linjc16/ctgov huggingface dataset:
Pain Prevalence After Major Craniotomy

Study Overview
=================
Brief Summary
-----------------
Craniotomies are generally thought to be less painful than other operations. Indeed recent studies have confirmed that pain is a common problem during the postoperative phase following craniotomy.Pain not only causes discomfort, but it is also associated with other potential adverse events such as increased sympathetic activity and elevated systemic blood pressure. These events in turn may contribute to increased intracranial pressure. Some patients may also develop chronic pain.Potent opioids have been avoided due to its potential to cause respiratory depression and risk of masking pupillary signs. As a result postoperative craniotomy pain controls are usually inadequate. In Siriraj hospital, there are 500-600 craniotomy patients per year. Still there are no definite guidelines for postoperative pain management in these patents due to lack of information about quality of postoperative pain control after craniotomy. Objectives Primary objective : - To study incidence of moderate to severe pain during first 48 hours after craniotomy. Secondary objectives : To determine risk factors for moderate to severe pain during first 48 hours after craniotomy To evaluate side effects and complications of postoperative craniotomy pain control To compare patient's expectation for pain management before and after surgery To determine patient's satisfaction for postoperative pain management

Official Title
-----------------
Pain Prevalence After Major Craniotomy in Siriraj Hospital

Conditions
-----------------
Pain, Craniotomy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient undergoing major craniotomy (supratentorial surgery and Infratentorial surgery) Age > 18 years Exclusion Criteria: Emergency or trauma Need postoperative ventilatory support Cannot communication Psychosis Not adherence to the treatment protocol History of using benzodiazepine or addictive substance

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 moderate to severe pain following major craniotomy |  | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| risk factors of moderate to severe pain following craniotomy. |  | 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pain, craniotomy
Study of OZURDEX® in the Treatment of Diabetic Macular Oedema (DME) in Australia - The AUSSIEDEX Study

Study Overview
=================
Brief Summary
-----------------
This prospective study will assess Ozurdex in the treatment of Diabetic Macular Oedema in clinical practice.

Official Title
-----------------
Phase 4, Open-label, Non-randomized, Prospective Study of OZURDEX® in the Treatment of Diabetic Macular Oedema - The AUSSIEDEX Study

Conditions
-----------------
Diabetic Macular Oedema

Intervention / Treatment
-----------------
* Drug: dexamethasone intravitreal implant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pseudophakic or phakic and scheduled for a cataract operation Macular oedema due to DME Exclusion Criteria: Previous Ozurdex® treatment

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 |
| --- | --- |
| Ozurdex® (dexamethasone intravitreal implant)<br>Patients who received Ozurdex® in the treatment of Diabetic Macular Oedema per local standard of care in clinical practice. | Drug: dexamethasone intravitreal implant<br>* Ozurdex® treatment for diabetic macular oedema as per standard of care in clinical practice.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in Best Corrected Visual Acuity (BCVA) from baseline |  | Baseline, Month 12 | 
| Mean change in Central Retinal Thickness (CRT) from baseline |  | Baseline, Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with a BCVA improvement of 15 letters or more |  | Baseline, Month 12 | 
| Percentage of patients with a BCVA improvement of 10 letters or more |  | Baseline, Month 12 | 
| BCVA average mean from baseline in area under the curve (AUC) analysis |  | Baseline, Month 12 | 
| Number of Intraocular Pressure (IOP)-lowering treatments used to control IOP increase |  | 12 Months | 
| Mean BCVA at each injection number |  | 12 Months | 
| Mean change from baseline in BCVA at each injection number |  | Baseline, Month 12 | 
| Mean change in BCVA across all the study injection numbers |  | Baseline, 12 Months | 
| Percentage of patients with BCVA improvement |  | Baseline, Month 12 | 
| Percentage of BCVA losers |  | Baseline, Month 12 | 
| Percentage of patients improving to 20/40 or better |  | Month 12 | 
| Mean number of Ozurdex injections |  | 12 Months | 
| Mean interval between Ozurdex® injections |  | 12 Months | 
| Change from baseline in central subfield retinal thickness by Optical Coherence Tomography (OCT) before each follow-up injection number |  | Baseline, Month 12 |
D-Dimer as Predictor of Disease Outcome in Intensive Care Unit in COVID-19m Patients

Study Overview
=================
Brief Summary
-----------------
Evaluating value of D-Dimer blood level of icu admitted patients on admission and 48 hours later as outcome predictor in SARS.COV.2 patients.

Detailed Description
-----------------
Evaluating value of D-Dimer blood level of icu admitted patients on admission and 48 hours later as outcome predictor in SARS.COV.2 patients. It has been reported that COVID 19 is associated with hemostatic abnormalities and elevated D-Dimer level, so its level is used to predict severity of disease.

Official Title
-----------------
D-Dimer as Predictor of Disease Outcome in Intensive Care Unit in SARS-COV-2 Patients: A Retrospective Study

Conditions
-----------------
Critical Illness, Pneumonia, Viral

Intervention / Treatment
-----------------
* Other: no intervention, just observational for D-Dimer level in blood


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients of both sex admitted in icu positive PCR requiring oxygen therapy Exclusion Criteria: ward patients negative PCR
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: no intervention, just observational for D-Dimer level in blood|observation for basal D-Dimer and 48 hours later D-Dimer in blood for ICU SARS.COV.2 patients|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28 days mortality | Outcomes of ICU stay | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of stay and mechanical ventilation | time of admission and need to escalate oxygen therapy | during ICU stay | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
D dimer, SARS-COV-2
Survey on Long-Term Use of BI-Sifrol® Tablets in Patients With Restless Legs Syndrome

Study Overview
=================
Brief Summary
-----------------
The survey is conducted to investigate the safety and efficacy of long-term use of BI-Sifrol Tablets in Restless Legs Syndrome (RLS) patients with or without renal dysfunction in routine medical practice.

Official Title
-----------------
Survey on Long-Term Use of BI-Sifrol® Tablets in Patients With Restless Legs Syndrome

Conditions
-----------------
Restless Legs Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patient with Restless Legs Syndrome Exclusion criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 15 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 |
| --- | --- |
| Patient with Restless Legs Syndrome<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Drug-related Adverse Events | Number of patients with drug-related adverse events | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Total Score of the International Restless Legs Syndrome Rating Scale (IRLS) | International Restless Legs Syndrome rating scale (IRLS): The IRLS rating scale is a selfrating scale used to evaluate the severity of RLS and the patients are requested to answer 10 questions on a scale of 0 to 4. Respective scores (0-4 points) for the 10 questions were added up to calculate the total score on the IRLS. Therefore the total score is 0-40. The lower values represent a better outcome. | after 12 months or at the end of observation |
A Double-Blind Study To Evaluate the Long-Term Safety and Effectiveness of 60 mg Versus 120 mg of Aerosol Pentamidine in the Prophylaxis of Pneumocystis Carinii Pneumonia in AIDS Patients

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety, tolerability, and description of time to Pneumocystis carinii pneumonia (PCP) for long-term biweekly administration of 1 of 2 doses of aerosol pentamidine when used as a prophylactic agent in patients who have had one episode of AIDS-associated PCP.

Official Title
-----------------
A Double-Blind Study To Evaluate the Long-Term Safety and Effectiveness of 60 mg Versus 120 mg of Aerosol Pentamidine in the Prophylaxis of Pneumocystis Carinii Pneumonia in AIDS Patients

Conditions
-----------------
Pneumonia, Pneumocystis Carinii, HIV Infections

Intervention / Treatment
-----------------
* Drug: Pentamidine isethionate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients who have completed 16 treatments under Fisons study no. 87-71 entitled, A Double-Blind Group Comparative Study To Evaluate the Safety and Effectiveness of Three Different Doses of Aerosol Pentamidine in the Prophylaxis of Pneumocystis Carinii Pneumonia in Patients With AIDS Post First Episode PCP. Detailed safety parameters must have been documented for 6 months. Patients must receive the first dose on this study within 2 weeks of their last dose under study no. 87-71. Exclusion Criteria Co-existing Condition: Patients with the following are excluded: Requiring ongoing active therapy for an opportunistic infection (O.I.) at time of entry or those patients with either of the following AIDS-defining O.I.'s at entry: Toxoplasmosis. Cryptococcosis. Pulmonary Kaposi's sarcoma. Asthma poorly controlled by medication. Receiving active therapy for tuberculosis. Patients with the following are excluded: Requiring ongoing active therapy for an opportunistic infection (O.I.) at time of entry or those patients with either of the following AIDS-defining O.I.'s at entry: Toxoplasmosis. Cryptococcosis. Pulmonary Kaposi's sarcoma. Unwilling to sign informed consent. Cannot cooperate with study procedures. Asthma poorly controlled by medication. Receiving active therapy for tuberculosis. Active substance abuse.

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
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Pentamidine isethionate|nan|

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
-----------------
AIDS-Related Opportunistic Infections, Pneumonia, Pneumocystis carinii, Pentamidine, Dose-Response Relationship, Drug, Acquired Immunodeficiency Syndrome
Pharmacodynamic Effects of Sacubitril/Valsartan on Natriuretic Peptides, Angiotensin and Neprilysin

Study Overview
=================
Brief Summary
-----------------
The study measure multiple neurohormones in patients with heart failure being treated with Sacubitril/Valsartan in increasing doses over an 8 week period.

Official Title
-----------------
Pharmacodynamic Effects of Sacubitril/Valsartan on Natriuretic Peptides, Angiotensin and Neprilysin. A Ringerike Heart Failure Cohort Phase IV Study of Angiotensin Receptor Neprilysin Inhibiton

Conditions
-----------------
Heart Failure, Systolic

Intervention / Treatment
-----------------
* Drug: Sacubitril / Valsartan Oral Tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must give written informed consent before any study assessment is performed. Ambulatory ≥ 18 years of age, male or female, treated at Ringerike Hospital. Patients with symptomatic chronic heart failure and reduced ejection fraction (≤ 40%). Patients on optimized medical treatment for heart failure. - Exclusion Criteria: Patients not able to comply in the study. Patients having contraindication for treatment with Entresto; Hypersensitivity to the active substances or to any of the excipients listed in section Hyperkalemia: > 5.4 mmol/L Known history of angioedema related to previous ACE inhibitor or ARB therapy. Hereditary or idiopathic angioedema. Concomitant use with Aliskiren-containing medicinal products in patients with diabetes mellitus or in patients with renal impairment (eGFR <60 ml/min/1.73m2) End-stage renal disease (<15 mL/min per 1.73m2 or treatment by dialysis). Severe hepatic impairment, biliary cirrhosis and cholestasis (Child-Pugh C classification). Pregnancy Breast-feeding-
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: Intervention<br>Increasing doses of Sacubitril/Valsartan | Drug: Sacubitril / Valsartan Oral Tablet<br>* Increasing doses of Sacubitril/Valsartan<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurohormonal plasma concentration |  | 8 weeks |
Mechanistic Evaluation of Response in TRD (MERIT)

Study Overview
=================
Brief Summary
-----------------
To evaluate the relapse prevention of AXS-05 relative to placebo in subjects with treatment resistant depression (TRD). This is a randomized, double-blind, placebo-controlled study to evaluate AXS-05 compared to placebo in delaying relapse of depressive symptoms in patients with TRD who are in stable remission after treatment with AXS-05.

Official Title
-----------------
MERIT: A Randomized, Double-blind, Placebo-controlled Study of AXS-05 for Relapse Prevention in Treatment Resistant Depression

Conditions
-----------------
Treatment Resistant Depression, Major Depressive Disorder

Intervention / Treatment
-----------------
* Drug: AXS-05
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Eligibility Criteria: Ongoing symptoms of depression despite receiving treatment with two or more prior antidepressants during the current major depressive episode, prior to receiving AXS-05 Agree to use adequate method of contraception for the duration of the study Additional criteria may apply

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 |
| --- | --- |
| Experimental: AXS-05<br> | Drug: AXS-05<br>* AXS-05 taken daily for up to 52 weeks, until relapse.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo taken daily for up to 52 weeks, until relapse.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse | Assessed by clinician-rated scales. | Time from randomization to first relapse (up to 52 weeks) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TRD, AXS-05, Treatment Resistant Depression, NMDA receptor, Refractory depression, Resistant depression, Depression, Major depression, Relapse prevention, Dextromethorphan, Bupropion
Safety and Efficacy of Hoodia Gordonii for Treatment of Non Alcoholic Fatty Liver Disease (NAFLD)

Study Overview
=================
Brief Summary
-----------------
This clinical study is designed to evaluate the safety of oral administration of the medical food Hoodia to patients with non alcoholic fatty liver disease. Oral administration of Hoodia is common in many western world countries for appetite suppression and as a food supplement or medical food used for dietary purposes. Nonalcoholic steatohepatitis or NASH is a common, often silent liver disease which affects about 2%-5% of Americans. NASH is strongly associated with the metabolic syndrome, diabetes type-2 and obesity and can lead to cirrhosis, HCC, liver transplantation or death.This clinical trial has been designed to assess the safety of short term oral administration of Hoodia to patients with NASH.

Conditions
-----------------
Non-Alcoholic Fatty Liver Disease

Intervention / Treatment
-----------------
* Dietary Supplement: Hoodia gordonii
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who have completed the informed consent process culminating with written informed consent by the subject Men and women age 18 to 65 years inclusive. Patients with biopsy proven NASH with a score of 4 or above. Altered glucose metabolism, including diabetes (non treated, or treated with up to 2 drugs (not including insulin) without any change in medication 2 months prior to enrolment), impaired fasting glucose or impaired glucose tolerance. HBA1C between 5.5 and 14%. Exclusion Criteria: -

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Patients receiving Hoodia | Dietary Supplement: Hoodia gordonii<br>* PO administration of 1 Tab Hoodia gordoni extract per day.<br>|
| Placebo Comparator: 2<br>Patients receiving placebo | Other: Placebo<br>* PO Placebo pill<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| decreased insulin resistance |  | 30 days | 
| safety |  | 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduced hepatic injury |  | 30 days | 
| reduced weight/BMI/abdominal circumference |  | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hoodia gordoni, NASH, NAFLD
Laparoscopic Adrenalectomy Versus Radiofrequency Ablation

Study Overview
=================
Brief Summary
-----------------
This is a prospective randomized controlled study comparing laparoscopic adrenalectomy (LA) versus image-guided percutaneous radiofrequency ablation (RFA) in treating aldosterone-producing adenoma. The objectives of this study are to compare the short-term outcomes of LA and RFA in treating aldosterone-producing adenoma. compare the treatment success rates of LA and RFA during follow-up for primary aldosteronism.

Official Title
-----------------
Laparoscopic Adrenalectomy Versus Radiofrequency Ablation for Aldosterone-producing Adenoma: a Prospective Randomized Controlled Trial

Conditions
-----------------
Hyperaldosteronism, Conn Syndrome, Adrenocortical Adenoma

Intervention / Treatment
-----------------
* Procedure: Radiofrequency Ablation
* Procedure: Laparoscopic Adrenalectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hypertensive individuals Biochemically confirmed primary aldosteronism Radiologically confirmed unilateral adrenal adenoma ≤3cm Exclusion Criteria: Bilateral adrenal disease Multiple adrenal tumors Other concomitant adrenal diseases Potentially malignant adrenal tumors as shown on imaging Uncorrected coagulopathy Surgically unfit for general anaesthesia Prior open abdominal surgery

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiofrequency Ablation<br>Radiofrequency Ablation | Procedure: Radiofrequency Ablation<br> <br> |
| Active Comparator: Laparoscopic Adrenalectomy<br>Laparoscopic Adrenalectomy | Procedure: Laparoscopic Adrenalectomy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity rate |  | 30-day | 
| Resolution of hyperaldosteronism |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time |  | 24 hours | 
| Periprocedural hypertensive crisis |  | 24 hours | 
| Mortality rate |  | 30 days | 
| Blood loss |  | 24 hours | 
| Analgesic requirement |  | 30 days | 
| Time to resumption of activity |  | 30 days | 
| Resolution of hypokalaemia |  | 1 year | 
| Blood pressure control |  | 1 year | 
| Hospital stay |  | 30 days | 
| Pain score |  | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hyperaldosteronism, Adrenocortical adenoma, Adrenalectomy, Catheter ablation