linjc16/ctgov huggingface dataset:
Effect of Neutrophil Elastase Inhibitor on Lung Injury After Esophagectomy

Study Overview
=================
Brief Summary
-----------------
A neutrophil elastase inhibitor may have effect on suppression of the lung injury after thoransthoracic esophagectomy. The investigators hypothesized that postoperative complication, particularly respiratory complication may be reduced by neutrophil elastase inhibitor after esophagectomy.

Detailed Description
-----------------
The aim of this study was to clarify the usefulness of perioperative administration of sivelestat sodium hydrate, a selective inhibitor of neutrophil elastase in the pulmonary function, systemic inflammatory response, and the postoperative clinical course following video-assisted thoracoscopic esohpagectomy for esophageal cancer.

Official Title
-----------------
A Pilot Study of Effect of Neutrophil Elastase Inhibitor on Lung Injury After Esophagectomy

Conditions
-----------------
Esophageal Cancer

Intervention / Treatment
-----------------
* Drug: sivelestat sodium hydrate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Thoracic esophageal squamous cell carcinoma Exclusion Criteria: Preoperative chemoradiotherapy Cardiovascular disease with NYHA grade III or IV Pulmonary disorder with Hugh-Jones classification II, III, IV, or V, preo Liver cirrhosis Renal failure

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 77 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control group<br>Patients in the control group received saline for 7 days starting at the beginning of surgery | Drug: sivelestat sodium hydrate<br>* saline or sivelestat sodium hydrate intravenously for 7 days starting the beginning of surgery<br>* Other names: Elaspol;|
| Active Comparator: S group<br>Patients in the S group received sivelestat sodium hydrate at a dosage 4.8mg/kg/day for 7 days starting at the beginning of surgery | Drug: sivelestat sodium hydrate<br>* saline or sivelestat sodium hydrate intravenously for 7 days starting the beginning of surgery<br>* Other names: Elaspol;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary function | the arterial oxygen pressure | 9 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary function | fraction of inspired oxygen ratio (PF ratio) | 9 days | 
| Pulmonary function | the duration of mechanical ventilation | 9 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Esophagectomy, Postoperative respiratory complications, neutrophil elastase inhibitor
Landing Biomechanics Following Fatigue in Athletes With and Without a History of Patellar Tendinopathy

Study Overview
=================
Brief Summary
-----------------
In this case-control study, two- and three-dimensional landing biomechanics, by means of lower limb joint angles and moments (opto-electronic system with synchronised force plate), will be compared between 30 male volleyball/basketball players with a history of patellar tendinopathy and 30 healthy controls.

Official Title
-----------------
Full-body Landing Biomechanics Following Fatigue in Male Jumping Athletes With and Without a History of Patellar Tendinopathy: a Case Control Study

Conditions
-----------------
Patellar Tendinitis, Fatigue

Intervention / Treatment
-----------------
* Diagnostic Test: Biomechanical analysis
* Other: Fatigue protocol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: volleyball or basketball players male history of patellar tendinopathy Exclusion Criteria: history of surgery of the lower extremities history of fractures of the lower extremities

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 65 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| History of patellar tendinopathy<br> | Diagnostic Test: Biomechanical analysis<br>* 3D analysis of landing manoeuvres.<br>Other: Fatigue protocol<br>* A circuit of different tasks (e.g. jumping, sprinting forward and backward, side-stepping exercise) was performed to induce fatigue.<br>|
| Healthy controls<br> | Diagnostic Test: Biomechanical analysis<br>* 3D analysis of landing manoeuvres.<br>Other: Fatigue protocol<br>* A circuit of different tasks (e.g. jumping, sprinting forward and backward, side-stepping exercise) was performed to induce fatigue.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in landing biomechanics (kinematics and kinetics) | Trunk and lower extremity joint angles and moments will be extracted with an opto-electronic system and synchronised force plate | Immediately after fatiguing exercises | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Biomechanics, Landing
Insulin NovoRapid Versus Actrapid in Treatment of Type 1 Diabetic Patients During Daily Adjustment of Insulin Dose

Study Overview
=================
Brief Summary
-----------------
The main purpose of the study is to investigate the reason for the reduced number of hypoglycaemic attacks in type 1 diabetic patients when, for a period of time, using Insulin Aspart at meals together with NPH insulin mornings and evenings, and when, in another period of time, using human fast-working insulin at meals and NPH insulin mornings and evenings, and when the patients in both periods simultaneously take extra insulin at meals if high blood glucose values are found before meals.

Official Title
-----------------
Is Insulin NovoRapid Better Than Actrapid for Treating Type 1 Diabetic Patients When Simultaneously, Daily Adjusting the Insulin Dose?

Conditions
-----------------
Type 1 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: Insulin NovoRapid versus Actrapid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 diabetes mellitus treated with insulin four times daily (basal bolus treatment) at least three months before screening. AGe: 18-60 years BMI: 18-27.5 No nefro- or neuropathy; i.e. S-creatinin below 120 μmol/l and normal monofilament examination Written informed consent Exclusion Criteria: Pregnant women or patients planning to become pregnant during the investigation period Reduced eyesight; i.e. visus > 0.3 evaluated at the latest eye exam. Patient lacking the ability to sens insulin sensitivity Serious rival disease, i.e. heart disease, severe liver or lung impairment, severe psychiatric disease. Suspicion of abuse or non-compliance Participation in another clinical trial

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Insulin NovoRapid versus Actrapid|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Meal-regulated insulin time two peaks after the two intervention periods |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
type 1 diabetes mellitus, hypoglycaemia, insulin profiles, growth hormone, cortisol, glucagon
Outcomes in Hospitalized Older Patients With COVID-19

Study Overview
=================
Brief Summary
-----------------
In December 2019, the first patients infected with the 2019 novel coronavirus (2019-nCoV) were diagnosed in Wuhan. The clinical presentation and course of Severe Acute Respiratory Syndrome-CoV-2 (SARS-CoV-2) infection is poorly understood in older patients and is certainly different from the general population. This project is designed to better understand and to determine clinical, biological and radiological markers of poor adverse outcomes in hospitalized older patients diagnosed with COVID-19.

Official Title
-----------------
COVIDAge Study- Hospital Des Trois-Chêne

Conditions
-----------------
Coronavirus Infection, Sars-CoV2, Elderly Infection, Old Age; Debility

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of COVID-19, defined by a positive polymerase chain reaction (PCR) test for SARS-CoV-2 detection, obtained by a nasopharyngeal swab or sputum sample. Or patients with negative virus detection in the PCR test, but with a high clinical suspicion will also be considered with COVID-19. Exclusion Criteria: - Presence of document indicating a refusal to participate in a research study.

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

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 |
| --- | --- | --- |
| To evaluate the relative contributions of comorbidities on intra-hospitalized death | We measure functional score of comorbidities | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the relative contributions of functional characteristics on intra-hospitalized death | We measure Functional Independence Measure scale | 1 month | 
| To explore specific clinical profiles that may influence COVID-19 disease outcomes in the elderly based on geriatrics syndromes | We describe the role fo geriatric syndrome such as delirium, falls | 1 month |
LMA Protector Cuff Pilot vs LMA Supreme Among Anaesthetised, Non-Paralysed Patients

Study Overview
=================
Brief Summary
-----------------
Comparison of clinical performance between LMA Protector Cuff Pilot and LMA Supreme in terms of oropharyngeal leak pressure, time to insertion, ease of gastric tube insertion, laryngeal view, incidence of sore throat

Official Title
-----------------
Comparison of Clinical Performance of LMA Protector Cuff Pilot and LMA Supreme Among Anaesthetised, Non-Paralysed Patients

Conditions
-----------------
Anesthesia

Intervention / Treatment
-----------------
* Device: LMA Protector Cuff Pilot
* Device: LMA Supreme


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients planned for general anaesthesia without muscle relaxant usage via supraglottic airway device. Exclusion Criteria: BMI > 35 Patients with likelihood of difficult intubation (Simplified Airway Risk Index Score of 4 or more) Patients with increased risks of aspirations (gastrooesophageal reflux disease, obstetric patients, hiatus hernia)

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LMA Protector Cuff Pilot<br> | Device: LMA Supreme<br>* Assessing the clinical performance of LMA Supreme<br>|
| Active Comparator: LMA Supreme<br> | Device: LMA Protector Cuff Pilot<br>* Assessing the clinical performance of LMA Protector Cuff Pilot<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oropharyngeal leak pressure (OLP) | To assess the OLP of LMA Protector Cuff Pilot and LMA Supreme | During induction of anaesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean time to insertion | To compare mean time to insertion of LMA Protector Cuff Pilot and LMA Supreme | During induction of anaesthesia | 
| Gastric tube insertion | To compare the ease of gastric tube insertion in LMA Protector Cuff Pilot and LMA Supreme | After induction of anaesthesia | 
| Laryngeal view | To compare the laryngeal view between LMA Protector Cuff Pilot and LMA Supreme | After induction of anaesthesia | 
| Complications | To compare the incidence of sore throat and hoarseness of voice after insertion of LMA Protector Cuff Pilot and LMA Supreme | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
LMA Protector Cuff Pilot, LMA Supreme, Clinical Performance
Efficacy, Tolerability and Handling of Daivobet® Gel in Patients With Psoriasis Vulgaris

Study Overview
=================
Brief Summary
-----------------
The purpose of this observational study is to evaluate the efficacy, tolerability, quality of life and handling of Daivobet® Gel by both physician and patient in daily practise.

Official Title
-----------------
Efficacy, Tolerability and Handling of Daivobet® Gel in Patients With Psoriasis Vulgaris

Conditions
-----------------
Psoriasis Vulgaris

Intervention / Treatment
-----------------
* Drug: Daivobet® Gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with light to moderate psoriasis vulgaris of trunk and extremities and treatment with Daivobet® Gel was planned anyway Exclusion Criteria: Previous therapy with Daivobet® Gel Systemic therapy of psoriasis vulgaris Contraindications of Daivobet® Gel in the German package insert

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 |
| --- |
|Drug: Daivobet® Gel|Once daily on areas with plaque psoriasis, treatment duration up to 8 weeks for body skin areas except scalp (scalp up to 4 weeks), treatment may be repeated under medical surveillance.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Handling of Daivobet® Gel | Compared to previous topical treatment: Time required for application (previous treatment versus present treatment), time required until dressing is possible (previous treatment versus present treatment) | After appr 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Dermatology Life Quality Index (DLQI) | 4 weeks | 
| Physician's global Assessment of psoriasis vulgaris | 6-step scale from no visible disease (O) to very severe disease (5) | 4 weeks | 
| Side effects | number of participants with serious and non-serious adverse drug reactions, according to organ classes | 4 weeks |
Prospective Randomized Trial Comparing Robotic Versus Open Radical Prostatectomy

Study Overview
=================
Brief Summary
-----------------
To date, no study has prospectively compared open versus robotic radical prostatectomy in a randomized fashion for patients with prostate cancer. For patients with newly diagnosed prostate cancer who choose surgical management, the choice of surgical approach is often limited to surgeon preference and experience. This study will prospectively randomize patients with localized prostate cancer who are candidates for surgical management to open versus robotic radical prostatectomy.

Conditions
-----------------
Prostatic Neoplasms, Adenocarcinoma

Intervention / Treatment
-----------------
* Procedure: Robotic Radical Prostatectomy
* Procedure: Open Radical Prostatectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Biopsy proven adenocarcinoma of the prostate Deemed a surgical candidate for a bilateral nerve bundle preservation Potent Continent of urine Surgical candidate for both open and robotic nerve-sparing radical prostatectomy Age >18 Exclusion Criteria: Previous treatment of prostate cancer (radiation, hormones, etc.)

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

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

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 |
| --- | --- |
| Active Comparator: Open Radical Prostatectomy<br> | Procedure: Open Radical Prostatectomy<br>* Open radical prostatectomy<br>|
| Active Comparator: Robotic radical prostatectomy<br> | Procedure: Robotic Radical Prostatectomy<br>* Robotic assisted radical prostatectomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trifecta | Free from biochemical recurrence, continent, and potent 2 years after radical prostatectomy | at 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Continence | Continent of urine | at 3, 12, and 24 months | 
| Potency | Satisfactory erections | at 3, 12, and 24 months | 
| Free from biochemical recurrence | PSA <0.2 ng/mL | at 3, 12, and 24 months | 
| Acute complications | Any complication according to Calvien classification | Within 30 days of surgery | 
| Long-term complication | bladder neck contracture, lymphocele | >30 days | 
| Estimated blood loss |  | Participants will be followed for the duration of the operation, an expected average of 3 hours | 
| Operative time |  | Participants will be followed for the duration of the operation, an expected average of 3 hours | 
| Length of hospital stay |  | Participants will be followed for the duration of the hospital stay, an expected average of 1-2 days |
Efficacy and Safety of MK0928 for Insomnia in Adults (0928-003)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to study the safety and effectiveness of MK0928 for adults with insomnia.

Official Title
-----------------
A Double-Blind, Randomized, Multicenter, Placebo-Controlled, Parallel-Groups Efficacy and Safety Extension Study of MK0928 in the Treatment of Adult Outpatients With Primary Insomnia

Conditions
-----------------
Insomnia

Intervention / Treatment
-----------------
* Drug: MK0928, gaboxadol / Duration of Treatment - 1 year
* Drug: Comparator: placebo / Duration of Treatment -1 year


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of insomnia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 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

| Intervention/Treatment |
| --- |
|Drug: MK0928, gaboxadol / Duration of Treatment - 1 year|nan|
|Drug: Comparator: placebo / Duration of Treatment -1 year|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-reported amount of sleep and time to fall sleep at night after three months |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-reported awakenings at night |  |  | 
| Sleep quality |  |  | 
| Functioning after 3 months |  |  |
Effects of Unloading on Muscle Mass

Study Overview
=================
Brief Summary
-----------------
In the present study, the effects of 3 weeks of unloading on muscle mass and muscle fiber characteristics will be determined. In addition, the effects of 6 weeks of recovery will be assessed.

Official Title
-----------------
The Effect of Immobilization on Myocellular Characteristics in Healthy, Young Males

Conditions
-----------------
Immobilization, Physical Inactivity

Intervention / Treatment
-----------------
* Behavioral: unloading


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy BMI < 30 kg/m2 Exclusion Criteria: Use of medication that may affect haemostasis Subjects with (recent) musculoskeletal/orthopaedic disorders known to affect the outcome of the study or that compromise their ability to walk with crutches Subjects with metal implants in their lower limbs Subjects with known cardiovascular and/or haemostasis disorders Subjects with known severe hypertension

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: unloading<br>2 weeks of unloading | Behavioral: unloading<br>* 2 weeks of unloading of a single leg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| muscle mass, muscle fiber size |  | 1 week before unloading; immediately (1 day) after unloading and 6 weeks after unloading | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| muscle strength |  | 1 week before unloading; immediately (1 day) after unloading and 6 weeks after unloading |