haemorrhoidal disease.

Official Title
-----------------
Prospective Observational Study of Recto-Anal-Repair in the Treatment Haemorrhoidal Disease Stage III/IV

Conditions
-----------------
Haemorrhoids

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stage III or IV hemorrhoidal disease (Appendix A) Patient age 18-80 years old Patient fit for general or local anesthesia No prior surgical treatment for hemorrhoidal disease No prior surgical treatment for anorectal sepsis Signed informed consent Exclusion Criteria: Stage I or II hemorrhoidal disease (Appendix A) Patient unfit for surgery Clotting disorders Anal or colorectal malignancy Secondary hemorrhoidal disease Pregnancy Unwilling or unable to sign informed consent

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 |
| --- | --- |
| treatment<br>patients undergoing treatment | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
International Multi Centre Randomized Clinical Trial Of Anticoagulation In Children Following Fontan Procedures

Study Overview
=================
Brief Summary
-----------------
Compare heparin/warfarin to ASA for thromboembolic prophylaxis in the first two years following Fontan procedures.

Official Title
-----------------
An International Multi Centre Randomized Clinical Trial Of Anticoagulation In Children Following Fontan Procedures

Conditions
-----------------
Heart Defect, Triscupid Atresia

Intervention / Treatment
-----------------
* Drug: Warfarin vs ASA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Patient is scheduled to have a Fontan or modified Fontan procedure Exclusion Criteria: Requirement for long-term anticoagulation (e.g., prosthetic heart valve, active DVT) Risk of significant bleeding or any other known medical contraindication to Heparin, Warfarin, or ASA. Inability to supervise therapy due to social or geographical reasons. Pregnancy or potential pregnancy during study period
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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Warfarin vs ASA|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Warfarin vs ASA in prevention of thrombosis 2 yrs after Fontan |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify subpopulation of Fontan pts at high risk for TEs |  |  | 
| Determine high risk period for TEs in first 2 yrs post Fontan |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fontan procedure, Anticoagulation, Thrombosis, Thromboembolism, Prevention
Study Of Safety, Tolerability And Effects Of PF-05175157 In Adults With Moderate To Severe Acne Vulgaris

Study Overview
=================
Brief Summary
-----------------
This is a 6 week study to characterize the safety, tolerability and effects of PF-05175157 administered for 6 weeks in subjects with moderate to severe acne vulgaris.

Official Title
-----------------
A Phase 2a Randomized, Double-blind, Placebo-Controlled Study To Evaluate The Safety, Tolerability And Effects Of PF-05175157 On Moderate To Severe Acne Vulgaris In Adult Subjects

Conditions
-----------------
Acne Vulgaris

Intervention / Treatment
-----------------
* Drug: PF-05175157
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males 18 years or older diagnosed with moderate to severe acne vulgaris who are otherwise healthy. Normal spirometry at screening (FEV1 and FVC (Forced Vital Capacity)at least 80% predicted). Minimum of 20 inflammatory lesions on the face. Willing to discontinue other acne treatments prior to and during the study period through follow-up. Exclusion Criteria: Subjects with active nodulocystic acne. Subjects unwilling to comply with lifestyle guidelines, commit to study visits, and perform study procedures. History of dry eye or other known disease that affects the sclera or cornea. History of pulmonary disease or inability to adequately perform testing.

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

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PF-05175157<br> | Drug: PF-05175157<br>* 200 mg (as 2x100 mg tablets) twice a day (BID) for 6 weeks<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* placebo matching 200 mg (as 2x100 mg tablets) BID for 6 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability | Physical examination, pulmonary function testing, adverse event monitoring, ECGs, vital signs, laboratory tests | Weeks 2, 4, and 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sebum measurements | Change from baseline in amount and rate of sebum excretion | Weeks 2, 4, and 6 | 
| Pharmacokinetics of PF-05175157 | Plasma concentrations | Weeks 2, 4, and 6 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
safety, tolerability, pharmacokinetics, oral dosing, moderate to severe acne vulgaris
Effect of Exosomes Derived From Red Blood Cell Units on Platelet Function and Blood Coagulation

Study Overview
=================
Brief Summary
-----------------
This study is designed to analyze the effect exosomes derived from red blood cell units have on blood coagulation and platelet function. It is an in vitro study using healthy volunteers' blood.

Detailed Description
-----------------
The blood of 25 healthy volunteers will be exposed to exosomes derived from red blood cell units. The effects on coagulation and platelet function will be measured using thromboelastometry (ROTEM®) and FACS analysis.

Official Title
-----------------
In Vitro Study of the Effect of Exosomes Derived From Red Blood Cell Units on Platelet Function and Blood Coagulation in Healthy Volunteers' Blood

Conditions
-----------------
Blood Coagulation, Platelet Function

Intervention / Treatment
-----------------
* Other: in vitro study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy volunteers Exclusion Criteria: pregnancy drug use

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br> | Other: in vitro study<br>* Exosomes will be mixed with healthy volunteers' blood in vitro<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clotting time | measured by thromboelastometry (ROTEM® Analysis) | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clot formation | measured by thromboelastometry (ROTEM® Analysis) | 1h after exposure | 
| clot stability | measured by thromboelastometry (ROTEM® Analysis) | 1h after exposure | 
| clot lysis | measured by thromboelastometry (ROTEM® Analysis) | 1h after exposure | 
| CD62P | FACS analysis | 3h after exposure |
MRI Scan and Intra-labyrinthine Schwannoma

Study Overview
=================
Brief Summary
-----------------
Evaluate the interest of gadolinium for the positive and topographic diagnosis of intra-labyrinthine schwannoma, comparing T1 sequence acquired after gadolinium injection to a sequence of fast imaging type employing steady state acquisition (FIESTA-C)

Official Title
-----------------
INTEREST OF INTRAVENOUS INJECTION OF GADOLINIUM IN EXPLORATION INTRA-LABYRINTHINE SCHWANNOMA IN MRI 3 TESLAS

Conditions
-----------------
Schwannoma

Intervention / Treatment
-----------------
* Other: No intervention in this restrospective study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-80 years Have intra-labyrinthine schwannoma Have benefited from an MRI with gadolinium injection on the MRI 3T with interpretable sequences of good quality Subject giving their consent for their participation Subjects who benefited, between 2009 and 2016, from an MRI of the external auditory canals, with gadolinous product injection and on the 3 Tesla MRI, in which a diagnosis of intra labyrinthine schwannoma was made Exclusion Criteria: - Refusal to participate in the study

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

| Intervention/Treatment |
| --- |
|Other: No intervention in this restrospective study|This study is an obervational study|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence or absence of intra labyrinthine vestibular nerve tumor using T2 FIESTA alone |  | 1 hour after the realization of the MRI | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intra labyrinthine schwannoma, schwannoma, magnetic resonance imaging (MRI), gadolinium, T2 weighted gradient echo
The Effect of Pnemoperitoneum on Intracranial Pressure and Cerebral Oxygenation During Laparoscopic Surgery According to Anesthesia Agents: Propofol Based Total Intravenous Anesthesia vs Desflurane Anesthesia

Study Overview
=================
Brief Summary
-----------------
The pneumoperitoneum during laparoscopic surgery have the potential to cause an increase of intracranial pressure (ICP). Previous studies have proposed that ultrasonographic measurements of the optic nerve sheath diameter (ONSD) correlate with signs of increased ICP. The aim of this study is to compare the effect of pnemoperitoneum on intracranial pressure and cerebral oxygenation during laparoscopic surgery according to anesthesia agents, propofol based total intravenous anesthesia (TIVA group) and desflurane anesthesia (Des group).

Conditions
-----------------
Optic Nerve Sheath

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients (20-80 years of age) scheduled for laparoscopic cholecystectomy undergoing general anesthesia Exclusion Criteria: Patients with previous history of neurologic disease, carotid disease, transient ischemic attack, ocular disease and ocular surgery

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TIVA<br>2% Propofol (Fresofol®), Remifentanil 20mcg/cc (Ultiva®) | Drug: Propofol<br>* 80 patients are randomly allocated into two groups: In TIVA group, propofol based total intravenous anesthesia is used to induce and maintain anesthesia for laparoscopic cholescystectomy.<br>|
| Active Comparator: Des<br>Desflurane (Suprane®), Remifentanil continuous infusion (20mcg/cc) | Drug: Desflurane<br>* 80 patients are randomly allocated into two groups : In Des group, inhalation anesthesia using desflurane is used to induce and maintain anesthesia for laparoscopic cholescystectomy.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the ultrasonographic measurement of optic nerve sheath diameter | optic nerve sheath diameter measured by ultrasonography | baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pneumoperitoneum, optic nerve sheath diameter, laparoscopy, Patients, general anesthesia, diameter
Treatment of Colonic Obstruction With Cook Evolution® Colonic Stent System

Study Overview
=================
Brief Summary
-----------------
The objective of this registry is to compile clinical data on the use of the Evolution® Colonic Stent System for the palliative treatment of colonic obstruction or strictures caused by malignant neoplasms and to relieve acute large bowel obstruction prior to colectomy in patients with malignant strictures.

Official Title
-----------------
Treatment of Colonic Obstruction With Cook Evolution® Colonic Stent System

Conditions
-----------------
Colonic Obstruction, Colonic Stricture, Large Bowel Obstruction

Intervention / Treatment
-----------------
* Device: Evolution(R) Colonic Stent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: per the IFU, colonic strictures caused by malignant neoplasms, and large bowel obstruction due to malignant strictures prior to colectomy. Exclusion: central ischemia, any contraindication to GI endoscopy and any procedure to be performed in conjunction with stent placement, suspected or impending perforation, intra-abdominal abscess/perforation, inability to pass wire guide or stent deployment system through the obstructed area, patients for whom endoscopic or percutaneous procedures are contraindicated, benign disease, and coagulopathy.

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 |
| --- | --- |
| Stent Group<br> | Device: Evolution(R) Colonic Stent<br>* Palliative treatment of colonic obstruction or strictures caused by malignant neoplasms and to relieve acute large bowel obstruction prior to colectomy in patients with malignant strictures.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relief of obstruction |  | At the Conclusion of the Procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant Duration |  | 6 months | 
| Symptoms at Follow-up |  | 6 months | 
| Complications | perforation, migration, obstruction, GI bleeding requiring intervention | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colonic obstruction
Pin Site Infection Prevention for Open Tibial Fracture

Study Overview
=================
Brief Summary
-----------------
This study aimed to compare the efficacy of pin-tract infection prevention between silversulfadiazine and dry dressing. Methods: 30 patients with an open tibial fracture admitted to Songklanagarind hospital from September 2007 to June 2008 and treated by emergency debridement and external fixation were randomized into two groups, one treated with silversulfadiazine for infection prophylaxis (15) and a control group treated with dry dressing only (15). All patients were followed until the external fixator was removed. Pin-site infections were assessed and graded at each follow-up visit by an orthopaedist blinded to the mode of treatment. A culture from the pin site was done if an infection occurred.

Official Title
-----------------
Can Silversulfadiazine Prevent Pin-site Infection in Open Tibial Fracture?: A Randomized Controlled Trial

Conditions
-----------------
Tibial Fracture

Intervention / Treatment
-----------------
* Drug: silversulfadiazine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Open tibial fracture treated with external fixator age between 15-60 years Exclusion Criteria: Immunocompromised patients (diabetes, HIV or malignancy)

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 60 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: dry dressing<br>local application | Drug: silversulfadiazine<br>* apply once a day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of pin site infection |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| type of organism |  | 2 years | 
| severity of pin site infection |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pin-site infection, silversulfadiazine, open fracture, open tibial fracture underwent external fixator
Placebo Controlled, Randomized Safety and Efficacy Study of RC-1291 in Cancer Anorexia/Cachexia.

Study Overview
=================
Brief Summary
-----------------
Anorexia and cachexia are devastating complications in late-stage cancer patients and is strongly associated with mortality in these patients. Activation of Ghrelin receptors have been demonstrated to stimulate appetite. RC-1291 HCl, by virtue of its ghrelin like activity and Growth Hormone releasing effects may have a dual role in the reversal of cancer induced anorexia and cachexia. This placebo controlled study will evaluate the safety and efficacy of RC-1291 HCl in cancer patients with anorexia and cachexia.

Conditions
-----------------
Cancer Cachexia

Intervention / Treatment
-----------------
* Drug: RC-1291 HCl
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Community-dwelling patients ≥ 18 years of age with incurable,histologically diagnosed cancer. Involuntary loss of body weight of ≥ 5 % within the past 6 months Exclusion Criteria: Presently hospitalized or in a nursing care facility. Inability to increase food intake from secondary causes. Liver disease If female-pregnant, breast-feeding or of childbearing potential.

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: RC-1291 HCl<br>50 mg | Drug: RC-1291 HCl<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight |  |  | 
| Lean body mass |  |  | 
| Functional performance |  |  |