linjc16/ctgov huggingface dataset:
Randomized Clinical Trial for Primary Molar Pulpotomy, Biodentine Vs Formocresol-ZOE

Study Overview
=================
Brief Summary
-----------------
This is a RCT that will compare the clinical and radiographic success of pulpotomies on primary molars between the traditional technique (Formocresol/ZOE) and the new technique with Biodentine. 180 pulpotomies (90 in each group) will be followed for a period of 12 months.

Official Title
-----------------
A New Technique for Primary Molar Pulpotomy : A Randomized Clinical Trial Comparing the Radiographic and Clinical Success of the Formocresol-zinc Oxide Eugenol Technique and the Biodentine Technique

Conditions
-----------------
Deep Dental Caries

Intervention / Treatment
-----------------
* Procedure: Pulpotomies with Formocresol/OZE and Biodentine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I and II less than 1/3 of physiologic root resorption asymptomatic tooth (with no history of symptoms) no clinical or radiological sign of pathology vital tooth, with carious pulpal exposure hemostasis must be obtained simply with pressure in less than 5 min teeth restored with stainless steel crowns Exclusion Criteria: more than 10 y.o. symptomatic tooth (presently or history of symptoms) previous pulpal treatment on the tooth necrotic pulp hyperemic pulp inadequate operative technique, defective restauration non diagnostic x-ray (pre or post treatment)

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

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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Formocresol/OZE<br>Conventional pulpotomy technique, with formocresol and zinc oxide eugenol | Procedure: Pulpotomies with Formocresol/OZE and Biodentine<br> <br> |
| Active Comparator: Biodentine<br>New technique, with biodentine | Procedure: Pulpotomies with Formocresol/OZE and Biodentine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical success |  | 12 months post treatment | 
| radiographic success |  | 12 months post treatment |
Plasma Biomarkers in Cardiac Valve Surgery

Study Overview
=================
Brief Summary
-----------------
The level of four biomarkers will be measured in the patients' plasma after induction of anaesthesia. There biomarkers are NT-ProBNP, ST2, Galectin-3 and GDF-15. The level of these marker will then be correlated with early (30 days) and late (one year) patients' prognosis and with functional recovery (MLHFQ score).

Official Title
-----------------
Measurement of Four Plasma Biomarkers for Risk Stratification and Determination of Functional Recovery After Cardiac Valve Surgery

Conditions
-----------------
Elective Valvular Cardiac Surgery

Intervention / Treatment
-----------------
* Procedure: Cardiac valve surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Elective/urgent aortic or mitral valve surgery in isolation or combined with CABG Exclusion Criteria: Emergency or salvage surgery Inability to consent Previous cardiac surgery Stage IV or V CDK (GFR ≤ 30 ml/min) or dialysis Active Endocarditis Liver cirrhosis Chronic atrial fibrillation Pacemaker

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

| Intervention/Treatment |
| --- |
|Procedure: Cardiac valve surgery|Aortic or mitral valve replacement/repair performed in isolation of in addition to coronary artery bypass graft(s).|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite primary outcome | In hospital or 30-days mortality or inotropic support during more than 48 hours or lengthy of ICU stay longer than 5 days | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU readmission |  | 30 days | 
| Post-operative AKI | AKIN stage during the first 48 hours | 48 hours | 
| Ejection fraction | EF at 30 days and at 1 year | 1 year | 
| NYHA | NYHA class at 30 days and at 1 year | 1 year | 
| MLHFQ | Minnesota living with heart failure questionnaire at 30 days and at 1 year | 1 year | 
| reshopitalisation | hospital admission for cardiac failure during the first postoperative year | 1 year | 
| one year mortality | mortality during the first postoperative year. | 1 year |
Effects of CoQ10 on Inflammatory Response in Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
Cardiovascular diseases are the leading causes of death and prescription drug use. Research on certain dietary supplements looks promising as a way to help reduce risk factors. Previous studies showed that CoQ10 levels were decreased in cardiovascular patients and worsening of mitochondrial dysfunction was observed. The overall objective of this study is to determine if supplementing with CoQ10 can reduce inflammatory risk factors in adults with cardiac surgery, independent of other dietary or physical activity changes.

Official Title
-----------------
The Effects of the Dietary Supplement Coenzyme Q10 on Inflammatory Responses in Individuals With Cardiac Surgery: A Randomized Controlled Trial

Conditions
-----------------
Cardiovascular Disease

Intervention / Treatment
-----------------
* Drug: Coenzyme Q10
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult men and women Elective cardiac surgery Cardiac surgery on cardiopulmonary bypass Exclusion Criteria: Pregnant or planning on getting pregnant during the study Emergency cardiac surgery Contain a minimum of 2 traits of metabolic syndrome Cardiac surgery without cardiopulmonary bypass

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Coenzyme Q10 group<br>Participants in the experimental group will be given 10mg of Coenzyme Q10 each time (3 times a day). | Drug: Coenzyme Q10<br>* Coenzyme Q10 is a cardiovascular health supplement. It is a component of the electron transport chain and participates in aerobic cellular respiration, which generates energy in the form of ATP. The ingredients in Coenzyme Q10 help regulate the body's production of free radicals, strengthen the arteries and heart, and reverse oxidation.<br>* Other names: ubiquinone;|
| Sham Comparator: Control<br>Participants in the experimental group will be given 10mg of placebo each time (3 times a day). | Dietary Supplement: Placebo<br>* placebo that looks and tastes identical to Coenzyme Q10<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C-reactive protein | Inflammatory and endothelial blood work biomarkers | Change from baseline of CRP in mg/L at 5 days after surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interleukin-6 | Inflammatory and endothelial blood work biomarkers | Change from baseline of IL-6 in pg/mL at 5 days after surgery. |
Effect of Dexmedetomidine on Bispectral Index and Propofol Requirements During Different Menstrual Cycle

Study Overview
=================
Brief Summary
-----------------
The study was done to evaluate the effects of the follicular and luteal phases of the menstrual cycle on sedation level at loss of consciousness and bispectral index reach to 50 during propofol anesthesia, in patients with and without preoperative intravenous dexmedetomidine .

Official Title
-----------------
Effect of Dexmedetomidine on Bispectral Index and Propofol Requirements During Different Menstrual Cycle

Conditions
-----------------
Abnormal Menstrual Cycle

Intervention / Treatment
-----------------
* Drug: dexmedetomidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: a regular menstrual cycle elective gynecologic surgery Exclusion Criteria: pregnancy breastfeeding obesity known hypersensitivity to drugs used in the study protocol; use of psychotropic drugs and steroids within 72 hours before the surgery central nervous system injury renal impairment alcoholism and opioid addiction.

Ages Eligible for Study
-----------------
Minimum Age: 24 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: Prevention
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: menstrual cycle,dexmedetomidine<br> | Drug: dexmedetomidine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bispectral index at loss of eyelash reflex |  | up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| propofol requirements from propofol administered to loss of eyelash reflex and bispectral index reduced to 50 |  | up to 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bispectral Index Monitor, Menstrual Cycle, Dexmedetomidine
The Evaluation of an Interface for the Treatment of Obstructive Sleep Apnea (OSA)

Study Overview
=================
Brief Summary
-----------------
This investigation is designed to evaluate the performance as well as the patients overall acceptance of the interface.

Detailed Description
-----------------
A minimum of 40 OSA participants who currently use CPAP will be recruited for the trial. Participant will be in the trial for three weeks- first week will be a collection of Positive Airway Pressure baseline data on participant's usual interface. The participant will then use the trial interface in-home for 2 weeks. There is also an option of a six month extension if the participant wish to continue on the trial interface.

Official Title
-----------------
The Evaluation of an Interface for the Treatment of Obstructive Sleep Apnea (OSA)

Conditions
-----------------
Sleep Disordered Breathing, Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Device: F&P Interface


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult (18+ years of age) Able to give written consent AHI ≥ 5 on diagnostic night Either prescribed APAP, CPAP or Bi-level PAP for OSA Exclusion Criteria: Inability to give written consent Anatomical or physiological conditions making PAP therapy inappropriate Commercial drivers who are investigated by New Zealand Transport Agency (NZTA) Current diagnosis of respiratory disease or CO2 retention Pregnant or may think they are pregnant.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm<br>F&P Interface will be used by OSA participants in-home for 2 weeks. | Device: F&P Interface<br>* F&P Interface to be used for OSA therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trial Mask usability | Questionnaire on ease-of-use (very easy to very difficult) Subjective | 14 ± 4 days in home | 
| Trial mask Performance | Questionnaire on performance (very good to very poor)- Subjective | 14 ± 4 days in home | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trial mask Reliability | Questionnaire on reliability - Subjective | 5 months and 2 weeks in home | 
| Trial mask performance measured in L/min | Objective leak data from PAP device | 14 ± 4 days in home |
Efficacy and Safety of Inhaled Insulin Compared to Metformin and Glimepiride in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe, Asia, North America and South America. The aim of this research trial is to compare the efficacy of inhaled insulin to glimepiride and metformin combination therapy in treatment of subjects with type 2 diabetes and to verify the safety of use (hypoglycaemia, pulmonary function, body weight, insulin antibodies and side effects).

Detailed Description
-----------------
The decision to discontinue the development of AERx® is not due to any safety concerns. An analysis concluded that fast-acting inhaled insulin in the form it is known today, is unlikely to offer significant clinical or convenience benefits over injections of modern insulin with pen devices.

Official Title
-----------------
Efficacy and Safety of Inhaled Prandial Insulin Compared to Metformin Plus Glimepiride in Type 2 Diabetes

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: inhaled human insulin
* Drug: metformin
* Drug: glimepiride
* Drug: inhaled human insulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes Treated with OADs for more than or equal to 3 months HbA1c greater than or equal to 8.0% and less than or equal to 11.0% Body Mass Index (BMI) less than or equal to 40.0 kg/m2 Exclusion Criteria: Recurrent major hypoglycaemia Current smoking or smoking within the last 6 months Impaired hepatic or renal function Cardiac problems Uncontrolled hypertension Proliferative retinopathy or maculopathy

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: inhaled human insulin<br>* Treat-to-target dose titration scheme, pre-prandial, inhalation.<br>* Other names: NN1998;|
| Experimental: B<br> | Drug: inhaled human insulin<br>* Treat-to-target dose titration scheme, post-prandial, inhalation.<br>* Other names: NN1998;|
| Active Comparator: C<br> | Drug: metformin<br>* Tablets, 2000 mg/day.<br>Drug: glimepiride<br>* Tablets, 4 mg/day.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c change from baseline |  | After 18 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | For the duration of the trial | 
| Body weight |  | after 18 weeks of treatment | 
| Lung function |  | after 18 weeks of treatment | 
| Blood glucose |  | after 18 weeks of treatment | 
| Hypoglycaemia |  | after 18 weeks of treatment |
Comparison of Three Methods of Hemoglobin Monitoring

Study Overview
=================
Brief Summary
-----------------
This study will further investigate the Masimo SpHb [FDA Approved] continuous non-invasive hemoglobin monitor in spine surgery patients. (See NCT00792597) We will investigate the effect of enhanced circulation to the finger (which will be attached to the sensor) following a local injection (digital block) of lidocaine (an FDA approved local anesthetic), and assess the accuracy of the SpHb reading as it relates to a standard laboratory hemoglobin value (tHb).

Detailed Description
-----------------
We have completed a study with 20 patients using the latest version of the SpHb monitor software and finger sensor. The purpose of this study is to assess the accuracy of the SpHb reading as it relates to a standard laboratory hemoglobin value (tHb) following the digital block.

Official Title
-----------------
Comparison of Three Methods of Hemoglobin Monitoring in Patients Undergoing Spine or Hip Surgery

Conditions
-----------------
Digital Block

Intervention / Treatment
-----------------
* Drug: Lidocaine digital block
* Device: Masimo SpHb continuous hemoglobin monitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or non-pregnant female 18 y/o or older ASA Classification 1, 2 or 3 Scheduled to undergo spine or hip revision surgery Exclusion Criteria: Pregnant or nursing Patients who in the study investigators clinical judgement would not be suitable for research.

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Digital block<br> | Drug: Lidocaine digital block<br>* One dose of lidocaine 2% injected locally into one finger (2 mls total)<br>Device: Masimo SpHb continuous hemoglobin monitor<br>* Masimo SpHb continuous hemoglobin monitor<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Categorical Groups Based on Magnitude of Differences Between Noninvasive (SpHb) and Laboratory Co-Oximeter (tHb) Hemoglobin in Patients With a Finger Regional Anesthetic Block. |  | A minimum of 2-4 differences recorded approximately hourly during surgery |
Sexual Functioning in Endometrial Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is estimate how sexual function in endometrial cancer survivors varies with severity of disease.

Official Title
-----------------
Sexual Functioning in Endometrial Cancer Survivors

Conditions
-----------------
Endometrial Cancer, Sexual Function

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of Stage I-IIIA endometrial adenocarcinoma of any grade 1-5 years out from primary surgical treatment Adjuvant therapy may only have consisted of radiation or hormonal therapy No evidence of disease Exclusion Criteria: Previous treatment for other malignancies Did not undergo surgery for primary treatment of endometrial cancer Inability to read, write and speak fluent English Major cognitive impairment affecting ability to provide consent

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- | --- |
| Female Sexual Function Index (FSFI). |  | at time of enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endometrial Cancer, Sexual Function
Effect of Postvitrectomy Proactive Use of Conbercept on Postoperative Complications in PDR Patients

Study Overview
=================
Brief Summary
-----------------
This is an unmasking randomized clinical trial. the main purpose of this study is to analyze whether posvitrectomy proactive use of conbercept can reduce the rate of postoperative complication in PDR patients.

Official Title
-----------------
Effect of Postvitrectomy Proactive Use of Conbercept on Postoperative Complications in PDR Patients

Conditions
-----------------
Proliferative Diabetic Retinopathy

Intervention / Treatment
-----------------
* Drug: proactive Anti-VEGF (conbercept) use
* Drug: passive Anti-VEGF (conbercept) use


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PDR patients undergoing vitrectomy Exclusion Criteria: patients who had received intravitreal injection or systemic use of all types of anti-VEGF agents in the recent three months before vitrectomy patients who had received intravitreal injection or systemic use of all types of steroid in the recent one month before vitrectomy patients who had received complete PRP before vitrectomy patients who are pregnant

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 70 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: group 1 (proactive use of conbercept after vitrectomy)<br>proactive use of conbercept after vitrectomy | Drug: proactive Anti-VEGF (conbercept) use<br>* preventive intravitreal injection of conbercept 2 weeks after vitrectomy, and repeat at 5 weeks and 8 weeks if either of the following is present: intravitreal VEGF concentration at 2 weeks postop is higher than 100 pg/ml, or clinical presentation of DME, VH or NVG.<br>|
| Experimental: group 2 (passive use of conbercept after vitrectomy)<br>passive use of conbercept after vitrectomy | Drug: passive Anti-VEGF (conbercept) use<br>* No intravitreal injection of conbercept is used until the patient present with postoperative DME, VH, NVG<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of postvitrectomy complication | postvitrectomy DME, VH (recurrent or nonabsorbent), NVG | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postvitrectomy BCVA | BCVA at 1,3,6 month after vitrectomy | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vitrectomy