linjc16/ctgov huggingface dataset:
Paracervical Block During II-trimester Abortion

Study Overview
=================
Brief Summary
-----------------
Paracervical blockage can reduce severe pain during second trimester induced medical abortion.

Official Title
-----------------
Paracervical Block (PCB) During II-trimester Abortion- A Randomized Controlled Trial

Conditions
-----------------
Second Trimester Medical Abortion

Intervention / Treatment
-----------------
* Drug: bipuvacain
* Other: NaCl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women who request second trimester medical abortion (13-22 weeks gestation according to ultrasound) 18 years of age or older able to understand and communicate in Swedish able to understand the study related information and willing to give her informed consent to participation in the study Exclusion Criteria: Known allergy to bupivakain or related substances

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bupivacain<br> | Drug: bipuvacain<br>* PCB with 20ml bupivakain or sodium cloride 9mg/ml will be administered one hour following misorpostol administration (first dose).<br>* Other names: (Marcain® 2,5mg/ml);|
| Sham Comparator: Sodium Chloride<br> | Other: NaCl<br>* PCB with 20ml sodium chloride (9mg/ml) inactive (sham) comparator<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score | Pain indicated on VAS at specific time intervals during the induction to expulsion | at 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy | Number of complete abortions within 24h without the need for surgery | after 24h from induction | 
| Time to abortion | Time from induction (first dose of misoprostol) to expulsion | at 24hours | 
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | AEs reported during the time period from mifepristone (Day 1)until follow up | at 6 to 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
medical abortion, second trimester, para cervical blockage, pain management
A Single Centre Randomized Study Evaluating The Safety And Tolerability Of GSK233705 In Healthy Volunteers.

Study Overview
=================
Brief Summary
-----------------
This study will investigate the safety and tolerability of inhaled doses of GSK233705 with a new formulation.

Detailed Description
-----------------
A single-centre, randomized, double-blind placebo-controlled, dose-ascending, cross-over study to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of single inhaled doses of GSK233705 (50, 100 and 200Âµg), formulated with the excipient magnesium stearate, in healthy volunteers.

Official Title
-----------------
A Single-centre, Randomized, Double-blind Placebo-controlled, Dose-ascending, Cross-over Study to Evaluate the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Single Inhaled Doses of GSK233705, Formulated With the Excipient Magnesium Stearate, in Healthy Volunteers

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
-----------------
* Drug: GSK233705


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male subjects 18-55 years old Non-Smokers Exclusion Criteria: Any subject with breathing problems. High blood pressure and heart abnormalities. Any subjects currently taking prescription and non-prescription medications.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Drug | Drug: GSK233705<br>* investigational drug<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General safety and tolerability endpoints: adverse events, blood pressure, heart rate, 12-lead electrocardiogram (ECG), Holter and Lead II ECG monitoring, lung function (FEV1, FVC) and clinical laboratory safety tests over 24 hours. |  | over 24 hours. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma and urine concentrations of GSK233705 and derived pharmacokinetic parameters from 0 to 24 hours. Serial Specific airway conductance (sGaw) and Forced Expiratory Volume in 1 second (FEV1) measurements over 24 hours post-dose. |  | over 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, GSK233705,, Magnesium Stearate,
Potential Role of Donor-derived Cell-Free DNA as a Biomarker in Cardiac Allograft Vasculopathy

Study Overview
=================
Brief Summary
-----------------
Cross-sectional study. We will prospectively obtain ddcf-DNA levels in all patients who undergo routine coronary angiography > 1 year after HT. Our main goal is to evaluate the performance of Donor-derived Cell Free DNA (ddcf-DNA) as a biomarker of CAV.

Official Title
-----------------
Potential Role of Donor-derived Cell-Free DNA as a Biomarker in Cardiac Allograft Vasculopathy

Conditions
-----------------
Cardiac Allograft Vasculopathy

Intervention / Treatment
-----------------
* Diagnostic Test: Donor-derived Cell Free DNA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over 18 and under 80 years old, HT > 1 year ago Exclusion Criteria: Patients under 18 or over 80 years old Multiorgan transplant History of acute cellular rejection ≥ 1R or antibody mediated rejection in the previous 6 months Concomitant infection by CMV

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Donor-derived Cell Free DNA|We will compare ddcfDNA with coronary angiogram determined CAV grading, according to ISHTL2010 classification|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between ddcf-DNA and CAV | Correlation between ddcf-DNA levels and the presence of any degree of CAV (CAV0 vs CAV1, 2, or 3) | 2 years | 
| Performance of the biomarker for the diagnosis of CAV | Determine the performance of this biomarker in this situation using receiver-operator characteristics analysis. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of ddcf-DNA with the different degrees of CAV (0, 1, 2 and 3) | Correlation of ddcf-DNA with the different degrees of CAV (0, 1, 2 and 3) | 2 years | 
| Correlation of ddcf-DNA with other biomarkers (NTproBNP and troponin I) | Correlation of ddcf-DNA with other biomarkers (NTproBNP and troponin I) | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Donor-derived Cell Free DNA, Heart Transplant
Frailty and Postoperative Outcomes After Emergency General Surgery

Study Overview
=================
Brief Summary
-----------------
The investigators will examine the association between preoperative frailty and postoperative outcomes and resource utilization after emergency general surgery.

Official Title
-----------------
Frailty and Postoperative Outcomes After Emergency General Surgery

Conditions
-----------------
General Surgery, Geriatrics, Outcomes Research

Intervention / Treatment
-----------------
* Other: Frailty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All residents of Ontario aged more than 65 years on their surgery date with valid provincial health insurance who have an emergency general surgery procedure (large bowel surgery, small bowel surgery, cholecystectomy, control of hemorrhage from duodenal ulcer, lysis of adhesions, appendectomy, laparotomy) Exclusion Criteria: No valid provincial health insurance

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- |
| Emergency General Surgery<br>All patients having emergency general surgery procedures as defined by Scott et al (JAMA Surgery 2016) | Other: Frailty<br>* Participants will be defined as frail based on the Johns Hopkins ACG Frailty Defining Diagnoses Indicator, which will be applied to available health administrative data in the 3 years preceding index hospital admission. If no frailty defining diagnoses are present participants will be defined as not frail<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Mortality events will be identified from the registered person's database in Ontario from the date of surgery to 365 days after surgery, at which time participants will be censored | 365 days (from date of surgery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital length of stay | Number of days in hospital from date of surgery to 365 days after surgery | day of surgery to 365 days after surgery | 
| Intensive care unit admission | Presence of a special care unit admission from the Discharge abstract database from the date of surgery to 30 days after surgery | from date of surgery to 30 days after surgery | 
| Institutional discharge | Discharge disposition to an institution in the discharge abstract database | Date of surgery to hospital discharge or 365 days after surgery (at which time participants will be censored) | 
| Costs | Total costs incurred by the provincial health care system from the day of surgery to 365 days after surgery | day of surgery to 365 days after surgery |
Flare Measurements in Human Radiation Therapy Patients

Study Overview
=================
Brief Summary
-----------------
This is a longitudinal Feasibility Study of a novel non-invasive device in assessing radiation dose exposure in humans. All patients receiving whole body irradiation therapy and meeting all other inclusion/exclusion criteria will receive ocular flare meter measurements and slit-lamp examinations on up to eleven occasions starting prior to the first fractional dose of irradiation.

Conditions
-----------------
The Impact of Whole Body Irradiation on Ocular Flare

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must be scheduled to receive whole body irradiation in a dose range from 1.5 to 12Gy. Subjects must not have received ocular surgery for at least three months prior to study enrolment. Subjects must not have a history of uveitis. Subjects must have at least one eye free of cataracts Subject age must be greater than 18 years Subjects must have the ability to understand and willingness to sign a written informed consent document. Exclusion Criteria: Inability to give informed consent Cataracts in both eyes Subject has received ocular surgery within the prior three months Subject has a history of uveitis

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 |
| --- | --- | --- |
| Ocular flare in radiotherapy patients | Determine if ocular flare meter spectra and/or a slit-lamp eye exam can assess radiation dose exposure in individual human radiotherapy patients. | Daily measurements for the duration of radiotherapy treatment (expected up to four days from start of treatment) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ocular flare
Effect of Magnesium Alginate on Gastroesophageal Reflux in Infants.

Study Overview
=================
Brief Summary
-----------------
A randomized controlled cross-over trial in full-term infants affected by symptoms suggestive of GER, evaluated through a validated questionnaire (Infant Gastroesophageal Reflux Questionnaire Revised). The parents of all of the enrolled infants will be reassured on the benign nature of the condition and will advise to apply lifestyle changes for one week. Than, the patients will be randomized into one of the two sequence treatment groups. (group A: Mg alginate/thickened formula; group B: thickened formula/Mg alginate) for two weeks. Evaluation of symptom scores will be performed at day 0, day 7, day 21 and day 35.

Conditions
-----------------
Gastroesophageal Reflux

Intervention / Treatment
-----------------
* Dietary Supplement: thickened formula
* Dietary Supplement: Mg alginate
* Behavioral: reassurance with lifestyle changes


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: full-term ages 3 to 12 months, affected by symptoms suggestive of GER. infant regurgitation defined according to the Rome IV criteria informed consent Exclusion Criteria: Evidence of chronic diseases, hepatic, renal, or cardiac diseases, metabolic or central nervous system diseases, or use of acid suppressor treatment (H2-receptor antagonists or proton pump inhibitors [PPIs]), thickened formula, or a history of prematurity or atopy

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum Age: 1 Year

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

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>Group A: Mg alginate/thickened formula | Dietary Supplement: thickened formula<br> <br> Dietary Supplement: Mg alginate<br> <br> Behavioral: reassurance with lifestyle changes<br> <br> |
| Active Comparator: Group B<br>Group B: thickened formula/Mg alginate | Dietary Supplement: thickened formula<br> <br> Dietary Supplement: Mg alginate<br> <br> Behavioral: reassurance with lifestyle changes<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of symptom scores | Infant Gastroesophageal Reflux Questionnaire Revised | From day 0 to day 35 |
Platelet Inhibition and Bleeding in Patients Undergoing Emergent Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate if there is an association between platelet inhibition and surgery-related bleeding in patients undergoing emergent cardiac surgery during dual antiplatelet therapy.

Detailed Description
-----------------
Blood for measuring platelet function is drawn before induction of anesthesia

Official Title
-----------------
Does Platelet Inhibition Predict Surgery Related Bleeding in Patients Undergoing Emergent Cardiac Surgery During Dual Antiplatelet Therapy - a Pilot Study

Conditions
-----------------
Bleeding

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: First time on-pump CABG with or without valve replacement Exclusion Criteria: Redo surgery, Renal insufficiency needing dialysis, Concomitant medication with warfarin, Preoperative fibrinogen < 150 mg%

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 80 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 |
| --- | --- |
| One group<br>Emergency surgery | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calculated Blood Loss |  | until postoperative day 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BARC Bleeding | Intracranial bleed within 48 hours, Reoperation after closure of sternotomy for the purpose of controlling bleeding, Transfusion of equal to or more than 5 Units of packed red blood cells within a 48-hour period, Chest tube output of equal to or more than 2 L within a 24-h period. | until postoperative day 2 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Emergent, Cardiac surgery, On-pump, Platelet function
Dose Confirmation Efficacy Study (V260-007)

Study Overview
=================
Brief Summary
-----------------
This study was designed to evaluate the safety of the investigational Rotavirus Vaccine and the efficacy to prevent Rotavirus Gastroenteritis.

Detailed Description
-----------------
The duration of treatment is 10 months.

Official Title
-----------------
Study of the Efficacy, Safety, and Immunogenicity of V260 at Expiry

Conditions
-----------------
Rotavirus Infections

Intervention / Treatment
-----------------
* Biological: RotaTeq™, rotavirus vaccine, live, oral, pentavalent
* Biological: Comparator: Placebo matching RotaTeq™


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy infants Exclusion Criteria: History of abdominal disorders from a birth defect, intussusception, or abdominal surgery Known or suspected problems with immune system Fever at time of immunization Prior administration of a rotavirus vaccine History of known prior rotavirus disease Chronic diarrhea, or failure to thrive

Ages Eligible for Study
-----------------
Minimum Age: 6 Weeks
Maximum Age: 12 Weeks

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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RotaTeq™ at Expiry Potency (≈1.1 x 10^7 IU/Dose)<br>Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart. | Biological: RotaTeq™, rotavirus vaccine, live, oral, pentavalent<br>* Three doses of RotaTeq™ administered 28 to 70 days apart.<br>* Other names: V260;|
| Placebo Comparator: Placebo matching RotaTeq™<br>Placebo matching RotaTeq™ administered 28 to 70 days apart. | Biological: Comparator: Placebo matching RotaTeq™<br>* Placebo matching RotaTeq™ administered 28 to 70 days apart.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurence of Clinical Rotavirus Disease Caused by the Composite of the Serotypes Contained Within the Vaccine More Than 14 Days Following the Third Dose. | G1, G2, G3, and G4 Serotype Rotavirus Gastroenteritis Cases Occurring at Least 14 Days Postdose 3 Through the First Rotavirus Season Postvaccination in the Per-Protocol Population Using Per-Protocol Case Definition | At least 14 days following the 3rd vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With ≥3 Fold Rise in Antibody Titer | Induction of postdose 3 rotavirus Serum neutralizing antibody (SNA) response (Number of subjects with ≥3 fold rise in antibody titer) | 14 days following the 3rd vaccination |
AV Node Isolation in Atrial Fibrillation vs. Modulation by Pace and Ablate Strategy

Study Overview
=================
Brief Summary
-----------------
AV-node ablation (AVNA) is a common therapy option for rate control strategy of permanent atrial fibrillation with numerous side effects. The investigators hypothesised that an isolation of the AV node is concomitant with less occurrence of new bundle brunch blocks, more frequent preservation and higher rate of escape rhythm compared to AVNA. This retrospective study includes 20 patients being treated with AV-node isolation (AVNI) and 40 historical AVNA-controls. Among others these two methods were compared regarding escape rhythm, delta QRS, procedure time, ablation points, fluoroscopy time and total dose area product (DAP).

Official Title
-----------------
AV Node Isolation in Atrial Fibrillation vs. Modulation by Pace and Ablate Strategy

Conditions
-----------------
Atrial Fibrillation, AV Node Ablation, Escape; Rhythm

Intervention / Treatment
-----------------
* Procedure: AV-node isolation
* Procedure: AV-node ablation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: paroxysmal, persistend or permanent atrial fibrillation; indication for AVNA Exclusion Criteria: other indications for AVNA than atrial fibrillation as AVNRT, atrial flutter, atrial tachycardia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| AVNA group<br>Group of historical controls beeing treated with AV-node ablation | Procedure: AV-node ablation<br>* Right sided ablation of the AV-node<br>* Other names: AVNA;|
| AVNI group<br>Inculudes all patients beeing treated with AV-node isolation | Procedure: AV-node isolation<br>* Abaltion performed in the right atrium isolating the AV-node from the atrium<br>* Other names: AVNI;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AV-node escape rhythm |  | intraoperative, follow-up after 1 to 3 month | 
| bundle branch blocks |  | intraoperative, follow-up after 1 to 3 month |