linjc16/ctgov huggingface dataset:
Musculoskeletal Ultrasound Study in Critical Care: Longitudinal Evaluation

Study Overview
=================
Brief Summary
-----------------
Each year, 110,000 English/Welsh patients are admitted to Intensive Care Units (ICU). Many face prolonged disability as a result. Over two thirds have moderate-extreme limitation in their usual activity a year later, and one-third are severely affected, being unable to continue most activities, or to live independently. Quite why known- but severe muscle wasting isn't may play an important role. We hope to find out, measuring the degree of wasting in patients, and seeking potential causes. We shall also address the mechanism of wasting, which may reflect an altered balance of activity in muscle growth pathways and those that break muscle down. We'll do this by collecting data, taking regular blood tests, scanning the leg muscles with an ultrasound machine, and analysing small muscle samples. In addition, we'll accurately and objectively measure how impaired these patients become, using specialist questionnaires, special monitoring equipment, simple walking tests and occasional special ('Cardio-Pulmonary') exercise tests. We'll try to see how badly activity is limited, and tease out whether muscle weakness plays a significant role in this. Finally, keeping muscles working (hard to do when unconscious/drowsy/bed-bound) may maintain muscle mass, so we'll see whether maintaining muscle activity using painless electrical stimulation will help.

Official Title
-----------------
Assessment of Peripheral Muscle and Bone Mass in the Critically Ill and Its Response to External Muscle Stimulation

Conditions
-----------------
Critical Illness, Septic Shock, Trauma, Organ Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ventilated patients aged > 18 years likely to survive and remain ventilated for 48 hours and on ICU for 7 days will be recruited. Exclusion Criteria: Those who are pregnant, Have active malignancy, Have primary muscle/bilateral lower limb disorders or Are unlikely to survive 48 hrs.

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 |
| --- | --- |
| Multi-organ failure<br>Sedated ventilated patients in multi-organ failure | |
| Single-organ failure<br>Sedated ventilated patients in single organ failure | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cross sectional area of Rectus Femoris | Loss of 15% of Cross sectional area over 10 days | 10 days |
Cellulite and Extracorporeal Shock Wave

Study Overview
=================
Brief Summary
-----------------
Hypothesis: The combination of extracorporeal shockwave and a daily gluteal muscle strength programme is superior to the gluteal muscle strength programme alone in cellulite. Study design: Randomized-controlled trial Analysis: Intention-to-treat Outcome parameters: a) Photo, b) Nürnberger Score, c) circumference measurements, d) capillary blood flow, e) tissue oxygen saturation, f) postcapillary venous blood flow Intervention: Extracorporeal shock wave for six sessions with 2000 impulses at both gluteal and thigh regions plus a specific gluteal strength exercise training Follow-up: 12 weeks

Official Title
-----------------
Cellulite and Extracorporeal Shock Wave - a Randomized Trial

Conditions
-----------------
Cellulite, Microcirculation

Intervention / Treatment
-----------------
* Device: Extracorporeal shockwave therapy
* Device: Sham extracorporeal shock wave plus gluteal strength exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Females ages 18-65yrs Cellulite 1°-4° Informed consent Exclusion Criteria: Pregnancy Open wounds Females >18yrs or >65yrs -

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

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

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 |
| --- | --- |
| Active Comparator: Shockwave plus strength training<br>6 sessions of extracorporeal shock wave plus daily gluteal strength exercises | Device: Extracorporeal shockwave therapy<br>* Extracorporeal shockwave therapy with focussed shock waves (2000 impulses, 0,25mJ/mm2) plus daily gluteal exercises<br>|
| Sham Comparator: Sham extracorporeal shock wave plus gluteal strength exercise<br>SHAM extracorporeal shock wave plus gluteal strength exercise | Device: Sham extracorporeal shock wave plus gluteal strength exercise<br>* Sham extracorporeal shock wave plus gluteal strength exercise<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nuernberger Score based on photo of cellulite |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Circumference of thigh in cm |  | 12 weeks | 
| Capillary blood flow |  | 12 weeks | 
| Tissue oxygen saturation |  | 12 weeks | 
| Postcapillary venous filling pressure |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cellulite; shockwave; microcirculation; skin
Prevalence of Pulmonary Embolism in Patients With Syncope

Study Overview
=================
Brief Summary
-----------------
All patients consecutively referred with the first episode of transient and short-lasting loss of consciousness will have a diagnostic workup for the assessment of the most common causes of syncope, and will be evaluated for the presence of pulmonary embolism (PE) with the use of an internationally accepted algorithm including a pre-test clinical probability (PTP according to the method of Wells et al.) and a high-sensitivity quantitative D-dimer assay. If the PTP is low and D-dimer negative, PE will be excluded. All other patients will undergo confirmatory diagnostic tests (either computerized tomography or ventilation/perfusion lung scanning) in order to confirm or rule out the presence of PE.

Official Title
-----------------
The Prevalence of Pulmonarym Embolism in Patients With the First Episode of Syncope

Conditions
-----------------
Syncope, Pulmonary Embolism

Intervention / Treatment
-----------------
* Other: Lung CT or V/Q scanning in patients with a high pre-test clinical probability of PE and/or a positive D-dimer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: first episode of syncope Exclusion Criteria: previous episodes of syncope ongoing anticoagulation age younger than 18 years pregnancy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: First episode of loss of consciousness<br> | Other: Lung CT or V/Q scanning in patients with a high pre-test clinical probability of PE and/or a positive D-dimer<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the prevalence of PE in a large series of consecutive patients presenting with the first episode of syncope |  | Up to 48 hours after hospital admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the prevalence of pulmonary embolism in patients with apparently unexplained syncope |  | Up to one week after hospital admission | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
syncope, pulmonary embolism
Lifestyle Heart Trial

Study Overview
=================
Brief Summary
-----------------
To assess long-term effects of a strict lifestyle change program on lipids, blood pressure, myocardial perfusion, and coronary atherosclerosis.

Detailed Description
-----------------
BACKGROUND: The trial was the first randomized, controlled trial to determine whether patients outside a hospital could be motivated to make and sustain comprehensive lifestyle changes and whether coronary disease regression could occur as a result of lifestyle changes alone. DESIGN NARRATIVE: Patients were randomly assigned to an experimental group or to a usual-care group. Experimental-group patients were prescribed a lifestyle program including a low-fat vegetarian diet, moderate aerobic exercise, stress management training, stopping smoking, and group support. No animal products were allowed in the vegetarian diet except egg white and one cup per day of non-fat milk or yogurt. The diet contained approximately 10 percent of calories as fat. Control-group patients were not asked to make lifestyle changes. Coronary angiography was performed at baseline and at one year to assess progression or regression of disease. Patients were recruited into the trial between January 1986 and November 1988. The trial was supported prior to April 1989 from various sources other than the National Heart, Lung, and Blood Institute. Follow-up continued for four years. The study completion date listed in this record was obtained from the Query/View/Report (QVR) System.

Conditions
-----------------
Cardiovascular Diseases, Coronary Arteriosclerosis, Coronary Disease, Heart Diseases, Hypercholesterolemia, Hypertension, Myocardial Ischemia

Intervention / Treatment
-----------------
* Behavioral: diet, vegetarianism
* Behavioral: diet, fat-restricted
* Behavioral: exercise
* Behavioral: smoking cessation


Participation Criteria
=================
Eligibility Criteria
-----------------
Men and women, ages 35 to 75, with angiographically documented one, two, or three vessel coronary disease; no myocardial infarction during the preceeding six weeks; and not receiving streptokinase, alteplase, or lipid-lowering drugs.

Ages Eligible for Study
-----------------
Minimum Age: 35 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: Prevention
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: diet, vegetarianism|nan|
|Behavioral: diet, fat-restricted|nan|
|Behavioral: exercise|nan|
|Behavioral: smoking cessation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Somatostatin Analogues With Perioperative Antibiotics Versus Prolonged Antibiotics

Study Overview
=================
Brief Summary
-----------------
Researchers are trying to determine how the length of antibiotic treatment in addition to octreotide after pancreatic surgery affects the amount of time subjects are hospitalized as well as how many subjects develop pancreatic fistulas.

Official Title
-----------------
Randomized Control Trial Comparing Somatostatin Analogues With Perioperative Antibiotics Versus Prolonged Antibiotics

Conditions
-----------------
Pancreatic Diseases

Intervention / Treatment
-----------------
* Drug: Somatostatin analog


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients undergoing a Whipple procedure for various diagnoses (neuroendocrine tumors, adenocarcinoma, benign cystic neoplasms, duodenal and ampullary malignancies, etc) who are deemed intermediate-high risk as per our institutional protocol as shown above. Patients > 18 years of age Exclusion Criteria Negligible and low risk patients All patients undergoing arterial resection. Age <18 years Currently pregnant

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized control trial comparing somatostatin analogues with perioperative antibiotics versus prolonged antibiotics
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>Active somatostatin analogue combined with perioperative antibiotics | Drug: Somatostatin analog<br>* Somatostatin analog plus perioperative antibiotics Placebo plus perioperative antibiotics<br>* Other names: Arm A;|
| Placebo Comparator: Group 2<br>Placebo combined with perioperative antibiotics | Drug: Somatostatin analog<br>* Somatostatin analog plus perioperative antibiotics Placebo plus perioperative antibiotics<br>* Other names: Arm A;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| This study aims to determine whether duration of antibiotic therapy coupled with octreotide leads to reduction of the severity or occurrence of pancreatic fistula. | To compare the active study medication with placebo to see if there is a reduction in the active drug arm in occurrence or pancreatic fistula | During operative time plus 2 to 5 days post op |
The Efficacy and Cost Effectiveness of Preoperative and Postoperative Cryotherapy in Proximal Tibia Fractures

Study Overview
=================
Brief Summary
-----------------
Consenting patients with proximal tibia fractures will be randomized to 10 degree or 21 degree cryotherapy sleeves. Time to discharge and complications will be monitored. Primary outcome measure: Cost of Treatment (based on length of stay) Secondary outcome measures: Satisfaction/pain relief and narcotic requirement

Official Title
-----------------
The Efficacy and Cost Effectiveness of Preoperative and Postoperative Cryotherapy in Proximal Tibia Fractures

Conditions
-----------------
Proximal Tibia Fracture

Intervention / Treatment
-----------------
* Device: Cryotherapy
* Device: Room temperature cuff


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Skeletally mature Trauma patients with single-system musculoskeletal injuries. Proximal tibia fractures treated with open reduction and internal fixation. Unilateral proximal tibial injuries. Exclusion Criteria: Previous ipsilateral knee surgery Upper extremity injuries impairing mobilization Pre-existing ipsilateral neurologic condition or acute ipsilateral neurologic injury Associated injuries impairing mobilization Suspected or confirmed compartment syndrome Open fractures Patients previously on narcotics Patients with impaired sensorium Concurrent head injury Intoxication

Ages Eligible for Study
-----------------
Minimum Age: 17 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 |
| --- | --- |
| Placebo Comparator: 21 degree Cooling<br>Room temperature water circulated through cryotherapy sleeve. | Device: Room temperature cuff<br>* sleeve with room temperature water placed over fracture site.<br>|
| Active Comparator: 10 degree cooling<br>Cooled water circulated through a cryotherapy sleeve. | Device: Cryotherapy<br>* cooled sleeve placed over fracture site.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS Pain Score |  | 2 weeks | 
| Narcotic Requirements |  | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tibial Plateau Fracture, AO/OTA 41
An Observational Study of Tarceva (Erlotinib) in Routine Practice For First Line Maintenance Therapy in Patients With Non Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
This observational study will investigate the tolerability and efficacy of Tarceva (erlotinib) in daily clinical practice under routine conditions in patients with locally advanced or metastatic non small cell lung cancer. Data will be collected for approximately 12 months.

Official Title
-----------------
Erlotinib (Tarceva) in Routine Clinical Practice for First Line Maintenance Therapy (1LM) in Patients With Advanced Non Small Cell Lung Cancer (NSCLC)

Conditions
-----------------
Non-Squamous Non-Small Cell Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients with locally advanced or metastatic non-small cell lung cancer (stage IIIb or IV) with stable disease after 4 cycles of standard platinum-based first-line chemotherapy Exclusion Criteria: Not willing or not able to sign written informed consent form

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 |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival at 1 year |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability of Tarceva in daily clinical practice under routine conditions |  | 12 months | 
| Efficacy of Tarceva in daily clinical practice under routine conditions |  | 12 months | 
| Reproducibility of the results of the controlled SATURN study |  | 12 months |
Study Evaluating the Bioequivalence of Levonorgestrel/Ethinyl Estradiol Combinations in Cycling Women

Study Overview
=================
Brief Summary
-----------------
Levonorgestrel/ethinyl estradiol (LNG/EE) is an investigational drug that is being developed as an oral contraceptive (birth control pill). The purpose of this trial is to compare different preparations of LNG/EE by assessing the way they are absorbed into the blood.

Official Title
-----------------
An Open-Label, Single-Dose, Randomized, 2-Period, Crossover, Bioequivalence Study to Compare Levonorgestrel 90 mg/Ethinyl Estradiol 20 mg in 2 Dosage Forms With Different Dissolution Characteristics in Healthy, Cycling Women

Conditions
-----------------
Contraception

Intervention / Treatment
-----------------
* Drug: Levonorgestrel/Ethinyl Estradiol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women aged 18 to 35 years. Healthy as determined by the investigator on the basis of medical history and screening evaluations. Must have a history of normal menstrual cycles (24 to 34 days) for the 3-month period preceding entry into the study. Exclusion Criteria: Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the test article. Presence, history, or family history of thrombophlebitis, thrombosis, or thromboembolitic disorders, deep vein thrombosis, pulmonary embolism, or known coagulopathy. Bethesda system report of low-grade squamous intraepithelial lesion or greater for a cervical cytologic smear obtained within the last 3 months.

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

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

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Levonorgestrel/Ethinyl Estradiol|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the bioequivalence of 2 batches of LNG/EE tablets with different dissolution characteristics |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To obtain additional safety and tolerability data concerning LNG/EE in healthy, cycling women |  |  |