linjc16/ctgov huggingface dataset:
The Quality of Life and Direct Financial Costs Associated With Home Ventilation of Children: A Prospective Study

Study Overview
=================
Brief Summary
-----------------
The investigators wish to learn about the quality of life (QOL) of children needing long term home ventilation and also that of their regular caregivers. In addition, the investigators will monitor the extra health-related expenses these families must meet. Data will be collected using two age-specific questionnaires of QOL plus a third one validated for assessing chronic health care costs. Questionnaires will be administered at an initial face to face meeting, supplemented by two telephone follow-up calls, to monitor medical expenses, one and two months later.

Official Title
-----------------
The Quality of Life a Direct Financial Costs Associated With Home Ventilation of Children: A Prospective Study

Conditions
-----------------
Children Receiving Ventilation at Home for Chronic Illness or Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All families, or appointed guardians, caring for children that need home ventilatory support will be eligible for enrollment Exclusion Criteria: Refusal to join the study

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 17 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 |
| --- | --- | --- |
| The Quality of Life and Direct Financial Costs Associated With Home Ventilation | Quality of life for children on home ventilation will be assessed using the validated PedsQL score. This has been specifically designed to measure quality outcome in children with long term health problems. | One year starting june 2013. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Quality of Life a Direct Financial Costs Associated With Home Ventilation | The quality of life for parents caring for a child needing home ventilation will be assessed using a validated questionnaire called the Caregiving Impact Scale (CIS) | One year starting june 2013 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
home ventilation
Measuring Skin Electrical Potential With the Kelvin Probe: Minimizing Noise

Study Overview
=================
Brief Summary
-----------------
The Scanning Kelvin Probe measures surface electrical potential without actually touching the skin. This is a pilot study to evaluate methods of minimizing noise during Scanning Kelvin Probe measurements. This project will focus specifically on noise arising from physical movement and environmental electrical field.

Official Title
-----------------
Measuring Skin Electrical Potential With the Kelvin Probe: Minimizing Noise

Conditions
-----------------
Healthy State

Intervention / Treatment
-----------------
* Other: Faraday cage, movement stabilization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age greater than 18 years Exclusion Criteria: chronic medical condition requiring daily medications (hypertension, diabetes, hypothyroidism, etc) movement disorders/tremors extensive scars on the hand latex-allergies cardiac implantation, metallic joint/bone replacements (defibrillator or pacemaker)

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy Volunteers<br> | Other: Faraday cage, movement stabilization<br>* The Faraday cage is a copper-mesh cage that surrounds the device and test site. It helps eliminate surrounding electrical noise. Movement stabilization will be achieved by placing a velcro strap over the arm to minimize random movements.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variability in surface electrical potential measurements | This study focuses on the ability of the Kelvin Probe to measure skin electrical potential. Because it does so without touching the skin, it is prone to noise - specifically physical movement and surrounding electrical noise. The variability in surface electrical potential is a way to determine how stable the measurements are. It can be determined immediately after testing - and will be used in data analyses (comparing across study volunteers) approximately 24 weeks after testing is complete. | Within 24 hours of testing | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Surface potential, Electrical, Motion stabilization
Effect of Dexmedetomidine on the Characteristics of High Volume/Low Concentration Ropivacaine in a Caudal Block in Pediatrics

Study Overview
=================
Brief Summary
-----------------
The investigators perform this study to evaluate the effects of caudal Dexmedetomidine (DEX) added to high volume/low-concentration of ropivacaine in children undergoing orchiopexy.

Conditions
-----------------
Ambulatory Orchipexy

Intervention / Treatment
-----------------
* Drug: Caudal ropivacaine + normal saline
* Drug: Caudal ropivacaine + dexmedetomidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children undergoing ambulatory orchiopexy, ASA status I Exclusion Criteria: mental retardation, developmental delay, neurological or psychiatric illness, coagulation disorder, spinal anomalies

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 6 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Caudal ropivacaine + normal saline<br>1.5ml kg-1 ropivacaine 0.15% with normal saline (Control group, n=40). | Drug: Caudal ropivacaine + normal saline<br> <br> |
| Experimental: Caudal ropivacaine + dexmedetomidine<br>1.5ml kg-1 ropivacaine 0.15% with dexmedetomidine 1 μg kg-1 (DEX group, n=40) | Drug: Caudal ropivacaine + dexmedetomidine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vital sign | systolic arterial pressure | up to 180 min after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| inhalation anesthetics requirements | end-tidal sevoflurane concentration required to maintain hemodynamic changes < 20% of the preoperative baseline | up to 180 min after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dexmedetomidine, caudal block, children, children (1-6 years) undergoing ambulatory orchipexy
Comparative Study of Circular Stapling Instruments

Study Overview
=================
Brief Summary
-----------------
After removing the rectum at surgery, bowel continuity can sometimes be restored by an anastomosis between the anus and the bowel. This anastomosis is most commonly created by the use of surgical circular stapling instruments. In a retrospective pilot study the risk of developing an acute leak in the anastomosis was increased with one of the most commonly used instruments in Sweden as compared to the other brand in use. In the current study the patient is randomized to either one of the instruments after a resection of the rectum for rectal cancer.

Official Title
-----------------
Comparative Study of Circular Stapling Instruments Concerning the Risk of Anastomotic Dehiscence After Anterior Resection for Rectal Cancer.

Conditions
-----------------
Anastomotic Leak, Rectal Cancer

Intervention / Treatment
-----------------
* Device: AutoSuture Premium Plus CEEA/Ethicon Proximate ILS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age over 18 Anterior resection for Rectal Cancer Informed consent Exclusion Criteria: Can not give informed consent Patient can not be followed

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: AutoSuture Premium Plus CEEA/Ethicon Proximate ILS|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical anastomotic leak |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Circular stapling devices, anastomotic leak, anastomotic dehiscence, rectal cancer
Pilot Bioequivalency Study of Exemestane 25 mg Tablet Under Fasted Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to prove the bioequivalence of Exemestane 25 mg tablet under fasted conditions

Official Title
-----------------
A Pilot Single Dose, 2-Period, 2-Treatment, 2-Way Bioequivalency Study of Exemestane 25 mg Tablets Under Fasting Conditions

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Drug: exemestane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening Exclusion Criteria: Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to exemestane or any comparable or similar product.

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

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

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: exemestane|25 mg tablet|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bioequivalence determined by statistical comparison Cmax |  | 21 days |
How Accurate INFANIB is Among Hospitalized Preterm Infants

Study Overview
=================
Brief Summary
-----------------
Reliability of infant neurological international battery (INFANIB) among hospitalized preterm infants will be checked. This study will mainly focus on test-retest reliability.

Detailed Description
-----------------
Background: NICU is a specialised intensive care unit that treats and cares for premature or critically ill newborn babies. A special category of high-risk babies consists of premature infants. Their motor growth differs from that of healthy full-term infants and their occurrence of motor disorders is greater. The outcome of neuromotor disorders can be substantially changed by treatments during the first year of life. So in order to detect these neuromotor disorder there must be a reliable screening tool present. Hence, in this study we will check reliability of INFANIB. Purpose: Reliability of INFANIB among hospitalized preterm infants. Methodology: It will be an observational study and will be carried out in Neonatal Intensive Care Unit (NICU). The study will recruit preterm infants that are stable and are present without any respiratory assistive devices. INFANIB screening tool will be performed on these infants. It has 20 items that measure the state of the infant for body tone and posture, primitive reflexes and French angles in the supine, prone, sitting, standing and suspended position upto 18 months. But we will take only preterm infants so only 14 items will be assessed and infants will be scored accordingly. The main focus will be on test- retest reliability. Discussion: A similar research has been carried out in Iran and China, that established that reliability of INFANIB is excellent. Another research was carried out in India that stated INFANIB's reliability to be low. So this study is required to be carried out in India to know the actual results.

Official Title
-----------------
Reliability of Infant Neurological International Battery (INFANIB) Among Hospitalized Preterm Infants.

Conditions
-----------------
Preterm Infants

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Preterm neonates. Stable neonates. Exclusion Criteria: Unstable neonates. Neonates on respiratory assistive devices.

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 28 Days

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| INFANIB score | Measuring neurodevelopmental maturity among neonates | Change from score of INFANIB scale at three consecutive days. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neonatal, Preterm, NICU, Newborn, INFANIB
AZD8075 Single Ascending Dose Study

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to assess the safety, tolerability and pharmacokinetics of single ascending oral doses of AZD8075 in healthy male volunteers

Official Title
-----------------
A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Single Ascending Oral Doses of AZD8075 in Healthy Male Volunteers

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: AZD8075
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of signed, written and dated informed consent prior to any study specific procedures. Have a body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg. Be non-smoker or ex-smoker who has stopped smoking (or using other nicotine products) for >6 months prior to study start. Exclusion Criteria: Any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the result of the study, or the subject's ability to participate Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs (vital signs (ie, supine BP and pulse) or ECG at baseline, which, in the opinion of the investigator, may put the subject at risk. Participation in another investigational drug study within 3 months before Visit 2 or participation in a method development study (no drug) 1 month prior to Visit 2

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: AZD8075<br>* Single dose, the starting dose will be 7 mg, oral suspension, with up to 8 dose escalations not exceeding AstraZeneca pre-defined upper exposure limits.<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* Oral suspension<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab) |  | Frequent sampling occasions during study days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK variables |  | Frequent sampling occasions during study days |
Safety and Efficacy of Sufentanil NanoTab for Management of Acute Pain Following Bunionectomy

Study Overview
=================
Brief Summary
-----------------
This is a dose-finding study to determine if the sublingual administration of the Sufentanil NanoTab is safe and effective in the treatment of post-operative pain.

Conditions
-----------------
Acute Pain

Intervention / Treatment
-----------------
* Drug: Sufentanil NanoTab 20 mcg
* Drug: Sufentanil NanoTab 30 mcg
* Drug: Placebo NanoTab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients scheduled for bunion surgery Exclusion Criteria: daily opioid use drug or alcohol abuse pregnant or breastfeeding women

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sufentanil NanoTab 20 mcg<br>Sufentanil NanoTab 20 mcg as needed every 60 minutes for 12 hours | Drug: Sufentanil NanoTab 20 mcg<br> <br> |
| Experimental: Sufentanil NanoTab 30 mcg<br>Sufentanil NanoTab 30 mcg as needed every 60 minutes for 12 hours | Drug: Sufentanil NanoTab 30 mcg<br> <br> |
| Placebo Comparator: Placebo NanoTab<br>Placebo NanoTab as needed every 60 minutes for 12 hours | Drug: Placebo NanoTab<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SPID-12 | The primary outcome measure is the summed pain intensity difference over the 12-hour study period (SPID-12). A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and throughout the 12 hour study period. The SPID-12 is calculated by summing the difference between baseline pain score and pain score at each assessment time point. The SPID-12 ranges from -120 (indicative of an increase in pain) to 120 (indicative of a decrease in pain). A higher SPID-12 score is better. | 12 hours |
A Comparative Study of the Outcomes of 2 Surgical Procedures for Safe Type of Chronic Otitis Media

Study Overview
=================
Brief Summary
-----------------
Mastoidotympanoplasty is a recognised surgery that is performed for chronic otitis media. But whether mastoidectomy in addition to tympanoplasty is really necessary in each and every case of quiescent chronic otitis media still remains controversial. Hence this study has been undertaken to study the differences in the outcomes of the 2 surgical procedures performed for chronic otitis media in a randomized control design.

Detailed Description
-----------------
Design: single blinded randomized control study. Setting: Tertiary referral medical college hospital. Sample size: 60. No of groups: 2 [30 cases in each group]. Group 1: Patients undergoing mastoidotympanoplasty. Group 2: Patients undergoing tympanoplasty only. No of strata: 3. Outcomes: Improvement of hearing Closure of tympanic perforation Recurrence of disease external ear canal stenosis Tools for measurement of outcomes [before and after surgery]: Pure tone audiometry Impedance audiometry Otoendoscopy External ear canal dimensions

Official Title
-----------------
A Randomized Control Study of the Outcomes of Mastoidotympanoplasty Versus Tympanoplasty in Quiescent Tubotympanic Otitis Media

Conditions
-----------------
Chronic Otitis Media, Tubotympanic Disease

Intervention / Treatment
-----------------
* Procedure: mastoidotympanoplasty and tympanoplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:Chronic tubotympanic otitis media in quiescent phase with intact ossicular chain - Exclusion Criteria:1. atticoantral otitis media 2. Specific otitis media 3. Sensorineural hearing loss 4. Fixed/Dislocated ossicular chain 5. Uncorrectable disease focus in nose/throat 6. Chronic otitis media in active phase 7. Chronic otitis media with complications 8. Extensive unresectable tympanosclerosis -

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 50 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

| Intervention/Treatment |
| --- |
|Procedure: mastoidotympanoplasty and tympanoplasty|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pure tone audiometry |  |  | 
| Impedance audiometry |  |  | 
| Otoendoscopy |  |  | 
| External ear canal dimensions |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Otitis media suppurative, surgery ear