linjc16/ctgov huggingface dataset:
Pathogenesis of Atypical Femur Fractures on Long Term Bisphosphonate Therapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this protocol is to determine the risk of atypical femoral shaft (thigh bone) fractures after long term fracture prevention therapy with a class of drugs called bisphosphonates, colloquially referred to as Alendronate, risedronate, Ibandronate, and Zoledronate. In addition, the study is designed to find out which patient is most likely to develop this potential life changing complication and why. Finally, the results of this study will help clinicians to better understand the reason and thus tailor patient specific treatments…i.e., the right treatment for the right patient for right duration.

Official Title
-----------------
Pathogenesis of Atypical Femur Fractures on Long Term Bisphosphonate Therapy

Conditions
-----------------
Osteoporosis, Atypical Femoral Fractures, Prodromal Bone Deterioration

Intervention / Treatment
-----------------
* Other: 500 without BP treatment
* Other: 500 with BP treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women with a diagnosis of osteopenia or osteoporosis as defined by Bone Mineral density (BMD) patient treated with BPs for >5 years patients treated with non-BP anti-fracture medications such as... estrogens, raloxifene, calcitonin treatment naive patients Exclusion Criteria: all men regardless of BMD result patients with obvious traumatic AFF patients with normal BMD (better than -1.0 T-score at spine or proximal hip) unable to take tetracycline previous use of teriparatide known allergies to the following: tetracycline antibiotics meperidine midazolam

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- |
| 500 with BP treatment<br>patients will undergo lab tests, X-ray, bone scan or MRI, as needed (90 of these individuals can opt for iliac crest bone biopsy) | Other: 500 with BP treatment<br>* lab tests, X-ray, bone scan or MRI, as needed (90 of these individuals can opt for iliac crest bone biopsy)<br>|
| 500 without BP treatment<br>patients will undergo lab tests, X-ray, bone scan or MRI, as needed | Other: 500 without BP treatment<br>* lab tests, X-ray, bone scan or MRI, as needed<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prodromal bone deterioration (PBD) | Determine the prevalence of PBD and/or Atypical Femoral Fractures (AFF) in patients with post-menopausal or glucocorticoid related osteoporosis, either treated with bisphosphonate (BP) for more than 2 years or never treated with a BP | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosis of PBD | Refine diagnostic criteria for the diagnosis of PBD | 5 years |
A Treatment-Option Protocol to Provide Brentuximab Vedotin to Eligible Patients Completing Studies SGN35-005 or C25001

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to provide the option of brentuximab vedotin treatment to eligible patients in studies SGN35-005 and C25001

Detailed Description
-----------------
The protocol was amended to reflect the change from a phase 2/3 to a study with an expanded access program (EAP) in the US that would include patients with ALCL and HL. A later amendment allowed patients with CD30-positive cutaneous T-cell lymphoma to enroll. Enrollment may continue and patients may receive brentuximab vedotin treatment on study until the drug is commercially approved and available to patients in a geographic region.

Official Title
-----------------
An Open-label, Treatment-option Protocol of Brentuximab Vedotin in Patients With Relapsed or Refractory Hodgkin Lymphoma, Systemic Anaplastic Large Cell Lymphoma, or CD30-positive Cutaneous T-cell Lymphoma

Conditions
-----------------
Disease, Hodgkin, Lymphoma, Large-Cell, Anaplastic, Lymphoma, Non-Hodgkin, Lymphoma, T-Cell, Cutaneous

Intervention / Treatment
-----------------
* Drug: brentuximab vedotin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participated in either the SGN35-005 or C25001 clinical study and experienced progression. Patients who received brentuximab vedotin in C25001 must have had an objective response at the time of discontinuation. Completed any previous treatment with radiation, chemotherapy, biologics and/or investigational agents at least 4 weeks prior to the first dose of brentuximab vedotin Exclusion Criteria: History of another primary malignancy that has not been in remission for at least 3 years Known cerebral/meningeal disease Peripheral neuropathy of grade 2 or greater Females who are pregnant or breastfeeding

Ages Eligible for Study
-----------------
Minimum Age: 6 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: brentuximab vedotin|Every 21 days by intravenous infusion (1.8 mg/kg)|

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
-----------------
Disease, Hodgkin, Lymphoma, Monomethylauristatin E, Lymphoma, Large-Cell, Anaplastic, Lymphoma, T-Cell, Cutaneous, Lymphoma, Non-Hodgkin, Antibodies, Monoclonal, Antibody-Drug Conjugate, Antigens, CD30, Hematologic Diseases, Immunotherapy
Doppler Assesment of Blood Flow in the Spiral Arteries

Study Overview
=================
Brief Summary
-----------------
In this study we will try to show that performing Doppler of the Spiral arteries is doable. No outcome will be followed at this stage

Detailed Description
-----------------
This will only be a pilot study to show that we can acurately perform Doppler studies of the spiral arteries

Official Title
-----------------
Pilot Study Which is Aiming at the Feasibility of Performing Doppler Studies of the Spiral Arteries

Conditions
-----------------
Early Pregnancy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnancy 1st trimester Exclusion Criteria: Not willing to participate

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 52 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Doppler, Pregnancy
Screening for Preeclampsia With Various Markers in Low-risk Pregnancy Populations

Study Overview
=================
Brief Summary
-----------------
For the prediction of late-onset preeclampsia (PE) in low risk women, the investigators established a cut-off value for sFlt-1/PlGF ratio and evaluated the combination models of Elecys, second trimester uterine artery (UtA) doppler, and fetoplacental proteins for Down syndrome screening.

Detailed Description
-----------------
A prospective study was carried on in Cha hospital. Serum samples for Down syndrome screening were assayed to estimate pregnancy-associated plasma protein-A (PAPP-A), alpha-fetoprotein , unconjugated estriol, human chorionic gonadotrophin , and inhibin-A. Women screened for Down syndrome were offered UtA Doppler at 20-24 weeks of gestation and then collected serial serum samples for sFlt-1/PlGF ratio at two time points (24-27 and 34-37 weeks' gestation).

Official Title
-----------------
Screening Models for Early Detection of Late-onset Preeclampsia With Various Markers in Low-risk Pregnancy Populations

Conditions
-----------------
Preeclampsia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women considered as a potential participant in this research were patients regularly visited at the prenatal care of Cha hospital in Seoul, Korea Exclusion Criteria: early onset and cases not to measure the sFlt/PlGF ratio and other markers twin pregnancy Chronic hypertension prior history of preeclampsia pregestational diabetes mellitus gestational diabetes mellitus patients delivered before 35 weeks of gestation preeclamptic patients with onset before 35 weeks of gestation patients with body mass index 25kg/m2 or greater maternal age 40 years older

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 39 Years

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

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 |
| --- | --- | --- |
| identification of patients at risk for late-onset preeclampsia with sFlt-1/PlGF ratio |  | at delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| identification of patients at risk for late-onset preeclampsia with combined biochemical markers |  | at delivery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
preeclampsia
Prognostic Value of Plasma DPP4 Activity in ST-elevation Myocardial Infarction Patients

Study Overview
=================
Brief Summary
-----------------
Increased plasma DPP4 activity (DPP4a) could predict both subclinical and new-onset atherosclerosis, and our previous study has found that the DPP4a was significantly lower in MI patients compared with patients having chest pain or unstable angina alone, and DPP4a is associated with no-reflow and major bleeding events in STEMI patients during hospital stay. As no-reflow phenomenon and major bleeding events independently associates with a worse in-hospital and long-term prognosis. One may speculate that the DPP4a is associated with long-term follow-up adverse cardiovascular events in these patients.The hypothesis was tested in this study.

Official Title
-----------------
The Association Between Plasma DPP4 Activity And Prognosis of Patients With ST-Elevation Myocardial Infarction Undergoing Percutaneous Coronary Intervention

Conditions
-----------------
Coronary Angiography, Dipeptidyl Peptidase 4

Intervention / Treatment
-----------------
* Diagnostic Test: plasma DPP4 activity


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: consecutive patients of acute STEMI come to our department,absent of cardiogenic shock, and survival for at least 24 h after PCI treatment. Exclusion Criteria: patients with cancer, and patients who were taking a DPP4 inhibitoror a glucagon-like peptide-1 (GLP-1) analogue

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: plasma DPP4 activity|DPP4a was determined by enzymatic assays.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| major adverse cardiac or cerebrovascular events | including cardiovascular death, non-fatal myocardial infarction, heart failure and stroke | The median follow-up was 30 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| non-cardiovascular death |  | The median follow-up was 30 months | 
| repeated revascularization | defined as repeated PCI or bypass grafting of not only infarct related artery but also non-infarct related artery, driven by ischemic symptoms (stable/unstable angina or re-infarction) or detection of ischemia by non-invasive tests | The median follow-up was 30 months | 
| stroke | defined using the World Health Organization criteria | The median follow-up was 30 months |
Calcium Electroporation for Basal Cell Carcinomas - Proof of Concept Study

Study Overview
=================
Brief Summary
-----------------
25 patients with primary low-risk basal cell carcinoma treated with calcium electroporation

Detailed Description
-----------------
25 patients with primary low-risk basal cell carcinoma treated with calcium electroporation, if partial or no response after 3 months the treatment was repeated. Follow-up 3 and 12 months after last treatment.

Official Title
-----------------
Calcium Electroporation for Basal Cell Carcinomas - Proof of Concept Study

Conditions
-----------------
Basal Cell Carcinoma

Intervention / Treatment
-----------------
* Drug: Calcium chloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary low risk basal cell carcinoma less than 3 cm in diameter - Exclusion Criteria: Immunosuppression or organ transplant recipients Pregnancy or breastfeeding Allergy to local anesthetics

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

| Intervention/Treatment |
| --- |
|Drug: Calcium chloride|Calcium electroporation|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete response |  | 3 months |
Prospective Study of TW in Treatment of IgAN With Asymptomatic Abnormal Urinalysis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to: To evaluate the latest effects of TW for IgA nephropathy (IgAN) with asymptomatic abnormal urinalysis. To evaluate the safety and tolerability of TW.

Detailed Description
-----------------
Patients who fit the inclusion criteria will be randomly divided into three groups: TW group (TW at dosage of 90 mg/d), ARB group (the control group, valsartan at dosage of 160 mg/d) and combined treatment group (TW at dosage of 60 mg/d and valsartan at dosage of 80 mg/d).

Official Title
-----------------
Prospective Clinical Study of TW in Treatment of IgAN With Asymptomatic Abnormal Urinalysis.

Conditions
-----------------
IgA Nephropathy

Intervention / Treatment
-----------------
* Drug: tripterygium wilfordii (TW)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-60 years old but no requirement for gender All well fit the Diagnostic Criteria for Primary IgAN and IgAN with asymptomatic abnormal urinalysis Informed consent is obtained from each research subject who agrees to conduct a periodic follow-up according to the research arrangement Exclusion Criteria: Secondary IgA nephropathy, such as Henoch-Schönlein purpura nephritis, Lupus nephritis and so on Some secondary kidney diseases like diabetic nephropathy or other systemic diseases which may effect the pathologic and physiological function of kidney like hypertension and arteriosclerosis Severe infection Abnormality of liver function with glutamic pyruvic transaminase (GPT) or glutamic-oxal(o)acetic transaminase (GOT) more than twice upper limit of normal Women during pregnancy and lactation Patients need to procreation lately Patients treated with TW or ARB within 4 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: immunosuppressor<br> | Drug: tripterygium wilfordii (TW)<br>* 90 mg/d for 6 months<br>* Other names: tripterygium wilfordii;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage got to complete remission (CR) of TW group, the combined treatment group, and the control group after the 3, 6 months treatment. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of total effect of the 3 groups and adverse event within the follow-up periods. |  | 12 months |
Systematic Review of Antiretroviral Treatments for Chronic Hepatitis B (CHB)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to support the clinical value of entecavir by assessing the relationship between viral load and histological improvement.

Detailed Description
-----------------
Systematic review of prospective clinical trials

Official Title
-----------------
A Systematic Review of Literature on Common Antiretroviral Treatments Against Hepatitis B Virus (HBV)

Conditions
-----------------
Hepatitis B, Chronic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with CHB diagnosis and no co-infection with Hep A, Hep C, Hep D, or HIV Age 16 years or older No post-transplant patients RCT, non-randomized trials, prospective cohort studies, prospectively analyses case series published since 2003 At least one arm of trial must include monotherapy with entecavir, lamivudine, tenofovir, adefovir, or telbivudine Study arms must include at least 10 patients Follow-up of at least 48 weeks Published results available in English language Exclusion Criteria: N/A

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- |
| entecavir<br>Patients initiating special antiviral treatments for CHB | |
| tenofovir<br>Patients initiating special antiviral treatments for CHB | |
| lamivudine<br>Patients initiating special antiviral treatments for CHB | |
| telbivudine<br>Patients initiating special antiviral treatments for CHB | |
| adefovir<br>Patients initiating special antiviral treatments for CHB | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viral load |  |  | 
| Histological improvement |  |  |
Taste Assessment of Ozanimod

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the taste characteristics of ozanimod formulations, alone and mixed, in order to develop a pediatric oral form of ozanimod.

Official Title
-----------------
An Open-Label Taste Assessment of Ozanimod in Healthy Subjects

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: Ozanimod


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women, between 25 and 80 years of age. Participant is a qualified sensory panelist selected by Senopsys based on training and experience Exclusion Criteria: Participant has any history of any illness, medical condition, laboratory abnormality, or psychiatric illness that might confound the results of the study or places the panelist at unacceptable risk if he or she were to participate in the study. Participant is a female that is pregnant, nursing, or planning to become pregnant during the study. Other protocol-defined inclusion/exclusion criteria apply

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 80 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: Ozanimod<br>A maximum of 10 healthy adult participants (i.e., sensory panelists) will complete a maximum of 20 taste assessment days, with at least 4 panelists required to evaluate the taste characteristics of ozanimod on each taste assessment day. | Drug: Ozanimod<br>* Taste assessment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Taste evaluation - Aromatic identity | Measured using the Flavor Profile method of descriptive sensory analysis | Up to 6 months | 
| Taste evaluation - Amplitude | Measured using the Flavor Profile method of descriptive sensory analysis | Up to 6 months | 
| Taste evaluation - Off-notes | Measured using the Flavor Profile method of descriptive sensory analysis | Up to 6 months | 
| Taste evaluation - Aftertaste | Measured using the Flavor Profile method of descriptive sensory analysis | Up to 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ozanimod