linjc16/ctgov huggingface dataset:
Genome Studies of Hepatocellular Carcinoma Developed in Hepatitis C Patients With Sustained Virological Response

Study Overview
=================
Brief Summary
-----------------
In this international collaboration study, the research group will analyze somatic mutations of hepatocellular carcinoma (HCC) developed after sustained virological response (SVR) in patients treated with hepatitis C (HCV) therapy

Detailed Description
-----------------
Method Paired liver tissue samples will be collected from the tumour sections and also from the adjacent non-tumour tissues, for comparison in each individual. The tissues have been collected as part of routine clinical work/other studies, by liver biopsies or at liver resection/liver transplantation. Data regarding the patient characteristic will be collected. Whole genome sequencing analyses are planned to be performed.

Official Title
-----------------
Genome Studies of Hepatocellular Carcinoma Developed in Hepatitis C Patients With Sustained Virological Response

Conditions
-----------------
Hepatocellular Carcinoma, Hepatitis C

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with sustained virological response (SVR) after interferon (IFN)-containing or IFN-free treatment, and developed hepatocellular carcinoma (HCC) Available liver biopsies from hepatocellular carcinoma and non-HCC tissue Exclusion Criteria: Co-infection with chronic hepatitis B (HBsAg positive) or HIV infection. Liver transplantation prior to treatment-start, leading to SVR. Patients with diagnosed HCC prior to treatment-start, leading to SVR.

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 |
| --- | --- |
| Patients with SVR and developed HCC<br>HCV patients with SVR and developed HCC plus available tissue from HCC | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterisation of genomic mutations of HCC, developed in HCV patients with SVR | Genetic characteristics of HCCs will be compared to non-HCC tissue | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sustained virological response, Whole genome sequencing
Pilot Study: Intraoperative Clonidine and Postoperative Behaviour

Study Overview
=================
Brief Summary
-----------------
Children who are upset during induction of general anaesthesia are frequently distressed postoperatively and are more likely to demonstrate negative behaviour changes. This pilot study is a randomised controlled study of clonidine vs placebo during anaesthesia to identify whether postoperative behavioural disturbance may be minimised.

Official Title
-----------------
Randomised Controlled Pilot Study: Does Intraoperative Clonidine Reduce the Incidence of Post-hospitalisation Negative Behaviour Changes in Children Who Are Distressed During the Induction of General Anaesthesia?

Conditions
-----------------
Negative Behaviour Change

Intervention / Treatment
-----------------
* Drug: Clonidine
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 2 to 10 years inclusive healthy (ASA 1 or 2) Exclusion Criteria: inability of parents to understand english

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 10 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: clonidine<br>Clonidine intravenous 1 or 2 micrograms / kg | Drug: Clonidine<br>* Comparison between placebo and 2 different concentrations of clonidine<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of negative changes on the post-hospitalization behavior questionnaire |  | 24 hours and 7 days |
Exploratory Study of Raised Serum Lactate as a Marker of Necrotizing Fasciitis

Study Overview
=================
Brief Summary
-----------------
The investigators examined the hypothesis that serum lactate is raised in early necrotizing fasciitis to a much greater extent than in other differential diagnoses, such as severe cellulitis, and therefore provides a diagnostic indicator.

Detailed Description
-----------------
A prospective comparison of serum lactate levels at referral to the Plastic Surgery team to the 'gold standard' test of histology at initial surgical debridement, looking at 53 consecutive patients referred with suspected necrotizing fasciitis to a single surgeon at one institution between 2000 and 2010.

Official Title
-----------------
Raised Serum Lactate as a Marker of Necrotizing Fasciitis; a Consecutive Prospective Review.

Conditions
-----------------
Fasciitis, Necrotizing

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Referral to one consultant (Mr A Armstrong) at one institution (Wexham Park Hospital) with a suspected diagnosis of necrotizing fasciitis between September 2000 and September 2010 Exclusion Criteria: Nil
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Necrotizing fasciitis proven<br>Histological evidence of necrotizing fasciitis at initial surgical debridement | |
| Not necrotizing fasciitis<br>A composite of those with no histological tissue necrosis at initial surgical debridement, and those clinically judged not to be a necrotizing infection who therefore did not undergo surgery. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum lactate level | Serum lactate level at initial referral to the plastic surgery team, as measured by arterial blood gas analysis (calibrated point-of-care testing). Levels compared between the group with confirmed histological necrosis at initial surgical debridement, versus those with no evidence of necrosis (a composite of those who did not undergo surgery as they were judged not to have necrotizing fasciitis, and those who did undergo surgery, but whose histology did not show tissue necrosis). | At referral to the Plastic Surgery Team | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Necrotizing fasciitis, Fournier's gangrene, Cellulitis, Serum Lactate
Laboratory Characteristics in Chronic Atrophic Acrodermatitis

Study Overview
=================
Brief Summary
-----------------
The main objective of this study is to characterize the inflammatory proteins, gene polymorphisms, and transcriptome profiles in patients with chronic atrophic dermatitis to gain better insight into pathogenesis of chronic infection with Borrelia burgdorferi sensu lato.

Official Title
-----------------
Inflammatory Proteins,Gene Polymorphisms, and Transcriptome Profiles in Patients With Chronic Atrophic Acrodermatitis

Conditions
-----------------
Chronic Atrophic Acrodermatitis

Intervention / Treatment
-----------------
* Drug: doxycycline orally, 100 mg, bid, 14 days
* Drug: doxycycline orally, 100 mg, bid, 28 days


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chronic atrophic dermatitis in patients >18 years Exclusion Criteria: none

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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ACA-doxy 14 days<br>patients with chronic atrophic acrodermatitis treated with doxycycline for 14 days | Drug: doxycycline orally, 100 mg, bid, 14 days<br> <br> |
| Active Comparator: ACA-doxy 28 days<br>patients with chronic atrophic acrodermatitis treated with doxycycline for 28 days | Drug: doxycycline orally, 100 mg, bid, 28 days<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| inflammatory proteins in patients with chronic atrophic dermatitis | The inflammatory immune profiles will be assessed using Luminex to measure the expression of cytokines and chemokines representative of innate and adaptive TH1, TH2, TH17, and B cell responses. | up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical characteristics of patients with chronic atrophic dermatitis treated with doxycycline for 14 or 28 days |  | at enrollment, at 2, 6 12 and 24 months follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic atrophic acrodermatitis, Lyme borreliosis, molecular characteristics, outcome
Hemodynamic Profile of Terlipressin and Octreotide in Patients With Cirrhosis and Portal Hypertension. A Randomised, Single Blinded Clinical Trial.

Study Overview
=================
Brief Summary
-----------------
Clinical trial to compare the effects of terlipressin and octreotide in the reduction of portal hypertension measured as hepatic venous pressure gradient (HVPG) in patients with liver cirrhosis

Official Title
-----------------
Hemodynamic Profile of Terlipressin and Octreotide in Patients With Cirrhosis and Portal Hypertension. A Randomised, Single Blinded Clinical Trial.

Conditions
-----------------
Liver Cirrhosis Portal

Intervention / Treatment
-----------------
* Drug: Terlipressin
* Drug: Terlipressin
* Drug: Octreotide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 18-75 years old. Liver Cirrhosis Portal hypertension Stable disease in the absence of vasoactive agents Signed informed consent form Exclusion Criteria: 1. Patients on medications that can prolong QT interval 2. Patients with HCC not fulfilling Milan criteria for transplant 3. Grade II-IV hepatic encephalopathy 4. GI bleeding in the last 10 days 5. Child-Pugh C above 12 points 6. Bacterial infection in the last 10 days 7. HVPG <12mmHg 8. Plasma sodium <130mmol/l 9. Serum creatinine >2mg/dl 10. Serum bilirubin >5mg/dl 11. INR>2.5 12. Uncontrolled cardiovascular disease 13. HIV infection 14. Extra hepatic malignancies 15. Heart failure NYHA Grade III/IV, COPD GOLD>2 16. Morbid obesity 17. Coronary heart disease or intestinal ischemia 18. Pregnancy or breastfeeding

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Terlipressin IV bolus<br>Terlipressin 1mg IV bolus | Drug: Terlipressin<br>* Terlipressin 1mg IV bolus<br>|
| Experimental: Terlipressin IV continuous infusion<br>Terlipressin by IV continuous infusion at a rate of 2mg/day (max 4mg/day) during 2 hours | Drug: Terlipressin<br>* Terlipressin by IV continuous infusion at a rate of 2mg/day (max 4mg/day) during 2 hours<br>|
| Experimental: Octreotide IV bolus plus continuous infusion<br>Octreotide 50mcg IV bolus plus continuous infusion at a rate of 50mcg/h during 2 hours | Drug: Octreotide<br>* Octreotide 50mcg IV bolus plus continuous infusion at a rate of 50mcg/h during 2 hours<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HVPG |  | 30 minutes, 1 hour and 2 hours |
Neulasta® in Subjects With Advanced Non-Small-Cell Lung Cancer (NSCLC) During Chemotherapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to estimate the relationship between patient reported outcomes (PROs) and neutropenia (or its complications) in NSCLC subjects receiving chemotherapy with or without Neulasta® (pegfilgrastim).

Official Title
-----------------
A Pilot Study of the Effects of Neutropenia on Patient Reported Outcomes During Chemotherapy With or Without Neulasta® (Pegfilgrastim) in Subjects With Advanced NSCLC

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

Intervention / Treatment
-----------------
* Drug: Neulasta® (pegfilgrastim)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Non-small cell lung cancer, not previously treated with chemotherapy or radiotherapy - ECOG performance status 0 or 1 - ANC greater than or equal to 2.0 x 10^9/L Exclusion Criteria: - Cancer other than NSCLC within 5 years of enrollment, with the exception of surgically cured basal cell carcinoma or in situ carcinoma of the cervix - Treatment less than or equal to 30 days prior with any experimental agent - Subjects with symptomatic brain metastases - Subject is currently enrolled or has not yet completed at least 30 days since ending other investigational device or drug trial(s) or is receiving other investigational agent(s)

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: Neulasta® (pegfilgrastim)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life, *Neutropenia, *Hospitalization, *Disease Response |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non Small Cell Lung Cancer, NSCLC, Fever, Neutropenia, Neulasta®, Quality of Life, Chemotherapy, Amgen
Intensity of Physical Activity Measured by Activity Monitors in Elderly Persons

Study Overview
=================
Brief Summary
-----------------
Aim of this study is to identify intensity cut off points for physical activity in a population over the age of 70.

Detailed Description
-----------------
Activity monitors measure activity in counts. The higher the counts, the higher the intensity of the measured activity. In this study the count cut off points for low, moderate and high intensity activity will be investigated in a population of elderly people over the age of 70. This information will subsequently (in future studies) be used to investigate the physical activity patterns in a population of elderly over the age of 70 who have worn an activity monitor for a duration of 7 days.

Official Title
-----------------
Assessment of Intensity Cut Off Points for Physical Activity Measured by Activity Monitors in Elderly Persons

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ability to walk at least 1km, born in 1938,1939,1940,1941 or 1942 Sufficiently good health to be able to take part in the study, as determined by the researchers Exclusion Criteria: Illness or disability that precludes exercise or hinders completion of the study Uncontrolled hypertension Symptomatic valve disease hyper tropic cardio-myopathy unstable angina Active cancer Test results indicating that study participation is unsafe Inclusion in other studies conflicting with participation in this one

Ages Eligible for Study
-----------------
Minimum Age: 70 Years
Maximum Age: 76 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 |
| --- | --- |
| Gen100<br>150 participants in the Generation 100 study with anticipated 3000 participants aged 70-75 | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensity of physical activity | measured in counts by activity monitors | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
oxygen consumption, activity monitors, METs, intensity
Estrogen, Cytokines and Heart Failure in Women

Study Overview
=================
Brief Summary
-----------------
To determine the effects of estrogen therapy on postmenopausal women with congestive heart failure.

Detailed Description
-----------------
BACKGROUND: Congestive heart failure (CHF) is a leading cause of morbidity, mortality, and hospitalization in women. The increase in mortality suggests that postmenopausal estrogen loss may alter the phenotypic expression of CHF. Because estrogen is a potent in vitro inhibitor of pro-inflammatory cytokines (e.g., TNFa, IL-1B, IL-6), which are re-expressed by the failing myocardium in patients with CHF and are related to an adverse prognosis, the study postulates that estrogen replacement will improve the outcome of postmenopausal women with CHF. DESIGN NARRATIVE: The randomized, double blind study was conducted in 166 postmenopausal women with congestive heart failure due to idiopathic (i.e.nonischemic) dilated cardiomyopathy and NYHA class II or III symptoms on either combined estrogen and progestin or placebo. Women maintained their then current congestive heart failure medications for six months. Three outcomes were measured: 1) Congestive heart failure severity/functional capacity quantified by maximum oxygen consumption during metabolic stress testing; 2) Left and right ventricular remodeling quantified by electron bean CT scan; 3) quality of life assessment by the Minnesota Living with Heart Failure and Kansas City cardiomyopathy questionnaires. In addition, measurements were made of pro-inflammatory markers, that had been demonstrated to be elevated in congestive heart failure to assess whether hormone replacement therapy reduced them. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Heart Failure, Congestive, Heart Diseases, Menopause

Intervention / Treatment
-----------------
* Drug: Hormone Replacement Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Postmenopausal women with NYHA Class II or Class III congestive heart failure due to idiopathic dilated cardiomyopathy.

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

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

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

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

Design Details

Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Hormone Replacement Therapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Multicenter Study to Evaluate the Safety of Seasonique, an Oral Contraceptive.

Study Overview
=================
Brief Summary
-----------------
This study is being conducted to evaluate the safety of ethinyl an extended-regimen oral contraceptive, with ethinyl estradiol supplementation during the usual hormone-free week, for up to an additional three consecutive years.

Detailed Description
-----------------
This study is being conducted to evaluate the safety of an extended-regimen oral contraceptive, with ethinyl estradiol supplementation during the usual hormone-free week, for up to an additional three consecutive years. This is an extension of the Seasonique Phase 3 clinical trial to evaluate long-term safety. Only patients enrolled in the earlier trial are eligible for participation.

Official Title
-----------------
A Prospective, Multiple Site Study to Evaluate the Safety of an Extended Cycle Combination Oral Contraceptive, Seasonique, Which Utilizes Ethinyl Estradiol During the Pill-free Interval.

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

Intervention / Treatment
-----------------
* Drug: Levonorgestrel/EE 0.15/0.03 mg and EE 0.01 mg tablets


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant in the earlier Phase 3 Seasonique clinical trial Exclusion Criteria: Any contraindication to the use of oral contraceptives

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

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Levonorgestrel/EE 0.15/0.03 mg and EE 0.01 mg tablets<br>* 1 tablet daily<br>* Other names: Seasonique;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient and Investigator reports of adverse events |  | Duration of Study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
oral contraceptives, birth control, ethinyl estradiol, pregnancy prevention