linjc16/ctgov huggingface dataset:
Vaginal Hysterectomy, Laparoscopic Hysterectomy, Postoperative Pain

Study Overview
=================
Brief Summary
-----------------
The previous studies have shown that recovery after laparoscopic or vaginal hysterectomy is faster than after abdominal approach. The aim of this study is to evaluate postoperative pain after vaginal or laparoscopic hysterectomy. The primary outcome measurement is opioid consumption.

Official Title
-----------------
Postoperative Pain After Vaginal or Laparoscopic Hysterectomy: a Prospective Trial

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Procedure: laparoscopy, laparoscopic hysterectomy
* Procedure: vaginal : vaginal hysterectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 -69 years Gender . female ASA status 1-3 Vaginal hysterectomy or laparoscopic hysterectomy Exclusion Criteria: Body mass Index over 35 Diabetes Mellitus Liver disease Allergies to pharmaceuticals used in the Study Present use of opioids Vaginal prolapse

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 69 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: laparoscopy<br>Intervention: Procedure: laparoscopy | Procedure: laparoscopy, laparoscopic hysterectomy<br>* laparoscopic hysterectomy<br>|
| Active Comparator: vaginal<br>Intervention: Procedure: vaginal | Procedure: vaginal : vaginal hysterectomy<br>* Vaginal hysterectomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative consumption of an opioid (oxycodone) | the consumption of oxycodone will be monitored by recording the amount of the drug received via a commercially available patient controlled analgesia (PCA) pump | 20 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NRS (numeral rating scale) of pain | NRS is evaluated frequently during the study period. | 20 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pain, postoperative, hysterectomy, vaginal, surgery, gynecological
HeartLight Ablation in Patients With Paroxysmal Atrial Fibrillation (PAF)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate the safety and effectiveness of the CardioFocus Endoscopic Ablation System with Adaptive Contact (HeartLight) in the treatment of atrial fibrillation by creating electrical isolation of the pulmonary veins.

Detailed Description
-----------------
A randomized, controlled trial designed to demonstrate the safety and effectiveness of the experimental device to deliver pulmonary vein isolation as a treatment for symptomatic atrial fibrillation.

Official Title
-----------------
Pivotal Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC) or HEARTLIGHT for the Treatment of Symptomatic Atrial Fibrillation

Conditions
-----------------
Paroxysmal Atrial Fibrillation

Intervention / Treatment
-----------------
* Device: EAS-AC (HeartLight)
* Procedure: Control Arm Ablation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 to 75 years. paroxysmal atrial fibrillation failure of at least one AAD others Exclusion Criteria: overall good health as established by multiple criteria

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: EAS-AC (HeartLight)<br>Treatment with the EAS-AC. | Device: EAS-AC (HeartLight)<br>* Pulmonary vien isolation<br>|
| Active Comparator: Control Arm Ablation<br>Treatment with standard ablation. | Procedure: Control Arm Ablation<br>* Treatment with standard ablation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants That Meeting the Efficacy Success Criteria as Described in the Outcome Measure Description | Episodes of AF were monitored during the follow-up period and the rate of participants with no documented, symptomatic episodes of AF in follow-up were be compared. Other efficacy success/failure criteria included acute isolation of all clinically relevant pulmonary veins, lack of ablation-induced left atrial flutter, use of AADs during a follow-up period and left heart ablation or implant for AF in follow-up. Randomized and treated participants that were evaluable for efficacy are reported on for the Outcome Measure. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AF, atrial fibrillation, PAF, PVI, ablation, paroxysmal atrial fibrillation, pulmonary vein isolation
Outcome of Patients Treated With ECLS

Study Overview
=================
Brief Summary
-----------------
Extracorporeal life support (ECLS), also called extracorporeal membrane oxygenation (ECMO), is an extracorporeal technique of providing effective circulatory and (or) respiratory failure, with a growing number of critically ill patients benefit from it. The aim of this study is to investigate the outcome of patients treated With ECMO, and to evaluate the short-term and long-term outcomes of patients with ECLS.

Official Title
-----------------
Outcome of Patients Treated With Extracorporeal Life Support

Conditions
-----------------
Cardiogenic Shock, Cardiac Arrest, Heart Failure, Acute Respiratory Failure, Acute Respiratory Distress Syndrome

Intervention / Treatment
-----------------
* Device: ECMO


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients receiving ECMO for circulatory and/or respiratory support Exclusion Criteria: Refusal of consent

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 100 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: ECMO|ECMO for circulatory and/or respiratory support|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of death from any cause, resuscitated circulatory arrest, and implantation of another mechanical circulatory support device |  | 30 days after ECMO implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality |  | 30 days after ECMO implantation | 
| All-cause mortality |  | 12 months after ECMO implantation |
A Survey on the Rate of Glucose Intolerance in Hong Kong Chinese

Study Overview
=================
Brief Summary
-----------------
Hypothesis: There is a high rate of glucose intolerance among Hong Kong Chinese. The investigators plan to screen Hong Kong Chinese from the community with oral glucose tolerance test (OGTT). The subjects will be referred from GP centers in the community and self-referred with public advertisement on this survey.

Official Title
-----------------
A Survey on the Rate of Glucose Intolerance in Hong Kong Chinese: Validation of the Chinese University Diabetes Screening Score

Conditions
-----------------
Diabetes, Impaired Glucose Tolerance (IGT), Impaired Fasting Glucose (IFG), Glucose Intolerance

Intervention / Treatment
-----------------
* Other: observational: no treatment involved


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hong Kong Chinese without history of diabetes Exclusion Criteria: known diabetic patients

Ages Eligible for Study
-----------------
Minimum Age: 12 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 |
| --- | --- |
| no treatment<br>observational: no treatment involved | Other: observational: no treatment involved<br>* observational: no treatment involved<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose intolerance status by OGTT |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose intolerance status predicted by Chinese University Diabetes Risk Score validated by OGTTT |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
oral glucose tolerance test, Hong Kong Chinese
Prednisolone in Infantile Spasms- High Dose Versus Usual Dose

Study Overview
=================
Brief Summary
-----------------
Infantile spasms comprise a difficult to treat type of epilepsy in young children. Hormonal treatment, i.e. Prednisolone and ACTH are considered the treatment of choice. There is no consensus on the dosage of Prednisolone required for the treatment of infantile spasms. Recent data has shown that a high dose (4 mg/kg/day) may be more efficacious than the usual dose (2 mg/kg/day). However, there are no randomized controlled trials comparing these doses. A higher steroid dose may also be associated with more side effects. Therefore, this study was planned to compare the efficacy and tolerability of the high dose versus the usual dose in children with infantile spasms, in a randomized open-label trial design

Official Title
-----------------
Randomized Trial of High Dose (4mg/kg) Versus Usual Dose (2mg/kg) Oral Prednisolone in the Treatment of Infantile Spasms.

Conditions
-----------------
Infantile Spasms, West Syndrome

Intervention / Treatment
-----------------
* Drug: Oral prednisolone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Children aged 3 months to 2 years presenting with epileptic spasms (at least 1 cluster/day) with EEG evidence of hypsarrhythmia or its variants Exclusion Criteria: Children with active systemic illness Children with evidence of active tuberculosis Severe Acute Malnutrition ad defined by WHO (visible wasting/Mid Upper Arm Circumference < 11 cm/pedal edema/Weight for height < 3 SD) Children with recurrent illness/chronic systemic illness

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum Age: 24 Months

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: High dose<br>Oral Prednisolone will be given at dose of 4 mg/kg/day for 14 days | Drug: Oral prednisolone<br>* Dose will be different in the two groups. the high dose group will receive 4 mg/kg/day. The usual dose group will receive 2 mg/kg/day<br>|
| Active Comparator: Usual dose<br>Oral prednisolone will be given at dose of 2 mg/kg/day for 14 days | Drug: Oral prednisolone<br>* Dose will be different in the two groups. the high dose group will receive 4 mg/kg/day. The usual dose group will receive 2 mg/kg/day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of children who achieved spasm freedom (for at least 48 hours) as per parental reports on day 14 . |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of children with adverse effects |  | 14 days |
Use of Loteprednol for Contact Lens Intolerance and Dryness

Study Overview
=================
Brief Summary
-----------------
Study of the effects of Loteprednol on CL dryness

Official Title
-----------------
Use of Loteprednol for Contact Lens Intolerance and Dryness

Conditions
-----------------
Contact Lenses Dryness

Intervention / Treatment
-----------------
* Drug: Loteprednol
* Other: Rewetter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Between the ages of 18 and over inclusive. Males or females Any race or ethnic background CL history- experienced intolerance and either switched solutions or lenses without satisfactory relief. Patient is in generally good & stable overall health. Patient likely to comply with study guidelines & study visits. Informed consent signed. OSDI score 18 or higher while wearing lenses Unsatisfactory wearing time with contact lenses Exclusion Criteria: Corneal refractive surgery within 6 months of this study. Contact lens use on day of examination. Corneal ectasia. Current use of Restasis Intra-ocular surgery within 6 months or ocular laser surgery within 6 months. Pregnant or lactating women. Ocular pathology (includes glaucoma and cataract) which could impact results and/or place patient at risk.

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Loteprednol<br>Loteprednol BID | Drug: Loteprednol<br>* Anti-inflammatory<br>|
| Placebo Comparator: Rewetter<br>Rewetter BID | Other: Rewetter<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wearing time |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OSDI |  | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Contact lenses, Loteprednol, Effect on CL dryness
Effects of Peritendinous Corticosteroid Injections, Eccentric Training and Heavy Slow Resistance Training in Patellar Tendinopathy

Study Overview
=================
Brief Summary
-----------------
We will investigate the effect of peritendinous corticosteroid injections, eccentric training and heavy resistance training in male patellar tendinopathy patients. The purpose is to compare the clinical effect of these three treatments in a randomised controlled trial. Also we wish to investigate the treatment mechanisms responsible for the effectiveness of the three treatments.

Detailed Description
-----------------
3 interventions groups as described above (n=13 in each group) 12 weeks intervention period. Clinical assessments before and after intervention: VAS, VISA, Tendon thickness, Doppler us activity. Before and after intervention tendon biopsies will be taken and analyzed for crosslinks and fibril diameter. Also tendon mechanical properties will be measured. Tendon and muscle structural properties will be measured with MRI. Treatment satisfaction will be stated after intervention period.

Official Title
-----------------
Effects of Peritendinous Corticosteroid Injections, Eccentric Training and Heavy Slow Resistance Training in Patellar Tendinopathy

Conditions
-----------------
Patellar Tendinopathy / Jumpers Knee

Intervention / Treatment
-----------------
* Procedure: peritendinous corticosteroid injections
* Procedure: eccentric decline squat training
* Procedure: heavy slow resistance training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical patellar tendinopathy pain. Tendon swelling Hypoechoic Doppler activity in tendon Exclusion Criteria: Previous knee surgery diabetes arthritis previous steroid injections

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CORT<br>Peritendinous corticosteroid injections at 0 and 4 weeks. 12 weeks total | Procedure: peritendinous corticosteroid injections<br>* 1 ml of40mg/ml methylprednisolone acetate at 0 and 4 weeks. 2 week observational<br>|
| Experimental: ECC<br>12 weeks of eccentric unilateral decline squats | Procedure: eccentric decline squat training<br>* eccentric decline unilateral squats performed twice daily. for 12 weeks<br>|
| Experimental: HSR<br>Heavy slow resistance training. 3/week. 12 weeks | Procedure: heavy slow resistance training<br>* Heavy slow resistance training for knee extensors. 3/week. total of 12 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Real-Life Use of Anti-fibrotic Drugs in Patients With Idiopathic Pulmonary Fibrosis in Sweden

Study Overview
=================
Brief Summary
-----------------
The objective of the current research project is, by using high quality Swedish registry data, to evaluate use, tolerance and effect of anti-fibrotic drugs in IPF-patients. Secondary study objectives are to determine the clinical profile, determinants of treatment adherence, long-term safety and to describe the patient journey from the first sign of disease to end of treatment.

Official Title
-----------------
Real-Life Use of Anti-fibrotic Drugs in Patients With Idiopathic Pulmonary Fibrosis in Sweden

Conditions
-----------------
Idiopathic Pulmonary Fibrosis

Intervention / Treatment
-----------------
* Other: Anti-fibrostic drugs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All subjects included in the Swedish IPF-registry Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Anti-fibrostic drugs|The real-Life use of anti-fibrotic drugs in patients with idiopathic pulmonary fibrosis in Sweden|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-fibrotic drugs among the patients recorded in the Swedish IPF-registry | The use of anti-fibrostic drugs | 2014-2020 |
A Comprehensive Study of Clinically Staged Pediatric Hodgkin's Disease: Chemotherapy for All Patients; Supplementary Low Dose Involved Field Irradiation for Selected Patients (CCG 5942)

Study Overview
=================
Brief Summary
-----------------
Study Hypothesis: Clinical staging without laparotomy/splenectomy is adequate for children and young adults with Hodgkin's disease who receive chemotherapy as a component of treatment.

Official Title
-----------------
A Comprehensive Study of Clinically Staged Pediatric Hodgkin's Disease: Chemotherapy for All Patients; Supplementary Low Dose Involved Field Irradiation for Selected Patients (CCG 5942)

Conditions
-----------------
Pediatric, Hodgkin's Disease

Intervention / Treatment
-----------------
* Drug: COPP/ABV
* Drug: COPP/ABV
* Drug: intensive chemo with concurrent growth factor


Participation Criteria
=================
Eligibility Criteria
-----------------
Age less than 21 years at diagnosis Previously untreated, pathologically confirmed diagnosis of Hodgkin's disease. Informed patient/parental consent as required by individual institution and in accordance with the Dept of Health and Human Services Approval of this protocol by the individual institutional Human Subjects Review Committee. Indicate Hodgkin's disease clinical stage. Indicate presence or absence of B symptoms. For Stage I and II disease indicate the following: presence or absence of bulk disease number of involved nodal regions presence or absence of hilar adenopathy

Ages Eligible for Study
-----------------
Maximum Age: 21 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: COPP/ABV<br>* 4 courses of COPP/ABV hybrid<br>* Other names: Vinblastine;|
| Experimental: 2<br> | Drug: COPP/ABV<br>* 6 courses of COPP/ABV hybrid<br>* Other names: Vinblastine;|
| Experimental: 3<br> | Drug: intensive chemo with concurrent growth factor<br>* 6 cycles (2 courses) of intensive chemotherapy with concurrent growth factor<br>* Other names: G-CSF (Filgrastim);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the role of adjuvant low dose involved field radiotherapy in pediatric patients with Hodgkin's disease who attain a complete response following initial chemotherapy |  | Conclusion of the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pediatric, Hodgkin's Disease, 96-016