linjc16/ctgov huggingface dataset:
Benefit of Elevation of HDL-C on Cardiovascular Outcomes in Women

Study Overview
=================
Brief Summary
-----------------
Several risk factors including high cholesterol contribute to heart disease. We know that lowering triglycerides and raising HDL (protective cholesterol) in men reduces the risk for heart disease. We expect that women will share this same benefit because the combination of high triglycerides and low HDL appears to be a more important risk for heart disease in women. Niacin reduces triglycerides and raises HDL. We also expect to see improvement in markers of inflammation and clot formation and blood vessel health, which we hypothesize should all confer a reduced risk of heart disease in women. Women already taking lipid lowering statin will receive niacin therapy. We will measure blood lipid levels, markers of inflammation and clotting as well as a non-invasive measure of blood vessel reactivity. After 3 months of therapy we will repeat these measures.

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Drug: Niaspan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stable women on statin therapy with LDL-C between 90-135mg/dl and triglycerides > 150mg/dl Exclusion Criteria: History of MI, PTCA or surgery within previous 3 months Currently on Niaspan and unwilling to withdraw Niaspan therapy or known intolerance to niacin Active or known gall bladder disease Pregnant or nursing women Significant comorbidity that precludes participation Significant liver disease, active alcoholism, or LFT >1.5x's ULN at screening Diabetes or glucose > 126 mg/dl at screening PI perceived inability to comply with protocol

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

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

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

| Intervention/Treatment |
| --- |
|Drug: Niaspan|1500 mg Niaspan for 16 weeks|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Women with and without CAD
Study of AT-527 in Combination With Daclatasvir in Subjects With Hepatitis C Virus (HCV) Infection

Study Overview
=================
Brief Summary
-----------------
The study will assess the safety and efficacy of AT-527 in combination with daclatasvir after 8 or 12 weeks of treatment.

Official Title
-----------------
A Phase 2 Study Assessing the Safety and Efficacy of AT-527 in Combination With Daclatasvir in Subjects With Chronic HCV Infection

Conditions
-----------------
Hepatitis C, Hepatitis C, Chronic, Chronic Hepatitis C, Hepatitis C Virus Infection, HCV Infection

Intervention / Treatment
-----------------
* Drug: AT-527
* Drug: Daclatasvir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body mass index (BMI) of 18-35 kg/m2 Must agree to use protocol-specified methods of contraception Negative pregnancy test HCV genotype 1 Documented history compatible with chronic hepatitis C HCV RNA ≥ 10,000 IU/mL at Screening. Willing to comply with the study requirements and to provide written informed consent Exclusion Criteria: Pregnant or breastfeeding Infected with hepatitis B virus or HIV Abuse of alcohol or drugs Prior exposure to any HCV NS5A inhibitor Cirrhosis Use of other investigational drugs within 30 days of dosing Other clinically significant medical conditions or contraindications to daclatasvir

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects will receive 8 or 12 weeks of treatment, based on treatment response.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 8 weeks<br> | Drug: AT-527<br>* Nucleotide prodrug inhibitor of HCV nonstructural protein 5B (NS5B) polymerase<br>Drug: Daclatasvir<br>* Inhibitor of HCV nonstructural protein 5A (NS5A)<br>|
| Experimental: 12 weeks<br> | Drug: AT-527<br>* Nucleotide prodrug inhibitor of HCV nonstructural protein 5B (NS5B) polymerase<br>Drug: Daclatasvir<br>* Inhibitor of HCV nonstructural protein 5A (NS5A)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects achieving sustained virologic response (SVR) | SVR defined as the HCV RNA < lower limit of quantitation (LLOQ) at 12 weeks after end of treatment | 12 weeks after end of treatment | 
| Incidence of treatment-emergent adverse events |  | Through 4 weeks after end of treatment |
Therapeutic Drug Monitoring of Teicoplanin in Children

Study Overview
=================
Brief Summary
-----------------
In this study, the therapeutic drug monitoring of teicoplanin is carried out among children to obtain the drug concentration, clinical efficacy and safety data of children patients in different gender and age groups. Then we analyze the relationship between blood drug concentration and efficacy and safety, and provide recommendations for the treatment window of teicoplanin in Chinese children.

Official Title
-----------------
Therapeutic Drug Monitoring of Teicoplanin in Children

Conditions
-----------------
Bacterial Infections

Intervention / Treatment
-----------------
* Drug: Teicoplanin-PMMA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Teicoplanin was administered intravenously; Teicoplanin was used for therapeutic purposes; Age:≤18 years; Clinician confirms and plans to diagnose the patient with gram-positive coccus infection; Patients with therapeutic concentration monitoring of teicoplanin. Exclusion Criteria: Teicoplanin was administered non-intravenously; Teicoplanin was used for prophylactic purposes; Patients without therapeutic concentration monitoring of teicoplanin; Patients who die within 24 hours of the use of teicoplanin； The blood concentrations of the patient was not approved by the quality control center.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Teicoplanin-PMMA|Therapeutic drug monitoring of teicoplanin|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma drug concentration | To detect the plasma concentrations of teicoplanin at therapeutic drug monitoring (TDM). | Through study completion, an average of 14 days |
Radiotherapy vs Observation for CRPC

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine whether radiotherapy improves cancer control and overall survival among patients with Castration resistant prostate cancer.

Official Title
-----------------
Salvage Radiotherapy vs Observation for Castration Resistant Prostate Cancer in Central China

Conditions
-----------------
Hormone Refractory Prostate Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligible patients had histologically or cytologically confirmed adenocarcinoma of the prostate with clinical or radiologic evidence of disease progression during hormonal therapy Patients were receiving primary androgen-ablation therapy as maintenance therapy. At least four weeks had to have elapsed between the withdrawal of antiandrogens (six weeks in the case of bicalutamide) and enroll ment, so as to avoid the possibility of confounding as a result of the response to antiandrogen withdrawal. Another requirement was disease progression, as indicated by increasing serum levels of PSA on three consecutive measurements obtained at least one week apart or findings on physical examination or imaging studies. Normal cardiac function was required. Exclusion Criteria: patients had a Karnofsky performance-status score of at most 60 percent prior treatment with cytotoxic agents or radioisotopes with history of another cancer within the preceding five years, brain or leptomeningeal metastases, symptomatic peripheral neuropathy of grade 2 or higher, and other serious medical condition.
Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Salvage radiotherapy<br>local radiation to the prostate and metastasis following biochemical or clinical recurrence | |
| observation<br>did not receive salvage following biochemical or clinical recurrence | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | From the date of biochemical or clinical recurrence of prostate cancer following hormonal therapy to December 31, 2016 or date of death from any cause, whichever came first, assessed up to 3 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prostate cancer specific mortality |  | From the date of biochemical or clinical recurrence of prostate cancer following hormonal therapy to December 31, 2016 or death from prostate cancer or treatment complications, whichever came first, assessed up to 3 years. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adenocarcinoma, Prostatic Neoplasms, Carcinoma, Prostatic Diseases
Xamiol®Gel in BODY Psoriasis: A One-year Non-interventional Study

Study Overview
=================
Brief Summary
-----------------
This study aims to describe the patient population treated and the real-life patients' experiences with Xamiol®gel in the long term, up to 52 weeks management of body psoriasis vulgaris in Russia. The result will increase the knowledge on Xamiol®gel enabling dermatologists and patients to optimize its use in the long term management of psoriasis.

Official Title
-----------------
Xamiol® Gel in BODY Psoriasis : lonG-term Management of Psoriasis vUlgARis With Xamiol® Gel in Daily Clinical Practice of Russian Dermatologists. A Long-term Observational, Prospective Study

Conditions
-----------------
Psoriasis Vulgaris

Intervention / Treatment
-----------------
* Drug: Calcipotriol/betamethasone dipropionate gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Psoriasis vulgaris on body Patients planned to receive topical treatment on the body with calcipotriol/betamethasone gel Written informed consent Exclusion Criteria: No or very mild symptoms of psoriasis vulgaris on the body at study start Any on-going treatments at study start with topical steroids, salicylic acid or its combination Other topical treatment for body psoriasis Pregnancy or planned pregnancy within treatment period Contraindications according to prescribing information.

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 |
| --- |
|Drug: Calcipotriol/betamethasone dipropionate gel|Topical treatment of psoriasis plaques located on the body|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient reported treatment satisfaction | Patient preference compared with previous therapy | Around 8 weeks after treatment initiation | 
| Adherence to treatment | Number of days during the last 7 days with no treatment | Around 8 weeks after treatment initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician Global Assessment of Psoriasis |  | Around 8 weeks after treatment initiation | 
| Frequency of treatment after completion of initial treatment |  | 12 months | 
| To evaluate the effect of treatment with Xamiol®gel on patients quality of life | Dermatology Life Quality Index (DLQI) | Around 8 weeks | 
| Overall rate of treatment success | Clear or almost clear by Physician Psoriasis Global Assessment | Around 8 weeks | 
| Patient's willingness to pay | Total consumption during study period in Russia where Xamiol®gel is not reimbursed | 12 months |
Prospective Tacrolimus Pharmacokinetics Study in Pediatric Living Donor Liver Transplantation

Study Overview
=================
Brief Summary
-----------------
Our first aim is thus to investigate, retrospectively first and then prospectively, in de novo pediatric (living donor) liver recipients, the tacrolimus in vivo and in vitro metabolism and its variability with focus on pharmacokinetics, pharmacodynamics, and pharmacogenomics and its evolution according to the age and transplant delay. Our second aim is then to find better tacrolimus exposure markers for therapeutic drug monitoring (TDM) such as Area Under the time-concentration Curve (AUC) or intralymphocytic (PBMCs) tacrolimus concentration and a way to model and predict it without invasive tests in pediatric patients. The final objective should be then to implement these findings in a more individualized and comprehensive immunosuppression protocol and monitoring in order to maintain adequate and well-balanced immunosuppression (preventing graft rejection while avoiding acute and long-term side effects). This is particularly important for a pediatric population exposed throughout their life to immunosuppressants.

Official Title
-----------------
Tacrolimus Disposition in Pediatric Transplantation: Influence of Age, Genetic Polymorphisms, Intestinal and Hepatic Relative Contribution on Pharmacokinetics, in Relationship With Clinical Outcomes

Conditions
-----------------
Pediatric Liver Transplantation

Intervention / Treatment
-----------------
* Drug: Tacrolimus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children aged 0 to 18 years First Liver transplantation Children eligible to receive tacrolimus post transplantation Consent from parents Exclusion Criteria: Multiorgan transplantation Retransplantation ABO incompatible donors (unless if recipients is<1 year and anti-AB antibodies are <1/32) Multi organ failure Need for additionnal therapy except for methylprednisolone to treat rejection Intravenous tacrolimus First tacrolimus administration postponed after day 3

Ages Eligible for Study
-----------------
Maximum Age: 18 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: Tacrolimus<br> | Drug: Tacrolimus<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Time Concentration curve |  | day 2-day 4; day 10-day 1; > day 21 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intralymphocytic tacrolimus concentration |  | Day 3 |
Serum DCAMKL1 Pre and Post Treatment in Patients With Pancreatic Cancer

Study Overview
=================
Brief Summary
-----------------
The investigators believe DCAMKL-1 is a stem cell tumor marker and is elevated in patients with pancreatic cancer. The investigators would like to analyze its expression pre and post treatment, to gauge the correlation between current pancreatic cancer therapies and the expression of DCAMKL-1

Detailed Description
-----------------
Pancreatic adenocarcinoma has the worst prognosis of any major malignancy with a 3% 5 year survival. Major obstacles in treating pancreatic cancer include extensive local invasion and early metastasis. The incidence of pancreatic adenocarcinoma (PAC) has been increasing steadily. Epithelial-mesenchymal transition (EMT) plays a key role in cancer invasion and metastasis. Recently, a direct link between EMT and the gain of epithelial stem cell properties has been described. We have recently determined that DCAMKL-1, a microtubule-associated kinase expressed in post mitotic neurons, is a putative intestinal stem cell marker. We have also demonstrated that DCAMKL-1, a protein expressed in both normal stem cells and in cancer, likely promotes tumorigenesis through the regulation of pri-let-7a microRNA and c-Myc. We have recently demonstrated evidence that DCAMKL-1 is a marker for pancreatic cancer stem cells in surgical specimens. This study will investigate expression of DCAMKL-1 in pancreatic tissue obtained through EUS-FNA. Furthermore expression of DCAMKL-1 will also be investigated in serum obtained simultaneously.

Official Title
-----------------
Expression Patterns of Stem Cell Marker Doublecortin and CaM Kinase-Like-1 (DCAMKL-1) in Human Pancreatic Adenocarcinoma

Conditions
-----------------
Pancreatic Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pancreatic cancer Exclusion Criteria: age < 18, history of other types of cancer

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 |
| --- | --- |
| Surgery group<br>Patients with pancreatic cancer who undergo surgical treatment only | |
| Chemotherapy group<br>Patients with pancreatic cancer who undergo chemotherapy treatment only | |
| Neoadjuvant group<br>Patients with pancreatic cancer who undergo neoadjuvant chemotherapy and surgery | |
| Adjuvant group<br>Patients with pancreatic cancer who undergo surgery followed by chemotherapy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Comparison of the Bioavailability of Fenofibric Acid and Rosuvastatin From ABT-143 Relative to That From the Coadministration of ABT-335 (Fenofibric Acid) and Rosuvastatin Calcium

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and compare the pharmacokinetic parameters from the fixed dose combination ABT-143 relative to that from the co-administration of the two monotherapies.

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

Intervention / Treatment
-----------------
* Drug: ABT-143
* Drug: ABT-335
* Drug: rosuvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A condition of general good health BMI 19 to 29 Exclusion Criteria: Currently enrolled in another clinical study Females who are pregnant or breast-feeding

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>ABT-143 capsules 20/135 mg | Drug: ABT-143<br>* once, see arm description for more information<br>|
| Active Comparator: 2<br>ABT-335 135 mg and rosuvastatin 20 mg | Drug: ABT-335<br>* once, see arm description for more information<br>Drug: rosuvastatin<br>* once, see arm description for more detail<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the safety and tolerability of ABT-143 vs (ABT-335 + rosuvastatin) in healthy adults |  | 7 days | 
| To determine the pharmacokinetic profile(s) for ABt-143 vs. (ABT-335 + rosuvastatin) in healthy adults |  | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adverse Events
Innate Immune Responses in Chronic Obstructive Pulmonary Disease (COPD) Patients

Study Overview
=================
Brief Summary
-----------------
We hypothesize that ongoing and more severe airway inflammation in COPD may result from the impairment in activation of innate immune response

Official Title
-----------------
Innate Immune Responses in Chronic Obstructive Pulmonary Disease Patients

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

Intervention / Treatment
-----------------
* Drug: Budesonide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical diagnosis of COPD or asthma a ratio of prebronchodilator FEV1 to forced vital capacity (FVC) equal to or less than 0.70 postbronchodilator FEV1 > or = 50% predicted Exclusion Criteria: Exacerbation systemic corticosteroids DM, HIV and autoimmune disease immunosuppressive therapy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: stable COPD<br>Postbronchodilator FEV1> or = 50% predicted | Drug: Budesonide<br>* Inhaled budesonide 400 mcg twice a day for 2 weeks<br>* Other names: Rhinocort;|
| Sham Comparator: Asthma<br>Postbronchodilator FEV1 > or = 50% predicted | Drug: Budesonide<br>* Inhaled budesonide 400 mcg twice a day for 2 weeks<br>* Other names: Rhinocort;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sputum IL-8, IL-17 |  | 2 WEEKS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The expression of NF-kappa B in sputum macrophages |  | 2 WEEKS |