linjc16/ctgov huggingface dataset:
Effect of Gui-Lu-Er-Xian-Jiao-Wan on Intradialytic Hypotension

Study Overview
=================
Brief Summary
-----------------
Intradialytic hypotension (IDH), a common complication during hemodialysis (HD) could increase patients' morbidity and mortality. Previous studies considered that some Chinese herbal medicine (CHM) plays a complementary role in reducing the frequency of IDH. This trial is aimed to investigate the effect of Gui-Lu-Er-Xian-Jiao-Wan (GLEXJW) in patients with intradialytic hypotension.

Official Title
-----------------
Effect of Gui-Lu-Er-Xian-Jiao-Wan on Intradialytic Hypotension: a Randomized Crossover Pilot Trial

Conditions
-----------------
Intradialytic Hypotension

Intervention / Treatment
-----------------
* Drug: Gui-Lu-Er-Xian-Jiao-Wan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: End stage renal disease treated with hemodialysis for ≥3 months Receive a standard thrice-weekly hemodialysis schedule More than 25% of hemodialysis sessions complicated by intradialytic hypotension Exclusion Criteria: Active malignancy Life-threatening conditions Pregnancy Recent participation in another clinical trial for intradialytic hypotension History of hypersensitivity or contraindication to herbal medicine

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Gui-Lu-Er-Xian-Jiao-Wan (GLEXJW) 3g orally twice daily for 12 weeks. | Drug: Gui-Lu-Er-Xian-Jiao-Wan<br>* Gui-Lu-Er-Xian-Jiao-Wan (GLEXJW) is an ancient CHM formula, mainly originating from processed tortoise shells, antlers, Ginseng, and wolfberry.<br>* Other names: GLEXJW;|
| No Intervention: Group B<br>No intervention. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intradialytic hypotension episode | Hypotension episode during hemodialysis | Each time of dialysis during 12-weeks study period. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early termination of hemodialysis | The episode of early termination in hemodialysis due to hypotension | Each time of dialysis during 12-weeks study period. | 
| SF-36 | Short Form (36) Health Survey (SF-36) | Baseline, 12 weeks, 28 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intradialytic Hypotension, Chinese herbal medicine, Gui-Lu-Er-Xian-Jiao
Preemptive and Preventive Use of Paracetamol for Pain Relief After Cesarean Section

Study Overview
=================
Brief Summary
-----------------
The investigators designed a prospective randomized study to investigate the efficacy of intravenous (IV) preemptive versus preventive paracetamol on postoperative pain scores, patient satisfaction, total morphine consumption and the incidence of morphine-related side effects in patients undergoing cesarean section.

Official Title
-----------------
A Double Blind Randomised Controlled Trial of Preemptive and Preventive Use of Paracetamol for Pain Relief After Cesarean Section

Conditions
-----------------
Cesarean Section; Dehiscence

Intervention / Treatment
-----------------
* Drug: Paracetamol was given intravenously in both group at different times


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 38 weeks pregnancy, elective cesarean section. - Exclusion Criteria: morbid obesity, cardiac failure, depression.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group Preemptive (Group PE),<br>Group I: i.V. paracetamol 1 g (100 ml) was given 30 min before induction of anesthesia. | Drug: Paracetamol was given intravenously in both group at different times<br> <br> |
| Active Comparator: Group Preventive (Group PV),<br>Group II: i.V. paracetamol 1 g (100 ml) was given before the end of surgery. | Drug: Paracetamol was given intravenously in both group at different times<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog score (VAS) for pain |  | 24 hours |
Risk Factors and Results of Emergency Ventral Hernia Repair

Study Overview
=================
Brief Summary
-----------------
The aim of present study was to evaluate the clinical course after emergency ventral hernia repair in terms of 30-day-readmission, -reoperation and -mortality and to identify risk factors for emergency repair.

Detailed Description
-----------------
All incisional, umbilical and epigastric hernias registered in the Danish Ventral Hernia Database

Official Title
-----------------
Risk Factors and Results of Emergency Ventral Hernia Repair

Conditions
-----------------
Ventral Hernia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All incisional, umblilical and epigastric hernia repiars

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Emergency hernia repairs<br> | |
| Elective hernia repairs<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| risk factors for emergency ventral hernia repair | evaluation of risk factors (hernia size, hernia type, type of surgery, age and gender) for poor outcome after emergency ventral hernia repair. | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day readmission | evaluation of risk factors (hernia size, hernia type, type of surgery, age and gender) for 30-day readmission after emergency ventral hernia repair | 30 days | 
| 30-day reoperation | evaluation of risk factors (hernia size, hernia type, type of surgery, age and gender) for 30-day reaoperation after emergency ventral hernia repair | 30 day | 
| 30-day mortality | evaluation of risk factors (hernia size, hernia type, type of surgery, age and gender) for 30-day mortality after emergency ventral hernia repair | 30 day |
Olmesartan Alone or in Combination With Hydrochlorothiazide in Subjects With Mild to Moderate Essential Hypertension

Study Overview
=================
Brief Summary
-----------------
Efficacy, tolerability and safety of olmesartan alone or in combination with hydrochlorothiazide in the treatment of mild to moderate essential hypertension

Official Title
-----------------
A Phase III, Multicenter, Open-Label, Dose-Titrating, 16-Week Study Evaluating The Efficacy, Tolerability and Safety of Olmesartan Medoxomil 20 Mg and 40 Mg Alone or in Combination With 12.5 Mg to 25 Mg of Hydrochlorothiazide in Subjects With Mild to Moderate Essential Hypertension

Conditions
-----------------
Essential Hypertension

Intervention / Treatment
-----------------
* Drug: olmesartan alone or in combination with hydrochlorothiazide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has mild to moderate hypertension Exclusion Criteria: History of secondary hypertension

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: olmesartan alone or in combination with hydrochlorothiazide|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of olmesartan alone or in combination with hydrochlorothiazide in the treatment of mild to moderate essential hypertension |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of olmesartan alone or in combination with hydrochlorothiazide in the treatment of mild to moderate essential hypertension |  |  |
Utility of MRI With Doppler Ultrasound Gating for Advanced Fetal Monitoring

Study Overview
=================
Brief Summary
-----------------
We will test an ultrasound device that uses sound waves to detect the fetal heart beat, and use this device to tell the MRI scanner when to collect pictures of the fetal heart. This will help freeze motion of the fetal heart, to make MRI pictures sharper. This will be important for assessing human fetal heart disease, an active area of research at our institution.

Official Title
-----------------
Utility of MRI With Doppler Ultrasound Gating for Advanced Fetal Monitoring

Conditions
-----------------
Congenital Heart Disease

Intervention / Treatment
-----------------
* Device: SMART-SYNC LM03


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant adults (age 18 and up) with fetus affected by congenital heart disease singleton pregnancy in their 2nd and 3rd trimesters scheduled for a clinical fetal ultrasound examination at the Fetal Echocardiography Clinic at SickKids Exclusion Criteria: claustrophobia cardiac pacemaker non-MRI compatible implants non-singleton pregnancy obesity (BMI > 30)

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SMART-SYNC LM03<br>All participants | Device: SMART-SYNC LM03<br>* Doppler ultrasound cardiac gating device for fetal MRI application<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison between fetal MRI and fetal echocardiography | Anatomic MR images of the fetal heart will be acquired using prospective gating information from the Doppler ultrasound probe (SMART-SYNC LM03) and used to calculate ejection fraction. These values will be compared with corresponding reference values obtained during the patient's visit to the Fetal Echocardiography Clinic. | within 2 weeks of participation in the study |
LDH as a Biochemical Biomarker to Predict Organ Failure in the Emergency Department Setting

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is evaluate if K3, a novel biomarker, sampled at arrival to the emergency department can be used to predict the development of organ failure measured as SOFA score. K3 consists of lactate dehydrogenase, albumin and magnesium combined.

Official Title
-----------------
LDH as a Biochemical Biomarker to Predict Organ Failure in the Emergency Department Setting

Conditions
-----------------
Multiple Organ Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 years Admitted to emergency department, Karlstad Central Hospital, Sweden Exclusion Criteria: Not in need of venous blood sample

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 |
| --- | --- |
| Adults admitted to ER<br>All adult patients admitted to emergency department during the study period. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of multiple organ failure | Measured as SOFA score. | 30 days or complete ICU stay | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac function | Is it possible to predict cardiac function with the novel biomarker K3, which consists of lactate dehydrogenase, albumin, and magnesium combined? | 30 days or complete ICU stay | 
| All cause mortality |  | 30 days after admission to emergency department |
Three Modalities of Treatment in Operable and Resectable Stage IIIA (T1-3, N2) Non-Small Cell Lung Cancer (NSCLC)

Study Overview
=================
Brief Summary
-----------------
Stage IIIA non-small cell lung cancers comprising a mediastinal ganglionic invasion N2 account for 20 to 30% of the NSCLCs. They are almost always potentially resectable, but the results obtained by surgery alone or surgery followed by chemotherapy (CT) and/or radiotherapy (RT) are insufficient. The neoadjuvant approach was tested, in randomized tests of exclusive CT, or in noncomparative tests of RT-CT.

Detailed Description
-----------------
These results justify the choice of the study design currently suggested, testing the preoperative feasibility chemotherapy: cisplatin-Gemzar (arm A) or chemoradiotherapy: cisplatin-navelbine-radiotherapy (arm B) or Carboplatin-Taxol-radiotherapy (arm C). The results obtained, in terms of feasibility and toxicity, will make it possible to select the optimal diagrams for a phase III study.

Official Title
-----------------
Three Modalities of Treatment in Operable and Resectable Stage IIIA (T1-3, N2) NSCLC. Randomized Phase II Study

Conditions
-----------------
Non-small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: Cisplatin-Gemzar
* Drug: Cisplatin-Navelbine-Radiotherapy
* Drug: Carboplatin-Taxol-Radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Operable and resectable stage IIIA (T1-3, N2) NSCLC World Health Organization (WHO) performance status of 1 or less Exclusion Criteria: Severe cardiac, respiratory, renal or hepatic failure

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cisplatin-Gemzar<br>Cisplatin-Gemzar | Drug: Cisplatin-Gemzar<br> <br> |
| Experimental: Cisplatin-Navelbine-Radiotherapy<br>Cisplatin-Navelbine-Radiotherapy | Drug: Cisplatin-Navelbine-Radiotherapy<br> <br> |
| Experimental: Carboplatin-Taxol-Radiotherapy<br>Carboplatin-Taxol-Radiotherapy | Drug: Carboplatin-Taxol-Radiotherapy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of patients alive and operated on without grade 4 toxicity (except for hematological and N/V toxicities) |  | at week 22 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
operable and resectable stage IIIA (T1-3, N2) NSCLC
Physiological Response to Salbutamol and Exercise

Study Overview
=================
Brief Summary
-----------------
The scope of the study is to investigate the physiological response to salbutamol and exercise. A particular focus is on the metabolic response and amine metabolism.

Official Title
-----------------
Physiological Response to Salbutamol and Exercise

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: salbutamol
* Other: exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy VO2max of >55 ml/min/kg for men and >50 ml/min/kg for women Body mass index (BMI) < 26 Exclusion Criteria: Chronic use of beta2-agonist or allergy towards beta2-agonist Serious adverse effects to beta2-agonist Chronic disease deemed by the study responsible medical doctor to interfere with any part of the study Smoking Chronic use of prescription medicine deemed by the study responsible medical doctor to interfere with any part of the study Pregnancy (for women)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: beta2-agonist and exercise<br>Subjects undergo exercise training with administration of salbutamol (800 microgram in 12 hours x 2) | Drug: salbutamol<br>* subjects ingest salbutamol<br>Other: exercise<br>* subjects undergo 6 weeks of endurance training (3 times weekly)<br>|
| Sham Comparator: placebo and exercise<br>Subjects undergo exercise training with administration of sham placebo | Other: exercise<br>* subjects undergo 6 weeks of endurance training (3 times weekly)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition | Change in body composition (measured by dual energy x ray absorptiometry) | Baseline, 2 weeks, 4 weeks and 6 weeks | 
| Maximal oxygen consumption (VO2max) | Change in VO2max (measured during bike ergometer cycling to exhaustion) | Baseline, 2 weeks, 4 weeks and 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Salbutamol urine concentration | Concentration of salbutamol in urine | Before (baseline) as well as 0-1 hours, 1-2 hours, 2-4 hours, 4-8 hours, and 8-16 hours after administration |
Parental Attitude Toward Children Dental Treatment During COVID-19 Pandemic

Study Overview
=================
Brief Summary
-----------------
The aim of this study is assessment of parental attitude toward children dental treatment and care during Covid 19- crisis

Detailed Description
-----------------
The recent spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and its associated coronavirus disease has gripped the entire international community and caused widespread public health concerns. Many countries all over the world including Egypt, have followed guidelines of limiting dental treatment for emergency cases only. However, as social distancing guidelines are starting to relax across many countries nowadays , dental offices start to reopen for elective procedures , many parents may still have a great concern regarding their children dental treatment during this pandemic. so the aim was to assess their attitude regarding their children dental visit

Official Title
-----------------
Parental Attitude Toward Children Dental Treatment and Care During COVID-19 Pandemic (Cross -Sectional Study)

Conditions
-----------------
Dental Treatment During Covid -19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Egyptian parents living in Egypt having children less than 16 years old Exclusion Criteria: incomplete questionnaire
Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of parental attitude toward children dental visit during Coronavirus crisis | To assess Egyptian parental attitude toward children dental treatment and care during the current Covid 19- Pandemic. outcome will be measured by quesstionnaire | 10 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Covid -19, Dental treatment, Dental Care, parental attitude
Effectiveness Of Single Doses Of Ibuprofen In Patients With Osteoarthritis Of The Knee

Study Overview
=================
Brief Summary
-----------------
To demonstrate that new drugs work, many complex multidose studies are often required. The intent of this study is to use Ibuprofen as an example of a marketed pain relief drug to validate a simpler single dose model for future assessment of new pain drugs.

Official Title
-----------------
A Double-Blind, Randomised, Placebo-Controlled, Cross-Over Pilot Study to Investigate the Efficacy of Ibuprofen in Patients With Osteoarthritis of the Knee Following Administration of a Single Dose

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Drug: Ibuprofen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Subjects diagnosed with primary Osteoarthritis of the knee. Have at least 3 months in symptom duration prior to screening visit. Regular user of a prescribed non-steroidal anti-inflammatory drug (NSAID) or selective cyclo-oxygenase II (COX2) inhibitor for management of knee pain. Pain walking on flat surface within specific interval prior to study start. Exclusion criteria: History of hypersensitivity to NSAIDS. Allergy to Ibuprofen. Use of assistive devices other than a cane or knee brace. History of specified diseases/illnesses. Abnormal blood tests pre-study.

Ages Eligible for Study
-----------------
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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ibuprofen|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity recorded over 0-8 hours using question 1 of the WOMAC (Western Ontario and McMaster University Osteoarthritis Index)pain subscale (visual analog scale). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responder rate Patient impression of change - 8 & 24 hrs post dose Time to use of rescue medication (paracetamol) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoarthritis, Ibuprofen, COX2, VAS, knee, single dose