linjc16/ctgov huggingface dataset:
Bupivacaine vs Oxybuprocaine Topical Anesthesia in IVI

Study Overview
=================
Brief Summary
-----------------
comparing two local anaesthetic agents, Bupivacaine 0.5% versus Oxybuprocaine used topically to provide surface anaesthesia before IVI procedures.

Detailed Description
-----------------
In preparation zone, we will cannulate the patients, connect them to the pulse oximetry and we will start providing appropriate surface anaesthesia for an adequate period of time before the patient administration of the injection, by applying the anaesthetic agents, 3 times with 5 minutes interval, for 15 minutes and then waitng the injection All patients are informed that they are going to receive topical anaesthetic agent before the IVI. pain is monitored during the injection by using the 11 points verbal numerical pain scaling as zero is for no pain and 10 is for severe unbearable pain.

Official Title
-----------------
A Double Blinded Randomized Controlled Study of Topical Anaesthetics Oxybuprocaine Versus Bupivacaine 0.5% in Intravitreal Injections

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

Intervention / Treatment
-----------------
* Drug: bupivacaine 0.5% and oxubuprocaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients between 30 to 70 years Exclusion Criteria: uncooperative patients

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: double blinded randomized syudy
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bupivacaine 0.5%<br> | Drug: bupivacaine 0.5% and oxubuprocaine<br>* using each drug as surface anesthesia before intravitreal injections<br>|
| Experimental: oxybuprocaine<br> | Drug: bupivacaine 0.5% and oxubuprocaine<br>* using each drug as surface anesthesia before intravitreal injections<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| verbal pain numerical scaling | 11 point scale from 0-10 zero measns No pain 10 means severe unbearable pain | 10 minutes |
Epidemiological Investigation of CRBSI, VAP, CAUTI in Chinese ICU

Study Overview
=================
Brief Summary
-----------------
The current protocol desires to implement a large-multicenter observational study of hospital acquired infection in ICU in China. The study will generate data on generate data about the epidemiology current management of nosocomial infection.

Detailed Description
-----------------
The objectives are as followings: Obtain incidence of three major nosocomial infection in ICU, catheter related blood stream infection(CRBSI), catheter related urinary tract infection (CRUTI), and ventilator associated pneumonia (VAP). Determine the epidemic of etiology and condition of management of three major nosocomial infection in ICU in China.

Official Title
-----------------
Colonization and Infection in Critically Ill Patients: a Multicenter, Prospective, Observational Study in Intensive Care Units (ICUs) in China

Conditions
-----------------
Nosocomial Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:all patients admitted into ICU
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 admitted to ICU<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| morbidity | the incidence rate of VAP, CRBSI,CAUTI of critical ill patients in Chinese ICU | one year |
Magnetic Resonance (MR) Colonography With Fecal Tagging

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if MR colonography with fecal tagging is better using air or water for distension of the colon. Patients referred to colonoscopy are offered MR colonography before colonoscopy. Two days before colonography, patients ingest a 200 ml Barium sulfate solution 2% four times a day, which will render fecal masses invisible on the following MR colonography. Air or water (randomised trial) is used for distension of the colon. The examinations are evaluated by two independent blinded readers.

Official Title
-----------------
MR Colonography With Fecal Tagging: A Prospective, Randomized Study

Conditions
-----------------
Colorectal Cancer, Polyps

Intervention / Treatment
-----------------
* Procedure: MR colonography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Suspicion of colorectal polyps or cancer Referred for colonoscopy Exclusion Criteria: Suspicion of IBD Pacemaker Metal in the body Claustrophobia Pregnancy

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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: MR colonography|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity/specificity for water versus air for distension of colon in MR colonography |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of MR colonography with fecal tagging |  |  | 
| Sensitivity/specificity of MR colonography versus colonoscopy |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
colorectal polyps, colorectal cancer, Virtual colonoscopy, Fecal tagging, MR colonography
Impact of Embryo Cryopreservation on Birth Weight

Study Overview
=================
Brief Summary
-----------------
Birth weight (BW) is higher after frozen embryo transfer (FET) than after fresh embryo replacement. No study has compared the BW of siblings conceived using the same oocyte/embryo cohort. The aim of this study was to determine whether the freezing-thawing procedure is involved in such difference.

Official Title
-----------------
Is Cryopreserved Embryo Replacement is Associated With Higher Birthweight Compared With Fresh Embryo ? Sibling Embryo Cohort Study

Conditions
-----------------
Infertility

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: sibling pairs where fresh embryo replacement resulting in a singleton live birth was followed by transfer of one or two frozen embryos from the same cohort that resulted in a singleton live birth, between May 2007 and June 2015. Exclusion Criteria: Twin pregnancies and stillbirths were excluded. If the BW of at least one sibling was unknown, the pair was not included in the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 43 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Frozen embryo transfer<br>Frozen embryo transfer | |
| Fresh embryo transfer<br>Fresh embryo transfer | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| birthweight | change after FET than after fresh embryo transfer | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ART, Birthweight, Siblings, Cryopreservation, Epigenetic, Medical assistance to procreation
Individual Survivorship Program for Ovarian Cancer Patients Based on PROM's and Shared Decision Making

Study Overview
=================
Brief Summary
-----------------
In 2015 the Danish healthcare authorities initiated major changes in the follow-up (FU) program for patients with ovarian cancer. The new FU program argues that there is no effect of routine monitoring, and every patient's FU is now individualized. These changes have caused major concern, especially regarding the omission of routine examinations aimed at detection of recurrence, since clinical symptoms of relapse can be diffuse. Clearly, tools and FU plans to support the patients in feeling safe during FU are of vital importance. Patient-reported outcome measures (PROM) is a tool to improve the focus on patients' needs, symptoms and preferences. It is also a tool to monitor quality of life (QoL), and side effects. 300 patients with ovarian cancer are planned to be enrolled after primary treatment when they enter follow-up program. This is a multi-center study. All participants fill in a questionnaire at baseline and then every 3 months for two years, and every 6 months the third year. The questionnaire consists of EORTC-QLQ-C30, EORTC-OV28, and questions on symptoms of relapse. At baseline the questionnaire is extended with demographic issues. The patients will also fill in a brief questionnaire (CollaboRATE) dealing with patient satisfaction and the level of shared decision making experienced. All participants are followed for 3 years.

Official Title
-----------------
Individual Survivorship Program for Ovarian Cancer Patients Based on PROM's and Shared Decision Making

Conditions
-----------------
PROM, Ovarian Cancer, Quality of Life

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients >18 years of age. Histologically confirmed epithelial ovarian, fallopian tube or serous primary peritoneal cancer. Have completed their first line treatment, with complete remission. Manage to read and speak Danish. Can receive active anti-cancer treatment such as maintenance bevacizumab Exclusion Criteria: •Have recurrent disease after first line treatment.

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

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

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 |
| --- | --- | --- |
| Patient satisfaction as measured by combined questionnaires CollaboRATE and Patient Experience. |  | 3 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life and symptom screening as measured by combined questionnaires EORTC QLQ-C30, EORTC-OV28, and symptom screening questions. |  | 3 years. Every 3 months for two years and every 6 months the third year. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Shared decision Making, Follow-up
Marijuana for Cancer Pain

Study Overview
=================
Brief Summary
-----------------
To find out if it is safe and effective to use smoked marijuana in combination with opioids to treat cancer pain. The study will evaluate whether smoked marijuana, when used with opioids, will have an effect on pain relief, and to see if marijuana reduces the side effects of opioids, which include nausea and/or vomiting.

Detailed Description
-----------------
To take part in this study, you must have ongoing cancer pain which is currently being treated with opioids. If you meet all the eligibility criteria you will be admitted to the General Clinical Research Center at San Francisco General Hospital for 9 days. The treatment consists of smoking one marijuana cigarette 3 times a day.

Official Title
-----------------
Marijuana in Combination With Opioids for Cancer Pain: A Pilot Study

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

Intervention / Treatment
-----------------
* Drug: Smoked Marijuana


Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA Have ongoing cancer pain Be diagnosed with cancer and have at least a six month survival. Be on a stable dose of opioid medication for at least 2 weeks before enrollment. Have smoked marijuana on at least 6 occasions in their lifetime prior to enrollment. EXCLUSION CRITERIA You must not: Start chemotherapy, radiation or biphosphonates during the study, or have received any new intervention with any such agents within the past 4 weeks. Currently be using smoked tobacco products. Currently be in methadone treatment. Have smoked marijuana within 30 days of enrollment. Be diagnosed with diabetes mellitus. Have severe heart disease, uncontrolled hypertension, or lung disease. Currently be receiving treatment with corticosteroids. Be pregnant or breastfeeding.

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 |
| --- |
|Drug: Smoked Marijuana|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in level of cancer pain as recorded on a 100mm Visual Analog Scale. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in level of experimentally induced pain on a 100mm Visual Analog Scale. |  |  | 
| Change in nausea and emesis in participants exhibiting these symptoms. |  |  | 
| Change in disposition kinetics of opioid analgesics. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer pain, All types of cancer except lung cancer
Evaluation of Neuroinflammation in Children With Infantile Spasms

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to investigate the presence of neuroinflammation in children with infantile spasms using 11C-PK11195 positron emission tomography (PK PET) scan, and its response to ACTH treatment by repeating the PK PET scan after treatment.

Official Title
-----------------
Neuroinflammation in Children With Infantile Spasms Measured With 11C-PK11195 Positron Emission Tomography: Response to ACTH

Conditions
-----------------
Infantile Spasms

Intervention / Treatment
-----------------
* Drug: ACTH


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A clinical diagnosis of 'cryptogenic IS' Normal MRI No other neurological disorder Exclusion Criteria: Abnormal MRI No anti-inflammatory medication 48 hrs prior to PK PET scans Parent/guardian unable to give written consent
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Infantile Spasms<br> | Drug: ACTH<br>* PK PET scan before and after ACTH treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuroinflammation in cortical and/or subcortical structures | Neuroinflammation in cortical and/or subcortical structures of the brain in patients with Infantile Spasms will be evaluated with 11-C-PK11195 PET scan at the baseline and 2 weeks after the completion of ACTH treatment (given over 4 weeks), i.e., 6 weeks after the baseline PET scan. | up to 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PET, Infantile Spasms, Neuroinflammation, PK11195, ACTH
Managed Access Programs for LDK378, Ceritinib

Study Overview
=================
Brief Summary
-----------------
The purpose of this registration is to list Managed Access Programs (MAPs) related to LDK378, Ceritinib.

Detailed Description
-----------------
CLDK378A2401 - No longer available - Managed Access Program (MAP) to provide access to Ceritinib, for ALK Positive Tumors. CLDK378A2402 - No longer available - An open-label, multi-center, Expanded Treatment Protocol (ETP) of oral LDK378 in adult patients with non-small cell lung cancer (NSCLC) characterized by ALK positivity. CLDK378A2003M - Available - Managed Access Program (MAP) Cohort Treatment Plan CLDK378A2003M to provide access to LDK378 (ceritinib), for ALK-Positive Tumor Pediatric Patients.

Official Title
-----------------
Managed Access Programs for LDK378, Ceritinib

Conditions
-----------------
Anaplastic Lymphoma Kinase (ALK)- Positive Tumors, Non-small Cell Lung Cancer (NSCLC)

Intervention / Treatment
-----------------
* Drug: ceritinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: An independent request was received from a licensed physician. The patient has a serious or life-threatening disease or condition and there is no comparable or satisfactory alternative therapy available for diagnosis, monitoring, or treatment. The patient is not eligible or able to enroll in a clinical trial or continue participation in such trial. There is a potential patient benefit to justify the potential risk of the treatment use, and the potential risk is not unreasonable in the context of the disease or condition to be treated. The patient must meet any other medical criteria established by the medical experts responsible for the product or by the health authority in the country of request (as applicable). Provision of the product will not interfere with the initiation, conduct, or completion of a Novartis clinical trial or overall development program. Managed Access provision is allowed per local laws/regulations.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ceritinib|Patients receive ceritinib|

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
-----------------
MAP, Manage access program, ceritinib, ALK positive tumors, Non-small cell lung cancer (NSCLC), Anaplastic large cell lymphoma (ALCL), Inflammatory myofibroblastic tumour (IMT),, LDK378
Complications in Hypertension and Obesity

Study Overview
=================
Brief Summary
-----------------
The study in aimed to investigate epidemiology of risk factors in Russian Federation its prognostic value aimed on acceptance of national specific definition of metabolic syndrome and guidelines for its management.

Official Title
-----------------
National Investigation of Cardiovascular Complications in Arterial Hypertension and Obesity

Conditions
-----------------
Metabolic Syndrome, Hypertension, Obesity, Dyslipidemia, Hyperglycemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age older 18 years Signed informed consent Blood pressure more than 130 and/or 85 mm Hg Waist circumference more than 80 sm in females and 94 in males and/or BMI more than 25 kg/m2 Dyslipidemia (elevated TG and/or decreased level of HDLP or therapy for high triglyceride level) Fasting glucose more than 5,6 mmol/l Exclusion Criteria: Associated clinical conditions (stroke, TIA, MI, heart failure, renal disease, diabetes mellitus) Severe concomitant diseases affecting outcome

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiovascular complications |  | 2007-2017 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diabetes mellitus |  | 2007-2017 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
metabolic syndrome, hypertension, obesity, dyslipidemia, hyperglycemia, cardiovascular complications
Left Bundle Branch Block (LBBB) After IntuityTM

Study Overview
=================
Brief Summary
-----------------
This study aimed to evaluate incidence, prognosis and predictive factors of new-onset of persistent left bundle branch block (LBBB) after rapid-deployment aortic valve replacement (RD-AVR) with the IntuityTM bioprosthesis. It was an observational, retrospective and single-center study. Two hundred and seventy-four consecutive patients without any baseline ventricular conduction disorder or previous permanent pacemaker or defibrillator implantation who underwent RD-AVR with the IntuityTM valve were included. Twelve-lead electrocardiogram and transthoracic echocardiography were performed preoperatively, postoperatively, at discharge, 1-month, and 1-year. Incidence, prognosis and predictive factors of new-onset of persistent LBBB were evaluated.

Official Title
-----------------
Persistent Left Bundle Branch Block After Rapid-Deployment Aortic Valve Replacement: Incidence, Long-term Prognostic and Predictive Factors

Conditions
-----------------
Aortic Valve Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: rapid-deployment aortic valve replacement (RD-AVR) with the Edwards Intuity™ bioprosthesis for severe aortic valve stenosis between July 2012 and May 2018 Exclusion Criteria: preoperative permanent pacemaker or defibrillator, complete intraventricular conductive disorder defined by a QRS width ≥ 120 ms. absence of patient's authorization for anonymous publication of their clinical data for research purposes.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Incidence of NOP-LBBB (new onset of persistent left bundle branch block) | QRS duration ≥ 120 ms with QS or rS patterns on the V1 lead, a large notched R wave in D1, aVL, V5 and V6 and the absence of Q wave in V5 and V6, according to the recommendations of the American Heart Association. NOP-LBBB was persistence of LBBB on the 12-lead recording electrocardiogram (ECG) at discharge from hospital. | at 1 year |