linjc16/ctgov huggingface dataset:
A Trial of SK-PC-B70M in Mild to Moderate Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find optimistic dose and to evaluate the efficacy and safety of SK-PC-B70M in patients with mild to moderate Alzheimer's disease.

Official Title
-----------------
Dose Finding Study to Assess the Efficacy and Safety of SK-PC-B70M in Patients With Mild to Moderate Alzheimer's Disease

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Drug: SK-PC-B70M


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age range : 50   85 years Clinical diagnosis of probable Alzheimer's disease (DSM-IV and NINCDS-ADRDA criteria) MRI within the last 12 months consistent with a diagnosis of AD MMSE score 10 to 26 AChEI or memantine was discontinued at least 3 months prior to screening Exclusion Criteria: Patient in mild cognitive impairment (MCI; CDR-SB <2.5) Other central nervous disease hypothyroidism, Vitamin B12/ Folic acid deficiency, hypercalcemia, neurosyphilis, AIDS T.I.A or Major infarction within the last 12 months Any serious disorder that could limit the ability of the patient to participate in the study COPD or asthma Any condition which would make the patient or the caregiver, in the opinion of the investigator, unsuitable for the study

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 85 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br> | Drug: SK-PC-B70M<br>* dosage, frequency<br>|
| Active Comparator: 2<br>200mg qd | Drug: SK-PC-B70M<br>* dosage, frequency<br>|
| Active Comparator: 3<br>200mg bid | Drug: SK-PC-B70M<br>* dosage, frequency<br>|
| Active Comparator: 4<br>400mg qd | Drug: SK-PC-B70M<br>* dosage, frequency<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADAS-cog(Alzheimer's Disease Assessment Scale-Cognitive subscale) |  | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MMSE(Mini Mental State Examination) |  | 10 minutes | 
| CDR-SB(Clinical Dementia Rating Sum of Box) |  | 20 minutes | 
| QOL-AD(Quality of Life in Alzheimer's Disease) |  | 10 minutes | 
| Delayed Word-Recall Task |  | 5 minute | 
| Symbol Digit Modalities Test |  | 5 minutes | 
| Digit Backward |  | 5 minutes | 
| Maze Task |  | 3 minutes | 
| Digit Cancellation Task |  | 5 minutes | 
| Verbal Fluency-Categories |  | 1 minutes | 
| Concentration / Distractibility |  | 1 minutes | 
| GDS |  | 10 minutes |
Hypercapnic Acute Respiratory Failure in the ICU : the YETI Study

Study Overview
=================
Brief Summary
-----------------
Hypercapnia is a frequent clinical situation defined as an elevation of the partial pressure of carbon dioxide (PaCO2) above 45 mmHg. Several physiopathological parameters such as respiratory minute volume, dead space volume or CO2 production influence the PaCO2. Therefore, hypercapnia can affect the time of various diseases. Available epidemiological data regarding hypercapnia are from studies investigating the efficacy of non-invasive ventilation (NIV), with different population cohorts. However, their interpretation must be cautious given the heterogeneity in patient case-mix and results. Then, whether hypercapnia is a common reason for intensive care unit (ICU) admission, epidemiological data is scarce and heterogeneous. The aim of this study is to investigate the epidemiological, clinical determinants and outcomes of patients admitted to ICU with hypercapnic respiratory failure.

Official Title
-----------------
Hypercapnic Acute Respiratory Failure in the ICU : the YETI Study

Conditions
-----------------
Hypercapnia, Intensive Care Unit Syndrome, Acute Respiratory Failure

Intervention / Treatment
-----------------
* Other: Hypercapnic respiratory failure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients ≥18 years old presenting with at least of the following items : respiratory rate ≥ 25/min, paradoxical motion of the abdomen, intercostal retraction AND a PaCO2 > 45 cm H20 before ICU admission or within the 12 hours following ICU admission. Exclusion Criteria: Refusal to give informed consent, pregnancy, < 18 years patient, dying patient

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 |
| --- |
|Other: Hypercapnic respiratory failure|Patients with hypercapnic respiratory failure will be followed without any additional intervention|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of hypercapnic acute respiratory failure in ICU | Number of patients with hypercapnic acute respiratory failure in ICU related to number of patients admitted in the ICU during study period | Intensive Care Unit length stay (Usually 7 days) |
Clinical Trial to Assess the Efficacy and Safety of Tacrolimus Ointment Treatment of Atopic Dermatitis in Adult Patients

Study Overview
=================
Brief Summary
-----------------
Objective: Assess efficacy and safety of tacrolimus ointment when used in adults with moderate or severe atopic dermatitis. The ointment was applied on the affected skin twice daily for 3 weeks and then once daily until all lesions were cleared

Detailed Description
-----------------
The study was a one arm non-comparative study. The only study medication was Tacrolimus ointment 0.1% (Protopic ® 0.1%).

Official Title
-----------------
A 12-week, Exploratory, Non-comparative, Multi-centre Study to Evaluate the Efficacy and Safety of 0.1% Tacrolimus Ointment Administered in Adults With Moderate to Severe Atopic Dermatitis

Conditions
-----------------
Dermatitis, Atopic

Intervention / Treatment
-----------------
* Drug: tacrolimus ointment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, any ethnic group, age ≥16 Moderate to severe atopic dermatitis Has given informed consent Exclusion Criteria: Erythroderma Pregnant or breast-feeding Skin infection on the affected area

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: tacrolimus ointment<br>* tacrolimus, single arm, 0.1 ointment<br>* Other names: FK506 Ointment;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patients with at least 50% (i.e. at least moderate) improvement according to the Physician's global evaluation of clinical response between Baseline and the Week 12/End of Study Visit |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician's evaluation of clinical response |  | 12 weeks | 
| Patient's assessment of global response |  | 12 weeks | 
| Affected body surface area |  | 12 weeks | 
| Quality of Life at Baseline/Day 1 and Week 12/End of study |  | 12 weeks | 
| Changes of mEASI |  | 12 weeks | 
| Incidence of adverse events during the study, including all clinically significant laboratory values |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dermatitis, atopic, tacrolimus, adult
Two Consecutive Sunscreen Applications Optimize Sun Protection

Study Overview
=================
Brief Summary
-----------------
The investigators aim to investigate how much two consecutive applications of sunscreen before sun exposure can increase the quantities of sunscreen applied and decrease the skin area left without sunscreen compared to a single application. Volunteers wearing swimwear applied sunscreen in a laboratory environment twice and had pictures taken in black light before and after. As sunscreens absorb black light the darkness of the skin increased with increasing amounts of sunscreen applied. The investigators conducted a standard curve establishing a link between picture darkness and applied sunscreen quantity. Participants were asked to apply sunscreen the way they would normally do but two consecutive times. No other advice was given. The level of protection was determined by picture analysis as measurements of darkness of selected skin sites as well as the percentages of skin area left without sunscreen in different body regions and in total.

Official Title
-----------------
Two Consecutive Sunscreen Applications Optimize Sun Protection

Conditions
-----------------
Sun Protection

Intervention / Treatment
-----------------
* Other: Sunscreen, Actinica


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Caucasians between older than 18 Exclusion Criteria: Suffering from a skin disease, were allergic to the content in sunscreen, were pregnant or breastfeeding

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Two Consecutive Sunscreen Applications | Other: Sunscreen, Actinica<br>* Two Consecutive Sunscreen Applications<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sun protection | Sun protection will be determined as sunscreen quantities applied in mg/cm^2 and areas of covered skin in percentage. | The day of intervention. Sun protection will be assessed right after sunscreen application. |
An Open-Label Study to Evaluate Retreatment With LIPO-202

Study Overview
=================
Brief Summary
-----------------
Evaluate the safety of three 8-week courses of treatment with LIPO-202 in non-obese patients who have central abdominal bulging. Efficacy measurements will also be collected.

Official Title
-----------------
An Open-Label Study to Evaluate Retreatment With LIPO-202

Conditions
-----------------
Central Abdominal Bulging

Intervention / Treatment
-----------------
* Drug: LIPO-202


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provided consent Healthy male or non-pregnant female subjects BMI < 30 kg/m2 Stable diet and exercise routine Central abdominal bulging that is at least Slight Bulge, Not Flat Exclusion Criteria: Have had any treatment of the fat around your abdomen, including surgical procedures (tummy tuck, liposuction), injections for fat loss or treatments with devices to reduce fat in your abdomen Plan on starting a weight loss or exercise program during the study. Be a woman who is pregnant, breast feeding, have had a baby within 6 months and/or not using appropriate birth control. Known hypersensitivity to study drugs Prior or current enrollment in any Neothetics (formerly Lithera) study involving LIPO-102 or LIPO-202

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LIPO-202<br> | Drug: LIPO-202<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: vital signs, physical exams, laboratory tests |  | 12 months |
Prediction of Donor Liver Adipose Content by Magnetic Resonance Imaging

Study Overview
=================
Brief Summary
-----------------
A pilot prospective cohort study assessing the clinical utility of MRI evaluation of graft steatosis prior to transplantation will be conducted. An MRI of the donor liver within the transport cooler will be obtained on its way to the operating room.

Detailed Description
-----------------
The images from MRI will be analyzed to obtain information of fat content in all eight segments of the liver. Demographic, intra-operative, and post-operative patient data will be collected for each imaged graft.

Official Title
-----------------
Pilot Study for the Prediction of Donor Liver Adipose Content by Magnetic Resonance Imaging

Conditions
-----------------
Fatty Liver, Steatosis of Liver

Intervention / Treatment
-----------------
* Other: MRI of donor liver prior to transplant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are scheduled to orthoptic liver transplant Exclusion Criteria: Patient's who do not agree to sign consent

Ages Eligible for Study
-----------------
Minimum Age: 19 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: MRI of donor liver<br>MRI evaluation of graft steatosis in donor liver prior to transplantation | Other: MRI of donor liver prior to transplant<br>* MRI of the on ice donor liver within the transport cooler on its way to the operating room<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Hepatic Steatosis of a Donor Liver Prior to Transplantation | Amount of fat measured in the donor liver prior to transplant surgery using MRI scan | Measured immediately prior to liver transplant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of steatosis percentages provided by biopsy to MRI results |  | Baseline | 
| Length of hospitalization of transplant recipient |  | Days to hospital discharge, approximately 2 weeks | 
| Mortality of liver transplant recipient at 1 year post transplantation |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
transplantation, liver
Cognitive and Emotional Impairment After Stroke

Study Overview
=================
Brief Summary
-----------------
Cognitive and emotional symptoms are often seen in the acute phase of a stroke. The prevalence of such symptoms later and the mechanisms explaining the symptoms are not fully known. The causes of poststroke dementia are likely to be multifactorial (Cerebrovascular Diseases 2006). The investigators want to include all patients with first ever stroke without significant cognitive decline prior to the stroke (IQCODE cut-off 3,7) and follow them up for one year. At baseline we will make stroke classifications, measure neurological deficits according to NIHSS, evaluate cognitive and emotional function and make registrations of vascular risk factors, including precerebral color duplex scan with measurement of IMT in CCA. The investigators will then randomize the patients into multifactorial vascular-risk-factor-intervention in the hospital or care as usual in the primary health care. 8-12 months after stroke onset, survivors will undergo new examinations to evaluate neurological, cognitive and emotional functions, as well as MRI and SPECT.

Official Title
-----------------
Cognitive and Emotional Impairment After Stroke

Conditions
-----------------
Stroke, Cognitive Impairment, Vascular Dementia

Intervention / Treatment
-----------------
* Other: Multifactorial vascular-risk-factor-intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: First ever stroke or TIA No cognitive decline (IQCODE < 3,7) Survived the acute stroke Expected to live at least for one year after stroke Exclusion Criteria: Cognitive decline
Sexes Eligible for Study
-----------------
All

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2<br>Intensive risk factor intervention | Other: Multifactorial vascular-risk-factor-intervention<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of vascular risk-factor-intervention on changes in TMTA, ten-words-test and HAD |  | 8-12 months after stroke onset | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of dementia and depression after stroke |  | 8-12 month after stroke onset | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
emotional symptoms, vascular risk-factors
Study to Assess Darbepoetin Alfa in Subjects With Chronic Kidney Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether darbepoetin alfa manufactured by the current roller bottle technology and darbepoetin alfa manufactured by a serum free process have a comparable safety profile.

Official Title
-----------------
An Open-label, Single-Arm Study to Assess the Safety of Darbepoetin Alfa Manufactured by a Serum Free Bioreactor Technology in Subjects With Chronic Kidney Disease

Conditions
-----------------
Kidney Disease, Chronic Kidney Disease

Intervention / Treatment
-----------------
* Drug: darbepoetin alfa SF


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Currently diagnosed with Chronic Kidney Disease, either receiving or not receiving dialysis Anemic Currently on erythropoietic therapy Controlled hypertension Clinically stable

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: darbepoetin alfa SF<br> | Drug: darbepoetin alfa SF<br>* Frequency of dosing depends on frequency at randomization: rHuEPO QW = darbepoetin alfa SF Q2W (dosing conversion table in protocol) rHuEPO biw or tiw = darbepoetin alfa SF QW (dosing conversion table in protocol) darbepoetin alfa RB = darbepoetin alfa SF at same dose and frequency PFS 10, 15, 20, 30, 40, 50, 60, 80, 100, 150, 200 or 300 mcg; Hb maintained between 11.0 - 13.0 g/dL<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine whether darbepoetin alfa manufactured by a roler bottle technology (darbepoetin alfa RB) and darbepoetin alfa manufactured by a serum free process (darbepoetin alfa SF) have a comparable safety profile |  | Entire Study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterize laboratory parameters in subjects with CKD |  | Entire Study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Kidney Disease, Dialysis, Anemia, Nephrology
Telephone Triage Study

Study Overview
=================
Brief Summary
-----------------
The advance of communication technology has changed medical practice. The concept of medical telemedicine centers receiving, assessing and managing calls from patients or their carers on a 24 hour, 7 days a week basis is spreading in the US as well as in European countries. Usually specially trained nurses using dedicated decision support software provide the service. One aspect is the so-called triage, i.e. the decision on urgency and optimal treatment path of a stated medical problem, which has the potential to contain overall treatment costs. Despite proliferation of these services, little is known about the quality of the services provided. In October 2000 the first 24-hour medical telemedicine centre staffed by medical doctors started operating in Switzerland. The aims of this study are to assess the quality of service provided by doctors using decision support software and to determine potential predictors of incorrect triage.

Official Title
-----------------
Outcome Evaluation of Triage for Health Maintenance Organization (HMO) Patients Performed by Doctors in a Medical Telemedicine Center

Conditions
-----------------
Any Medical Condition Presented by Patient

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult Insured with HMO Basel Patient of HMO practise Sternengasse First call to Medgate for a given medical problem Call is a telephone triage Informed consent 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HMO Patients<br>Measurement of telephone triage outcome. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correctness of triage decision |  | 3 Months |