linjc16/ctgov huggingface dataset:
Mechanisms of Low Levels of Apolipoprotein B

Study Overview
=================
Brief Summary
-----------------
To determine mechanisms of low levels of apolipoprotein B.

Detailed Description
-----------------
BACKGROUND: Elevated apoB levels are associated with an increased risk of coronary heart disease. Hypobetalipoproteinemia (HBLP) is characterized by apoB levels less than the 5 percentile. Dr. Welty, the principal investigator, sequenced mutations for truncated forms of apoB-67, apoB-55 and apoB-44.4 which causes HBLP, described a kindred from the Framingham Heart Study with HBLP due to an unidentified apoB gene mutation and purified apoB-67 containing lipoprotein particles. Heterozygous apoB-67 subjects have one normal allele making apoB-100; therefore, apoB levels would be predicted to be at least 50 percent of normal; however, they are 24 percent of normal. Dr. Welty has shown that these lower than expected levels result from decreased production of VLDL apoB-100, LDL apoB-100 and apoB-67, increased catabolism of VLDL apoB-100, and increased direct removal of apoB-67 from VLDL. DESIGN NARRATIVE: The first aim is to locate the apoB gene mutation in the Framingham kindred. The second aim is to perform stable isotope studies in the apoB-55 and apoB-44.4 kindreds to determine if apoB metabolism for these shorter truncations is similar to that for apoB-67. In aim three, apoB-100 synthesis is studied in heterozygous apoB-70 transgenic mice. If it is 25-25 percent of normal litter mates, the mechanism for this reduction in apoB-100 levels will be studied in hepatocytes isolated from the transgenic mice. In specific aim 4, size and composition of VLDL are compared in apoB-67 subjects and controls to determine if larger size or compositional changes account for the faster catabolism of VLDL apoB-100. The study has been extended through June 2007.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Hypobetalipoproteinemia

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

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

Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- | --- |
Chronic Pain After Thoracotomy (Video Assisted Thoracic Surgery - VATS)

Study Overview
=================
Brief Summary
-----------------
This is an explorative study investigating potential nerve injury after VATS.

Official Title
-----------------
Chronic Pain After Thoracotomy (VATS)

Conditions
-----------------
Neuropathic Pain, Thoracic Surgery, Video Assisted, Chronic Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to understand and give consent Can read Residing in Denmark Exclusion Criteria: Unable to understand the written information in Danish Abuse (Medicine, Drugs, Alcohol) Severe psychiatric Illness Conflicting neurological disease

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| PTPS<br>Patients with pain after VATS | |
| Pain free<br>Patients reporting no pain late after VAT | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thresholds via QST |  | Late postoperatively (3months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
persistent pain, neuropathic pain, Thoracic Surgery, Video Assisted, Chronic Pain
Sebacia Postmarket Study of Real-World Use

Study Overview
=================
Brief Summary
-----------------
Postmarket study of Sebacia Microparticles treatment during adoption into clinical use for patients with mild to moderate inflammatory acne vulgaris.

Official Title
-----------------
A Prospective, Multicenter, Postmarket Study of Sebacia Microparticles Treatment in Patients Using Topical Acne Products for Mild to Moderate Inflammatory Acne Vulgaris

Conditions
-----------------
Acne Vulgaris

Intervention / Treatment
-----------------
* Other: Sebacia Microparticles Treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mild to moderate facial inflammatory acne vulgaris (IGA 2 or 3) Between 10 and 50 papules/pustules Fitzpatrick skin phototype I, II or III Able to provide informed consent and comply with study schedule and other requirements Exclusion Criteria: Moderately severe or severe acne vulgaris (IGA 4 or 5) Nodulocystic acne, significant scarring or excoriation Requires oral retinoid, antibiotic or corticosteroid for acne New or fluctuating hormone or hormone-regulating therapy Photosensitivity or allergy to gold Medical or mental health condition that would pose a risk to patient or impair treatment and evaluation

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Sebacia Microparticles Treatment<br> | Other: Sebacia Microparticles Treatment<br>* Sebacia Microparticles procedure involving microparticles and 1064 nm laser. Three treatment procedures over a two-week period.<br>* Other names: Sebacia treatment, Microparticles and Nd:Yag laser treatment;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory Lesion Count | Percent change in number of inflammatory lesions from baseline | Months 2, 3, 6, 9 and 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator's Global Assessment | Percent of subjects clear (IGA 0) or almost clear (IGA 1) | Months 2, 3, 6, 9 and 12 | 
| Physician's Overall Assessment of Improvement | Categorical improvement from baseline (worse, no change, minimal, moderate, marked, complete) | Months 2, 3, 6, 9 and 12 |
Establishment of Risk Indicators and Early Warning System in Infection Patients

Study Overview
=================
Brief Summary
-----------------
Serious infections refer to life-threatening infections with a morbidity and mortality rate of up to 50%, and are the main cause of death in critically ill patients, mainly including systemic inflammatory response syndrome, sepsis, infectious shock, or systemic multiple organ dysfunction syndrome. Patients with severe infections have rapid disease development, which can cause disorders of cellular circulation and metabolism and impairment of multi-organ function in the early stage, mostly accompanied by clinical complications, and despite the progress of medical technology and the popularization of antibiotic application, the mortality and disability rate is high, which is a hot spot of clinical research today. Patients with severe infections are exposed to a wide range of medical risk factors, including patient factors (advanced age, frailty, malnutrition, long hospital stay, prolonged bed rest), disease factors (immune deficiency, malignancy, diabetes, renal failure, liver failure), drug factors (long-term use of steroid hormones, chemotherapeutic drugs, NSAIDs, etc.), interventional factors (central venous catheter, recent invasive surgery, hemodialysis, endotracheal intubation or mechanical ventilation, etc.), which bring great challenges to clinical treatment. Therefore, early identification of risk indicators for deterioration of infected patients provides a strategic basis for the medical team to take early warning measures to prevent deterioration and poor prognosis, and to reduce the risk of deterioration of patients, which is also the key to reduce the risk of death of infected patients.

Official Title
-----------------
Establishment of Risk Indicators and Early Warning System for Deterioration of Infected Patients in Real-world Data.

Conditions
-----------------
Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with infection Exclusion Criteria: Case information is incomplete Do not accept follow-up
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 |
| --- | --- | --- |
| Among patients with infections admitted to the hospital | primary outcome measure were defined as the death. | 30 days of hospitalization |
Physiologic Elasticity Changes During Pregnancy and After Labor.

Study Overview
=================
Brief Summary
-----------------
Female pregnant patients in their 2nd trimester will be evaluated for vaginal elasticity using vaginal tactile imaging in addition to elasticity evaluation during the 3rd trimester and 6 weeks postpartum.

Detailed Description
-----------------
Female pregnant patients in their 2nd trimester will be evaluated for vaginal elasticity using vaginal tactile imaging. Vaginal elasticity will also be evaluated during the 3rd trimester and 6 weeks postpartum. Patients will be recruited and sign a consent form. Assessment of vaginal elasticity via vaginal tactile imaging will be performed at 3 different points: During the 2nd trimester. During the 3rd trimester. 6 weeks postpartum. Every patient will serve as her own control. Demographic, gynecologic and obstetric history will be obtained from patients' electronic files.

Official Title
-----------------
Vaginal Tactile Imaging for the Assessment of Physiologic Elasticity Changes During Pregnancy and After Labor.

Conditions
-----------------
Vaginal Prolapse

Intervention / Treatment
-----------------
* Diagnostic Test: Vaginal tactile imager


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant patients in their 2nd trimester. Exclusion Criteria: Pregnant patients presenting after their 2nd trimester.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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 |
| --- | --- |
| Pregnant patients<br>Pregnant patients in their 2nd trimester. | Diagnostic Test: Vaginal tactile imager<br>* Vaginal elasticity evaluation by vaginal tactile imaging analysis.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal elasticity | Vaginal elasticity evaluation by vaginal tactile imaging analysis | From the beginning of the 2nd trimester of pregnancy up to 6 weeks postpartum. |
RD13-01 for Patients With r/r CD7+ T/NK Cell Hematologic Malignancies

Study Overview
=================
Brief Summary
-----------------
This study is designed to explore the safety of RD13-01 for patients with CD7+ relapsed and/or refractory T/NK-cell hematologic malignancies. And to evaluate the efficacy and pharmacokinetics of RD13-01 in patients.

Official Title
-----------------
RD13-01 for Patients With r/r CD7+ T/NK Cell Hematologic Malignancies

Conditions
-----------------
Hematologic Malignancies

Intervention / Treatment
-----------------
* Drug: RD13-01 cell infusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 3 to 70 years. Diagnosis of r/r T-ALL/NK-ALL, T-LBL, or T-NHL (including PTCL-NOS, AITL, ALCL, Extranodal NK/T cell lymphoma). ECOG: 0-2. Life expectancy greater than 12 weeks. Cardiac left ventricle ejection fraction ≥50%. Informed consent explained to, understood by and signed by the patient/guardian. Patient/guardian is given a copy of informed consent. Exclusion Criteria: Pregnant or lactating. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer detection is not within the normal range; hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C Viral (HCV) RNA positive; human immunodeficiency virus (HIV) antibody positive; cytomegalovirus (CMV) DNA positive; syphilis positive. Patients with graft-versus-host disease (GVHD) or who need to use immunosuppressive drugs. Participated in other clinical studies within 2 weeks prior to screening. History of alcoholism, drug abuse or mental illness. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.

Ages Eligible for Study
-----------------
Minimum Age: 3 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RD13-01 cell infusion<br> | Drug: RD13-01 cell infusion<br>* Universal CAR-T cells targeting CD7<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose-limiting toxicity (DLT) |  | 4 weeks after infusion |
Acute Combined Care for Seniors in Southern Denmark

Study Overview
=================
Brief Summary
-----------------
the elderly population (+ 65 years) is increasing. Acute medical conditions often leads to hospital admissions in this age group. However hospital admission is linked to adverse events. like confusion, medication errors or new infections. the ACCESS project aims to examine alternatives to acute admissions for senior medical patients. the aims are: How many patients will be admitted to hospital due to acute medical conditions if cared for by their own General Practitioner (GP) versus a hospital intern specialist ? how many patients will be admitted to hospital due to acute medical conditions if cared for by acute team in their home versus in specialised care centres ?

Official Title
-----------------
Acute Combined Care for Seniors in Southern Denmark

Conditions
-----------------
Acute Medical Conditions

Intervention / Treatment
-----------------
* Other: hospital specialist
* Other: General Practitioner


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acute medical condition requiring immediate intervention. Exclusion Criteria: GP not available next days absolutely admission requiring condition no informed consent obtainable nursing home resident inclusion in ACCESS within the last 3 months home care capacity limit reached

Ages Eligible for Study
-----------------
Minimum Age: 60 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 |
| --- | --- |
| Other: own GP<br>The patient is cared for by own General Practitioner in the acute stage | Other: General Practitioner<br> <br> |
| Other: Hospital specialist<br>The patient is cared for by a hospital specialist in the acute stage | Other: hospital specialist<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of participants with hospital admission |  | 3 months after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline in De Morton Mobility Index (DEMMI) |  | 3 months after inclusion | 
| change from baseline in quality of life (EQ5D scale) |  | 3 months after inclusion | 
| change from baseline in Orientation Memory-Concentration (OMC) |  | 3 months after inclusion | 
| patient and relatives satisfaction questionnaire |  | 3 months after inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patient admission
A Study of MK0359 in Patients With Chronic Obstructive Pulmonary Disease (COPD)(0359-016)

Study Overview
=================
Brief Summary
-----------------
A study to test the effect of MK0359 in lessening the symptoms of COPD as compared to salmeterol and placebo.

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
-----------------
* Drug: MK0359


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: You are between the ages of 40 and 75 You have had a history for at least a year of COPD symptoms You have a history of smoking one pack of cigarettes per day for 10 years Exclusion Criteria: You have been in a research study with an investigational drug or vaccine in the last 4 weeks. You have donated blood in the last 4 weeks. You have been hospitalized or had major surgery in the last 4 weeks You have been treated in the emergency room within the last 2 months or hospitalized within the last 3 months for your COPD symptoms You have a history of heart problems in the last 6 months You have a history of stomach problems You are unwilling to avoid grapefruit juice throughout the study

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0359|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Sunitinib as Second-line Treatment in Advanced Biliary Tract Carcinoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether sunitinib as second-line treatment in advanced biliary tract carcinoma

Detailed Description
-----------------
Phase II study of sunitinib as second-line treatment in advanced biliary tract carcinoma: multicenter, multinational study

Official Title
-----------------
Phase II Study of Sunitinib as Second-line Treatment in Advanced Biliary Tract Carcinoma: Multicenter, Multinational Study

Conditions
-----------------
Advanced Biliary Tract Adenocarcinoma

Intervention / Treatment
-----------------
* Drug: Sunitinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age ≥ 18 histologically or cytologically confirmed adenocarcinoma of biliary tract unresectable or metastatic ECOG performance status of 0 2 measurable or evaluable lesion per RECIST criteria adequate marrow, hepatic, renal and cardiac functions One prior treatment of cytotoxic chemotherapy (including adjuvant treatment within 12 months) provision of a signed written informed consent Exclusion Criteria: severe co-morbid illness and/or active infections pregnant or lactating women active CNS metastases not controllable with radiotherapy or corticosteroids known history of hypersensitivity to study drugs

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Sunitinib<br>Sunitinib, 37.5 mg orally once daily continuously, comprising a 4-week cycle | Drug: Sunitinib<br>* Sunitinib 37.5 mg orally once daily continuously, comprising a 4-week cycle<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression |  | 12months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety profile |  | 12 months | 
| Response rate |  | 12 months | 
| Duration of response |  | 12 months | 
| Overall survival |  | 12 months | 
| Correlative analyses: EGFR mutational analysis, EGFR immunohistochemical staining, RAS mutational analysis, KIT, PDGFRA, PDGFRB, Beta-Catenin (CTNNB1) mutations |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
advanced biliary tract carcinoma, Sunitinib
Efficacy Study of Bromfenac Ophthalmic Solution in Patients Undergoing Cataract Surgery

Study Overview
=================
Brief Summary
-----------------
Efficacy study of Bromfenac Ophthalmic Solution in cataract surgery

Conditions
-----------------
Pain, Inflammation

Intervention / Treatment
-----------------
* Drug: Bromfenac Ophthalmic Solution
* Drug: Placebo Comparator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female at least 18 years of age who are scheduled for unilateral cataract surgery Exclusion Criteria: Have known hypersensitivity to bromfenac or to any component of the investigational product

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bromfenac ophthalmic solution 0.09%<br>dosed 1 drop daily in study eye for 2 weeks | Drug: Bromfenac Ophthalmic Solution<br>* sterile ophthalmic solution<br>|
| Placebo Comparator: Placebo<br>dosed 1 drop daily in study eye for 2 weeks | Drug: Placebo Comparator<br>* sterile ophthalmic solution<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Summed Ocular Inflammation Score (SOIS) of Zero | Participants with SOIS of 0. Measured on a scale of 0-4: 0=0 cells (complete absence); 0.5=1-5 cells ; 1=6-15 cells (very slight); 2=16-25 cells (moderate); 3=26-50 cells (marked); 4=>50 cells (intense) | Day 15 (Primary Endpoint) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Free | Participants that are pain free at day 1, taken from patient questionnaire with multiple possible responses measured on a scale of 0-3, where 0=none and 3=severe. | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pain and Inflammation as a function of cataract surgery