linjc16/ctgov huggingface dataset:
Clinical Evaluation of the AmniSure ROM Test

Study Overview
=================
Brief Summary
-----------------
To show that having less qualified personnel (non-Laboratory trained professionals) perform the test yields the same result as if a Laboratory trained professional performed the test.

Detailed Description
-----------------
The main goal of this study is to show that when performed by less qualified personnel, the AmniSure® ROM Test is so simple and accurate that the likelihood of erroneous results by the Intended-User is negligible and that the test poses no unreasonable risk of harm to the patient if performed incorrectly.

Official Title
-----------------
Clinical Evaluation of the AmniSure ROM Test

Conditions
-----------------
Rupture of Fetal Membranes

Intervention / Treatment
-----------------
* Device: AmniSure ROM test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must be pregnant. Subjects must be between 18 and 50 years of age and have a gestational age of 11.0-42.0 weeks. Subjects reporting suspicion, signs, or symptoms suggestive of ROM, PROM, PPROM. Subjects providing informed consent. Exclusion Criteria: Subjects who have placenta previa. Subjects who have heavy vaginal bleeding. Subjects who have had digital vaginal examination immediately prior to evaluation for ROM.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Symptomatic<br>Individuals with signs, symptoms or suspicion of membrane rupture at 11 to 42 weeks gestation that will receive the AmniSure ROM test. | Device: AmniSure ROM test<br>* Comparison of AmniSure ROM test to clinical diagnosis of ROM.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The evaluation the clinical performance of the AmniSure® ROM test performed by the Intended-User relative to the clinical diagnosis of rupture of membranes. | The investigational AmniSure ROM test will be compared to the three standard tests of nitrazine, ferning and pooling to determine rupture of fetal membranes. | One time at time of enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ROM, PROM, PPROM (preterm premature rupture of membranes)
PH 1 Evaluation Of Oral CI-1033 In Combination With Paclitaxel/ Carboplatin As 1st Line Chemotherapy In NSCLC Patients

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to evaluate the overall safety and maximum dose of CI 1033 in combination with paclitaxel and carboplatin in patients with NSCLC.

Official Title
-----------------
A Phase 1 Evaluation Of Oral CI-1033 In Combination With Paclitaxel And Carboplatin As First-Line Chemotherapy In Patients With Advanced Non-Small Cell Lung Cancer

Conditions
-----------------
Carcinoma, Non-Small Cell Lung

Intervention / Treatment
-----------------
* Drug: CI 1033
* Drug: PACLITAXEL
* Drug: CARBOPLATIN


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least one target lesion that is unidimensionally measurable as defined by Response Evaluation Criteria in Solid Tumors (RECIST ; Appendix B.2 ) and has not been previously irradiated; a tumor that expresses at least one member of the erbB family of receptors (as determined by immunohistochemical evaluation by a Sponsor-designated core laboratory) Exclusion Criteria: Prior chemotherapy, biologic therapy, immunotherapy, treatment with Herceptin, or treatment with investigational agents (including CI 1033); hormonal therapy within 28 days prior to baseline disease assessment (to exclude the possibility of a hormone-withdrawal response); prior definitive radiation therapy to the primary cancer site; not yet recovered from the acute effects of surgery or palliative radiotherapy; brain metastases.

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: CI 1033|nan|
|Drug: PACLITAXEL|nan|
|Drug: CARBOPLATIN|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective is to evaluate the overall safety profile, including dose-limiting toxicities and the maximum tolerated dose, of CI 1033 in combination with paclitaxel (225 mg/m2) and carboplatin (area under the concentration time curve [AUC] of 6 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the recommended Phase 2 dose of CI 1033 in combination with paclitaxel and carboplatin for patients with advanced NSCLC; to further define the safety profile of the recommended Phase 2 dose combination in an expanded cohort (22 patients) |  |  |
ABX-EGF (a Monoclonal Antibody) Given to Patients With Prostate Cancer With or Without Tumor in Other Parts of the Body

Study Overview
=================
Brief Summary
-----------------
A clinical trial examining the safety and effectiveness of ABX-EGF when given to patients with prostate cancer with or without tumor in other parts of the body. Patients will be treated for a maximum of 48 doses (6 treatment courses; 8 doses per course) or until evidence of progressive disease.

Official Title
-----------------
A Clinical Trial Evaluating the Safety and Efficacy of ABX-EGF in Patients With Hormone Resistant Prostate Cancer With or Without Metastasis

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: ABX-EGF


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male 18 years of age or older Has tumor tissue available for diagnostics Failed front line luteinizing hormone-releasing hormone analogue (LHRH) such as leuprolide or goserelin, or failed orchiectomy, as evidenced by disease progression. Patients must continue on a LHRH analogue (unless the patient had an orchiectomy) throughout the course of the study ECOG score of 0 or 1 Exclusion Criteria: Any prior chemotherapy for prostate cancer besides hormonal therapy (including no prior EGFr targeting agent) Prior history of cancer other than prostate carcinoma within the past 5 years that has required treatment or been active (prior basal cell carcinoma is allowed) Known to be HIV positive Myocardial infarction within one year prior to entering the study

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ABX-EGF|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
-----------------
Prostate Cancer, PSA, Hormone refractory, Rising PSA
Impact of Acute Kidney Injury on Sarcopenia and Frailty in Patients With Liver Cirrhosis

Study Overview
=================
Brief Summary
-----------------
The aim of this prospective observational study is to evaluate the impact of acute kidney injury on sarcopenia and frailty in patients with liver cirrhosis.

Detailed Description
-----------------
The aim of this prospective study is to collect data on patients with liver cirrhosis and to investigate the impact of acute kidney injury on sarcopenia and frailty in patients with liver cirrhosis. If patients agree to participate in this clinical trial, the patients' data (such as age, sex, height, weight, nutrition status [RFH-NPT], history of medication, laboratory findings, endoscopic findings, and radiologic findings) will be collected in a research database. Renal injury was measured using conventional and novel serum biomarkers (serum creatinine, cystatin-C, neutrophil gelatinase-associated lipocalin, kidney injury molecule 1, and interleukin-18. Sarcopenia was evaluated using skeletal muscle index on abdominal computed tomography. Frailty was measured using Liver Frailty Index. The research database will be updated to include data on patients' disease outcomes and follow-up care.

Official Title
-----------------
Impact of Acute Kidney Injury on Sarcopenia and Frailty in Patients With Liver Cirrhosis

Conditions
-----------------
Cirrhosis, Kidney Injury, Sarcopenia, Frailty

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Liver cirrhosis aged over 20 years Exclusion Criteria: serum creatinine >1.5 mg/dL on dialysis liver transplant

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- | --- |
| Number of Participants with Acute kidney injury | an increase in SCr of 0.3 mg/dL (26.4 µmoL/L) in <48 hours, or a 50% increase in SCr from a baseline within ≤3 months | up to 24 weeks |
Swiss Atrial Fibrillation Pulmonary Vein Isolation Registry

Study Overview
=================
Brief Summary
-----------------
Registry of patients with atrial fibrillation undergoing catheter-based ablation of atrial fibrillation (pulmonary vein isolation) to determine long-term success rates of catheter-based ablation of atrial fibrillation (pulmonary vein isolation) and to evaluate factors associated with long-term success of catheter-based ablation of atrial fibrillation (pulmonary vein isolation).

Official Title
-----------------
Swiss Atrial Fibrillation Pulmonary Vein Isolation Registry

Conditions
-----------------
Catheter-based Ablation of Atrial Fibrillation

Intervention / Treatment
-----------------
* Procedure: catheter-based ablation of atrial fibrillation (pulmonary vein isolation)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing catheter-based ablation of atrial fibrillation (pulmonary vein isolation) Exclusion Criteria: Patients not able or willing to participate in this study

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 |
| --- |
|Procedure: catheter-based ablation of atrial fibrillation (pulmonary vein isolation)|catheter-based ablation of atrial fibrillation (pulmonary vein isolation)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in retention rate of normal sinus rhythm after catheter-based ablation of atrial fibrillation (pulmonary vein isolation) | changes in retention rate of normal sinus rhythm after catheter-based ablation of atrial fibrillation (pulmonary vein isolation) | before catheter-based ablation of atrial fibrillation and 3, 6 and 12 months after catheter-based ablation of atrial fibrillation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| morphologic changes of left cardiac atrium | echocardiography of left cardiac atrium | before catheter-based ablation of atrial fibrillation (pulmonary vein isolation) | 
| changes in retention rate of normal sinus rhythm after catheter-based ablation of atrial fibrillation (pulmonary vein isolation) | changes in retention rate of normal sinus rhythm after catheter-based ablation of atrial fibrillation (pulmonary vein isolation) | 12 months after catheter-based ablation of atrial fibrillation and then at intervals of one year until 2035 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
atrial fibrillation, pulmonary vein isolation
Study of the Influence of Sleep on Hemodynamic Parameters in Patients With Sleep Disorders

Study Overview
=================
Brief Summary
-----------------
Several epidemiological studies in large cohorts suggest a strong association between sleep duration, complaint of insomnia and risk of hypertension.These findings suggest an important role of sleep quality in development of hypertension. Principal limitations of these studies are the cross-sectional study design, self-report sleep duration and poor measurement of blood pressure. The investigators propose to study an insomniac population with complete evaluation of quality and quantity of sleep, associated to complete hemodynamic measurement of hypertension.

Detailed Description
-----------------
Hypertension and sleep disorders is a cross sectional study realised in an adult cohort with chronic complain of insomnia. In our study, sleep duration is evaluated by complete evaluation of quality and quantity of sleep: one night PSG, associated with sleep agenda during 3 weeks, actigraphy, and several sleep questionnaires. We join to this sleep evaluation, a complete hemodynamic evaluation with: path way velocity and central BP obtained by tonometry, ambulatory BP measurement (ABBM), and self- BP measurement. The primary objective of this epidemiological study is to show an increase risk of hypertension when sleep duration is less than 7 hours, with objective measurement of sleep duration and hypertension. Secondary objectives are to evaluate role of complain of insomnia in the risk of hypertension, and to determine cardiovascular risk in insomnia with hemodynamic explorations.

Official Title
-----------------
Study of the Influence of Sleep on Hemodynamic Parameters in Patients With Sleep Disorders

Conditions
-----------------
Hypertension, Sleep, Insomnia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult with insomnia (6 months or more) Exclusion Criteria: sleep disorders with obstructive apnea

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hypertension | hypertension is defined by blood pressure obtained with 24 hours ambulatory blood pressure measurement when mean blood pressure is over 135/80 in the day, and 125/70 in the night, or when patient take antihypertensive drugs | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hemodynamic measures | central blood pressure, pathway velocity, blood pressure amplification, visit-to-visit variability of blood pressure, cardiac rhythm variability. | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypertension, sleep, insomnia
Visceral Stiffness Measurement Using Acoustic Radiation Force Impulse

Study Overview
=================
Brief Summary
-----------------
The acoustic radiation force impulse (ARFI) technology provides real-time measurements of tissue stiffness. Aim: Using the ARFI ultrasonography, the investigators aims are to complete the correlation and validity studies between visceral ARFI quantification and the referenced Metavir fibrosis scoring and to conduct subsequent innovative studies on liver diseases.

Detailed Description
-----------------
Using ARFI technology, we are establishing a complete hepatic and visceral shear wave spectrum to correspond to the entire METAVIR fibrosis scoring and various functional stratifications.

Official Title
-----------------
Clinical Application of the Spectrum of Visceral Stiffness Measurement Using Acoustic Radiation Force Impulse Technology

Conditions
-----------------
Visceral Stiffness, Liver Fibrosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with chronic liver diseases who underwent liver biopsy patients with pathologically or radiologically proven cirrhosis Exclusion Criteria: Post major abdominal surgery After interferon or neucleos(t)ides treatment PBC,PSC,WD,AIH,viral coinfections Liver abscess Exposure to hepatotoxic drugs or chemicals Thrombosis of splenic vein, portal veins After resection or embolism of the spleen Acute or chronic pancreatitis Biopsy contraindications (not exclusive) ARFI measurements low quality Fibrotest contraindications: Acute hepatitides, Extrahepatic cholestasis, e.g., pancreatic cancer, gallstones, CBD>0.7cm Severe hemolysis Cardiac congestion Liver cancer other than HCC Treated HCC

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| HBV-infected<br> | |
| HCV-infected<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Delirium, Electroencephalographic Alterations and Cortical Spreading Depression (CSD) in Critical Illness

Study Overview
=================
Brief Summary
-----------------
Delirium in the intensive care unit is an acutely developed brain dysfunction affecting up to 80 % of patients. It is associated with significantly increased morbidity and mortality during admission and post-discharge. The mechanism behind the condition is poorly understood but assumably multifactorial, and the purpose of this study is to investigate the pathophysiology further.

Detailed Description
-----------------
The pathophysiology behind delirium in critical illness is not clarified but assumed to involve inflammation, changes in cerebral perfusion and neurotransmission, sleep deprivation and the use of i.e. sedatives. Cortical spreading depression is a phenomenon occuring in critically ill patients with acute cerebral trauma and likely associated with significant secondary neuron damage. The hypothesis is that Delirium in critically ill patients without acute cerebral damage is a clinical manifestation of cortical spreading depression and can be recorded in a noninvasive direct current-electroencephalography Electroencephalographic alterations or potentially specific signatures occur in delirium and thus, delirium can be predicted by recording continuous alternate current electroencephalography on admission in an ICU

Official Title
-----------------
Delirium, Electroencephalographic Alterations and Cortical Spreading Depression in Critical Illness

Conditions
-----------------
Delirium

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: expected admission in the ICU >24 hours Exclusion Criteria: Cerebral trauma <6 months existing delirium severe dementia

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 |
| --- | --- | --- |
| The occurence of electroencephalographic alterations and potential electroencephalographic signatures prior to and during delirium in the ICU |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The occurence of cortical spreading depression in noninvasive direct current-EEG in critically ill patients without acute cerebral trauma |  | Cortical spreading depression in the ICU | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Delirium, electroencephalography, CSD
Physical Activity, Function and Quality of Life in Patients After Endovascular Treatment

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate how systematic physical training after endovascular treatment influence the durability of the endovascular treatment and how it effects physical function, quality of life and future cardiovascular events.

Official Title
-----------------
Physical Activity, Function and Quality of Life in Patients After Endovascular Treatment

Conditions
-----------------
Peripheral Vascular Disease

Intervention / Treatment
-----------------
* Other: Systematic physical training with instructor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 55 years old or older successful endovascular living in Oslo or in the close area being able to come to physical training classes at the hospital Exclusion Criteria: endovascular treatment on study-leg last 2 years other reasons for reduced walking function than peripheral arterial disease
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 |
| --- | --- |
| Experimental: Systematic physical training<br>Hospital-based SET two days per week for 12 weeks and one home-based exercise session every week. The group-based SET was based on The Norwegian Ullevaal Model, a modified cardiac rehabilitation program, and was slightly adjusted to be applicable to this patient group. Each SET session lasted for 60 minutes and consisted of warm-up exercises, three high-intensity, two moderate-intensity and cool-down exercises, including stretching. The exercises were generally simple aerobic dance movements and walking and involved the use of both upper and lower extremities. The warm-up exercises included large muscle movements that were repeated later in the higher-intensity intervals, but with greater force and a larger range of movement. | Other: Systematic physical training with instructor<br>* Training 3 times per week for 6 months, the first 3 months with an instructor<br>|
| No Intervention: Treatment as of today<br>The control group did not receive any additional follow-up regarding exercise at discharge beyond the general advice about the importance of exercise that is routinely provided at the hospital. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to potential occlusion |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 Minutes Walk Test |  | 1 year |