linjc16/ctgov huggingface dataset:
Photodynamic Therapy of Actinic Keratosis of the Face and Scalp With and Without Prior Curettage

Study Overview
=================
Brief Summary
-----------------
Guidelines for photodynamic therapy (PDT) of actinic keratosis recommend pretreatment with curettage. The impact of curettage on the treatment effect is, however, not known. The present study aimed to evaluate whether daylight-PDT without curettage would reduce treatment effect compared to daylight-PDT with curettage.

Official Title
-----------------
Photodynamic Therapy of Actinic Keratosis of the Face and Scalp With and Without Prior Curettage

Conditions
-----------------
Keratosis, Actinic

Intervention / Treatment
-----------------
* Drug: No curettage
* Drug: Curettage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Multiple actinic keratosis on the forehead or scalp Exclusion Criteria: Known allergy to methyl aminolevulinate Porphyria Pregnancy Lactation

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PDT with no curettage<br> | Drug: No curettage<br>* Standard PDT without curettage<br>|
| Active Comparator: Standard PDT<br> | Drug: Curettage<br>* Standard PDT<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete lesion response rate | Complete lesion response rate, was defined as the number of completely responding lesions divided by the total number of treated lesion in each field. Complete lesion response was defined as complete disappearance of the lesion both by palpation and visually. | Treatment efficacy was evaluated 3 months after PDT |
MRI of the Liver With Eovist

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if a new magnetic resonance (MR) protocol is better at diagnosing liver lesions.

Detailed Description
-----------------
Hepatocellular carcinoma (HCC), a form of liver cancer, is the seventh most common cause of cancer mortality in the US. The incidence rate of HCC is increasing along with the incidence of Hepatitis B and C which are known to promote HCC. Patients have a better prognosis (survival outlook) if HCC is found and treated at an early stage. MRI is the best imaging modality for diagnosing HCC. This study will compare standard MRIs and MRIs performed with a newly developed MR protocol to determine if it is possible to more confidently diagnose HCC.

Official Title
-----------------
Dynamic Contrast Evaluation of the Liver Using Gadoxetate Disodium (Eovist®) for Hepatocellular Carcinoma (HCC)

Conditions
-----------------
Hepatocellular Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: known hepatocellular carcinoma undergoing MRI of the liver Exclusion Criteria: Contraindication to MRI with IV contrast

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 |
| --- | --- | --- |
| Accuracy of a new MR protocol in diagnosing HCC and other liver lesions. |  | One day: participants will have one MRI of the liver. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HCC, hepatocellular carcinoma, Eovist, MR, MRI, magnetic resonance
Eradication of Malignant Carcinoma in the Breast Tissue

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to confirm the findings of an early study and expand our knowledge of treating Malignant Carcinoma in the Breast Tissue Using an ATP (Adenosine-5'-Triphosphate) Inhibitor.

Official Title
-----------------
The Eradication of Malignant Carcinoma in the Breast Tissue Using an ATP (Adenosine-5'-Triphosphate) Inhibitor

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Dietary Supplement: Acetogenins
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of breast cancer Referred to the study by their treating physician Exclusion Criteria: Any type of treatment for breast cancer before starting the study

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 75 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Acetogenins<br>Dietary Supplement: Acetogenins BID for 12 months | Dietary Supplement: Acetogenins<br>* Acetogenins BID for 12 months<br>|
| Placebo Comparator: Placebo<br>Dietary Supplement: No Acetogenins BID for 12 months | Dietary Supplement: Placebo<br> <br> |
| No Intervention: Control<br>Control subjects will not receive the Acetogenins or the placebo. They will be evaluated every other month to monitor disease progress. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants tumor free | assessed by MRI | 12 months |
A Trial Investigating the Concentration in the Blood of NN1250 in Children, Adolescents and Adults With Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial was conducted in Europe. The aim of this clinical trial was to look into the concentration of NN1250 (insulin degludec/insulin 454) in the blood after one injection of NN1250 in children, adolescents and adults with type 1 diabetes.

Official Title
-----------------
A Trial Investigating the Pharmacokinetic Properties of NN1250 in Children, Adolescents and Adults With Type 1 Diabetes

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

Intervention / Treatment
-----------------
* Drug: insulin degludec
* Drug: insulin glargine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female aged 6-65 years (both inclusive) Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months Body mass index for children: 15.0-20.0 kg/m^2 (both inclusive), for adolescents: 18.0-28.0 kg/m^2 (both inclusive) and for adults maximum 30.0 kg/m^2 Exclusion Criteria: Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening Not able or willing to refrain from smoking during the inpatient period Female of childbearing potential who is pregnant, breast-feeding or intends to become pregnant or is not using adequate contraceptive methods

Ages Eligible for Study
-----------------
Minimum Age: 6 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A1, first period<br> | Drug: insulin degludec<br>* 0.4 U/kg body weight injected subcutaneously (under the skin), single dose<br>|
| Active Comparator: A2, second period<br> | Drug: insulin glargine<br>* 0.4 U/kg body weight injected subcutaneously (under the skin), single dose<br>|
| Active Comparator: B1, first period<br> | Drug: insulin glargine<br>* 0.4 U/kg body weight injected subcutaneously (under the skin), single dose<br>|
| Experimental: B2, second period<br> | Drug: insulin degludec<br>* 0.4 U/kg body weight injected subcutaneously (under the skin), single dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the NN1250 concentration-time curve after single dose |  | 0-72 hours after dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed NN1250 concentration after single dose |  | 0-72 hours after dosing | 
| Time to maximum observed NN1250 concentration after single dose |  | 0-72 hours after dosing |
Lithium Dilution Method in Guiding Fluid Therapy in Critically Ill Patients

Study Overview
=================
Brief Summary
-----------------
Hypothesis: Fluid management guided by LiDCO doesn´t increase cumulative fluid balance and shorten organ dysfunction compared to fluid management based on CVP and clinical judgment.

Official Title
-----------------
LIGA Trial-Lithium Dilution Method in Guiding Fluid Therapy in Critically Ill Patients

Conditions
-----------------
Critical Illness

Intervention / Treatment
-----------------
* Device: LiDCO technology


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age Needs for fluid chalange Invasive ventilatory supportinvasive blood pressure monitoring Lidco monitoring Central venous catheter Exclusion Criteria: DNR Need for CRRT Head injury

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LI<br>arm controled by LIDCO technology | Device: LiDCO technology<br>* non invasive monitoring of cardiac output<br>|
| No Intervention: CA<br>standard approach | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| positive or negative fluid balance |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effect of LiDCO monitoring on cumulative fluid balance |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fluid, Lidco technology, guided therapy, fluid management guided by Lidco technology
A Low Dose Remifentanil Infusion During Tracheal Extubation in Surgical Intensive Care Unit Patients

Study Overview
=================
Brief Summary
-----------------
Tracheal extubation can be associated with hyperdynamic circulatory response. The investigators examined the effect of maintaining a remifentanil infusion on the cardiovascular response during extubation in propofol-remifentanil sedated patients after surgery.

Official Title
-----------------
A Low Dose Remifentanil Infusion During Tracheal Extubation in Surgical Intensive Care Unit Patients

Conditions
-----------------
Tracheal Extubation

Intervention / Treatment
-----------------
* Drug: Remifentanil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 20 Short term ventilator care after surgery in intensive care unit Exclusion Criteria: pneumonia chronic obstructive lung disease asthma end stage renal disease risk factors for aspiration

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| No Intervention: Control<br>stopping of propofol and remifentanil infusion | |
| Active Comparator: Remifentanil<br>stopping of propofol and maintenance of remifentanil infusion | Drug: Remifentanil<br>* Control group : stopping of propofol and remifentanil infusion Remifentanil group : stopping of propofol and maintenance of remifentanil infusion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Arterial Pressure Changes During Extubation |  | 10 min | 
| HR Changes During Extubation |  | 10 min | 
| The Grade of Coughing During Extubation | Grade of cough was assessed on a four-point scale (0=no coughing, 1=single cough, 2=more than one episode of nonsustained coughing, 3=sustained and repetitive coughing with head lift). | 2 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of Awake | Time of BIS > 80 : time between 'stopping of propofol' | 1 hour | 
| Time of Extubation | Time of extubation : time between 'stopping of propofol' and 'extubation' | 1 hr | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
safety and efficacy of maintaining a remifentanil infusion during extubation in propofol-remifentanil sedated patients after surgery
ORWH:SCOR on Sex and Gender Factors Affecting Women's Incontinence

Study Overview
=================
Brief Summary
-----------------
This study consists of two studies with overlapping cohorts. One is a follow up epidemiological study of urinary incontinence, the other is a case control study of lower urinary tract dysfunction in women with diabetes. Study One: Subjects for the study will be a retrospective cohort of 2100 middle-aged and older women from a large health maintenance organization who have participated in the Reproductive Risk Factor for Incontinence Study at Kaiser (RRISK). The RRISK I study assembled a retrospective cohort of long-term female Kaiser Permanente members to determine the association between specific childbirth events, hysterectomy, hormone use and urinary incontinence later in life. The study also provides descriptive information on urinary incontinence by type, age, ethnicity, severity and age of onset. Study Two: Women with diabetes have a 30-70% increased risk of lower urinary tract dysfunction, including lower urinary tract symptoms, urinary incontinence, and ultimately bladder cystopathy. This sudy investigates the natural history, risk factors, and possible mechanisms of lower urinary tract dysfunction and infection among women with type 2 diabetes as compared to women without diabetes.

Official Title
-----------------
ORWH:SCOR on Sex and Gender Factors Affecting Women's Incontinence

Conditions
-----------------
Urinary Incontinence, Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Previous participation in the Reproductive Risk Factors for Incontinence Study at Kaiser.

Ages Eligible for Study
-----------------
Minimum Age: 44 Years
Maximum Age: 73 Years

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

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 |
| --- | --- | --- |
| Urinary Outcomes |  | 1999-2012 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy
A Drug Interaction Study Between Tocilizumab, Methotrexate and Simvastatin on Patients With Rheumatoid Arthritis.

Study Overview
=================
Brief Summary
-----------------
This 2 arm study will investigate the pharmacokinetics of simvastatin and methotrexate in combination with tocilizumab to assess any potential drug interactions. Patients will be randomized to receive either tocilizumab (10mg/kg iv infusion on day 8) + methotrexate (10-25mg po /week) or tocilizumab + methotrexate + simvastatin (40mg po on days 1, 15 and 43). Blood samples will be taken for analysis at intervals up to day 44. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.

Official Title
-----------------
A Randomized, Open-label Study to Assess the Pharmacokinetics of Simvastatin and Methotrexate in Combination With Tocilizumab in Patients With Rheumatoid Arthritis.

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: tocilizumab [RoActemra/Actemra]
* Drug: Methotrexate
* Drug: Simvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients, 18-75 years of age; rheumatoid arthritis for >=6 months; methotrexate for >=12 weeks prior to day 1 (stable at 10-25mg/week for 8 weeks). Exclusion Criteria: history of, or current inflammatory joint disease or rheumatic autoimmune disease other than RA; concurrent treatment with any DMARD other than methotrexate; prior treatment with tocilizumab.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: tocilizumab [RoActemra/Actemra]<br>* 10mg/kg iv on day 8<br>Drug: Methotrexate<br>* 10-25mg po/week<br>Drug: Simvastatin<br>* 40mg po on days 1, 15 and 43<br>|
| Active Comparator: 2<br> | Drug: tocilizumab [RoActemra/Actemra]<br>* 10mg/kg iv on day 8<br>Drug: Methotrexate<br>* 10-25mg po/week<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameters for simvastatin and metabolite, and methotrexate and metabolite. |  | Days 1, 15 and 43 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameters for tocilizumab. |  | Days 11, 22, 29 and 36. | 
| CRP, IL-6, sIL-6R changes |  | Throughout study | 
| AEs, laboratory parameters. |  | Throughout study |
Long Term Cognitive Impact of Pediatric Acute Renal Injury

Study Overview
=================
Brief Summary
-----------------
The research study will investigate the longitudinal cognitive outcomes in subjects admitted as children diagnosed with sepsis who may have had acute kidney injury. Each subject will be contacted 2-15 years after their incident admission in order to solicit responses to a functional and cognitive quality of life survey. Children admitted during the same time frame that did not have kidney injury will also be surveyed.

Detailed Description
-----------------
250 subjects with a prior admission for pediatric sepsis will be contacted 2-15 years following the incident admission in order to complete a survey to assess their overall quality of life. Children will be administered the Pediatric Quality of Life (PedsQL) survey with a parental section to allow for parental response. Adult subjects will take the adult version of the PedsQL.

Official Title
-----------------
Long Term Cognitive Impact of Pediatric Acute Renal Injury

Conditions
-----------------
Acute Kidney Injury

Intervention / Treatment
-----------------
* Other: Pediatric Quality of Life (Peds QL) Survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects may be adults or children who were admitted to the hospital with a severe infection between January 1998 to December 2014. Consent from adult or parent/guardian of child to participate in study. Assent from subjects between 7 and 17 years of age. Exclusion Criteria: Failure or inability to complete the survey Participant is unable to understand written or spoken English Subjects between 7 and 17 years of age unwilling to assent.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 36 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 |
| --- | --- |
| Sepsis with acute kidney injury (AKI)<br>Prior admission for sepsis with a diagnosis of AKI as a child. Intervention: The subjects will be administered the Peds QL survey. | Other: Pediatric Quality of Life (Peds QL) Survey<br>* The subjects will be administered the Peds QL survey. Children will also have a parental section for parental response. This is NOT an interventional study.<br>|
| Sepsis without acute kidney injury (AKI)<br>Prior admission for sepsis without a diagnosis of AKI as a child. Intervention: The subjects will be administered the Peds QL survey. | Other: Pediatric Quality of Life (Peds QL) Survey<br>* The subjects will be administered the Peds QL survey. Children will also have a parental section for parental response. This is NOT an interventional study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall health related quality of life score (HRQOL) | Scale 0-100 | Baseline |