linjc16/ctgov huggingface dataset:
Prehospital CPAP vs. Usual Care for Acute Respiratory Failure

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effectiveness of continuous positive airway pressure ventilation when applied by paramedics to individuals with severe breathing difficulties in the prehospital setting.

Detailed Description
-----------------
Continuous positive airway pressure ventilation (CPAP) has been shown to be effective in avoiding endotracheal intubation (ETI) for patients with acute respiratory failure in hospital but despite several case series, the effectiveness of the prehospital application of CPAP by paramedics has not been studied in a randomized fashion. We performed a prospective, randomized, non blinded trial to determine whether patients in acute respiratory failure treated with CPAP in the prehospital setting had lower overall ETI rates than those treated with standard care.

Official Title
-----------------
Prehospital CPAP Versus Usual Care for Acute Respiratory Failure: a Randomized Controlled Trial

Conditions
-----------------
Respiratory Insufficiency, Hypoxia

Intervention / Treatment
-----------------
* Device: Continuous positive airway pressure ventilation mask


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: severe dyspnea respiratory rate >25 breaths/minute hemodynamically stable able to cooperate with ventilatory support measures assessed by paramedics as being in urgent need of ETI and/or manual positive pressure ventilation a trip destination of the QEII Health Sciences Center or Dartmouth General Hospital Exclusion Criteria: require ETI for immediate airway protection respiratory rate < 8 breaths/minute evidence of hemodynamic instability cardiac ischemia any chest pain within 3 hours of presentation valid do not resuscitate advanced directive an inadequate supply of portable oxygen

Ages Eligible for Study
-----------------
Minimum Age: 16 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Continuous positive airway pressure ventilation mask|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of patients in each group endotracheally intubated prior to hospital discharge or death |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality |  |  | 
| critical care unit length of stay |  |  | 
| hospital length of stay |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
respiratory failure, non invasive ventilation, prehospital, endotracheal intubation, continuous positive airway pressure
Ultrasound Diagnosis of Cleft Lip and Palate

Study Overview
=================
Brief Summary
-----------------
Cleft lips and palate are one of the most frequent congenital malformation. From 2005 to 2009, a French study, conducted by Dr Bäumler et al. evaluated the accuracy of prenatal ultrasound in the diagnosis of cleft palate when cleft lip is present. The aim of this study is to continue this study from 2009 till 2016. The hypothesis is that the diagnosis rate is constant since 2005.

Official Title
-----------------
Ultrasound Diagnosis of Cleft Lip and Palate - FENCHU

Conditions
-----------------
Cleft Lip and Palate

Intervention / Treatment
-----------------
* Other: Study of medical records


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Age over 18 Prenatal ultrasound diagnosis of cleft palate/lip. Viable pregnancy or Intrauterine fetal demise or medical termination of pregnancy Exclusion criteria: - Diagnosis not confirmed at birth and ultrasound picture not interpretable

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 46 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant women who have a foetus with a cleft lip/palate<br>Pregnant women who have a foetus with a cleft lip/palate | Other: Study of medical records<br>* Study of medical records<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the prenatal and postnatal diagnosis of cleft lip and palate | Compare the prenatal and postnatal diagnosis of cleft lip and palate | At birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study the cleft palate diagnosis when cleft lip is present | Study the cleft palate diagnosis when cleft lip is present | At birth | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ultrasound, Pregnancy, Diagnosis
D-cycloserine Augmented CBT for Panic Disorder

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether d-cycloserine augments the clinical effects of exposure-based cognitive-behaviour therapy for panic disorder.

Official Title
-----------------
The Effect of a Single-dose of D-cycloserine on the Basic Effects of Cognitive-behaviour Therapy for Panic Disorder - a Randomized Placebo-controlled Trial

Conditions
-----------------
Panic Disorder

Intervention / Treatment
-----------------
* Drug: d-cycloserine
* Drug: placebo
* Behavioral: cognitive-behaviour therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical diagnosis of panic disorder at least moderate agoraphobic avoidance Exclusion Criteria: psychoactive medication last 6 weeks exposure-based cognitive-behaviour treatment for panic disorder and agoraphobia during last 3 months female participant who is pregnant or breast-feeding lifetime history of psychosis, bipolar disorder, alcohol, medication or drug abuse or dependence; current primary depressive disorder lifetime history of epilepsy or other significant disease or disorder

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: d-cycloserine<br>oral, capsule, 250 mg, once | Drug: d-cycloserine<br> <br> Behavioral: cognitive-behaviour therapy<br> <br> |
| Placebo Comparator: sugar pill<br>oral, capsule, once | Drug: placebo<br> <br> Behavioral: cognitive-behaviour therapy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| self-reported and clinician-rated anxiety and depression measures |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| emotional information processing |  | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
d-cycloserine, cognitive-behaviour therapy, panic disorder
Antimicrobial Coated Sutures in Paediatric Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if suture material coated by antimicrobial agent triclosan would decrease the incidence of surgical site infections (SSIs) in paediatric surgery compared to ordinary sutures. 1500 children (age form 4 weeks to 18 years) coming for general pediatric surgery to the Oulu University Hospital are randomised to have sutures coated with triclosan (Vicryl Plus, Monocryl Plus) or ordinary sutures. The occurrence of SSIs is monitored by email questionnaires to the parents on days 10 and 30. The diagnosis of SSIs are made along CDC criteria.

Detailed Description
-----------------
We have now (spring 2014) recruited almost 1500 patients to the study. When reviewing the recruited material, we found out that the study suture material has been used in 83% of the recruited patients. The reasons for this have been clinical issue during the operation where melting suture material may not have been needed at all. We have decided to prolong recruiting so that we would gather the calculated sample size of 1500 of patient with study suture material. This will take 12-18 months (probably till autumn 2015).

Official Title
-----------------
Antimicrobial Coated Sutures in Paediatric Surgery

Conditions
-----------------
Wound Infections

Intervention / Treatment
-----------------
* Other: Triclosane
* Other: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: any general surgery during childhood where melting sutures will be used Exclusion Criteria: wound infection as a cause for surgery

Ages Eligible for Study
-----------------
Minimum Age: 4 Weeks
Maximum Age: 18 Years

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Triclosane<br>triclosan coated suture material | Other: Triclosane<br>* Triclosane coated suture material<br>* Other names: Vicryl plus;|
| Active Comparator: Control<br>ordinary suture material | Other: Control<br>* Ordinary suture material<br>* Other names: Vicryl;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occurrence of surgical site infections |  | 30 days |
the Effects of Epidural Fentanyl on Vaginal Delivery

Study Overview
=================
Brief Summary
-----------------
The study hypothesis was that epidural fentanyl may accelerate the dilation of the cervix and possibly result in a shorter duration of vaginal delivery.

Official Title
-----------------
The Effects of Fentanyl Added to Ropivacaine for Labour Epidural Analgesia on the Progress, Duration or Mode of Delivery: a Randomized, Double Blind Study.

Conditions
-----------------
Cervical Dilatation, Bishop Score, Duration of Delivery

Intervention / Treatment
-----------------
* Drug: Fentanyl
* Drug: Normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anaesthesiologists physical status I or II nulliparous normal singleton uncomplicated pregnancies of more than 38 weeks cephalic presentation of the fetus anticipated vaginal delivery active stage of labour cervical dilatation between 3-5 cm regular uterine contractions normal cardiotocographic recordings. Exclusion Criteria: medical problems during pregnancy BMI≥40 kg m-2 opioid allergy prior administration of opioids or other analgesics

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fentanyl<br>20 microgram per hour | Drug: Fentanyl<br> <br> |
| Placebo Comparator: Normal saline<br>0.4 ml per hour | Drug: Normal saline<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cervical dilatation |  | every 60 min starting from the first epidural dose up to cervical dilatation of 10 cm | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bishop score based on Cervical Position, Effacement, Dilation, Softness and Fetal Station. | Bishop score is a pre-labor scoring system which reflects the stage of the procedure (mainly the cervix condition) assessing the following: Cervical Position, Effacement, Dilation, Softness and also Fetal Station. | every 60 min from the time the first epidural dose is administered up to delivery |
Prospective Clinical Evaluation of ASR/Re-Cap Resurfacing Arthroplasty

Study Overview
=================
Brief Summary
-----------------
ASR/Re-cap versus 28 MoM

Official Title
-----------------
Prospective Clinical Evaluation of ASR/Re-Cap Resurfacing Arthroplasty

Conditions
-----------------
Bearings

Intervention / Treatment
-----------------
* Device: ASR/Re-cap


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of THA ASA I-II Willing to return for follow-up evaluations Exclusion Criteria: Collum femurs < 2 cm Cysts > 1 cm Caput necrose

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

| Intervention/Treatment |
| --- |
|Device: ASR/Re-cap|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
An Investigation of Effectiveness and Safety of Varenicline Tartrate in Helping People Quit Smoking

Study Overview
=================
Brief Summary
-----------------
To investigate safety and efficacy of varenicline tartrate in helping people quit smoking

Official Title
-----------------
A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Multinational Study Of Efficacy And Safety Of Varenicline Tartrate For Smoking Cessation

Conditions
-----------------
Smoking Cessation

Intervention / Treatment
-----------------
* Drug: Varenicline tartrate
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Current cigarette smokers between the ages of 18 and 75 years, who are motivated to stop smoking Exclusion Criteria: Patients currently suffering from depression, or have been diagnosed with depression in the last 12 months, or subjects with past or present history of psychosis, panic disorder, or bipolar disorder Any subject with known severe chronic obstructive pulmonary disease (COPD)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Varenicline tartrate|nan|
|Drug: Placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare 12 weeks of treatment with varenicline 1 mg BID to placebo for smoking cessation, and to evaluate continuous abstinence from smoking for 12 weeks after the treatment period. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To gather safety data for 12 weeks of treatment with varenicline 1 mg BID or placebo followed by 12 weeks of non-treatment follow-up. |  |  |
Risk Stratification of Patients With Suspected COVID-19 Presenting to the ED

Study Overview
=================
Brief Summary
-----------------
This project is an unfunded collaboration of approximately 30 emergency departments across Europe led by the EUSEM research network. It involves collection of data in relation to determining the epidemiology and outcome of adult patients who present to emergency departments with a suspected Covid infection.

Detailed Description
-----------------
Over the past 6 months, the world has faced a novel infection disease outbreak, due to a novel coronavirus, the severe acute respiratory syndrome coronavirus (SARS-CoV2), with a massive impact on healthcare resource. In Europe, numbers of confirmed cases continue to rise. Europe is currently one of the regions with the highest number of Covid-19 cases and deaths due to this emergent diseases. Most COVID-19 infected patients present with mild to moderate acute respiratory symptoms, including cough, fever, dyspnea and pneumonia. About 20% will present with severe or critical manifestations of the disease, including pneumonia, respiratory failure and acute respiratory distress syndrome (ARDS). Anticipating the needs for hospitalization in ward and/or intensive care is crucial. Emergency departments are at the front line for triaging patients with suspected Covid-19 and referring them to the appropriate level of care. In Europe, the number of ED patients with suspected Covid-19 is variable; rate of hospitalization from ED reaches 40% for this population. Risk stratification and management decisions of patients presenting to the ED with suspected COVID-19 is a challenge for emergency physicians.

Official Title
-----------------
Risk Stratification of Patients With Suspected COVID-19 Presenting to the ED (EUROCOV Study)

Conditions
-----------------
Covid19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients (>= 18 years old) attending the ED with a clinical suspicion of COVID-19 based on the presence of the following criteria Fever >= 38 °C respiratory symptoms (dyspnea, cough, expectorations) any other symptoms suggestive of COVID-19 including digestive signs (diarrhea, anosmia…) Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 130 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 |
| --- | --- | --- |
| hospitalization | hospitalization after ED visit | 30 days | 
| length of hospital stay | Hospital LOS | 30 days | 
| in-hospital mortality | Death during hospitalization | 30 days | 
| ICU admission | ICU admission after ED visit | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Covid19, Emergencies, epidemiology, prognosis
Web-based vs In-person Personalized Feedback Intervention for Comorbid Substance Use and Disordered Gambling

Study Overview
=================
Brief Summary
-----------------
Rates of gambling and substance use behaviors are elevated among emerging adults (ages 18-24), and these behaviors are individually and jointly associated with a host of negative consequences. Evidence suggests there is significant overlap between these behaviors as well as comorbidity of associated mental disorders (i.e., pathological gambling and substance abuse/dependence). Prior research suggests that a brief in-person delivered personalized feedback intervention (PFI) may be an effective method of reducing these behaviors and their associated consequences among emerging adults. Thus, the purpose of this study is to determine the relative efficacy of an in-person delivered PFI versus a Web-based PFI in reducing gambling, alcohol and marijuana use behaviors and related-consequences in a sample of emerging adults, as well as explore potential moderators and mediators of intervention efficacy and the longevity of intervention effects (over a period of 18-months).

Official Title
-----------------
RTC of Web Versus In-Person SUD and Comorbidity Treatment

Conditions
-----------------
Gambling, Alcohol Consumption, Cannabis

Intervention / Treatment
-----------------
* Behavioral: Personalized Feedback Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Endorse disordered gambling behavior (including 1 or more consequence) Meet diagnostic criteria for one or more substance use disorder Exclusion Criteria: Not meeting inclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 24 Years

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: In-person PFI<br>In-person personalized feedback intervention | Behavioral: Personalized Feedback Intervention<br>* Printed or electronic form containing personalized information about health-relevant behaviors<br>|
| Experimental: Web-based PFI<br>Web-based personalized feedback intervention | Behavioral: Personalized Feedback Intervention<br>* Printed or electronic form containing personalized information about health-relevant behaviors<br>|
| No Intervention: Assessment Only<br>Complete online survey assessments only. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gambling behavior and consequences |  | across 18 months |