linjc16/ctgov huggingface dataset:
Assisted Intubation

Study Overview
=================
Brief Summary
-----------------
The study investigates assisted intubation using a videolaryngoscope in anesthesia.

Conditions
-----------------
Intubation Conditions

Intervention / Treatment
-----------------
* Other: Intubation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Easy airway assessment Exclusion Criteria: Difficult airway ASA 3

Ages Eligible for Study
-----------------
Minimum Age: 18 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 undergoing general anesthesia<br> | Other: Intubation<br>* Intubation, endotracheal<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance | Success rate in % of intubation: Number of patients where 'assisted intubation' was successful | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time | Time to intubate: time in sec between insertion of scope into mouth and insertion of endotracheal tube through vocal cords | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endotracheal, intubation, video, time
Pilot Study Evaluating the Use of a New Device for Transanal Irrigation in Patient With Bowel Disorders

Study Overview
=================
Brief Summary
-----------------
The study descripted of efficacy of IryPump®R Set in term of success of the procedure at each irrigation

Official Title
-----------------
Pilot Study Evaluating the Use of a New Device for Transanal Irrigation in Patient With Bowel Disorders

Conditions
-----------------
Therapeutic Irrigation

Intervention / Treatment
-----------------
* Device: IryPump R Set


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is at least 18 years old, Patient having signed an informed consent Patient having neurologic or non neurologic bowel disorders, being initiated to TAI and practicing TAI with Peristeen® for the management of her/his bowel disorders, for at least 6 weeks, with satisfying results. Patient practicing TAI on the basis of 1 procedure/ week as a minimum or more frequently Patient capable to perform the procedure of transanal irrigation himself or with the help of a caregiver Patient having a mental capacity to participate to the study (i.e. to understand the study and to answer to the questions) Patient agrees to test IryPump® Set R for a time corresponding to 5 consecutive irrigations and a maximum of 4 weeks. Patient covered by social security Exclusion Criteria: Patient with bowel obstruction Patient already participating in another clinical study or who have previously participated in this investigation, Pregnant or breast-feeding woman

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IryPump R Set<br>A new set for transanal irrigation composed by 2 parts : 1 pump and 1 rectal catheter . 1 rectal catheter used per irrigation respecting the patient usual frequency of transanal irrigation | Device: IryPump R Set<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success of the trans anal irrigation (TAI) procedure | The patient will practice TAI following his usual frequency (depending on his intestinal transit). After each TAI, the patient will evaluate the success of the procedure (defined as satisfying output evacuation of the bowel according to the patient usual pattern in term of volume of water instilled and absence of leakages between 2 irrigations). | Duration of the study per patient will correspond to the realisation of 5 consecutive TAI in a maximum of 41 days of follow up |
Avastin for CNV Secondary to Pattern Dystrophy

Study Overview
=================
Brief Summary
-----------------
The natural history of subfoveal CNV secondary to Pattern Dystrophy is little understood, but it seems that visual function may be preserved only in the short-term follow-up, with progressive deterioration thereafter. Photodynamic therapy with verteporfin is the most studied therapeuthic option for this kindf of lesion, but unfortunately, this approach does not appear to guarantee long-term vision stabilization, and alternative therapies should be investigated.

Detailed Description
-----------------
Diagnosis of Pattern Dystrophy Diagnosis of subfoveal CNV Intravitreal injection of avastin (1.25 mg) in operating room under sterile condition. Retreatment on the basis of the detection of disease progression and of lack of central retinal thickness reduction on OCT.

Official Title
-----------------
Intravitreal Avastin Injection for the Treatment of Choroidal Neovascularization Secondary to Pattern Dystrophy

Conditions
-----------------
Choroidal Neovascularization Secondary to Pattern Dystrophy

Intervention / Treatment
-----------------
* Procedure: intravitreal triamcinolone injection of avastin (1.25 mg)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of RPD (hyperpigmented yellowish-greyish network, other family members sharing RPD, normal electroretinogram and normal/subnormal electrooculogram) classic or occult CNV involving the foveal avascular zone's geometric centre Exclusion Criteria: conditions other than RPD intraocular surgery or capsulotomy within the last 2 or 1 months pregnancy

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

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: intravitreal triamcinolone injection of avastin (1.25 mg)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of eyes with <15 letter loss (approximately <3 lines) at 6-month examination compared with the baseline value |  |  | 
| numeber of eyes with <15 letter loss at 12-month examinations, compared with the baseline value. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CNV progression |  |  | 
| number of injections. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pattern Dystrophy, Choroidal Neovascularization, Intravitreal Avastin Injection
Study of the Causes of the Breakdown of Muscle Fibers in Hospitalized Patients

Study Overview
=================
Brief Summary
-----------------
Analyze the various causes of breakdown of muscle fibers in hospitalized patients. Analyze the characteristics of these patients in Taiwan (including the drugs history, risk factors and the incidence of complications).

Detailed Description
-----------------
Find the causes of breakdown of muscle fibers in hospitalized patients through medical record review. especially drug-related Find the risk factors of muscle fibers breakdown.

Official Title
-----------------
Rhabdomyolysis - A Retrospective Study in Hospitalized Patients

Conditions
-----------------
Rhabdomyolysis, Myopathy, Acute Renal Failure, Neuroleptic Malignant Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who admitted to The National Taiwan University Hospital during 2003/1/1 2008/12/31 with the following discharge diagnosis: myoglobinuria, rhabdomyolysis, myopathy, toxic myopathy, malignant hyperthermia, neuroleptic malignant syndrome, polymyositis, myalgia and had acute neuromuscular illness presentations and serum creatinine kinase (CK) more than 5 times the upper limit of normal (male > 900 IU/L; female > 835 IU/L). Exclusion Criteria: Patients with recent myocardial infarction or stroke, unless clinical history, examination, or electromyography showed a concomitant myopathy.
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fibrates, rhabdomyolysis, myopathy, acute renal failure, neuroleptic malignant syndrome, Pharmaceutical Preparations, Hydroxymethylglutaryl-CoA Reductase Inhibitors, creatine kinase
A Study of R547 in Patients With Advanced Solid Tumors.

Study Overview
=================
Brief Summary
-----------------
This single arm study will determine the maximum tolerated dose, and recommended dose for further development, of R547, in patients with advanced solid tumors. Groups of patients will receive ascending doses of R547 as weekly intravenous infusions administered over a) 90 minutes and b) 180 minutes, on days 1 and 8 of a 21 day cycle. In the absence of dose-limiting toxicity following the starting dose, incremental dose-escalations will be allowed in subsequent cohorts of patients until the maximum tolerated dose is reached. The anticipated time on study treatment is until disease progression or dose-limiting toxicity, and the target sample size is <100 individuals.

Official Title
-----------------
A Multiple Ascending Dose (MAD) Study of R547 Administered as an Intravenous Infusion on a Weekly Schedule in Patients With Advanced Solid Tumors

Conditions
-----------------
Neoplasms

Intervention / Treatment
-----------------
* Drug: RG547


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients, >=18 years of age; locally advanced or metastatic solid tumors; measurable or evaluable disease. Exclusion Criteria: prior chemotherapy, radiotherapy or immunotherapy within 3 weeks of start of study; prior history of CNS metastases with disease progression; patients taking strong inhibitors and/or inducers of CYP3A4.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: RG547<br>* Administered iv on days 1 and 8 of a 3 week cycle at escalating doses to successive groups of patients until MTD is reached.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AEs, laboratory parameters. |  | Throughout study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic and pharmacodynamic profiles of R547 |  | Throughout study |
Evaluation of Efficacy of Lumbar Plexus Bloc After Hip Surgery

Study Overview
=================
Brief Summary
-----------------
Compare lumbar plexus block with ropivacaine 0.475%, 0.4 ml/kg to saline. Each group randomized, includes 30 patients. block performed preoperatively Surgery under general anesthesia. Postoperative evaluation of pain (VAS) as first endpoint, and also morphine consumption via PCA device. Follow-up : 24h. Expectation : sizeable reduction of pain with block, of duration.

Detailed Description
-----------------
Compare lumbar plexus block (randomized) ropivacaine 0.475%, 0.4 ml/kg saline 0.4 ml/kg . Each group includes 30 patients. Block performed preoperatively. Surgery under general anesthesia (sufentanil, propofol, atracurium ; maintenance : sevoflurane and nitrous oxide in O2. Sufentanil added peroperatively as clinically needed. Postoperative evaluation of pain (VAS, by an independant blind observer) as first endpoint, and also morphine consumption via PCA device. Adverse effects (nausea, vomiting, etc) recorded Follow-up : 24h. Expectation : sizeable reduction of pain with block, of duration.

Official Title
-----------------
Study of Posterior Lumbar Plexus Block for Pain Relief After Hip Surgery

Conditions
-----------------
Pain, Postoperative

Intervention / Treatment
-----------------
* Drug: ropivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults ASA 1-3 Exclusion Criteria: cognitive impairement ASA IV

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: Single Group Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| decrease of postoperative pain |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| decrease in morphine consumption |  |  | 
| duraration of analgesic effect |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ropivacaine, posterior lumbar plexus block, hip arthroplasy, analgesia, postoperative
Neuroendocrine Mechanisms of Growth and Body Composition in Preterm and Term Infants

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test the feasibility of measuring body composition by air displacement plethysmography (ADP) in rapidly growing, medically stable late gestation [32-35 weeks post-menstrual age (PMA)] premature infants.

Detailed Description
-----------------
To assess the feasibility of measuring body fat deposition by ADP in medically stable late gestation (32-35 weeks), premature infants during a period of rapid postnatal growth. To test the relationship between %BF by ADP to %BF by DXA, as well as characterize the relationship between these fat measures with bone measures by quantitative ultrasound and serum levels of insulin, IGF-1, IGF binding proteins, adiponectin and leptin. To perform inter- and intra-rater testing of anthropometric, ultrasound, and ADP measurements. Compare growth, body composition and bone strength between infants born preterm to infants born full term.

Official Title
-----------------
Neuroendocrine Mechanisms of Growth and Body Composition in Preterm and Term Infants

Conditions
-----------------
Premature Birth

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants born between 32 4/7 and 35 3/7 weeks gestation or 37 4/7 and 42 3/7 weeks gestation, by physical exam at birth Birth weight between the 5th and 95th percentile corrected for gestational age Exclusion Criteria: Chromosomal abnormalities Major congenital anomalies Major surgery Severe CNS injury Inborn errors of metabolism Assisted ventilation Inability to start enteral feeds by 96 hours of age

Ages Eligible for Study
-----------------
Minimum Age: 31 Weeks
Maximum Age: 42 Weeks

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 |
| --- | --- |
| Full Term Infants<br>Infants born between 37 4/7 weeks and 42 3/7 weeks gestation. | |
| Preterm Infants<br>Infants born between 32 4/7 weeks and 35 3/7 weeks gestation. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth trajectory |  | Weekly | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
premature birth
Characterization of Aortic Tissue at Reoperation

Study Overview
=================
Brief Summary
-----------------
This study will analyse factors contributing to cardiac re-operation to determine causative effects

Detailed Description
-----------------
This study will collect clinical data on the characteristics of aortic tissue on which BioGlue has been applied during a previous cardiovascular surgery. This is a post market surveillance study.

Official Title
-----------------
Clinical Observation and Pathological Characterization of Aortic Tissue at Reoperation

Conditions
-----------------
Aortic Aneurysm, Aortic Dissection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects undergoing an aortic re-operation Subject has had BioGlue used during previous aortic surgery Subject is willing and able to give written informed consent for participation Exclusion Criteria: Subject with a history of vasculitis Subject with active infection (endocarditis) Subject with a history of chronic inflammatory condition which may have led to ongoing tissue damage Subject with a history of auto immune disease
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cardiac Reoperation<br>Patients who have previously undergone a cardiac operation with the use of BioGlue and are now undergoing a reoperation | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The microscopic evaluation of the presence of BioGlue on aortic tissue |  | participants will be followed for the duration of their surgery, an expected average of 5 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observation and characterization of BioGlue usage during the reoperation procedure |  | participants will be followed for the duration of their surgery, an expected average of 5 hours |
Biomechanical and Electrophysiological Effects of Duloxetine in the Treatment of Women With Urinary Stress Incontinence

Study Overview
=================
Brief Summary
-----------------
Biomechanical and electrophysiological effects of duloxetine in the treatment of women with urinary stress incontinence

Official Title
-----------------
Effect of Duloxetine on Valsalva Leak Point Pressure and Quantitative Rhabdosphincter Electromyography Measures in Women With Stress Urinary Incontinence

Conditions
-----------------
Urinary Stress Incontinence

Intervention / Treatment
-----------------
* Drug: Duloxetine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have a diagnosis of only stress urinary incontinence Have no pelvic organ prolapse protruding more than 1 cm beyond the hymen Exclusion Criteria: At visit 1, have a positive urine culture or a history of four or more urinary tract infections in the preceding year. Have had more than one continence surgery. Have a current or past urogenital cancer.

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

Design Details

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the effects of duloxetine in women with urodynamically proved stress urinary incontinence on the within-group change in vesical Valsalva leak point pressure (VLPP) from baseline to endpoint. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the within-group endpoint/baseline ratios of Root Mean Square Voltage and Mean Rectified Voltage from the rhabdosphincter electromyogram (EMG) at rest and with coughing, and the ratio of cough/rest ratios from baseline to endpoint. |  |  | 
| To evaluate the within-group changes in VLPP and ratios of EMG variables from baseline to 6 months and from 4 weeks to 6 months. |  |  | 
| To describe the percent change in incontinence episode frequency (IEF) from baseline to post-baseline and define two groups, responders and non-responders, based on threshold value of < 50% IEF reduction values. |  |  | 
| To compare the changes in VLPP and EMG ratios from baseline to 4 weeks and from baseline to 6 months in responder and non responders |  |  | 
| To evaluate the safety and tolerability of duloxetine for up to 28 weeks in subjects diagnosed with urodynamic stress incontinence.Based on treatment-emergent adverse events, discontinuation rates, vital signs, and laboratory analyses |  |  |