linjc16/ctgov huggingface dataset:
Mortality and Risk Factors in Patients With Acute Cardiogenic Pulmonary Edema: a Multicentric, Observational, Prospective Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to define the current treatment of patients ospitalized with acute cardiogenic pulmonary edema. Clinical and laboratory data collected in the Emergency Department will used to investigate the primary outcome (mortality) and risk factors related to the primary outcome.

Detailed Description
-----------------
ACPE is a common cause of presentation to the Emergency Department (ED). Early recognition of high-risk patients could help in better locating human and technical resources and in deciding adequate treatment and site of care. The investigators planned a real life, multicentric, prospective, web-based observational study performed in Italian Emergency Departments. The investigators enroll consecutive patients admitted to the Emergency Department with acute cardiogenic pulmonary edema, that is defined as all the following: respiratory distress, bilateral rales and congestion on chest X-ray. Demographic, clinical and laboratory findings are collected on admission and during hospitalization to evaluate mortality and risk factors related to mortality.

Official Title
-----------------
Mortality and Risk Factors in Patients With Acute Cardiogenic Pulmonary Edema: a Multicentric, Observational, Prospective Study

Conditions
-----------------
Pulmonary Edema, Respiratory Insufficiency

Intervention / Treatment
-----------------
* Device: Non invasive ventilation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all of the following: age ≥ 18 acute-onset dyspnea widespread pulmonary rales pulmonary congestion on chest X- ray plus one of the following: respiratory distress respiratory rate ≥ 30 emogasanalysis: pH < 7.35 and pCO2 > 45 mmHg in Venturi-Mask 50%

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 |
| --- | --- |
| Patients with acute cardiogenic pulmonary edema<br> | Device: Non invasive ventilation<br>* Indications for the use of NIV are at least one of the following: Respiratory Rate ≥ 30 bpm PaO2/FiO2 < 200 pH < 7.35 and PaCO2 > 45 mmH Contraindications for the use of NIV are at least one of the following: Coma Hemodynamic instability / shock Lack of compliance Indications for endotracheal intubation (ETI) are at least one of the following: Respiratory or cardiac arrest Coma Hemodynamic instability<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality |  | Discharge from hospital | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ACPE, Acute respiratory failure, Non invasive ventilation, acute cardiogenic pulmonary edema
Surgery for Recurrent Intrahepatic Cholangiocarcinoma

Study Overview
=================
Brief Summary
-----------------
The investigators retrospectively reviewed the participants suffering from recurrent intrahepatic cholangiocarcinoma after curative resection and aimed to explore the predictive factors for recurrence and clarify the potential benefit of repeat hepatectomy or/with metastasectomy.

Official Title
-----------------
Surgery for Recurrent Intrahepatic Cholangiocarcinoma: a Promise or an Excess?

Conditions
-----------------
Cholangiocarcinoma, Intrahepatic, Recurrence Cholangiocarcinoma, Re-hepatectomy

Intervention / Treatment
-----------------
* Procedure: hepatectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: R0 resection for intrahepatic cholangiocarcinoma at initial diagnosis. Exclusion Criteria: (1)Patient with R1 or R2 resection (2)Distant metastasis noted when laparotomy (3)Surgical mortality

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: hepatectomy|Hepatectomy for patients with recurrent intrahepatic cholanigocarcinoma|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | Including overall survival and disease free survival | 1977 2014 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Recurrent intrahepatic cholangiocarcinoma, Intrahepatic cholangiocarcinoma, Repeat hepatectomy, Metastasectomy
Ziprasidone in the Psychosis Prodrome

Study Overview
=================
Brief Summary
-----------------
This study aims to determine whether ziprasidone is superior to placebo over 24 weeks for patients with the psychosis prodrome.

Official Title
-----------------
Ziprasidone vs Placebo in the Prevention of Psychosis Among Symptomatic Adolescents and Young Adults at Prodromal Risk

Conditions
-----------------
Psychosis Prodrome

Intervention / Treatment
-----------------
* Drug: ziprasidone
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Structured Interview for Psychosis-risk Syndromes criteria for Clinical High Risk for Psychosis clinically referred Exclusion Criteria: prolonged corrected QT interval history of syncope

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 40 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: Ziprasidone<br>Patients will be treated with Ziprasidone for 6 months | Drug: ziprasidone<br>* 20-160 mg/d<br>* Other names: Geodon;|
| Placebo Comparator: Placebo<br>Patients will be treated with placebo for 6 months | Drug: placebo<br>* placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conversion to Psychosis | Conversion to psychosis according to the Structured Interview for Psychosis-risk Syndromes (SIPS) require psychotic symptom severity ratings in the frankly psychotic range, along with meeting persistence or urgency criteria. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Scale of Psychosis-risk Symptoms Total Score | The Scale of Psychosis-risk Symptoms, a 19-item scale with items scored 0-6. Positive Symptom scores on the SOPS in the 1 to 2 range are considered non-prodromal. Scores of 6 are considered psychotic. Scores in the 3 to 5 range are considered at the clinical high risk level. Minimum value 0. Maximum value 114. Higher score means worse outcome. | baseline and 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
psychosis, schizophrenia, prodrome, ziprasidone, placebo
A Feasibility Study to Collect Data in Patients With Haemophilia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect reference data in patients with haemophilia. The study will also collect and store blood samples for potential future exploratory research in the disease area.

Official Title
-----------------
A Multi Centre Study With no Treatment, Designed to Gain Information About the Haemophilia Patient Population

Conditions
-----------------
Hemophilia

Intervention / Treatment
-----------------
* Other: Laboratory variables


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of written informed consent Patients with haemophilia, all severities At least 18 years old. Exclusion Criteria: No exclusion criteria

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Laboratory variables | Other: Laboratory variables<br>* 1 visit<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Laboratory variables related to coagulation, SAEs in connection to blood sampling procedures will be collected, non-serious AEs will not be recorded |  | The variables will be measured at first visit. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
haemophilia, patients with haemophilia
Obesity and Liver Function in Oesophageal Cancer

Study Overview
=================
Brief Summary
-----------------
There is an established link between sarcopenia and outcomes in oesophageal cancer. There is scant reports in the literature regarding the influences of different obesity in different compartments.

Detailed Description
-----------------
Oesophageal cancer rates are increasing as a result of obesity in Western society. Thr investigators are evaluating the influence of viscerala dn subcutaneous obesity on overall outcomes of the participants. In addition the investigators are evaluating if there is a correlation with Liver Function Tests and liver histopathology such as steatosis on survival in participants and post operative sequele.

Official Title
-----------------
Elucidating the Role of Obesity, Liver Function and Pathology With Overall Outcomes in Oesophageal Cancer

Conditions
-----------------
Obesity, Liver Function

Intervention / Treatment
-----------------
* Other: Observation of different types of obesity and liver pathology in patients undergoing and oesophagectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Those undergoing oesophagectomy Exclusion Criteria: patients who only had chemotherapy/chemoradiotherapy without surgery
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 |
| --- | --- |
| Liver biopsy, Visceral and subcutaneous obesity<br>Those with histology and LFT's and quantificaiton of obesity | Other: Observation of different types of obesity and liver pathology in patients undergoing and oesophagectomy<br>* Patinets undergoing surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | 1 year | 
| Disease free survival |  | 1 year |
Comparative Performance of PureVision Lens Designs

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the performance of the PureVision Lens designs when worn on a 30-day continuous wear basis

Official Title
-----------------
A Study to Evaluate the Product Performance of the Redesigned Bausch & Lomb PureVision® Contact Lens (Test) Compared to the Currently Marketed Bausch & Lomb PureVision® Contact Lens (Control) When Worn on an Extended Wear Basis.

Conditions
-----------------
Myopia

Intervention / Treatment
-----------------
* Device: Currently Marketed PureVision Contact Lens.
* Device: Alternate Design of the PureVision Contact Lens.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: subject is myopic VA correctable to 0.3 logMAR or better (driving vision) Clear central cornea Exclusion Criteria: Systemic disease affecting ocular health using systemic or topical medications wear monovision, multifocal or toric contact lenses Any grade 2 or greater slit lamp findings

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Purevision Contact Lens #1<br>PureVision Soft Contact Lens Design (currently marketed) | Device: Currently Marketed PureVision Contact Lens.<br>* Contact lens for continuous wear<br>|
| Experimental: PureVision Contact Lens #2<br>Redesign of the currently marketed PureVision soft contact lens. | Device: Alternate Design of the PureVision Contact Lens.<br>* Contact lens for continuous wear<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Responses to Symptoms/Complaints | Subjective responses to symptoms/complaints on a scale 0-100, where 100 is the most favorable score. Subjects rated various aspects of lens comfort, vision, and handling. The average of each symptom/complaint over all follow-up visits was assessed as the primary endpoint. | Measured at screening/dispensing visit, 1 day, 1 week and 1 month follow-up visits | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LogMAR Visual Acuity | The mean distance high contrast LogMAR visual acuity (VA) score for test eyes over all visits, determined by the total number of letters correctly identified on the logMAR chart. | Mean over all visits - 1 day, 1 week, 1 month | 
| Lens Characteristics | Investigators evaluated study lenses, while on eye, for the number of eyes showing 100% wettability, no discoloration, none-light deposits, fully centered centration, and adequate movement. | Over all scheduled visits day 1 - 1 month |
Comparison of BTDS (Buprenorphine Transdermal System) and Placebo in Low Back Pain

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to evaluate the efficacy and safety of BTDS compared to placebo in subjects with moderate to severe low back pain.

Detailed Description
-----------------
The primary objective of this study is to evaluate the efficacy and safety of buprenorphine transdermal system (BTDS) compared to placebo in subjects with moderate to severe low back pain who have a sub-optimal response to their non-opioid analgesic treatment and require opioid analgesics for pain control.

Official Title
-----------------
A Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Determine the Efficacy and Safety of BTDS Compared to Placebo in Subjects With Moderate to Severe Low Back Pain

Conditions
-----------------
Low Back Pain

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: Buprenorphine Transdermal System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or females age 20 years or older. Clinical diagnosis of low back pain for 4 weeks or longer with non-malignant pain etiology. Exclusion Criteria: Subjects who have a current chronic disease(s) or who have a past history and high possibilities to relapse, in addition to low back pain, requiring frequent analgesic therapy (e.g. headache, fibromyalgia, gout, rheumatoid arthritis, osteoarthritis and diabetic neuropathy).

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Placebo Comparator: 0<br> | Drug: Placebo<br>* Corresponding placebo is applied for 12weeks<br>|
| Experimental: 1<br> | Drug: Buprenorphine Transdermal System<br>* Buprenorphine Transdermal System 5, 10 or 20 mg/patch is applied for 12weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time to the development of inadequate analgesia. |  | Up to 12weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects who developed inadequate analgesia, 'Average pain over the last 24 hours' scores |  | Up to 12 weeks |
Manuka Honey Eye Drops VS Conventional Treatment of Meibomian Gland Dysfunction Related Dry Eye Disease

Study Overview
=================
Brief Summary
-----------------
Assessor-masked (Single blind, randomized controlled trial comparing the conventional treatment group to an interventional group using 16% Manuka Honey topical eye drops.

Detailed Description
-----------------
Purpose To evaluate the effects of conventional treatment compared to use of Manuka Honey eye drops in the treatment of meibomian gland dysfunction related dry eye disease. Design Assessor-masked (Single blind, randomized controlled trial comparing the conventional treatment group to an interventional group using 16% Manuka Honey topical eye drops. Methods Patients were randomized into two groups, one group given conventional treatment for meibomian gland dysfunction. The other group was given additional manuka honey 16% eye drops which are registered as a medical device by the australian FDA. SPEED score was taken at baseline and upon follow up. Multiple parameters were graded from slit lamp examination by a masked assessor. Results were compared from baseline to follow up date 3 weeks later.

Official Title
-----------------
Randomized Assessor Masked Trial Comparing Manuka Honey Eye Drops to Conventional Treatment of Meibomian Gland Dysfunction Related Dry Eye Disease.

Conditions
-----------------
Meibomian Gland Dysfunction

Intervention / Treatment
-----------------
* Device: manuka honey 16% eye drops ( Optimel )
* Device: systane eye drops


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: meibomian gland dysfunction stage 2-4 Exclusion Criteria: <18 years old Unable to consent Recent ophthalmic surgery <6m Abnormalities of lid position Allergy to honey/bee products Contact lens wearers Patients on long term topical medications apart from lubricants

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Conventional<br> | Device: systane eye drops<br>* systane lubricant eye drops<br>|
| Active Comparator: Manuka Honey<br> | Device: manuka honey 16% eye drops ( Optimel )<br>* 16% manuka honey eye drops, australian FDA approved<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| speed score | questionnaire | 3 weeks |
Systolic Ankle arteriaL Pressure and Transcutaneous oximetrY During a TURTLE Test in Athletes

Study Overview
=================
Brief Summary
-----------------
Aim of the study is to test the feasibility of transcutaneous oxygen pressure (TcPO2) recording in the diagnosis of iliac kinking in 20 patients with suspected of endofibrosisoriliackinking and 40 asymptomatic control heathy subjects

Detailed Description
-----------------
Patients suspected of PES and healthy controls after detailled explanation of the protocol will have a recording of tcpO2 on both calves and will perform a series of thigh flexion in the standing position.

Official Title
-----------------
Application de l'oxymétrie Dynamique et Des Index de Pression Pour le Diagnostic Des Plicatures Iliaques du Sportif

Conditions
-----------------
Iliac Kinking

Intervention / Treatment
-----------------
* Diagnostic Test: Transcutaneous oximetry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Age over 18 years Insurance company affiliation Symptoms consistent with iliac kinking (patients) or absence of symptoms (controls) Exclusion Criteria: Refuse to participate Exclusion period from another protocole Non affiliation to the French healthcare system

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

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: transcutaneous oximetry
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patients<br>Patients suspected of iliac kinking will have a transcutaneous oximetry test during hip flexion | Diagnostic Test: Transcutaneous oximetry<br>* Measurement of TcpO2 on calves and chests. Calculation of the DROP index (decrease from rest of oxygen pressure)on both calves.<br>|
| Sham Comparator: controls<br>Healthy asymptomatic athletes will have a transcutaneous oximetry test during hip flexion | Diagnostic Test: Transcutaneous oximetry<br>* Measurement of TcpO2 on calves and chests. Calculation of the DROP index (decrease from rest of oxygen pressure)on both calves.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of a significant DROP decrease | Comparison of DROP value between PES patients and controls | 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diagnosis, Peripheral artery disease, Sports